Merck has announced positive results from its Phase 3 KEYNOTE-B96 trial (ENGOT-ov65), demonstrating significant clinical benefits for patients with platinum-resistant recurrent ovarian cancer. The study met its primary endpoint of progression-free survival (PFS) across all patients, regardless of PD-L1 status, and achieved a secondary endpoint of overall survival (OS) among patients whose tumors express PD-L1.
Trial Design and Results
The KEYNOTE-B96 trial evaluated KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab. An independent Data Monitoring Committee analysis confirmed that the KEYTRUDA-based regimen significantly improved progression-free survival for all patients and demonstrated marked overall survival benefits among those with PD-L1-positive tumors, defined as Combined Positive Score (CPS) ≥1.
The safety profile of KEYTRUDA in this trial remained consistent with previously reported studies, with no new safety signals identified during the analysis. Further evaluation of overall survival in the complete study population continues.
Clinical Significance
"This marks a major advancement for patients with platinum-resistant ovarian cancer, as it is the first time a KEYTRUDA-based regimen has demonstrated the potential to extend survival," stated Dr. Gursel Aktan, Vice President of Global Clinical Development at Merck Research Laboratories. "These findings further validate the role of KEYTRUDA in gynecological cancers."
Platinum-resistant ovarian cancer represents a particularly challenging form of the disease, where patients have limited treatment options and poor prognoses. The positive outcomes from KEYNOTE-B96 provide new hope for this patient population.
Regulatory and Development Pipeline
While KEYTRUDA is not currently approved for treating ovarian cancer, these positive trial results highlight its therapeutic potential in this indication. The full findings from the KEYNOTE-B96 trial will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
Beyond this trial, Merck continues to advance its ovarian cancer research pipeline. The company has initiated the Phase 2/3 REJOICE-Ovarian01 trial, exploring raludotatug deruxtecan (R-DXd), an innovative CDH6-directed DXd antibody-drug conjugate, specifically for platinum-resistant ovarian cancer.
Broader Ovarian Cancer Portfolio
Merck's commitment to ovarian cancer treatment extends beyond KEYTRUDA. Through its partnership with AstraZeneca, the company has achieved three U.S. approvals for LYNPARZA (olaparib) in treating various forms of ovarian cancer, demonstrating sustained investment in addressing this challenging malignancy.
The KEYNOTE-B96 results underscore Merck's ongoing efforts to expand KEYTRUDA's therapeutic applications across gynecological malignancies and provide new treatment options for patients facing difficult-to-treat cancers.
