PD-1 Inhibitor Plus Azacitidine and HAG Regimen Demonstrates Promising Activity for R/R Acute Myeloid Leukemia
The combination of a PD-1 inhibitor with azacitidine and a homoharringtonine, cytarabine, and G-CSF (HAG) regimen demonstrated encouraging response rates and manageable toxicity among patients with relapsed/refractory (R/R) acute myeloid leukemia (AML), according to study results.
Researchers at The First Affiliated Hospital of Soochow University conducted a prospective, single-arm phase 2 trial to determine the efficacy and safety of a PD-1 inhibitor combined with azacitidine and HAG therapy among patients with R/R AML from December 2020 to August 2023.
Overall, 20 patients with R/R AML were included. The median age was 50.7 (± 15.3) years. Most patients were male (n=14). Following 1 cycle of After one cycle of PD-1 inhibitor and azacitidine with HAG treatment, the overall response rate (ORR) was 75%. Following 2 cycles, 35% achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi). After treatment with a PD-1 inhibitor and azacitidine with HAG, 8 patients received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
In terms of safety, the most common adverse events were hematologic toxicities, and no grade 5 adverse events were reported.
The researchers concluded, “The combination of PD-1 inhibitor, azacitidine, and the HAG regimen is a feasible and relatively safe treatment option for R/R AML, thus, to be worth further study.”
Source:
Cai CS, Wang RJ, Xu XY, et al. [PD-1 Inhibitor Combined with Azacitidine and HAG Regimen for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia: A Prospective, Single-Arm, Phase II Clinical Study]. PubMed. Published online August 2025. doi:10.19746/j.cnki.issn.1009-2137.2025.04.007
