Trial Outcomes & Findings for Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients (NCT NCT05222555)

Last Updated: 2026-01-16

Results Overview

An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Therefore, an AE could be any unfavorable or unintended sign (including an abnormal laboratory finding) or symptom temporally associated with the use of study treatment. A TEAE was defined as any AE that started or worsened after the first dose of study treatment until 90 days after the last dose of the study treatment. An AE that was present prior to study drug administration but increased in severity after treatment start was also included as a TEAE.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

53 participants

Primary outcome timeframe

up to approximately 2 years

Results posted on

2026-01-16

Participant Flow

A total of 53 participants were enrolled at 26 study sites in Austria, Czech Republic, Israel, Italy, Poland, South Korea, Spain, and the United States through the data cutoff date of 17 July 2024.

Participant milestones

Participant milestones
Measure	Tafasitamab Dose Level 1 + 25 mg Lenalidomide Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Tafasitamab Dose Level 2 + 25 mg Lenalidomide Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.
Overall Study STARTED	6	47
Overall Study COMPLETED	3	11
Overall Study NOT COMPLETED	3	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Tafasitamab Dose Level 1 + 25 mg Lenalidomide Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Tafasitamab Dose Level 2 + 25 mg Lenalidomide Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.
Overall Study Ongoing	2	18
Overall Study Adverse Event	1	1
Overall Study Death	0	6
Overall Study Withdrawal by Subject	0	11

Baseline Characteristics

Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tafasitamab Dose Level 1 + 25 mg Lenalidomide n=6 Participants Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Tafasitamab Dose Level 2 + 25 mg Lenalidomide n=47 Participants Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Total n=53 Participants Total of all reporting groups
Age, Continuous	70.0 years STANDARD_DEVIATION 10.49 • n=9 Participants	71.9 years STANDARD_DEVIATION 9.97 • n=6 Participants	71.7 years STANDARD_DEVIATION 9.94 • n=9 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	14 Participants n=6 Participants	16 Participants n=9 Participants
Sex: Female, Male Male	4 Participants n=9 Participants	33 Participants n=6 Participants	37 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants	1 Participants n=6 Participants	2 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=9 Participants	44 Participants n=6 Participants	49 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	2 Participants n=6 Participants	2 Participants n=9 Participants
Race/Ethnicity, Customized Asian	0 Participants n=9 Participants	18 Participants n=6 Participants	18 Participants n=9 Participants
Race/Ethnicity, Customized White	6 Participants n=9 Participants	27 Participants n=6 Participants	33 Participants n=9 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=9 Participants	1 Participants n=6 Participants	1 Participants n=9 Participants

PRIMARY outcome

Timeframe: up to approximately 2 years

Population: Safety Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 postbaseline safety assessment. A valid safety assessment included death. Treatment groups were determined according to the actual treatment the participant received regardless of assigned study treatment.

Outcome measures

Outcome measures
Measure	Tafasitamab Dose Level 1 + 25 mg Lenalidomide n=6 Participants Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Tafasitamab Dose Level 2 + 25 mg Lenalidomide n=47 Participants Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	6 Participants	45 Participants

PRIMARY outcome

Timeframe: up to approximately 2 years

Population: Safety Analysis Set

The toxicity grade of TEAEs was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) using the following definitions: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal; local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE.

Outcome measures

Outcome measures
Measure	Tafasitamab Dose Level 1 + 25 mg Lenalidomide n=6 Participants Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Tafasitamab Dose Level 2 + 25 mg Lenalidomide n=47 Participants Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.
Number of Participants With Any ≥Grade 3 TEAE	5 Participants	38 Participants

SECONDARY outcome

Timeframe: predose on Cycle 3 Day 15; predose on Cycle 12 Day 28 (up to approximately 1 year [after twelve 28-day cycles])

Population: Pharmacokinetic Analysis Set: all participants who received at least 1 dose of tafasitamab and had at least 1 quantifiable serum tafasitamab concentration. Only participants with available data were analyzed.

Ctrough was defined as the minimum concentration of tafasitamab.

Outcome measures

Outcome measures
Measure	Tafasitamab Dose Level 1 + 25 mg Lenalidomide n=6 Participants Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Tafasitamab Dose Level 2 + 25 mg Lenalidomide n=28 Participants Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.
Ctrough of Tafasitamab After 3 and 12 Treatment Cycles Cycle 3 Day 15	170 micrograms per milliliter (μg/mL) Standard Deviation 117	228 micrograms per milliliter (μg/mL) Standard Deviation 102
Ctrough of Tafasitamab After 3 and 12 Treatment Cycles Cycle 12 Day 28	87 micrograms per milliliter (μg/mL) Standard Deviation 26	149 micrograms per milliliter (μg/mL) Standard Deviation 69

SECONDARY outcome

Timeframe: 30 minutes after the end of tafasitamab infusion on Cycle 3 Day 15 (up to approximately 85 days [after three 28-day cycles])

Population: Pharmacokinetic Analysis Set. Only participants with available data were analyzed.

Cmax was defined as the maximum observed plasma concentration of tafasitamab.

Outcome measures

Outcome measures
Measure	Tafasitamab Dose Level 1 + 25 mg Lenalidomide n=4 Participants Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Tafasitamab Dose Level 2 + 25 mg Lenalidomide n=28 Participants Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.
Cmax of Tafasitamab After 3 Treatment Cycles	792 micrograms per milliliter (μg/mL) Standard Deviation 420	797 micrograms per milliliter (μg/mL) Standard Deviation 273

SECONDARY outcome

Timeframe: up to 19.8 months

Population: Full Analysis Set: all participants who received at least 1 dose of study treatment. Participants were analyzed according to the dose group to which they were initially assigned. Confidence intervals were calculated based on the Clopper-Pearson exact method for binomial distributions.

ORR was defined as the percentage of participants with complete response (CR: disappearance of all evidence disease) or partial response (PR: regression of measurable disease and no new sites) as the best response achieved at any time during the study. Only responses of CR or PR that were documented before the initiation of new antilymphoma therapy (NALT) were considered. Response assessments were based on revised International Working Group response criteria for malignant lymphoma.

Outcome measures

Outcome measures
Measure	Tafasitamab Dose Level 1 + 25 mg Lenalidomide n=6 Participants Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Tafasitamab Dose Level 2 + 25 mg Lenalidomide n=47 Participants Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.
Best Objective Response Rate (ORR) by Investigator Assessment up to Treatment Cycle 12	50.0 percentage of participants Interval 11.8 to 88.2	48.9 percentage of participants Interval 34.1 to 63.9

SECONDARY outcome

Timeframe: up to approximately 64 months (approximately 5 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to approximately 64 months (approximately 5 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to approximately 1 year (after twelve 28-day cycles)

Population: Immunogenicity Analysis Set: all participants who received at least 1 dose of tafasitamab and had at least 1 valid anti-tafasitamab antibody assessment

Anti-tafasitamab antibody samples were defined as negative if they were screened or confirmed negative. Anti-tafasitamab antibody samples were defined as positive if they were positive in both the screening and the confirmatory assays.

Outcome measures

Outcome measures
Measure	Tafasitamab Dose Level 1 + 25 mg Lenalidomide n=6 Participants Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.	Tafasitamab Dose Level 2 + 25 mg Lenalidomide n=47 Participants Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen.
Number of Participants Developing Anti-tafasitamab Antibodies up to Treatment Cycle 12	0 Participants	0 Participants

Adverse Events

Tafasitamab Dose Level 1 + 25 mg Lenalidomide

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Tafasitamab Dose Level 2 + 25 mg Lenalidomide

Serious events: 20 serious events

Other events: 40 other events

Deaths: 8 deaths

Total

Serious events: 22 serious events

Other events: 46 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Publication restrictions are in place

Restriction type: OTHER