Trial Outcomes & Findings for Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes (NCT NCT02281084)

Last Updated: 2024-10-04

Results Overview

The overall response rate (ORR) was defined as the percentage of participants who achieved an objective response including: hematologic improvement (HI), partial remission (PR), complete remission (CR), or marrow complete remission (mCR). Hematologic response was defined as: • CR: ≤ 5% myeloblasts with normal maturation of all cell lines; peripheral blood (PB) shows: hemoglobin ≥11 g/dL, neutrophils ≥1.0x10\^9/L, platelets ≥100x10\^9/dL, blasts (0%) • PR: same as CR bone marrow (BM) shows blasts decreased by ≥ 50% over pre-treatment but still \> 5%; cellularity and morphology not relevant • mCR: BM: ≤ 5% myeloblasts and decrease by ≥ 50% over pre-treatment PB, PB: if HI responses, noted in addition to mCR • HI: HI erythroid response (HI-E); HI neutrophil response (HI-N) ; HI platelet response (HI-P)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

Response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for SD/PD for oral AZA arms respectively, and 1.84 months for AZA and Durva SD/PD arms

Results posted on

2024-10-04

Participant Flow

Participants were randomized at 33 sites globally. The sites were located in: Australia (3), Europe (18) and the United States (12).

Participants were eligible who did not respond to an adequate course of therapy with an injectable hypomethylating agent (iHMA - azacitidine or decitabine) or were unable to tolerate an iHMA following at least 3 months of attempted treatment.

Participant milestones

Participant milestones
Measure	Stable Disease (SD) Cohort: Oral Azacitidine Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Overall Study STARTED	32	22	6	5
Overall Study COMPLETED	3	1	1	0
Overall Study NOT COMPLETED	29	21	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Stable Disease (SD) Cohort: Oral Azacitidine Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Overall Study Death	21	18	3	5
Overall Study Adverse Event	1	0	0	0
Overall Study Withdrawal by Subject	2	2	0	0
Overall Study Site Closure by Sponsor	5	1	2	0

Baseline Characteristics

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=6 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Total n=65 Participants Total of all reporting groups
Age, Continuous	73.9 Years STANDARD_DEVIATION 7.62 • n=5 Participants	75.1 Years STANDARD_DEVIATION 7.56 • n=7 Participants	70.0 Years STANDARD_DEVIATION 7.21 • n=5 Participants	72.4 Years STANDARD_DEVIATION 5.55 • n=4 Participants	73.9 Years STANDARD_DEVIATION 7.42 • n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	15 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	46 Participants n=21 Participants
Race/Ethnicity, Customized White	28 Participants n=5 Participants	18 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	57 Participants n=21 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Not Collected or Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	30 Participants n=5 Participants	21 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	60 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Myelodysplastic Syndrome (MDS) World Health Organization Classification 2008 Refractory Anemia (RA) with Ringed Sideroblasts	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Myelodysplastic Syndrome (MDS) World Health Organization Classification 2008 Refractory Cytopenia with Multilineage Dysplasia	11 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	14 Participants n=21 Participants
Myelodysplastic Syndrome (MDS) World Health Organization Classification 2008 RA With Excess Blasts-1 (RAEB-1)	10 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	19 Participants n=21 Participants
Myelodysplastic Syndrome (MDS) World Health Organization Classification 2008 RA With Excess Blasts-2 (RAEB-2)	8 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	26 Participants n=21 Participants
Myelodysplastic Syndrome (MDS) World Health Organization Classification 2008 MDS Unclassified (MDS-U)	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Myelodysplastic Syndrome (MDS) World Health Organization Classification 2008 MDS Associated with Isolated del (5q)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Myelodysplastic Syndrome (MDS) World Health Organization Classification 2008 Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
International Prognostic Scoring System Risk Classification Low (0)	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
International Prognostic Scoring System Risk Classification Intermediate 1 (0.5-1.0)	12 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	20 Participants n=21 Participants
International Prognostic Scoring System Risk Classification Intermediate (2) (1.0-2.0)	7 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	20 Participants n=21 Participants
International Prognostic Scoring System Risk Classification High (2) (≥ 2.5)	8 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	18 Participants n=21 Participants
International Prognostic Scoring System Risk Classification Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
French-American-British (FAB) Classification Refractory Anemia (RA)	6 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
French-American-British (FAB) Classification Refractory Anemia with Ringed Sideroblasts (RARS)	6 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
French-American-British (FAB) Classification Refractory Anemia with Excess Blasts (RAEB)	17 Participants n=5 Participants	16 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	42 Participants n=21 Participants
French-American-British (FAB) Classification RAEB in Transformation	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
French-American-British (FAB) Classification Chronic Myelomonocytic Leukemia (CMML)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
French-American-British (FAB) Classification Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Time Since Initial Diagnosis of MDS	26.79 months STANDARD_DEVIATION 29.678 • n=5 Participants	26.97 months STANDARD_DEVIATION 33.835 • n=7 Participants	40.20 months STANDARD_DEVIATION 61.663 • n=5 Participants	23.51 months STANDARD_DEVIATION 30.524 • n=4 Participants	27.84 months STANDARD_DEVIATION 34.266 • n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 (Fully active)	5 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	16 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 (Restricted but Ambulatory)	22 Participants n=5 Participants	13 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	41 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 2 (Ambulatory But Unable to Work)	5 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 3 (Limited Self-Care)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 4 (Completely Disabled)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 5 (Death)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Baseline Platelet Transfusion Status Dependent	4 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Baseline Platelet Transfusion Status Independent	25 Participants n=5 Participants	13 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	48 Participants n=21 Participants
Baseline Platelet Transfusion Status Other	3 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Baseline Red Blood Cell (RBC) Transfusion Status Dependent	8 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	17 Participants n=21 Participants
Baseline Red Blood Cell (RBC) Transfusion Status Independent	8 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	19 Participants n=21 Participants
Baseline Red Blood Cell (RBC) Transfusion Status Other	16 Participants n=5 Participants	9 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	29 Participants n=21 Participants
Average Red Blood Cell (RBC) Transfusion Requirement	4.00 units per 56 days n=5 Participants	3.50 units per 56 days n=7 Participants	3.00 units per 56 days n=5 Participants	4.00 units per 56 days n=4 Participants	4.00 units per 56 days n=21 Participants

PRIMARY outcome

Timeframe: Response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for SD/PD for oral AZA arms respectively, and 1.84 months for AZA and Durva SD/PD arms

Population: The intent-to-treat (ITT) population included all enrolled participants who received at least one dose of investigational product (IP).

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=6 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Overall Response Rate Based on the Modified International Working Group (IWG) 2006 Response Criteria for Myelodysplastic Syndrome (MDS)	6.3 Percentage of Participants Interval 0.8 to 20.8	4.5 Percentage of Participants Interval 0.1 to 22.8	16.7 Percentage of Participants Interval 0.4 to 64.1	0 Percentage of Participants Could not be estimated as there were 0 responders.

SECONDARY outcome

Timeframe: From first dose till death due to any cause (Up to 91 months)

Population: The ITT population included all enrolled participants who received at least one dose of IP.

Overall survival (OS) was defined as the time from randomization to death from any cause, and was calculated using date of first dose and date of death, or date of last follow-up for censored subjects.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=6 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Kaplan-Meier Estimate of Overall Survival	17.00 Months Interval 10.03 to 24.99	6.28 Months Interval 4.5 to 15.19	14.70 Months Interval 1.58 to Not calculated due to insufficient number of events	14.56 Months Interval 9.73 to Not calculated due to insufficient number of events

SECONDARY outcome

Population: The ITT population included all enrolled participants who received at least one dose of IP.

Time to onset of first response was defined as the time between the date of first investigational product (IP) dose and the earliest date any response (CR, PR, mCR, or HI) was first observed. Participants who did not achieve any defined response during the treatment period were censored at the date of treatment discontinuation, disease progression, or death, whichever occurred first. Best response is the best recorded response or treatment outcome from the start of the study treatment until the end of the study treatment taking into account the requirements for confirmation of response.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=6 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Kaplan Meier Estimate of Time to Onset of First and Best Response Onset of First Response	NA Months Interval 10.85 to Could not be estimated due to the insufficient number of events.	11.97 Months Could not be estimated due to the insufficient number of events.	NA Months Interval 1.64 to Could not be estimated due to the insufficient number of events.	NA Months Could not be estimated due to the insufficient number of events.
Kaplan Meier Estimate of Time to Onset of First and Best Response Onset of Best Response	3.68 Months Interval 2.1 to Could not be estimated due to the insufficient number of events.	4.41 Months Interval 1.68 to Could not be estimated due to the insufficient number of events.	3.29 Months Interval 1.64 to Could not be estimated due to the insufficient number of events.	2.17 Months Interval 1.64 to Could not be estimated due to the insufficient number of events.

SECONDARY outcome

Population: The ITT population included all enrolled participants who received at least one dose of IP; participants who achieved a response.

Duration of hematologic response and/or improvement was defined as the time from the date response or improvement was first observed to the date of documented relapse or disease progression as defined by the modified IWG 2006 criteria. Particpants who maintained hematologic response and/or improvement through the end of the treatment period were censored as the date of treatment discontinuation or death, whichever occurred first.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=3 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=2 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=1 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Kaplan Meier Estimate of Duration of First Response	NA Months Interval 9.24 to Could not be estimated due to the insufficient number of events.	NA Months Could not be estimated due to the insufficient number of events.	NA Months Could not be estimated due to the insufficient number of events.	—

SECONDARY outcome

Population: The ITT population included all enrolled participants who received at least one dose of IP; participants who achieved a best response.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=6 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Kaplan Meier Estimate of Duration of Best Response	NA Months Interval 9.24 to Could not be estimated due to the insufficient number of events.	NA Months Could not be estimated due to the insufficient number of events.	NA Months Could not be estimated due to the insufficient number of events.	NA Months Could not be estimated due to the insufficient number of events.

SECONDARY outcome

Timeframe: From first dose to the first documented progressive disease (PD), relapse, or death due to any cause (Up to 91 months)

Population: The ITT population included all enrolled participants who received at least one dose of IP.

Progression-free survival is defined as the time from first dose to the first documented progressive disease (PD), relapse, or death due to any cause during or after the treatment period, whichever occurred first, according to IWG 2006 response criteria for MDS. Participants who were still alive and progression-free were censored at the date of their last response assessment. Progressive disease is defined as follows: - an increase in BM blasts relative to nadir: •If nadir less than 5% blasts: ≥ 50% increase in blasts to \> 5% blasts •If nadir 5% - 10% blasts: ≥ 50% increase in blasts to \> 10% blasts •If nadir 10% - 20% blasts: ≥ 50% increase in blasts to \> 20% blasts •If nadir 20% - 30% blasts: ≥ 50% increase in blasts to \> 30% blasts And any of the following: •At least 50% decrement from maximum remission/response levels in granulocytes or platelets •Reduction in Hgb concentration by ≥ 2 g/dL •Transfusion dependence

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=6 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Kaplan-Meier Estimate of Progression Free Survival (PFS)	14.86 Months Interval 9.27 to 24.99	6.28 Months Interval 4.5 to 15.19	14.70 Months Interval 1.58 to Could not be estimated due to the insufficient number of events.	12.10 Months Interval 2.17 to Could not be estimated due to the insufficient number of events.

SECONDARY outcome

Population: Includes participants who had progressive disease at baseline who achieved stable disease.

A participant was considered as having a stable disease if the disease neither responded nor progressed during or after study treatment.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Percentage of Participants With Progressive Disease at Baseline Who Achieved Stable Disease	—	36.4 Percentage of Participants	—	20.0 Percentage of Participants

SECONDARY outcome

Population: Includes all participants in the ITT population with progressive disease at baseline and achieved stable disease; those who didn't achieve SD or better were censored.

A participant was considered as having a stable disease if the disease neither responded nor progressed during or after study treatment.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Kaplan-Meier Estimate of Onset to Achieve Stable Disease	—	NA Months Interval 1.74 to Could not be estimated due to the insufficient number of events	—	NA Months Interval 1.64 to Could not be estimated due to the insufficient number of events

SECONDARY outcome

Population: The population includes participants who achieved stable disease as their best response.

The duration of stable disease was defined as the time between any two observations of objective disease progression (modified IWG criteria), starting from the first day of dosing with IP. Participants who maintained stable disease through the end of the treatment period were censored at the date of study termination.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Kaplan-Meier Estimate of Duration of Stable Disease	NA Months Interval 10.85 to Could not be estimated due to the low number of events.	NA Months Interval 10.16 to Could not be estimated due to the low number of events.	—	NA Months Could not be estimated due to the low number of events.

SECONDARY outcome

Timeframe: From first dose and until death, loss to follow-up, withdrawal of consent for further data collection (Up to 91 months)

Population: The ITT population included all enrolled participants who received at least one dose of IP.

For all participants who received at least one dose of study drug, continuous monitoring for progression to AML occurred in the post treatment follow up period.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=6 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Percentage of Participants Who Progressed to Acute Myelogenous Leukemia (AML)	31.3 Percentage of Participants	18.2 Percentage of Participants	33.3 Percentage of Participants	60.0 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose and until death, loss to follow-up, withdrawal of consent for further data collection (Up to 91 months)

Population: The ITT population included all enrolled participants who received at least one dose of investigational product (IP).

Time to AML progression was defined as the time from the date of first dose of IP until the date the participant had documented progression to AML.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=6 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Kaplan-Meier Estimate of Time to Progression to AML	NA Months Interval 12.89 to Could not be estimated due to the insufficient number of events.	NA Months Interval 8.42 to Could not be estimated due to the insufficient number of events.	21.47 Months Interval 1.68 to Could not be estimated due to the insufficient number of events.	6.21 Months Interval 1.64 to Could not be estimated due to the insufficient number of events.

SECONDARY outcome

Timeframe: From first dose until 28 days after the last dose of CC-486 (90 days after the last dose of durvalumab) or the last follow up visit, whichever date is later (Up to 91 months)

Population: The safety population included all enrolled participants who received at least 1 dose of IP and had at least 1 post-dose safety assessment.

TEAEs were defined as AEs occurring or worsening on or after the date of the first dose of oral aza or durva and within 28 days after last dose of oral aza or 90 days after last dose of durva A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.

Outcome measures

Outcome measures
Measure	Stable Disease (SD) Cohort: Oral Azacitidine n=32 Participants Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease (PD) Cohort: Oral Azacitidine n=22 Participants Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Stable Disease Cohort: Oral Azacitidine and Durvalumab n=6 Participants Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.	Progressive Disease Cohort: Oral Azacitidine and Durvalumab n=5 Participants Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE	32 Participants	22 Participants	6 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Related to (R/T) Oral Azacitidine (AZA)	28 Participants	20 Participants	6 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE R/T Durvalumab (Durva)	0 Participants	0 Participants	5 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE R/T Oral AZA or Durva	28 Participants	20 Participants	6 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 Serious TEAE	25 Participants	15 Participants	4 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 Serious TEAE R/T Oral AZA	4 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 Serious TEAE R/T Durva	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 Serious TEAE R/T Oral AZA or Durva	4 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 NCI CTC Grade (GR) 3 or 4 TEAE	32 Participants	19 Participants	5 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 NCI CTC GR 3 or 4 TEAE R/T Oral AZA	18 Participants	10 Participants	4 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 NCI CTC GR 3 or 4 TEAE R/T Durva	0 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 NCI CTC GR 3 or 4 TEAE R/T AZA or Durva	18 Participants	10 Participants	4 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to Death	4 Participants	4 Participants	2 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to Death R/T Oral AZA	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to Death R/T Durva	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to Death R/T AZA or Durva	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to Dose Reduction of AZA	10 Participants	8 Participants	1 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to Reduction of Durva	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to Reduction of AZA or Durva	10 Participants	8 Participants	1 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥1 TEAE Leading to Interruption of AZA	21 Participants	13 Participants	3 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥1 TEAE Leading to Interruption of Durva	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥1 TEAE Leading to Interruption of AZA or Durva	21 Participants	13 Participants	3 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to Discontinuation (D/C) of AZA	15 Participants	8 Participants	4 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to D/C of Durva	0 Participants	0 Participants	3 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ 1 TEAE Leading to D/C of AZA or Durva	15 Participants	8 Participants	4 Participants	4 Participants

Adverse Events

Stable Disease (SD) Cohort: Oral Azacitidine

Serious events: 25 serious events

Other events: 32 other events

Deaths: 22 deaths

Progressive Disease (PD) Cohort: Oral Azacitidine

Serious events: 15 serious events

Other events: 22 other events

Deaths: 18 deaths

Stable Disease Cohort: Oral Azacitidine and Durvalumab

Serious events: 4 serious events

Other events: 6 other events

Deaths: 3 deaths

Progressive Disease Cohort: Oral Azacitidine and Durvalumab

Serious events: 5 serious events

Other events: 5 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER