- Exelixis (NASDAQ:EXEL) is up 8% premarket on light volume in response to its announcement of positive results from a Phase 2 clinical trial, CABOSUN, assessing CABOMETYX (cabozantinib) compared to Pfizer's (PFE) SUTENT (sunitinib malate) in treatment-naive patients with advanced renal cell carcinoma (RCC). The data were presented at the European Society for Medical Oncology 2016 Annual Meeting in Copenhagen.
- With a median follow-up period of 20.8 months, patients treated with cabozantinib experienced 31% less risk of death or cancer progression (hazard ratio: 0.69) than those treated with sunitinib. Median progression-free survival (PFS) in the cabozantinib cohort was 8.2 months versus 5.6 months for sunitinib. Median overall survival (OS) also favored cabozantinib (30.3 months vs. 21.8 months) as did the objective response rate (ORR) (46% vs. 18%).
- Exelixis plans to submit a supplement New Drug Application (sNDA) with the FDA as soon as feasible.
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CABOMETYX is currently approved in the U.S. for the treatment of RCC. SUTENT is approved in the U.S. for treating gastrointestinal stromal tumors, RCC and pancreatic neuroendocrine tumors.
- The company and commercialization partner Ipsen will host a conference call today at 1:00 pm ET to discuss the data.