Ipsen and its partner Exelixis announce independent radiology committee review confirms results from Phase 2 CABOSUN trial of cabozantinib versus sunitinib in previously untreated advanced renal cell carcinoma
IRC confirms cabozantinib significantly improved progression-free survival compared to sunitinib
E.U. regulatory submission remains on track for Q3 2017
Ipsen (Euronext: IPN; ADR: IPSEY) and its partner Exelixis (NASDAQ:EXEL) today announced that the analysis of the review by a blinded independent radiology review committee (IRC) has confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS) from the CABOSUN randomized Phase 2 trial of cabozantinib as compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). 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. Ipsen remains on track to submit the regulatory dossier for cabozantinib as a treatment for first-line advanced renal cell carcinoma in Europe 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 (NCI-CTEP). Exelixis and the Alliance cooperative group plan to submit these results for presentation at an upcoming international medical meeting.
David Meek, Ipsen’s Chief Executive Officer stated: “Following the European commission approval of cabozantinib in second line advanced RCC, cabozantinib has demonstrated clinical benefit in patients with advanced RCC in the first-line setting. With our partner Exelixis, we are very pleased that CABOSUN’s primary endpoint of a statistically significant improvement of progression-free survival has been confirmed by the independent radiology review committee in patients with previously untreated advanced intermediate- or poor-risk RCC. We intend to file these important data with European regulatory authorities in the third quarter of 2017.”