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
– Full data to be presented at a future medical meeting –
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
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.,
All patients joined the trial upon progression from at least one prior systemic chemotherapy cycle, with a median of one prior therapy. Tipifarnib has been generally well-tolerated in the trial; adverse events observed are consistent with the known safety profile of tipifarnib. Further analyses of the trial are ongoing, and detailed data are expected to be presented at a future medical meeting.
“We are very encouraged to see that this investigator-sponsored trial in HRAS mutant urothelial carcinoma met its primary endpoint prior to the completion of enrollment,” said
About Urothelial Carcinoma
Urothelial carcinoma, also known as transitional cell carcinoma, develops from urothelial cells that line the inside of the bladder. Urothelial carcinoma accounts for 90 percent of all bladder cancers, and can also arise in the renal pelvis and ureters.
Kura Oncology’s lead drug candidate, tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen in
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Kura’s product candidate tipifarnib, the market potential for tipifarnib, and progress and expected timing of Kura’s drug development programs and clinical trials. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the
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Source: Kura Oncology, Inc.