Ziftomenib + venetoclax/azacitidine

June 02, 2026 — Kura Oncology and Kyowa Kirin announced publication in Blood of updated results from the relapsed/refractory (R/R) NPM1-mutated acute myeloid leukemia cohort of the Phase 1a/b KOMET-007 trial (NCT05735184) evaluating ziftomenib plus venetoclax/azacitidine (ven/aza). In 64 response-evaluable patients (data cutoff Jan 16, 2026; 55% previously exposed to venetoclax), responses were rapid (median time to composite complete remission [CRc] 3.9 weeks) and nearly two-thirds achieved clinically meaningful deep/durable responses.

At the recommended ziftomenib dose (600 mg QD), venetoclax-naïve patients had 87% ORR (20/23) and 70% CRc (16/23); 75% of CRc responders were centrally MRD-negative (<0.01%), median CRc duration was 9.2 months, and median overall survival was not reached after 10.7 months’ median follow-up. Venetoclax-experienced patients had 48% ORR (12/25) and 24% CRc (6/25), with median OS 7.4 months.

Safety (N=67) was described as well tolerated; differentiation syndrome occurred in 3% (2/67) and one ziftomenib-related QTc event resolved without dose changes. Findings support further development of ziftomenib-based combinations, including ongoing Phase 3 KOMET-017 in newly diagnosed NPM1-m and KMT2A-r AML.