Roche in Combo Cancer Therapy Deal
Roche has formed a collaboration with Exelixis, a South San Francisco, California-headquartered biopharmaceutical company, for a Phase Ib dose escalation study to evaluate the safety and tolerability of Exelixis’ cabozantinib, a tyrosine kinase inhibitor indicated for treating advance renal cell carcinoma (RCC), in combination with Roches’ Tecentriq (atezolizumab), an anti-programmed death-L1 immunotherapy approved by the US Food and Drug Adminstration in 2016 for treating locally advanced or metastatic solid tumors.
Under the agreement, Exelixis will sponsor the trial, and Roche will provide atezolizumab, the active ingredient in Tecentriq. Enrollment in the Phase Ib trial is scheduled to begin mid-year 2017. Based on the dose-escalation results, the trial has the potential to enroll up to four expansion cohorts, including a cohort of patients with previously untreated advanced clear cell RCC and three cohorts of urothelial carcinoma.
Ipsen, a Paris-headquartered pharmaceutical company and Exelixis’ global partner for cabozantinib, except in the US and Japan, will participate in this Phase Ib study and have access to the results for potential future development in its territories. Under its February 2016 agreement with Ipsen, Exelixis granted Ipsen an exclusive license for the commercialization and further development of indications for cabozantinib, the active ingredient in Cabometyx, outside of the US, Canada, and Japan. This agreement was amended in December 2016 to include commercialization rights for Ipsen in Canada. Ipsen has also opted in to participate in a Phase III pivotal trial in first-line RCC and will have access to the results to support potential future regulatory submissions.
Takeda, Exelixis’ partner for the drug in Japan, may also participate in these and future studies and have access to the results to support potential future regulatory submissions in their territories, if Takeda opts into its funding obligations under its January 2017 collaboration with Exelixis. Exelixis granted Takeda an exclusive license for the commercialization and further development of cabozantinib indications in Japan.
Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the US. Cabometyx is the tablet formulation of cabozantinib and is available in 20-mg, 40-mg, or 60-mg doses. The FDA approved Cabometyx tablets in April 2016 for treating patients with advanced RCC, and the European Commission approved it for use in the European Union, Norway, and Iceland in September 2016 for the same indication.