An ongoing phase 1b/2a clinical trial is showing encouraging early results for Nadunolimab combined with azacitidine in patients with high-risk myelodysplastic syndrome (MDS), and with azacitidine plus Venetoclax in relapsed or refractory acute myeloid leukemia (AML).
The investigator-initiated study, conducted at MD Anderson Cancer Center, has completed its phase 1b dose-escalation stage without any dose-limiting toxicities. Researchers are now advancing into the phase 2a expansion phase.
Among six patients enrolled in the high-risk MDS cohort, five were evaluable at the time of analysis. All five achieved complete remission, resulting in a preliminary 100% complete remission rate in this small early-stage group.
Investigators reported that the treatment combinations were generally well tolerated with a manageable safety profile, although full adverse event and hematologic toxicity data have not yet been released.
The study plans to enroll about 40 adult patients with ECOG performance status scores of 0 to 2. Primary goals include confirming safety and determining the recommended phase 2 dose, while secondary objectives focus on efficacy, pharmacokinetics, and biomarker analysis.