SAN DIEGO and TOKYO - Kura Oncology, Inc. (NASDAQ:KURA) and Kyowa Kirin Co., Ltd. (TSE:4151), a $11.5 billion market cap pharmaceutical company currently trading below its InvestingPro Fair Value, have reported positive interim results from the KOMET-007 Phase 1 trial, evaluating ziftomenib in combination with standard treatments for acute myeloid leukemia (AML). The trial showed a 100% complete remission (CR) rate for patients with newly diagnosed NPM1-mutant (NPM1-m) AML and an 83% CR rate for those with newly diagnosed KMT2A-rearranged (KMT2A-r) AML when treated with a combination of ziftomenib and cytarabine/daunorubicin (7+3).
The data, presented at the 2024 American Society of Hematology (ASH) Annual Meeting, also indicated that ziftomenib, when combined with venetoclax/azacitidine (ven/aza), was effective in relapsed/refractory (R/R) AML patients, including those previously treated with venetoclax. In this cohort, the overall response rate (ORR) was 68% for NPM1-m patients.
Patients in the trial tolerated ziftomenib well, with manageable side effects and no discontinuations due to differentiation syndrome (DS). The Phase 1b expansion of the trial is currently enrolling patients at a dose of 600 mg across all cohorts.
As of the data cutoff on October 1, 2024, survival rates were high, with all patients with NPM1-m and 96% of those with KMT2A-r AML alive following a median follow-up of 31 and 19 weeks, respectively.
The findings have encouraged Kura Oncology and Kyowa Kirin to announce plans for KOMET-017, a pivotal Phase 3 study set to begin in mid-2025, which will further evaluate ziftomenib in combination with standard care for adults with newly diagnosed KMT2A-r or NPM1-m AML. Kyowa Kirin brings strong financial fundamentals to this partnership, with a healthy 9.9% revenue growth in the last twelve months and an overall GOOD financial health score according to InvestingPro metrics.
The companies aim to address the significant unmet medical need in AML, particularly for patients with NPM1 mutations who have poor survival outcomes upon relapse. The data suggests that ziftomenib could potentially improve current standards of care for AML patients. With Kyowa Kirin trading at a P/E ratio of 15.9 and maintaining strong profit margins, InvestingPro subscribers can access over 20 additional financial metrics and exclusive insights about the company's growth potential.
The information is based on a press release statement from Kura Oncology, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.