Trial Outcomes & Findings for Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma (NCT NCT05626322)

NCT ID: NCT05626322

Last Updated: 2025-09-05

Results Overview

DLTs included: Hematological: Grade (G) 4 thrombocytopenia (\<25,000/microliter \[mcL\]) lasting \>=72 hours or a platelet count \<=10,000/mcL at any time, unexplained by underlying disease; \>=G3 thrombocytopenia associated with \>=G2 bleeding, unexplained by underlying disease. G4 anemia; unexplained by underlying disease; G4 neutropenia lasting \>=7 days, unexplained by underlying disease; G3 febrile (\>38.3-degree Celsius \[C\]) neutropenia lasting \>=7 days, unexplained by underlying disease; G4 febrile neutropenia unexplained by underlying disease. Non-hematological: any treatment-related \>=G3 non-hematologic toxicity; Other \>=G2 PF-07901801-related non-hematologic toxicities that, in the opinion of the investigator, required a dose reduction or discontinuation of PF-07901801 were considered a DLT.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Cycle 1 (28 Days)

Results posted on

2025-09-05

Participant Flow

A total of 9 participants were screened of which 3 participants failed screening, and 6 participants were enrolled and received study treatment.

The study was planned to be conducted in 2 parts: phase 1b dose escalation and phase 2 dose expansion. Phase 2 of the study was not initiated per business decision made by Sponsor; hence, data for Phase 2 is not reported in any part of the record.

Participant milestones

Participant milestones
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly (QW) during Cycle 1 to 3 followed by twice weekly (Q2W) dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 milligrams (mg) by mouth (PO) on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Overall Study
STARTED
3
2
1
Overall Study
COMPLETED
0
0
0
Overall Study
NOT COMPLETED
3
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly (QW) during Cycle 1 to 3 followed by twice weekly (Q2W) dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 milligrams (mg) by mouth (PO) on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Overall Study
Death
2
0
0
Overall Study
Physician Decision
1
0
0
Overall Study
Progressive Disease
0
1
1
Overall Study
Study terminated by sponsor
0
1
0

Baseline Characteristics

Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Total
n=6 Participants
Total of all reporting groups
Age, Customized
Age · 18-44 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Age, Customized
Age · 45-64 years
1 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
Age, Customized
Age · >=65 years
2 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
Sex/Gender, Customized
Gender · Female
2 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
Sex/Gender, Customized
Gender · Male
1 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
Sex/Gender, Customized
Gender · Not disclosed
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Race/Ethnicity, Customized
Race · White
1 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
Race/Ethnicity, Customized
Race · Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race/Ethnicity, Customized
Race · Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race/Ethnicity, Customized
Race · Not disclosed
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
3 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
5 Participants
n=4 Participants
Race/Ethnicity, Customized
Ethnicity · Not disclosed
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Cycle 1 (28 Days)

Population: DLT evaluable set included all enrolled participants who received at least 1 dose of the study treatment in the Phase 1b of the study and either experienced DLTs or completed the DLT observation period without DLT.

DLTs included: Hematological: Grade (G) 4 thrombocytopenia (\<25,000/microliter \[mcL\]) lasting \>=72 hours or a platelet count \<=10,000/mcL at any time, unexplained by underlying disease; \>=G3 thrombocytopenia associated with \>=G2 bleeding, unexplained by underlying disease. G4 anemia; unexplained by underlying disease; G4 neutropenia lasting \>=7 days, unexplained by underlying disease; G3 febrile (\>38.3-degree Celsius \[C\]) neutropenia lasting \>=7 days, unexplained by underlying disease; G4 febrile neutropenia unexplained by underlying disease. Non-hematological: any treatment-related \>=G3 non-hematologic toxicity; Other \>=G2 PF-07901801-related non-hematologic toxicities that, in the opinion of the investigator, required a dose reduction or discontinuation of PF-07901801 were considered a DLT.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are those events with onset dates occurred during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
3 Participants
2 Participants
1 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect or other important medical event. TEAEs are those events with onset dates occurred during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Number of Participants With Serious Treatment Emergent Adverse Events
3 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Related AEs were those related to any study drug (i.e., at least one of the study drugs) reported by the investigator.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Number of Participants With Treatment-Related AEs
3 Participants
2 Participants
1 Participants

SECONDARY outcome

Timeframe: From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

The following hematological parameters were assessed: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell (WBC) decreased. Lab abnormalities were graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) version (v) 5.0 where Grade 0= no AE, Grade 1= mild AE, Grade 2 =moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated. Only those parameters with at least 1 non-zero data values showing any shift in grades from Baseline to any time post-baseline in any reporting group were reported in this outcome measure. Participants whose grade category was unchanged (e.g. Grade 0 to Grade 0) were not reported.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Anemia: Grade 1 to Grade 2
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count decreased: Grade 0 to Grade 2
0 Participants
1 Participants
1 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count decreased: Grade 0 to Grade 3
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count decreased: Grade 1 to Grade 2
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count decreased: Grade 1 to Grade 3
0 Participants
1 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count increased: Grade 0 Grade 2
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Neutrophil count decreased: Grade 0 to Grade 2
0 Participants
1 Participants
1 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Neutrophil count decreased: Grade 0 to Grade 4
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Platelet count decreased: Grade 0 to Grade 1
2 Participants
0 Participants
1 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
WBC decreased: Grade 0 to Grade 1
0 Participants
1 Participants
1 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Anemia: Grade 2 to Grade 3
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Leukocytosis: Grade 0 Grade 3
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Neutrophil count decreased: Grade 0 to Grade 3
2 Participants
1 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Platelet count decreased: Grade 0 to Grade 4
0 Participants
1 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Platelet count decreased: Grade 1 to Grade 4
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
WBC decreased: Grade 0 to Grade 2
0 Participants
1 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
WBC decreased: Grade 0 to Grade 4
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
WBC decreased: Grade 1 to Grade 2
1 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

The following clinical chemistry parameters were assessed: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia and hyponatremia. Lab abnormalities were graded according to NCI CTCAE v5.0 where Grade 0= no AE, Grade 1=mild AE, Grade 2 = moderate AE, Grade 3 =severe AE, and Grade 4 =life-threatening consequences; urgent intervention indicated. Only those parameters with at least 1 non-zero data values showing any shift in grades from Baseline to any time post-baseline in any reporting group were reported in this outcome measure. Participants whose grade category was unchanged (e.g. Grade 0 to Grade 0) were not reported.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Alanine aminotransferase increased: Grade 0 to Grade 1
1 Participants
1 Participants
1 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Blood bilirubin increased: Grade 0 to Grade 1
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Creatinine increased: Grade 0 to Grade 3
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypermagnesemia: Grade 0 to Grade 1
0 Participants
1 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypernatremia: Grade 0 to Grade 1
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypoalbuminemia: Grade 1 to Grade 3
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypocalcemia: Grade 0 to Grade 1
2 Participants
1 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypokalemia: Grade 0 to Grade 2
3 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypomagnesemia: Grade 0 to Grade 2
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hyponatremia: : Grade 0 to Grade 1
3 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Alanine aminotransferase increased: Grade 1 to Grade 0
0 Participants
1 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Alkaline phosphatase increased: Grade 0 to Grade 1
2 Participants
1 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Alkaline phosphatase increased: Grade 1 to Grade 0
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Aspartate aminotransferase increased: Grade 0 to Grade 1
1 Participants
2 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Blood bilirubin increased: Grade 0 to Grade 2
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Creatinine increased: Grade 0 to Grade 1
0 Participants
1 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Creatinine increased: Grade 1 to Grade 2
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypercalcemia: Grade 0 to Grade 1
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hyperkalemia: Grade 0 to Grade 1
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypoalbuminemia: Grade 1 to Grade 2
1 Participants
0 Participants
0 Participants
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypomagnesemia: Grade 0 to Grade 1
1 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From date of first dose until first documentation of disease progression (PD), death or start of new anticancer therapy, whichever occurred first (maximum up to 14.2 months)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

OR:best overall response (BOR) of complete response (CR) or partial response (PR) per Lugano Response Classification Criteria 2014 as determined by investigator. CR:positron emission tomography-computed tomography (PET-CT) score 1 (complete metabolic response), 2 (likely benign), or 3 (uncertain significance) with or without a residual mass on Deauville five-point scale (\[5PS\] standardized scoring system used to evaluate the extent of disease activity in patients with lymphoma through PET scans, ranging from 1 to 5, higher scores indicates more disease activity) or on computed tomography (CT),target nodes/nodal masses regressed to \<=1.5 centimeter (cm) in longest diameter (LDi). PR:PET-CT score 4 (possible residual disease) or 5 (progressive disease) with reduced uptake compared with baseline and residual mass(es) of any size or On CT \>=50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extra nodal sites. 95% CI was based on Wilson method.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Percentage of Participants With Objective Response (OR) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
66.7 Percentage of participants
Interval 12.5 to 98.2
100.0 Percentage of participants
Interval 19.8 to 100.0
0 Percentage of participants
Interval 0.0 to 94.5

SECONDARY outcome

Timeframe: From first documentation of OR until PD or death due to any cause whichever occurred first or date of censoring (maximum up to 14.2 months)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only participants with objective response were included in the analysis.

DoR: time from first documentation of OR until PD, or death due to any cause, whichever occurred first. DoR was censored on date of last adequate disease assessment for participants without an event. OR=BOR of CR or PR,CR=PET-CT score 1,2,or 3 with/without a residual mass on Deauville five-point scale(1 to 5,higher scores=more disease activity)or on CT,target nodes/nodal masses regressed to \<=1.5cm in LDi. PR:PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass of any size or On CT \>=50% decrease in SPD of up to 6 target measurable nodes and extra nodal sites. PD:PET-CT score 4 or 5 with increase in intensity of uptake from baseline and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim or end-of-treatment assessment or on CT,an individual abnormal node/lesion with: LDi\>1.5cm and increase by \>=50% from product of perpendicular diameters nadir and increase in LDi or SDi from nadir 0.5cm for lesions \<=2cm and 1.0cm for lesions \>2cm.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Duration of Response (DoR) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
11.9 Months
Interval 9.6 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
NA Months
Interval 3.3 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From date of first dose until first documentation of CR (maximum up to 14.2 months)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

CR as per Lugano Response Classification Criteria 2014 as assessed by the investigator was defined as: PET-CT score 1 (complete metabolic response), 2 (likely benign), or 3 (uncertain significance) with or without a residual mass on 5PS (standardized scoring system used to evaluate the extent of disease activity in patients with lymphoma through PET scans, ranging from 1 to 5, higher scores indicates more disease activity) or on CT, target nodes/nodal masses regressed to \<=1.5 cm in LDi.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Percentage of Participants With CR as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
66.7 Percentage of participants
Interval 12.5 to 98.2
100.0 Percentage of participants
Interval 19.8 to 100.0
0.0 Percentage of participants
Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From time of first documentation of CR until PD, or death due to any cause, whichever occurred first or date of censoring (maximum up to 14.2 months)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only participants with complete response were included in the analysis.

DoCR:time from first documentation of CR until PD,or death, whichever occurred first. CR:PET-CT 1(complete metabolic response),2(likely benign),3(uncertain significance)with or without residual mass on 5PS(scale from 1 to 5,higher scores=more disease activity)/CT,target nodes/nodal masses regressed \<=1.5cm in LDi.PD:PET-CT 4(possible residual disease)or 5(PD)with increase intensity of uptake and new FDG-avid foci consistent with lymphoma at interim/EOT assessment/CT,individual abnormal node/lesion with:LDi \>1.5cm and increase \>=50% from PPD nadir, increase in LDi or SDi from nadir 0.5cm for lesions \<=2cm and 1.0cm for lesions \>2cm. DoCR censored on date of last adequate assessment for participants without an event on date of last adequate disease assessment before new anti-cancer therapy if new anti-cancer therapy started prior to event,date of last adequate disease assessment before 2 or more missing disease assessments for participants with event after 2 or more missing assessments.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Duration of Complete Response (DoCR) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
11.9 Months
Interval 9.6 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
NA Months
Interval 3.3 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From date of first dose until PD or death due to any cause, whichever occurred first or censoring date (maximum up to 14.2 months)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

PFS: time from date of first dose until PD per Lugano Response Classification Criteria 2014 or death due to any cause,whichever occurred first.Participants without any event,censored on date of last adequate disease assessment;participants with new anticancer therapy prior to an event,censored on date of last disease assessment before new anticancer therapy;participants with an event after a gap of 2 or more missing disease assessments,censored on date of last disease assessment before gap;participants without an adequate post-baseline disease assessment were censored on date of first dose of study intervention unless death occurred on or before time of second planned disease assessment in which case death was considered an event.PD:PET-CT score 4 or 5 with increase in intensity of uptake from baseline and/or new FDG or LDi\>1.5cm and increase by \>=50% from product of perpendicular diameters nadir and increase in LDi or SDi from nadir 0.5cm for lesions \<=2cm and 1.0cm for lesions \>2cm.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Progression Free Survival (PFS) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
13.7 Months
Interval 11.4 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
NA Months
Interval 5.6 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
1.2 Months
Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Cycle 1 and 2 Day 1: Predose, 1 Hour (H) and 5H post dose; Cycle 1 Day 8: pre-dose, Day 1 of Cycles 3, 4, 5, 7, 10 and 13: Predose

Population: The Pharmacokinetic (PK) analysis set included all participants in the safety analysis set who had at least 1 post-dose concentration measurement. Here, "Number Analyzed" signifies number of participants evaluable at specified timepoints. The participant in PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide withdrew consent hence, the "Overall Number of Participants Analyzed" is reported as 0.

All concentrations assayed below the level of quantification (BLQ) were set to 0 and their data is not reported in this outcome measure.

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Plasma Concentration of PF-07901801
Cycle 1 Day 1: Predose
0.1 Micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimated as only 1 participant was analyzed.
Phase 1b: Plasma Concentration of PF-07901801
Cycle 1 Day 1: 1 hour
64.3 Micrograms per milliliter
Geometric Coefficient of Variation 45
213.4 Micrograms per milliliter
Geometric Coefficient of Variation 31
Phase 1b: Plasma Concentration of PF-07901801
Cycle 1 Day 1: 5 hours
50.7 Micrograms per milliliter
Geometric Coefficient of Variation 47
194.2 Micrograms per milliliter
Geometric Coefficient of Variation 42
Phase 1b: Plasma Concentration of PF-07901801
Cycle 1 Day 8: Predose
4.0 Micrograms per milliliter
Geometric Coefficient of Variation 159
21.1 Micrograms per milliliter
Geometric Coefficient of Variation 85
Phase 1b: Plasma Concentration of PF-07901801
Cycle 2 Day 1: Predose
7.9 Micrograms per milliliter
Geometric Coefficient of Variation 201
88.3 Micrograms per milliliter
Geometric Coefficient of Variation 35
Phase 1b: Plasma Concentration of PF-07901801
Cycle 2 Day 1: 1 hour
75.3 Micrograms per milliliter
Geometric Coefficient of Variation 63
308.1 Micrograms per milliliter
Geometric Coefficient of Variation 42
Phase 1b: Plasma Concentration of PF-07901801
Cycle 2 Day 1: 5 hours
67.6 Micrograms per milliliter
Geometric Coefficient of Variation 71
276.4 Micrograms per milliliter
Geometric Coefficient of Variation 31
Phase 1b: Plasma Concentration of PF-07901801
Cycle 3 Day 1: Predose
10.9 Micrograms per milliliter
Geometric Coefficient of Variation 168
130.4 Micrograms per milliliter
Geometric Coefficient of Variation 10
Phase 1b: Plasma Concentration of PF-07901801
Cycle 4 Day 1: Predose
15.0 Micrograms per milliliter
Geometric Coefficient of Variation 190
75.1 Micrograms per milliliter
Geometric Coefficient of Variation 110
Phase 1b: Plasma Concentration of PF-07901801
Cycle 5 Day 1: Predose
2.0 Micrograms per milliliter
Geometric Coefficient of Variation 57
35.2 Micrograms per milliliter
Geometric Coefficient of Variation 187
Phase 1b: Plasma Concentration of PF-07901801
Cycle 7 Day 1: Predose
2.3 Micrograms per milliliter
Geometric Coefficient of Variation 20
21.0 Micrograms per milliliter
Geometric Coefficient of Variation 50
Phase 1b: Plasma Concentration of PF-07901801
Cycle 10 Day 1: Predose
2.0 Micrograms per milliliter
Geometric Coefficient of Variation 15
28.6 Micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimated as only 1 participant was analyzed.
Phase 1b: Plasma Concentration of PF-07901801
Cycle 13 Day 1: Predose
1.6 Micrograms per milliliter
Geometric Coefficient of Variation 83
26.9 Micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimated as only 1 participant was analyzed.

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 14.2 months)

Population: Immunogenicity analysis set included all participants in the safety analysis set who had at least 1 sample tested for ADA.

Number of participants with ADA and NAb against PF-07901801 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).

Outcome measures

Outcome measures
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Phase 1b: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-07901801
0 Participants
0 Participants
0 Participants

Adverse Events

PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide

Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths

PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Infections and infestations
Appendicitis
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Pneumonia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Sepsis
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Acute kidney injury
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Urinary tract obstruction
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

Other adverse events

Other adverse events
Measure
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
Blood and lymphatic system disorders
Anaemia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Lymph node pain
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Eye disorders
Vision blurred
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Eye disorders
Visual impairment
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Abdominal pain
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Constipation
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Diarrhoea
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
100.0%
2/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Gingival ulceration
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Nausea
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Stomatitis
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Vomiting
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
General disorders
Fatigue
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
General disorders
Influenza like illness
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
General disorders
Oedema peripheral
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
General disorders
Pain
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
General disorders
Pyrexia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Immune system disorders
Hypogammaglobulinaemia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
COVID-19
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Conjunctivitis
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Cytomegalovirus viraemia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Gastroenteritis
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Herpes zoster
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Oral infection
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Parainfluenzae virus infection
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Pneumonia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Soft tissue infection
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Upper respiratory tract infection
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Infections and infestations
Urinary tract infection
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Contusion
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
100.0%
2/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
Alanine aminotransferase increased
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
Aspartate aminotransferase increased
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
Blood alkaline phosphatase increased
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
Blood creatinine increased
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
International normalised ratio increased
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
Neutrophil count decreased
100.0%
3/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
Platelet count decreased
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
SARS-CoV-2 test positive
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
White blood cell count decreased
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Investigations
White blood cell count increased
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Decreased appetite
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hyperkalaemia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hypokalaemia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hypomagnesaemia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Tumour lysis syndrome
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Back pain
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Nervous system disorders
Dizziness
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Nervous system disorders
Dysgeusia
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Nervous system disorders
Headache
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Nervous system disorders
Neuropathy peripheral
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Urinary tract obstruction
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Cough
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Eczema
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Pruritus allergic
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Vascular disorders
Deep vein thrombosis
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
Vascular disorders
Haematoma
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

Additional Information

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Results disclosure agreements

  • Principal investigator is a sponsor employee The sponsor (or its agents) has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER