Trial Outcomes & Findings for Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (NCT NCT04623216)

Last Updated: 2025-10-16

Results Overview

Assessment of tolerability of sabatolimab in adults and adolescents in the post allogenic stem cell transplantation setting. This was determined by the number of participants with at least one event - All grades. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value considered by the Investigator to be at least possibly related to sabatolimab as a single contributor that occurs during the DLT observation period and meets the severity criteria as per protocol.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

From Cycle 1 Day 1 to end of Cycle 2; Cycle =28 Days

Results posted on

2025-10-16

Participant Flow

A total of 24 participants were enrolled in this study: 21 in Safety run-in sabatolimab monotherapy and 3 in Expansion part.

Due to the recruitment halt by Novartis, recruitment in the expansion phase was not completed.

Participant milestones

Participant milestones
Measure	Sabatolimab 400mg Mono Adults Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Overall Study STARTED	10	11	2	1
Overall Study Did Not Enter Post-treatment Follow-up (f/u)	7	9	2	1
Overall Study Entered Post-treatment f/u, Discontinued	3	2	0	0
Overall Study Completed Treatment	2	0	0	0
Overall Study COMPLETED	1	7	0	1
Overall Study NOT COMPLETED	9	4	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sabatolimab 400mg Mono Adults Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination
Overall Study Death	5	2	0
Overall Study Terminated by Sponsor	3	2	2
Overall Study Physician Decision	1	0	0

Baseline Characteristics

Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sabatolimab 400mg Mono Adults n=10 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=11 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults n=2 Participants Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent n=1 Participants Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.	Total n=24 Participants Total of all reporting groups
Age, Customized Category 1 : 12 - <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Age, Customized Category 1 : 18 - <65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	16 Participants n=21 Participants
Age, Customized Category 1 : 65 - <85 years	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	9 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	21 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: From Cycle 1 Day 1 to end of Cycle 2; Cycle =28 Days

Population: Dose Determining Set included all participants from the FAS enrolled in the safety run-in part who met the minimum exposure criterion described and had sufficient safety evaluations or experienced a dose limiting toxicity (DLT) between Cycle 1 Day 1 (first dose of sabatolimab) and the end of Cycle 2 (both inclusive).

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults n=8 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=10 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Rate of Dose Limiting Toxicities (Safety Run-in in Adult Sabatolimab 400mg & 800mg Only)	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: From Cycle 1 Day 1 to end of Cycle 6; Cycle = 28 Days

Population: All adult participants treated with sabatolimab 800 mg monotherapy.

The percentage of adult participants for whom no evidence of hematologic relapse (no evidence of bone marrow blasts ≥5%, no evidence of reappearance of blasts in the blood; no evidence of development of extramedullary disease) has been documented after 6 cycles of study treatment or earlier discontinuation at the recommended dose of sabatolimab 800 mg.

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=11 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Percentage of Adult Subjects With Absence of Hematologic Relapse Per Investigator Assessment (Safety Run-in and Expansion)	—	36.4 Percentage of participants Interval 10.9 to 69.2	—	—

PRIMARY outcome

Timeframe: From Cycle 1 Day 1 to end of Cycle 2; Cycle =28 Days

Population: Dose Determining Set included all participants from the FAS enrolled in the adolescent cohort who met the minimum exposure criterion described and had sufficient safety evaluations or experienced a dose limiting toxicity (DLT) between Cycle 1 Day 1 (first dose of sabatolimab) and the end of Cycle 2 (both inclusive).

Assessment of tolerability of sabatolimab in adolescent participants in the post allogeneic stem cell transplantation setting. This was determined by the number of participants with at least one event - All grades. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value considered by the Investigator to be at least possibly related to sabatolimab as a single contributor that occurs during the DLT observation period and meets the severity criteria as per protocol.

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults n=1 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Rate of Dose Limiting Toxicities (Safety Confirmation in Adolescent Cohort Only)	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From start of treatment to up to 36 months from last patient first treatment.

Population: Safety Set includes all participants from the FAS.

Assessment of the treatment emergent grade III or IV aGvHD. Acute GvHD: Grade IV acute GvHD, Stage ≥3 lower GI acute GvHD (consistent with Grade III acute GvHD) or Stage ≥3 liver acute GvHD (consistent with Grade III GvHD).

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults n=10 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=11 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults n=2 Participants Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent n=1 Participants Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Incidence of Grade III or IV Acute Graft Versus Host Disease (aGvHD)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of treatment to up to 36 months from last patient first treatment.

Population: Safety Set includes all participants from the FAS.

Assessment of the treatment emergent moderate or severe cGvHD. Chronic GvHD: Moderate chronic GvHD of the lungs, Severe chronic GvHD.

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults n=10 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=11 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults n=2 Participants Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent n=1 Participants Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Incidence of Moderate to Severe Chronic GVHD (cGvHD)	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 5 (end of infusion) and Cycle 3 Day 1 or Day 5 (end of infusion) and Cycle 24 Day 1 (end of infusion); Cycle =28 Days

Population: Pharmacokinetics (PK) analysis set included all participants from the Safety Set who provided at least one evaluable sabatolimab PK concentration at the considered timepoint.

Cmax is the maximal serum concentration of sabatolimab.

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults n=6 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=7 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults n=1 Participants Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Peak of Serum Concentration (Cmax) Sabatolimab Cycle 1 Day 5 at 2 hours (hr) (end of infusion)	—	—	256 ug/ml Geometric Coefficient of Variation 0.0	—
Peak of Serum Concentration (Cmax) Sabatolimab Cycle 3 Day 1 at 2 hr (end of infusion)	137 ug/ml Geometric Coefficient of Variation 52.7	304 ug/ml Geometric Coefficient of Variation 31.4	—	—
Peak of Serum Concentration (Cmax) Sabatolimab Cycle 3 Day 5 at 2 hr (end of infusion)	—	—	315 ug/ml Geometric Coefficient of Variation 0.0	—
Peak of Serum Concentration (Cmax) Sabatolimab Cycle 24 Day 1 at 2 hr (end of infusion)	163 ug/ml Geometric Coefficient of Variation 23.7	—	—	—

SECONDARY outcome

Timeframe: Adult cohorts: Pre-dose on Day 1 (safety run-in) or Day 5 (expansion) of Cycle 1, 3, 6 and 24 (safety run-in only); Adolescent cohort: Pre-dose on Day 1 of Cycle 1, 2, 3 and 6; Cycle = 28 Days

Population: Pharmacokinetics (PK) analysis set included all participants from the Safety Set who provided at least one evaluable sabatolimab PK concentration at the considered timepoint.

Cmin is the concentration of sabatolimab prior to next dosing or after end of treatment.

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults n=6 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=7 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults n=2 Participants Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent n=1 Participants Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Trough Serum Concentration of (Cmin) Sabatolimab 0-hour (hr) Pre-dose at Cycle 1 Day 1	0.00 µg/ml Geometric Coefficient of Variation 0.0	0.00 µg/ml Geometric Coefficient of Variation 0.0	—	0.00 µg/ml Geometric Coefficient of Variation 0.0
Trough Serum Concentration of (Cmin) Sabatolimab 0 hr (pre-dose) at Cycle 1 Day 5	—	—	0.00 µg/ml Geometric Coefficient of Variation 0.0	—
Trough Serum Concentration of (Cmin) Sabatolimab 0 hr (pre-dose) at Cycle 2 Day 1	—	—	—	70.7 µg/ml Geometric Coefficient of Variation 0.0
Trough Serum Concentration of (Cmin) Sabatolimab 0 hr (pre-dose) at Cycle 3 Day 1	40.4 µg/ml Geometric Coefficient of Variation 20.2	70.7 µg/ml Geometric Coefficient of Variation 47.5	—	129 µg/ml Geometric Coefficient of Variation 0.0
Trough Serum Concentration of (Cmin) Sabatolimab 0 hr (pre-dose) at Cycle 3 Day 5	—	—	42.9 µg/ml Geometric Coefficient of Variation 0.0	—
Trough Serum Concentration of (Cmin) Sabatolimab 0 hr (pre-dose) at Cycle 6 Day 1	46.4 µg/ml Geometric Coefficient of Variation 66.4	99.8 µg/ml Geometric Coefficient of Variation 52.1	—	219 µg/ml Geometric Coefficient of Variation 0.0
Trough Serum Concentration of (Cmin) Sabatolimab 0 hr (pre-dose) at Cycle 6 Day 5	—	—	71.9 µg/ml Geometric Coefficient of Variation 0.0	—
Trough Serum Concentration of (Cmin) Sabatolimab 0 hr (pre-dose) at Cycle 24 Day 1	49.7 µg/ml Geometric Coefficient of Variation 44.1	—	—	—

SECONDARY outcome

Timeframe: From start of treatment to up to 36 months from last patient first treatment

Population: Full Analysis Set (FAS) included all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).

Time from start of treatment to the date of first documented occurrence or worsening of treatment emergent grade III or IV aGvHD or moderate to severe cGvHD requiring initiation of systemic treatment, morphologic/hematologic relapse, or death due to any cause, whichever occurs first

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults n=10 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=11 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults n=2 Participants Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent n=1 Participants Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Graft Versus Host Disease (GvHD)-Free/Relapse-free Survival (GRFS)	NA Months NA: Not estimable due to insufficient number of participants with events resulting from the early termination of the study in part 2 (expansion cohort).	NA Months NA: Not estimable due to insufficient number of participants with events resulting from the early termination of the study in part 2 (expansion cohort).	NA Months NA: Not estimable due to insufficient number of participants with events resulting from the early termination of the study in part 2 (expansion cohort).	NA Months NA: Not estimable due to insufficient number of participants with events resulting from the early termination of the study in part 2 (expansion cohort).

SECONDARY outcome

Timeframe: From start of treatment to up to 36 months from last patient first treatment

Population: FAS included all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).

Time from start of treatment to the date of first documented hematologic relapse or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults n=10 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=11 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults n=2 Participants Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent n=1 Participants Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Relapse-free Survival (RFS)	2.56 Months Interval 0.95 to NA: The upper limit of Confidence Interval (CI) was not estimable due to an insufficient number of participants and limited follow-up, resulting from the early termination of the study in part 2 (expansion cohort).	6.74 Months Interval 0.95 to NA: The upper limit of CI was not estimable due to an insufficient number of participants and limited follow-up, resulting from the early termination of the study in part 2 (expansion cohort).	NA Months NA: CI was not estimable as no participants had an event within the limited number of participants, resulting from the early termination of the study in part 2 (expansion cohort).	7.16 Months NA: The CI was not estimable due to the limited number of participants, resulting from the early termination of the study in part 2 (expansion cohort).

SECONDARY outcome

Timeframe: From start of treatment until end of Cycle 6 (Cycle = 28 Days)

Population: FAS included all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).

Percentage of participants with centrally confirmed MRD+ status at baseline converting to MRD- within the first 6 cycles of study treatment.

Outcome measures

Outcome measures
Measure	Sabatolimab 400mg Mono Adults n=10 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=11 Participants Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults n=2 Participants Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent n=1 Participants Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Percentage of Participants With Measurable Residual Disease (MRD) Positive at Baseline Who Become MRD Negative	0 Percentage of participants Interval 0.0 to 30.8	0 Percentage of participants Interval 0.0 to 28.5	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 97.5

Adverse Events

Sabatolimab 400mg Mono Adults

Serious events: 2 serious events

Other events: 9 other events

Deaths: 5 deaths

Sabatolimab 800mg Mono Adults

Serious events: 3 serious events

Other events: 9 other events

Deaths: 2 deaths

Sabatolimab 800mg + Azacitidine Adults

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sabatolimab 800mg Mono Adolescent

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sabatolimab 400mg Mono Adults n=10 participants at risk Safety run-in cohort: Adult participants in this arm received sabatolimab 400mg only.	Sabatolimab 800mg Mono Adults n=11 participants at risk Safety run-in cohort: Adult participants in this arm received sabatolimab 800mg only.	Sabatolimab 800mg + Azacitidine Adults n=2 participants at risk Expansion cohort: Adult participants in this arm received sabatolimab 800 mg + azacitidine combination	Sabatolimab 800mg Mono Adolescent n=1 participants at risk Adolescent safety cohort: ≥12 to \< 18-year-old adolescent participants in this arm received sabatolimab 800mg only.
Cardiac disorders Myocarditis	0.00% 0/10 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	9.1% 1/11 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/2 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/1 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).
Infections and infestations Bronchitis	10.0% 1/10 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/11 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/2 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/1 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).
Infections and infestations Febrile infection	10.0% 1/10 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/11 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/2 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/1 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).
Infections and infestations Oral herpes	0.00% 0/10 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	9.1% 1/11 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/2 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/1 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).
Infections and infestations Pneumonia	10.0% 1/10 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/11 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/2 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/1 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).
Injury, poisoning and procedural complications Femoral neck fracture	10.0% 1/10 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/11 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/2 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/1 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).
Nervous system disorders Nervous system disorder	0.00% 0/10 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	9.1% 1/11 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/2 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/1 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).
Renal and urinary disorders Acute kidney injury	10.0% 1/10 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/11 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/2 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).	0.00% 0/1 • Adverse Events were collected from start of treatment (FPFT) up to 30 days after the last dose of study treatment (sabatolimab or azacitidine), for a maximum duration of approx. 25 months (max. duration of treatment 24 months + 30 days). Deaths were collected on-treatment period up to 30 days and after Day 31 after last dose of study treatment. An Adverse Event is any sign or symptom occurring during a trial and safety follow-up. The Safety Set comprises all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine).

Other adverse events

Additional Information

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