Merck Secures FDA Approval for KEYTRUDA Ovarian Cancer Regimen, Cuts Progression 28%
Merck gained FDA approval for KEYTRUDA and KEYTRUDA QLEX with paclitaxel, ± bevacizumab, as second- or third-line therapy for adults with PD-L1+ platinum-resistant epithelial ovarian and related carcinomas. The Phase 3 KEYNOTE-B96 trial showed the regimen reduced progression or death risk by 28% and mortality by 24% versus control.
1. FDA Approval Details
Merck’s FDA approvals cover KEYTRUDA and KEYTRUDA QLEX plus paclitaxel, with or without bevacizumab, for adult patients with PD-L1 positive platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma after one or two prior systemic regimens. These approvals mark the first PD-1 inhibitors authorized in this indication.
2. Phase 3 KEYNOTE-B96 Trial Results
The Phase 3 KEYNOTE-B96 study demonstrated that the KEYTRUDA regimen lowered the risk of disease progression or death by 28% and reduced mortality risk by 24% compared to placebo plus paclitaxel with or without bevacizumab. KEYTRUDA QLEX’s efficacy and safety aligned closely with original KEYTRUDA in comparative pharmacokinetic analyses (MK-3475A-D77).
3. Implications and Patient Impact
This expanded indication positions Merck as the only PD-1 inhibitor available for this treatment-resistant ovarian cancer cohort, potentially addressing a patient population with limited options. Commercial rollout is expected to drive incremental revenue as eligible patients seek targeted immunotherapy after platinum-based regimen failures.