Sandra Horning, MD
The FDA has granted an accelerated approval to atezolizumab (Tecentriq) as a frontline treatment for cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma (mUC), according to Genentech, the manufacturer of the PD-L1 inhibitor.
The treatment-naive IMvigor210 cohort enrolled 123 patients with cisplatin-ineligible locally advanced or mUC at 47 locations in North America and Europe between June 9, 2014, and March 30, 2015. Patients received 1200 mg of atezolizumab IV every 3 weeks until progression. The primary endpoint was ORR, with secondary outcomes measures including progression-free survival (PFS) and overall survival (OS).
Among the 123 patients, 119 received at least 1 dose of atezolizumab. There was an association between tumor mutation load and response. The median PFS and OS were 2.7 months (95% CI, 2.1-4.2) and 15.9 months (95% CI, 10.4 to not estimable), respectively.
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