Kura Oncology Inc (NASDAQ: KURA) and Kyowa Kirin Co Ltd announced publication of updated results from their KOMET-007 trial evaluating ziftomenib combined with venetoclax and azacitidine in patients with relapsed/refractory NPM1-mutated acute myeloid leukemia.

The study included 64 response-evaluable patients who had received one to eight prior lines of therapy. Among venetoclax-naive patients receiving 600 mg ziftomenib daily, the composite complete remission rate reached 70% with 87% overall response rate. The median duration of composite complete remission was 9.2 months, and median overall survival was not reached after median follow-up of 10.7 months.

In venetoclax-experienced patients at the same dose, composite complete remission rate was 24% with 48% overall response rate. Median overall survival was 7.4 months after median follow-up of 9.9 months.

The combination demonstrated a safety profile consistent with venetoclax and azacitidine alone. Differentiation syndrome occurred in 3% of patients, while one case of ziftomenib-related QT interval prolongation was observed that resolved without dose modification.

Ziftomenib is FDA-approved as monotherapy for adults with relapsed or refractory AML with susceptible NPM1 mutations who have no satisfactory alternative treatment options. The combination with venetoclax and azacitidine remains investigational.

The companies continue evaluating ziftomenib across multiple combination regimens, including ongoing pivotal KOMET-017 Phase 3 trials in newly diagnosed NPM1-mutated and KMT2A-rearranged AML. The information is based on a company press release.