Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer

22 May 2018

Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.

Despite a US FDA announcement about decreased survival with Merck & Co. Inc.’s Keytruda (pembrolizumab) and Genentech Inc.’s Tecentriq (atezolizumab) in certain first-line urothelial cancer patients, the immune checkpoint inhibitors’ accelerated approvals in this indication do not appear to be at risk, at least for the time being.

In a May 18 alert targeted to healthcare professionals and clinical investigators, FDA announced that in two ongoing first-line studies...