A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for higher-risk myelodysplastic syndromes
Open accessAbstract
Azacitidine-mediated hypomethylation promotes tumor cell immune recognition but may increase the expression of inhibitory immune checkpoint molecules. We conducted the first randomized phase 2 study of azacitidine plus the immune checkpoint inhibitor durvalumab vs azacitidine monotherapy as first-line treatment for higher-risk myelodysplastic syndromes (HR-MDS). In all, 84 patients received 75 mg/m2 subcutaneous azacitidine (days 1-7 every 4 weeks) combined with 1500 mg intravenous durvalumab on day 1 every 4 weeks (Arm A) for at least 6 cycles or 75 mg/m² subcutaneous azacitidine alone (days 1-7 every 4 weeks) for at least 6 cycles (Arm B). After a median follow-up of 15.25 months, 8 patients in Arm A and 6 in Arm B remained on treatment. Patients in Arm A received a median of 7.9 treatment cycles and those in Arm B received a median of 7.0 treatment cycles with 73.7% and 65.9%, respectively, completing ≥4 cycles. The overall response rate (primary end point) was 61.9% in Arm A (26 of 42) and 47.6% in Arm B (20 of 42; P = .18), and median overall survival was 11.6 months (95% confidence interval, 9.5 months to not evaluable) vs 16.7 months (95% confidence interval, 9.8-23.5 months; P = .74). Durvalumab-related adverse events (AEs) were reported by 71.1% of patients; azacitidine-related AEs were reported by 82% (Arm A) and 81% (Arm B). Grade 3 or 4 hematologic AEs were reported in 89.5% (Arm A) vs 68.3% (Arm B) of patients. Patients with TP53 mutations tended to have a worse response than patients without these mutations. Azacitidine increased programmed cell death ligand 1 (PD-L1 [CD274]) surface expression on bone marrow granulocytes and monocytes, but not blasts, in both arms. In summary, combining azacitidine with durvalumab in patients with HR-MDS was feasible but with more toxicities and without significant improvement in clinical outcomes over azacitidine alone. This trial was registered at www.clinicaltrials.gov as #NCT02775903.
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IC blockade has been negative to date in high-risk trials including the subset of TP53 mutant patients.
“Although IC blockade has been negative to date in high‐risk trials including the subset of TP53 mutant patients”
From Long‐term follow‐up and combined Phase 2 results of eprenetapopt and azacitidine in patients with <i>TP53</i> mutant MDS/AML (2025) · cites this paper as [50]
The Results (Biomarker analyses; page unavailable) found no significant response advantage from adding durvalumab among patients with TP53 mutations. The Discussion likewise reports no response-rate difference across the higher-risk MDS population. But this paper reports one anti–PD-L1 trial, not negative results across immune-checkpoint blockade trials generally. (LLM, conf=0.86)
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- Authors
- Zeidan, A. M., Boss, I., Beach, C. L., Copeland, W. B., Thompson, E., Fox, B. A., Hasle, V. E., Ogasawara, K., Cavenagh, J., Silverman, L. R., Voso, M. T., Hellmann, A., Tormo, M., O’Connor, T., Previtali, A., Rose, S., & Garcia-Manero, G.
- Affiliations
- Yale Cancer Center (US)
- Bristol-Myers Squibb (United States) (US)
- Bristol Myers Squibb, Princeton, NJ;
- National Health Service (GB)
- Tisch Cancer Institute (US)
- University of Rome Tor Vergata (IT)
- University Clinical Centre (PL)
- Hospital Clínico Universitario de Valencia (ES)
- The University of Texas MD Anderson Cancer Center (US)
- Corresponding author
- Zeidan, Amer M.
- Venue
- Blood Advances
- Publisher
- American Society of Hematology
- Published
- 2022-04-01
- Volume
- 6
- Issue
- 7
- Pages
- 2207-2218
- ISSN
- 2473-9529 (ISSN-L)
- 2473-9537
- PMC
- PMC9006291
- OpenAlex
- W4206198716
- Cited by
- 61
- References
- 28
- Citations by year
- 2026: 10 · 2025: 16 · 2024: 11 · 2023: 13 · 2022: 11
- FWCI
- 5.72
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Blood Advances (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Epigenetics and DNA Methylation
- Keywords
- azacitidine, durvalumab, myelodysplastic syndrome, immune checkpoint inhibitors, first-line therapy, PD-L1 expression, TP53 mutation, overall survival, overall response rate, hematologic adverse events, bone marrow immune cells, combination therapy
- MeSH terms
- Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Azacitidine, Humans, Myelodysplastic Syndromes
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