FDA approves Merck's KEYTRUDA and KEYTRUDA QLEX for ovarian cancer

The U.S. Food and Drug Administration has approved Merck & Co.'s (NYSE: MRK) KEYTRUDA and KEYTRUDA QLEX in combination with paclitaxel, with or without bevacizumab, for treating adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1, the company announced Monday.

The approval covers patients who have received one or two prior systemic treatment regimens and whose tumors have a Combined Positive Score of at least 1, as determined by an FDA-authorized test.

The approvals are based on results from the Phase 3 KEYNOTE-B96 trial involving 643 patients. In patients whose tumors express PD-L1, the KEYTRUDA regimen reduced the risk of disease progression or death by 28% compared to placebo plus paclitaxel with or without bevacizumab. The treatment also reduced the risk of death by 24%.

Median progression-free survival was 8.3 months for patients receiving the KEYTRUDA combination versus 7.2 months for those receiving placebo. Overall survival was 18.2 months for the KEYTRUDA group compared to 14.0 months for the placebo group.

Of the enrolled patients, 72% had tumors expressing PD-L1, 73% received bevacizumab in the study, and 47% had a platinum-free interval of less than three months.

These mark the first PD-1 inhibitors approved for adults with platinum-resistant ovarian cancer. Serious adverse reactions occurred in 54% of patients receiving the KEYTRUDA regimen, with the most common being pneumonia, urinary tract infection, and adrenal insufficiency.

KEYTRUDA QLEX is a subcutaneous formulation that combines pembrolizumab with berahyaluronidase alfa to enable injection administration rather than intravenous infusion.

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