- KEYTRUDA plus paclitaxel with or without bevacizumab showed a statistically significant improvement in overall survival in the KEYNOTE-B96 trial.
- The trial enrolled 643 patients with platinum-resistant recurrent ovarian cancer, regardless of PD-L1 status.
- KEYTRUDA regimen reduced the risk of death by 18% and disease progression by 27% in the all comers population.
- The European Medicines Agency's CHMP recommended approval for KEYTRUDA in combination with paclitaxel for certain ovarian cancer patients.
Trial Results
The Phase 3 KEYNOTE-B96 trial demonstrated that KEYTRUDA, combined with paclitaxel with or without bevacizumab, significantly improved overall survival (OS) in patients with platinum-resistant recurrent ovarian cancer. This improvement was observed regardless of PD-L1 status, marking a notable advancement in treatment options.
Study Design
The trial, also known as ENGOT-ov65, was a multicenter, randomized, double-blind, placebo-controlled study. It enrolled 643 patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, who had received one or two prior lines of systemic therapy, including at least one line of platinum-based chemotherapy. Patients were randomized to receive either the KEYTRUDA regimen or a placebo, with the option to include bevacizumab based on investigator choice.
Key Findings
In the all comers population, the KEYTRUDA regimen reduced the risk of death by 18% and disease progression by 27% compared to the control group. For patients whose tumors expressed PD-L1 (CPS ≥1), the regimen reduced the risk of death by 24%. The median overall survival for patients receiving the KEYTRUDA regimen was 17.7 months, compared to 14.0 months for the control group.
Regulatory Approvals
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of KEYTRUDA in combination with paclitaxel, with or without bevacizumab, for treating platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults with PD-L1 expressing tumors. The U.S. FDA has also approved this regimen for similar indications based on the trial's findings.
