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Kura Oncology Announces Publication of Tipifarnib Phase 2 Data in Journal of Clinical Oncology
– Phase 2 RUN-HN trial showed ORR of 55%, median PFS of 5.6 months and median OS of 15.4 months in recurrent/metastatic HRAS mutant HNSCC – – Statistically
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– Phase 2 RUN-HN trial showed ORR of 55%, median PFS of 5.6 months and median OS of 15.4 months in recurrent/metastatic HRAS mutant HNSCC – – Statistically significant improvement in median PFS compared with median PFS of 3.6 months on last prior therapy (p=0.0012) – – Safety profile consistent with previously published data for tipifarnib – – Results support continuation of AIM-HN registration-directed trial in HRAS mutant HNSCC – SAN DIEGO, March 22, 2021 (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 the publication of results 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. The paper, titled “Tipifarnib in Head and Neck Squamous Cell Carcinoma with HRAS Mutations,” was published online in the Journal of Clinical Oncology earlier today. As of the April 10, 2020 data cutoff, a total of 22 HNSCC patients with high HRAS mutant variant allele frequency1 were enrolled, of whom 20 were evaluable for response. Eleven of the 20 evaluable patients met RECIST v1.1 criteria for confirmed partial response (PR) and, for an objective response rate (ORR) of 55% (95% CI, 31.5 to 76.9). Median progression-free survival (PFS) of 5.6 months (95% CI, 3.6 to 16.4) on tipifarnib was a statistically significant improvement over the median PFS of 3.6 months (95% CI, 1.3 to 5.2) on last prior therapy (p=0.0012). The median overall survival (OS) was 15.4 months (95% CI, 7.0 to 29.7). Robust activity was seen despite resistance to chemotherapy, immunotherapy and/or cetuximab. The 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. “We are encouraged by the compelling efficacy and safety profile of tipifarnib in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma,” said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the trial. “Importantly, these patients experienced limited benefit on prior therapies, including immunotherapies, which demonstrates the high unmet need ...