Kura provides update on Phase 2 Tipifarnib trial
Kura Oncology announced the presentation of updated preliminary results from its Phase 2 clinical trial of its lead product candidate, tipifarnib, in patients with head and neck squamous cell carcinomas with HRAS mutations. The results are being presented by Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center at the 2018 Multidisciplinary Head and Neck Cancers Symposium, taking place today in Scottsdale, Arizona. Nine patients with HRAS mutant HNSCC had been enrolled in the Phase 2 trial as of the February 8, 2018 data cutoff date. Five out of the six evaluable patients achieved a confirmed, partial response as defined by standard RECIST criteria for an overall response rate of 83%, including durable responses of more than 18 months in two patients. The sixth evaluable patient experienced tumor shrinkage and prolonged disease stabilization. Three additional patients were enrolled since the last update in October 2017, however, none of the three additional patients was evaluable as of the February 8th data cutoff date; two are off study and one was still too early for disease assessment. All patients joined the trial upon progression from at least one line of therapy, including chemotherapy, cetuximab or immune therapy, with patients having experienced a median of two prior therapies. Response rates for the three agents approved for treatment of HNSCC in the second line are in the range of 13-16%, with a median progression-free survival of approximately 2 months and a median overall survival of up to 7.5 months. Tipifarnib was generally well-tolerated in the trial. Adverse events observed are consistent with the known safety profile of tipifarnib. In September 2017, Kura announced that the Phase 2 trial in HRAS mutant HNSCC had achieved its primary efficacy endpoint prior to the completion of enrollment. The trial protocol required four confirmed, partial responses, per RECIST 1.1 criteria, out of 18 patients to meet its primary endpoint.