Merck has announced that its Phase 3 KEYNOTE-B96 trial evaluating KEYTRUDA (pembrolizumab) in combination with chemotherapy for platinum-resistant recurrent ovarian cancer has met its primary endpoint of progression-free survival, as well as a key secondary endpoint of overall survival in patients whose tumors express PD-L1.
The trial represents the first time an immune checkpoint inhibitor-based regimen has demonstrated a survival benefit in ovarian cancer, according to the company. The study evaluated KEYTRUDA in combination with paclitaxel chemotherapy with or without bevacizumab.
“This marks the first time a KEYTRUDA-based regimen has shown the ability to help certain patients with platinum-resistant ovarian cancer live longer, and the first time an immune checkpoint inhibitor-based regimen has demonstrated an overall survival benefit in ovarian cancer,” said Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories.
The KEYNOTE-B96 trial, also known as ENGOT-ov65, was conducted in collaboration with the European Network for Gynecologic Oncology Trial groups and enrolled approximately 643 patients. At interim analysis, the treatment demonstrated statistically significant and clinically meaningful improvements in progression-free survival regardless of PD-L1 status, and in overall survival specifically for patients whose tumors express PD-L1.
Ovarian cancer is the third most common gynecologic malignancy worldwide, with approximately 324,603 diagnoses and 206,956 deaths globally in 2022. In the United States, an estimated 20,890 patients will be diagnosed with ovarian cancer in 2025, with approximately 12,730 deaths expected.
KEYTRUDA is not currently approved for ovarian cancer treatment. Merck reports that detailed results from the trial will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
The company states that the safety profile observed in this trial was consistent with that seen in previous studies, with no new safety signals identified.
