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Kura Oncology Reports Overall Survival Data from Phase 2 Trial of Tipifarnib in HRAS Mutant Head and Neck Squamous Cell Carcinoma
– Median OS of 15.4 months, median PFS of 5.9 months and ORR of 50% observed in recurrent/metastatic HRAS mutant HNSCC – – Outcomes with approved therapies
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– Median OS of 15.4 months, median PFS of 5.9 months and ORR of 50% observed in recurrent/metastatic HRAS mutant HNSCC –\n – Outcomes with approved therapies are poor, with reported median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the second line – – Compelling single-agent activity also observed in HRAS mutant salivary gland cancer and urothelial carcinoma – – Data featured in oral presentation at ASCO20 Virtual Scientific Program – SAN DIEGO, May 29, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced updated clinical outcome data from its RUN-HN study, a Phase 2 open-label, single-arm trial of tipifarnib in patients with HRAS mutant head and neck squamous cell carcinoma (HNSCC) whose disease had progressed after prior therapy. These data are being presented in an oral session at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program, being held May 29-31, 2020. A copy of the presentation is available on Kura's website at www.kuraoncology.com/pipeline/publications. At data cutoff, 21 patients with HRAS mutant HNSCC were enrolled1, of whom 18 were evaluable for efficacy. Nine of the 18 evaluable patients achieved a confirmed partial response (PR), for an objective response rate (ORR) of 50% (95% CI, 26.0 to 74.0), with a median duration of response of 14.7 months. Median progression-free survival (PFS) was 5.9 months (95% CI, 3.5 to 19.2), compared to 2.8 months on the patients’ last prior therapy. Median overall survival (OS) was 15.4 months (95% CI, 7.0 to 46.4). Patients had a median of two prior lines of therapy (range 0-6). Robust activity was seen despite resistance to chemotherapy, immunotherapy and/or cetuximab. ORR for three FDA-approved therapies for treatment of HNSCC in the second line range from 13-16%, with median PFS of 2-3 months and median OS of 5-8 months. “It’s encouraging to see robust overall survival data for tipifarnib, which demonstrate a potentially meaningful development for HNSCC patients with HRAS mutations in the advanced setting,” said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the study. “These data add to the body of evidence emerging for tipifarnib in second...