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FDA Warns Against Single-Agent Checkpoint Inhibition for PD-L1-Low Untreated Urothelial Carcinoma

Silas Inman @silasinman
Published: Saturday, May 19, 2018

The FDA has issued a drug safety notification warning against the use of frontline single-agent immune checkpoint inhibition for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma, following a demonstration of lower overall survival with pembrolizumab (Keytruda) and atezolizumab (Tecentriq) compared with platinum-based chemotherapy.

the ORR was 23%, with a CR rate of 9%. In PD-L1 assessment via tumor infiltrating immune cell (IC), the ORR was 21% in those with an IC0 score and 21% in those with an IC1 score. ORR was 28% in the IC2/3 group and 24% across all PD-L1–positive groups (IC1/2/3).

The FDA alert highlighted an overall lack of efficacy in the PD-L1–low expressing group in the frontline setting, regardless of platinum eligibility, according to Alison Birtle, MB BS, MD. Although there were not comparator arms in the KEYNOTE-052 and IMvigor210 studies, the phase II/III EORTC 30986 study showed higher ORRs for gemcitabine and carboplatin for patients with advanced platinum-ineligible urothelial carcinoma.4 The ORR in this study was 41.2% with gemcitabine/carboplatin.

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