On November 5, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that two abstracts highlighting clinical data from the KOMET-007 combination trial of ziftomenib, the Company’s potent and selective menin inhibitor, have been accepted for presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held in San Diego from December 7-10, 2024 (Press release, Kura Oncology, NOV 5, 2024, View Source [SID1234647731]).

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KOMET-007 is a multicenter Phase 1 trial of ziftomenib in combination with standards of care, including cytarabine plus daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The data presented at ASH (Free ASH Whitepaper) will be from the Phase 1a dose-escalation portion of the study, which was conducted in newly diagnosed patients with adverse risk in combination with 7+3 and in relapsed/refractory patients with ven/aza. Notably, all four cohorts in the Phase 1a dose-escalation portion of KOMET-007 have cleared the highest dose and have advanced into the Phase 1b expansion study at 600 mg.

"The growing body of clinical data continue to support a potential best-in-class safety and tolerability profile for ziftomenib, as well as robust and durable activity in combination with standards of care," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "In the relapsed/refractory AML setting, ziftomenib combined with ven/aza is well tolerated and continues to demonstrate encouraging activity in R/R patients, including activity in previously ven-exposed NPM1-m and KMT2A-r patients. No DLTs or ziftomenib-induced QTc prolongation were reported, and events of differentiation syndrome were mitigated in combination."

"In the AML frontline population, we are very encouraged by the safety and tolerability profile and high rates of complete response and MRD negativity as of the abstract’s June 21st data cutoff," Dr. Wilson continued. "We are particularly encouraged by the fact that, in the context of the very challenging 7+3 adverse risk AML patient cohorts, 100% (15/15) of the NPM1-m AML patients and 84% (16/19) of the KMT2A-r patients remained on study as of the data cutoff, approximately one year after study start. These preliminary results support the potential for ziftomenib to transform the standard of care in these high-risk patients. We look forward to sharing a more mature dataset from more than 100 patients, including data from the 600 mg cohorts, in the Phase 1a dose-escalation portion of KOMET-007, at the ASH (Free ASH Whitepaper) Annual Meeting next month."

Session titles and information for the two abstracts are listed below and are now available on the ASH (Free ASH Whitepaper) online itinerary planner.

Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1-m or KMT2A-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007
Session: 616. AML: Investigational Drug & Cellular Therapies: Menin Inhibitors in AML
Date and Time: Saturday, December 7, 2024; 2:00 – 3:30 PM PT
Oral Presentation Time: 2:45 PM PT
Location: San Diego Convention Center, Ballroom 20CD
Publication Number: 214

Ziftomenib Combined with Venetoclax/Azacitidine in Relapsed/Refractory NPM1-m or KMT2A-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET 007
Session: 616. AML: Investigational Drug & Cellular Therapies: Poster II
Date and Time: Sunday, December 8, 2024; 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Halls G-H
Publication Number: 2880

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications/ following presentation at the meeting.