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US FDA lifts partial clinical hold on Kura Oncology’s KOMET-001 phase 1b study of KO-539 to treat AML

San Diego
Monday, January 24, 2022, 15:00 Hrs  [IST]

Kura Oncology, Inc., a clinical-stage biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the KOMET-001 phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukaemia (AML). The partial clinical hold was lifted following agreement with the FDA on the company’s mitigation strategy for differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.

“I am very proud of our team for working diligently with the FDA and site investigators to resolve the partial clinical hold in such a timely manner,” said Troy Wilson, Ph.D., J.D., president and chief executive officer of Kura Oncology. “Activities to resume patient screening are underway, and we look forward to expediting enrollment of patients in the phase 1b study and determining the recommended phase 2 dose for KO-539 in the coming months. Meanwhile, we continue to be encouraged by the safety, tolerability and clinical activity observed among currently enrolled patients and look forward to sharing a comprehensive update on the phase 1 study at a future medical meeting.”

KOMET-001 (Kura Oncology Menin Inhibitor Trial) is a phase 1/2, first-in-human, open-label trial to determine the safety, tolerability and anti-tumour activity of KO-539 in patients with refractory or relapsed AML. KO-539 demonstrated a wide therapeutic window in the phase 1a dose-escalation portion of KOMET-001, with promising single-agent activity in an all-comer population of patients with relapsed or refractory AML, including patients with NPM1 mutations and KMT2A rearrangements. The phase 1b portion includes two expansion cohorts – a lower dose of 200 mg and a higher dose of 600 mg. Kura expects to enroll 12 patients with NPM1-mutant or KMT2A-rearranged relapsed or refractory AML in each cohort and assess those patients for safety and tolerability, pharmacokinetics and efficacy to determine the recommended phase 2 dose for KO-539.

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer.


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