| 2016-10-10 05:26:53|
IPSEY, EXEL 05:26 10/10 10/10/16
Ipsen, Exelixis announces results from Phase 2 CABOSUN phase 2 trial
Ipsen (IPSEY) and its partner Exelixis (EXEL) announced detailed results from the CABOSUN randomized phase 2 trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma, or RCC, with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium, or IMDC. In CABOSUN, with a median follow-up of 20.8 months, cabozantinib demonstrated a clinically meaningful and statistically significant 31% reduction in the rate of disease progression or death. The median progression-free survival, or PFS, for cabozantinib was 8.2 months versus 5.6 months for sunitinib, corresponding to a 2.6 months improvement favoring cabozantinib over sunitinib. PFS benefits were independent of IMDC risk group and presence or absence of bone metastases at baseline. The results for sunitinib were in line with a previously published retrospective analysis of 1,174 intermediate- and poor-risk RCC patients from the IMDC database, which documented a median PFS of 5.6 months with a first-line targeted therapy, mainly sunitinib, in this patient population.