Exelixis: IRC confirms cabozantinib improved PFS vs. sunitinib
Exelixis announced that the analysis of the review by a blinded independent radiology review committee, or IRC,has confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival from the CABOSUN randomized phase 2 trial of cabozantinib as compared with sunitinib in patients with previously untreated advanced renal cell carcinoma with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium. Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS. Exelixis remains on target to complete a supplemental New Drug Application for cabozantinib as a treatment of first-line advanced renal cell carcinoma in the third quarter of 2017. CABOSUN was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis' agreement with the National Cancer Institute's Cancer Therapy Evaluation Program. Exelixis and the Alliance cooperative group plan to submit these results for presentation at an upcoming international medical meeting.