Ipsen: initiates phase 3 pivotal trial in CHC
(CercleFinance.com) - Exelixis and Ipsen today announced the initiation of COSMIC-312, a phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) versus sorafenib in previously untreated advanced hepatocellular carcinoma (HCC).
The COSMIC-312 multicenter aims to enroll approximately 640 patients at up to 200 sites globally. The co-primary endpoints of the trial are progression-free survival and overall survival. An exploratory arm will also evaluate cabozantinib monotherapy in this first-line setting.
Exelixis is sponsoring COSMIC-312, and Ipsen will co-fund the trial. Ipsen will have access to the results to support potential future regulatory submissions outside the US and Japan. Genentech (Roche Group member), is providing atezolizumab for use in this trial.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The COSMIC-312 multicenter aims to enroll approximately 640 patients at up to 200 sites globally. The co-primary endpoints of the trial are progression-free survival and overall survival. An exploratory arm will also evaluate cabozantinib monotherapy in this first-line setting.
Exelixis is sponsoring COSMIC-312, and Ipsen will co-fund the trial. Ipsen will have access to the results to support potential future regulatory submissions outside the US and Japan. Genentech (Roche Group member), is providing atezolizumab for use in this trial.
Copyright (c) 2018 CercleFinance.com. All rights reserved.