COSMIC-021 trial

As part of Ipsen’s ongoing commitment to improve outcomes for patients with high unmet medical needs, we are pleased to announce an update to the COSMIC-021 trial. Our partner, Exelixis, is expanding the protocol for COSMIC-021, the phase 1b trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with locally advanced or metastatic solid tumors.


Following encouraging early efficacy and safety data from the original lung and prostate cancer cohorts in COSMIC-021, this update includes:


  • Original metastatic castration-resistant prostate cancer and immunotherapy-refractory non-small cell lung cancer cohorts expanded to 80 subjects


  • Four cohorts added for metastatic castration-resistant prostate cancer based on encouraging early data


With these additions, the trial now includes 20 expansion cohorts and four exploratory cohorts and aims to enroll up to 1,732 patients with advanced or metastatic solid tumors such as renal cell carcinoma (RCC) and urothelial carcinoma (UC), among others. The primary objective in the expansion stage of this trial remains to determine the objective response rate in each cohort.


Together with Exelixis, we look forward to advancing this potentially pivotal trial to understand whether the combination of cabozantinib and atezolizumab may benefit patients with multiple tumor types.


For further information, Exelixis’ press release is available here

© Ipsen Pharma, 65 Quai Georges Gorse, 92100 Boulogne-Billancourt, France. All rights reserved - 2021