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Kura Oncology Announces Positive Phase 2 Trial of Tipifarnib in HRAS Mutant Urothelial Carcinoma
– Confirmed objective responses achieved in five of 13 evaluable patients –
– Primary endpoint met prior to completion of enrollment with four patients experiencing progression-free survival greater than 6 months –
–Proof-of-concept trial sponsored by Samsung Medical Center in Seoul, Korea –
– Full data to be presented at a future medical meeting –
SAN DIEGO, Sep. 3, 2019 – Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced positive topline results from an investigator-sponsored Phase 2 trial of its lead drug candidate, tipifarnib, in patients with relapsed or refractory urothelial carcinomas that carry HRAS mutations.
The ongoing, single-agent,single-arm trial is designed to enroll at least 18 patients, with a primary endpoint of progression-free survival (PFS) rate at 6 months. Secondary endpoints include objective response rate, duration of response and safety. The trial is being conducted at the Samsung Medical Center in Korea.
To date, more than 200 patients with relapsed or refractory urothelial carcinoma have been screened for the presence of tumor HRAS mutations. A total of 15 patients were identified to carry tumors with HRAS mutations. Two patients withdrew from the trial prior to their first response assessment. Of the 13 evaluable patients, five experienced confirmed objective responses, according to RECIST 1.1 criteria, for an overall response rate of 38%. Notably, four patients have experienced PFS of greater than 6 months. According to the trial protocol, the primary endpoint is met when at least four patients achieve PFS at 6 months.
“Although the treatment paradigm for advanced urothelial carcinoma has evolved with the introduction of checkpoint inhibitors, there remains a need for more precise and effective treatment options for these patients,” said Se Hoon Park, M.D., Ph.D., Samsung Medical Center, principal investigator for the trial. “These biomarker-driven data in patients with relapsed or refractory urothelial carcinoma are promising and further underscore the potential for tipifarnib in HRAS mutant solid tumors.”