Merck's KEYTRUDA Approved by FDA for Ovarian Cancer Treatment
Merck announced the FDA approved KEYTRUDA, or pembrolizumab, and KEYTRUDA QLEX, or pembrolizumab and berahyaluronidase alfa-pmph, plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+, as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens. These approvals are based on data from the Phase 3 KEYNOTE-B96 trial, which were presented at the 2025 European Society for Medical Oncology, or ESMO, Congress. Results from the trial showed that KEYTRUDA plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant improvement in progression-free survival, or PFS, reducing the risk of disease progression or death by 28% in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 when compared to placebo plus paclitaxel with or without bevacizumab. In this same population, the KEYTRUDA regimen also demonstrated a statistically significant improvement in overall survival, or OS, reducing the risk of death by 24% compared to placebo plus paclitaxel with or without bevacizumab. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK-3475A-D77 comparing the pharmacokinetic, efficacy, and safety profiles of KEYTRUDA QLEX and KEYTRUDA. In patients whose tumors express PD-L1 the median PFS was 8.3 months for those receiving KEYTRUDA plus paclitaxel, with or without bevacizumab, versus 7.2 months for those receiving placebo plus paclitaxel with or without bevacizumab. The median OS for these patients receiving the KEYTRUDA regimen was 18.2 months versus 14.0 months for those receiving the placebo regimen. Of the 643 enrolled patients, 72% of patients had tumors expressing PD-L1 73% received bevacizumab in the study, and 46% received prior bevacizumab. A total of 47% had a platinum-free interval of less than 3 months. Patients were enrolled regardless of PD-L1 tumor expression status. The safety of KEYTRUDA in combination with paclitaxel with or without bevacizumab was evaluated in 463 patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 enrolled in KEYNOTE-B96. The median duration of exposure to KEYTRUDA was 7.4 months. Serious adverse reactions occurred in 54% of patients receiving KEYTRUDA and paclitaxel with or without bevacizumab. Serious adverse reactions in greater than or equal to2% of patients were pneumonia, urinary tract infection, adrenal insufficiency, hyponatremia, COVID-19, decreased neutrophil count, pulmonary embolism, abdominal pain, anemia, colitis, diarrhea, febrile neutropenia, pyrexia and vomiting. Fatal adverse reactions occurred in 3.9% of patients receiving KEYTRUDA and paclitaxel with or without bevacizumab, including assisted suicide, death, intestinal perforation, sepsis, COVID-19, cardio-respiratory arrest, colitis, and embolic stroke.