Kura Oncology and Kyowa Kirin Report Strong Results from KOMET-007 Trial of Ziftomenib in Newly Diagnosed AML Patients

Kura Oncology and Kyowa Kirin announced positive results from the KOMET-007 trial of ziftomenib combined with chemotherapy in newly diagnosed AML patients, showing high complete remission rates of 93% for NPM1-m and 89% for KMT2A-r patients, along with significant rates of measurable residual disease negativity and a well-tolerated safety profile. These findings support the potential of ziftomenib as a frontline treatment, with Phase 3 trials expected to begin in late 2025; however, the timeline for broader regulatory approval remains uncertain. Kura will host a virtual investor event on June 18, 2025, to discuss these results and future development plans.

Analysis

Kura Oncology (KURA) and Kyowa Kirin reported highly encouraging clinical data from the KOMET-007 Phase 1a/1b trial, where ziftomenib combined with standard chemotherapy demonstrated substantial efficacy in newly diagnosed acute myeloid leukemia (AML) patients. Specifically, the combination achieved composite complete remission (CRc) rates of 93% in NPM1-mutant (NPM1-m) and 89% in KMT2A-rearranged (KMT2A-r) AML patients, with corresponding measurable residual disease (MRD) negativity in 71% and 88% of responding patients, respectively. The treatment was well-tolerated, showing no additive myelosuppression, and a high percentage of patients (96% NPM1-m, 88% KMT2A-r) remain alive and on study. These results signify a potential advancement in frontline AML treatment, addressing a significant unmet need. The progression towards pivotal Phase 3 trials (KOMET-017-IC and NIC), expected to commence in late 2025, further underscores this potential. Additionally, the FDA has accepted a New Drug Application for ziftomenib for relapsed/refractory NPM1-m AML, with a PDUFA target action date of November 30, 2025, indicating regulatory progress for ziftomenib in another AML setting. However, a timeline for broader regulatory approval or commercialization for the newly diagnosed indication post the Phase 3 trials remains undefined, introducing an element of uncertainty. Contrasting the positive clinical news, KURA insiders have exclusively sold stock in the past six months, with 17 sales and zero purchases reported, involving key executives such as the Chief Legal Officer, Chief Medical Officer, and SVP of Finance & Accounting. Hedge fund activity presents a mixed picture: while 101 institutional investors added KURA shares, 122 decreased their positions in the most recent quarter. Notably, Deerfield Management and Paradigm Biocapital Advisors fully exited their substantial positions in Q4 2024, and Avoro Capital Advisors did so in Q1 2025, whereas BVF Inc/IL significantly increased its stake by 202% in Q1 2025 and Suvretta Capital Management also added substantially.

Key Decisions for Investors

• Investors should view the KOMET-007 trial results as a significant positive catalyst for Kura Oncology, demonstrating ziftomenib's strong potential in frontline AML treatment, but weigh this against the considerable insider selling activity.
• Monitor the initiation and progress of the KOMET-017 Phase 3 trials scheduled for late 2025 and the upcoming PDUFA date of November 30, 2025, for ziftomenib in R/R NPM1-m AML, as these are key near-term inflection points.
• Consider the mixed institutional ownership changes, noting both large divestitures and significant new investments, as a sign of divergent views on valuation and future prospects pending further data and regulatory clarity.
• Pay close attention to Kura Oncology's virtual investor event on June 18, 2025, for further details on ziftomenib's development strategy, potential timelines, and management's perspective on the clinical data and market opportunity.