Kura Gets FDA Breakthrough Status for Head and Neck Squamous Cell Carcinoma

 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 that its investigational drug, tipifarnib, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (HNSCC) with variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy. Tipifarnib is currently being evaluated in an ongoing registration-directed clinical trial (AIM-HN) in this indication of high unmet need.

HNSCC is the seventh most common cancer worldwide, accounting for more than 885,000 new cases each year. Despite recent treatment advances, prognosis remains poor, with a 5-year survival rate of less than 40%. Second-line treatments provide limited clinical benefit for many patients, with objective response rates (ORR) of 6-16%, median progression-free survival (PFS) of 2-3 months and median overall survival (OS) of 5-8 months.

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