Trial Outcomes & Findings for A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants (NCT NCT04812548)

Last Updated: 2025-10-09

Results Overview

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 or in combination with other component(s) of study treatment that occurs during the DLT observation period and meets severity criteria as per protocol.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

From Cycle 1 Day 8 to end of Cycle 2 (Cycle = 28 Days)

Results posted on

2025-10-09

Participant Flow

Ten centers across 7 countries enrolled a total of 20 participants in this study.

Prior to dosing at Cycle 1 Day 1, participants who fulfilled all the inclusion/exclusion criteria were enrolled via IRT and a treatment number was provided for the study treatments sabatolimab, venetoclax, and azacitidine.

Participant milestones

Participant milestones
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Overall Study STARTED	5	15
Overall Study Did Not Enter Post-treatment Follow-up	1	5
Overall Study Entered Post-treatment Follow-up	4	10
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Overall Study Adverse Event	2	7
Overall Study HSCT Planned	2	3
Overall Study Progressive Disease	0	2
Overall Study Death	0	1
Overall Study Post Study Access to Treatment	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study Physician Decision	1	0

Baseline Characteristics

A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=5 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) n=15 Participants Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Total n=20 Participants Total of all reporting groups
Age, Continuous	67.2 Years STANDARD_DEVIATION 11.28 • n=93 Participants	69.3 Years STANDARD_DEVIATION 9.45 • n=4 Participants	68.8 Years STANDARD_DEVIATION 9.67 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	11 Participants n=4 Participants	16 Participants n=27 Participants
Race/Ethnicity, Customized White	4 Participants n=93 Participants	14 Participants n=4 Participants	18 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: From Cycle 1 Day 8 to end of Cycle 2 (Cycle = 28 Days)

Population: Dose determining set (DDS): The DDS included all participants from the FAS enrolled in the Safety run-in part who met the minimum exposure criterion and had sufficient safety evaluations or experienced a dose limiting toxicity (DLT) during the first two cycles.

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=4 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) n=13 Participants Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Rate of Dose Limiting Toxicities (DLTs) - All Grades (Safety run-in Patients Only) Number of participants with at least one event	0 Participants	2 Participants
Rate of Dose Limiting Toxicities (DLTs) - All Grades (Safety run-in Patients Only) Blood and lymphatic system disorders (Thrombocytopenia)	0 Participants	1 Participants
Rate of Dose Limiting Toxicities (DLTs) - All Grades (Safety run-in Patients Only) Nervous system disorders (Haemorrhage intracranial)	0 Participants	1 Participants

PRIMARY outcome

Timeframe: up to approx. 23 months

Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) comprises all participants who received at least one dose of study treatment. If a participant were assigned to a specific cohort without any administration of sabatolimab, but received venetoclax or azacitidine, the participant is included in the analysis.

This endpoint assessed Complete Remission (CR) Rate of participants from Cohort 2 of Part 1 and Part 2 according to Investigator assessment per modified IWG-MDS - Cheson 2006 criteria. CR is defined as follows: bone marrow blasts \<=5%, hemoglobin level ≥ 10 g/dL, platelets count ≥ 100\*10\^9/L, neutrophils count ≥ 1.0\*10\^9/L, absence of blasts in peripheral blood.

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=15 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Percentage of Participants (Receiving 800mg Sabatolimab) Achieving Complete Remission (CR) Per Investigator Assessment	1 Participants	—

SECONDARY outcome

Timeframe: up to approx. 23 months

Assessed the durability of complete remission (CR) or morphologic complete remission (mCR) rate. mCR is defined as \<=5% blasts and blast count decrease by \>=50% compared to baseline as per modified IWG-MDS Cheson 2006 criteria.

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=5 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) n=15 Participants Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Percentage of Subjects Achieving a Complete Remission (CR) + Morphologic Complete Remission (mCR): Safety run-in (Part 1)	4 Participants	13 Participants

SECONDARY outcome

Timeframe: up to approx. 23 months

The percentage of participants achieving \[CR + mCR + partial remission (PR) + hematologic improvement (HI)\], per modified IWG-MDS Cheson 2006 criteria. Partial response (PR): all complete response (CR) criteria except \>=50% decrease from baseline in blasts in bone marrow AND blast count in bone marrow \>5%. HI (erythroid response or platelet response or neutrophil response) must last at least 8 weeks.

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=5 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) n=15 Participants Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Overall Response Rate (ORR) of Participants Who Achieved Hematologic Improvement (HI) or Better as Best Response	4 Participants	13 Participants

SECONDARY outcome

Timeframe: up to approx. 23 months

Improvement in red blood cells (RBC)/platelets transfusion post-baseline as per International Working Group - Myelodysplastic syndromes (IWG-MDS) by dose level for the safety run-in part (Cohort 1 (400 mg Q4W) and Cohort 2 (800 mg Q4W)) and for participants treated with sabatolimab 800 mg (Q4W) (Cohort 2 of safety run-in and expansion parts). RBC/Platelets transfusion independence is defined as participants having received no RBC/Platelets transfusions during at least 8 consecutive weeks after start of treatment.

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=5 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) n=15 Participants Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Percentage of Participants Who Are RBC/Platelets Transfusion Independent RBC	2 Participants	5 Participants
Percentage of Participants Who Are RBC/Platelets Transfusion Independent Platelets	2 Participants	7 Participants

SECONDARY outcome

Timeframe: up to approx. 23 months

Sum of each period of the transfusion independence for participants with at least one period of transfusion independence post-baseline by dose level for the safety run-in part (Cohort 1 (400 mg Q4W) and Cohort 2 (800 mg Q4W)) and for participants treated with sabatolimab 800 mg (Q4W) (Cohort 2 of safety run-in and expansion parts) for both red blood cells and platelets. RBC/Platelets transfusion independence is defined as participants having received no RBC/platelets transfusions during at least 8 consecutive weeks after start of treatment.

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=2 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) n=7 Participants Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Duration of Transfusion Independence Packed Red Blood Cells	16.43 Weeks Standard Deviation 0.808	23.11 Weeks Standard Deviation 12.636
Duration of Transfusion Independence Platelets	18.93 Weeks Standard Deviation 2.727	24.02 Weeks Standard Deviation 16.423

SECONDARY outcome

Timeframe: Continuously collected for patients during treatment with sabatolimab up to 150 days after last treatment, approx. 23 months

Population: PK analysis set: The sabatolimab and venetoclax pharmacokinetic analysis sets included all participants from the Safety Set who provided at least one evaluable sabatolimab/venetoclax PK concentration. No data is reported as only pre-dose samples were collected

Maximal concentration of sabatolimab for participants treated with sabatolimab by dose level for the safety run-in part (Cohort 1 (400 mg Q4W) and Cohort 2 (800 mg Q4W)).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Continuously collected for patients during treatment with sabatolimab up to 150 days after last treatment, approx. 23 months

Population: PK analysis set: The sabatolimab pharmacokinetic analysis set included all participants from the Safety Set who provided at least one evaluable sabatolimab PK concentration.

Concentration of sabatolimab prior to next dosing or after end of treatment by dose level for the safety run-in part (Cohort 1 (400 mg Q4W) and Cohort 2 (800 mg Q4W)).

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=5 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) n=13 Participants Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Trough Serum Concentration (Cmin) Sabatolimab Cycle (C) 1 Day (D) 8	0.0 ug/ml Geometric Coefficient of Variation 0.0	0.0 ug/ml Geometric Coefficient of Variation 0.0
Trough Serum Concentration (Cmin) Sabatolimab C2D8	23.0 ug/ml Geometric Coefficient of Variation 137.0	30.7 ug/ml Geometric Coefficient of Variation 41.7
Trough Serum Concentration (Cmin) Sabatolimab C3D8	0.0 ug/ml Geometric Coefficient of Variation 0.0	34.4 ug/ml Geometric Coefficient of Variation 72.2
Trough Serum Concentration (Cmin) Sabatolimab C6D8	—	68.6 ug/ml Geometric Coefficient of Variation 11.5
Trough Serum Concentration (Cmin) Sabatolimab C9D8	—	71.2 ug/ml Geometric Coefficient of Variation 33.8
Trough Serum Concentration (Cmin) Sabatolimab C12D8	—	0.0 ug/ml Geometric Coefficient of Variation 0.0

SECONDARY outcome

Timeframe: Continuously collected for patients during treatment with sabatolimab up to 150 days after last treatment, approx. 23 months

Population: Immunogenicity (IG) analysis set: included all participants in the Full Analysis Set with a non-missing baseline IG sample or at least one non-missing post-baseline IG sample. A non-missing IG sample was a sample that was analyzed and not ADA-inconclusive.

Immunogenicity of sabatolimab prior to sabatolimab exposure and during treatment

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=4 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) n=13 Participants Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Anti-drug Antibody (ADA) Prevalence at Baseline and ADA Incidence On-treatment by Dose Level Treatment-induced ADA-positive	1 Participants	1 Participants
Anti-drug Antibody (ADA) Prevalence at Baseline and ADA Incidence On-treatment by Dose Level Treatment-boosted ADA-positive	0 Participants	1 Participants
Anti-drug Antibody (ADA) Prevalence at Baseline and ADA Incidence On-treatment by Dose Level ADA prevalence at baseline	0 Participants	2 Participants
Anti-drug Antibody (ADA) Prevalence at Baseline and ADA Incidence On-treatment by Dose Level ADA incidence (i.e., ADA positive) on-treatment	1 Participants	2 Participants

SECONDARY outcome

Timeframe: up to approx. 23 months

Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) comprises all participants who received at least one dose of study treatment. Analysis is based on participants with CR.

Duration of complete remission (CR) is defined as time from first occurrence of CR to relapse from CR, progression or death due to any cause whichever occurs first for the safety run-in part (Cohort 2 (800 mg Q4W)). CR is defined as follows: bone marrow blasts \<=5%, hemoglobin level ≥ 10 g/dL, platelets count ≥ 100\*10\^9/L, neutrophils count ≥ 1.0\*10\^9/L, absence of blasts in peripheral blood. Relapse from complete remission (CR)is when at least 1 of the following criteria is met: 1. Return to baseline bone marrow blast percentage. 2. Decrease of ≥ 50% from maximum remission/response levels in neutrophils AND neutrophils \<1.0\*10\^9/L. 3. Decrease of ≥ 50% from maximum remission/response levels in platelets AND platelets \<100\*10\^9/L. 4. Decrease from maximum remission/response levels in Hgb concentration by ≥ 1.5g/dL AND Hgb \< 10g/dL. 5. Becoming transfusion dependent

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=1 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Duration of Complete Remission (CR)	NA months NA: not enough evens to calculate the median and 95% confidence interval	—

SECONDARY outcome

Timeframe: up to approx. 23 months

Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) comprises all participants who received at least one dose of study treatment.

Time to CR/mCR is defined as time from start of treatment to first occurrence of CR or mCR as per investigator assessment for the safety run-in part (Cohort 2 (800 mg Q4W)).

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=15 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Time to Complete Remission(CR)/Marrow Complete Remission (mCR)	2.33 months Interval 1.61 to 2.83	—

SECONDARY outcome

Timeframe: up to approx. 23 months

Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) comprises all participants who received at least one dose of study treatment. Analysis is based on participants with CR or mCR.

Duration of CR/mCR is defined as time from first occurrence of CR/mCR to relapse from CR, progression or death due to any cause whichever occurs first for the safety run-in part (Cohort 2 (800 mg Q4W)).

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=13 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Duration of Complete Response (CR)/Marrow Complete Response (mCR)	5.60 months Interval 4.14 to NA: with the small sample size and limited follow-up, the survival curve just barely reached the median, so a finite CI upper limit could not be reached.	—

SECONDARY outcome

Timeframe: up to approx. 23 months

Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) comprises all participants who received at least one dose of study treatment. Analysis is based on participants with CR, mCR, PR or HI.

The duration of response was derived for participants treated with sabatolimab at the higher dose who achieved HI or better as per investigator assessment and is defined from the first occurrence of complete response (CR), marrow complete response (mCR), partial response (PR) or hematologic improvement (HI) until relapse, progression or death due to any reason for the safety run-in part (Cohort 2 (800 mg Q4W)).

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=13 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Duration of Response for Participants Who Achieved Hematologic Improvement (HI) or Better	5.60 months Interval 4.14 to NA: with the small sample size and limited follow-up, the survival curve just barely reached the median, so a finite CI upper limit could not be reached.	—

SECONDARY outcome

Timeframe: up to approx. 23 months

Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) comprises all participants who received at least one dose of study treatment.

Time from start of treatment to disease progression (including transformation to acute leukemia per WHO 2016 classification), relapse from CR or death due to any cause, whichever occurs first for the safety run-in part (Cohort 2 (800 mg Q4W)).

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=15 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Progression-Free Survival (PFS)	6.77 months Interval 3.71 to NA: with the small sample size and limited follow-up, the survival curve just barely reached the median, so a finite CI upper limit could not be reached.	—

SECONDARY outcome

Timeframe: up to approx. 23 months

Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) comprises all participants who received at least one dose of study treatment.

Time from start of treatment to transformation to acute leukemias per investigator assessment \[as defined as ≥ 20% blasts in bone marrow/ peripheral blood (per WHO 2016 classification) or diagnosis of extramedullary acute leukemia or death due to any cause, whichever occurs first for the safety run-in part (Cohort 2 (800 mg Q4W)).

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=15 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Leukemia-Free Survival (LFS)	7.59 months Interval 4.24 to NA: with the small sample size and limited follow-up, the survival curve just barely reached the median, so a finite CI upper limit could not be reached.	—

SECONDARY outcome

Timeframe: up to approx. 23 months

Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) comprises all participants who received at least one dose of study treatment.

Time from start of treatment to lack of reaching CR within the first 6 cycles, relapse from CR or death due to any cause, whichever occurs first for the safety run-in part (Cohort 2 (800 mg Q4W)).

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=15 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Event-Free Survival (EFS)	0.03 months NA: lower and upper limit of 95 Confidence Interval could not be reached because most participants had an EFS event on Day 1 due to treatment failure	—

SECONDARY outcome

Timeframe: Date of start of treatment to date of death due to any reason, for up to approx. 23 months

Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) comprises all participants who received at least one dose of study treatment.

Time from start of treatment to death due to any cause for the safety run-in part (Cohort 2 (800 mg Q4W)).

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=15 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
Overall Survival (OS)	NA months Interval 6.77 to NA: median and upper limit of 95 Confidence Interval could not be reached because of small sample size and limited survival follow up due to study termination of study	—

SECONDARY outcome

Timeframe: throughout study until progressive disease, death or study discontinuation, approx. 3 years

Population: As expansion phase was not opened, there is no data as nothing was analyzed.

Changes in fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue for participants treated with sabatolimab at the higher dose of the expansion part only. Measurements would have been taken via scores from 0 (not at all) to 4 (very much). The higher the score, the better the Quality of Life.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: On-treatment deaths: up to approx. 23 months, post-treatment deaths: up to approx 18 months

Population: All enrolled patients

On-treatment deaths were collected from start of study treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of approx. 23 months. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study treatment to end of study up to approx. 18 months All deaths refer to the sum of on-treatment and post-treatment survival follow-up deaths, up to approx. 23 months

Outcome measures

Outcome measures
Measure	Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) n=5 Participants Part 1 Cohort 1: Safety run-in cohort of a lower dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.	Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) n=15 Participants Part 1 Cohort 2: Safety run-in cohort of a higher dose of sabatolimab in combination with fixed dose of venetoclax and azacitidine.
All Collected Deaths All deaths	1 Participants	6 Participants
All Collected Deaths On-treatment deaths	0 Participants	1 Participants
All Collected Deaths Post-treatment deaths	1 Participants	5 Participants

Adverse Events

Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) - On-treatment

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) - On-treatment

Serious events: 14 serious events

Other events: 15 other events

Deaths: 1 deaths

Sabatolimab (MBG453) 400 mg + AZA + VEN (Part 1 Cohort 1) - Post-treatment Survival Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Sabatolimab (MBG453) 800 mg + AZA + VEN (Part 1 Cohort 2) - Post-treatment Survival Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

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