KENILWORTH (NJ) (dpa-AFX) - Merck & Co Inc. (MRK) on Wednesday said the U.S. Food and Drug Administration has approved Keytruda and Keytruda Qlx, a subcutaneous formulation of Keytruda, in combination with paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1 positive platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one or two prior systemic therapies.
The approvals are based on results from the Phase 3 KEYNOTE-B96 trial. The study showed that Keytruda plus paclitaxel, with or without bevacizumab, significantly improved progression-free survival, reducing the risk of disease progression or death by 28% compared with placebo plus paclitaxel, with or without bevacizumab.
In the same patient population, the Keytruda regimen also demonstrated a statistically significant improvement in overall survival, reducing the risk of death by 24% versus the comparator treatment.
The immunotherapy drug Keytruda is approved to treat multiple types of cancer, including melanoma, non-small cell lung cancer, head and neck squamous cell cancer, and classical Hodgkin lymphoma, among others.
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