FDA approves Keytruda and Keytruda Qlex for PD-L1-positive platinum-resistant ovarian cancer

The FDA approved Keytruda and Keytruda Qlex with paclitaxel, with or without bevacizumab, for adults with PD-L1-positive (CPS of 1 or more) platinum-resistant ovarian, fallopian tube or primary peritoneal cancer who have had one or two prior systemic regimens. The approval is based on the KEYNOTE-B96 trial, where the regimen reduced the risk of progression or death by 28% versus placebo plus paclitaxel and met its key secondary endpoint of overall survival. Merck describes these as the first and only PD-1 inhibitors approved for this population.

• Population: PD-L1 CPS of 1 or more, after one or two prior regimens
• Progression-free survival: hazard ratio 0.72; median 8.3 vs 7.2 months
• Overall survival: hazard ratio 0.76; median 18.2 vs 14.0 months
• Covers Keytruda and Keytruda Qlex