Exelixis, Ipsen report additional Phase II data for cabozantinib in untreated RCC

In September, Exelixis Inc. (NASDAQ:EXEL) and partner Ipsen Group (Euronext:IPN; Pink:IPSEY) reported additional data from the open-label Phase II CABOSUN trial in 157 patients with previously untreated advanced renal cell carcinoma (RCC) showing that first-line treatment with once-daily 60 mg oral cabozantinib (XL184) led to a median progression-free survival (PFS), the primary endpoint, of 8.6 months as assessed by a blinded independent radiology review committee (IRC) vs. 5.3 months for Sutent sunitinib (HR=0.48, 95% CI: 0.31, 0.74, p=0.0008). On a secondary endpoint, cabozantinib led to an objective response rate (ORR) as assessed by an IRC of 20% vs. 9% for Sutent. Cabozantinib non-significantly improved the secondary endpoint of median overall survival (OS) vs. Sutent (26.6 vs. 21.2 months, HR=0.8, 95% CI: 0.53, 1.21, p=0.29). Data were presented at the European Society for Medical Oncology meeting in Madrid.

The partners previously reported that cabozantinib met the primary endpoint of improving median PFS by investigator assessment vs. Sutent (8.3 vs. 5.4 months, p=0.0042). The trial was conducted by the Alliance for Clinical Trials in Oncology (see BioCentury, May 30, 2016)...