FDA Approves Pembrolizumab Combo for Recurrent Ovarian Cancer

The FDA has approved pembrolizumab (Keytruda) plus paclitaxel, with or without bevacizumab (Avastin) for the treatment of patients with platinum-resistant recurrent ovarian cancer.¹

The approval follows a priority review of the supplemental biologics license application (sBLA) of the drug combination granted in October 2025. The priority review was granted based on data from the phase 3 KEYNOTE-B96 trial (NCT05116189), presented during the 2025 European Society for Medical Oncology (ESMO) Congress.

The KEYNOTE-B96 trial was the first trial of an immune checkpoint inhibitor-based treatment regimen in platinum-resistant recurrent ovarian cancer to show statistically significant improvements in progression-free survival (PFS) for all patients, and overall survival (OS) for patients whose tumors express PD-L1 vs placebo plus chemotherapy with or without bevacizumab.²

The study had a median follow-up of 15.6 months at the first interim analysis. There were 322 patients in the pembrolizumab plus chemotherapy with or without bevacizumab arm vs 321 patients in the placebo arm. At this analysis, the pembrolizumab arm demonstrated statistically significant and clinically meaningful improvement in PFS, the primary end point of the trial, reducing the risk of disease progression or death by 30% (HR, 0.70; 95% CI, 0.58–0.84). The 12-month PFS rate was 33.1% in the pembrolizumab arm vs 21.3% in the placebo arm. In patients with PD-L1 tumor expression (n = 234) receiving pembrolizumab, the PFS was 28%. The 12-month PFS rate for patients with PD-L1 tumor expression was 35.2% in the pembrolizumab arm vs 22.6% in the placebo arm.

At the second interim analysis with a median follow-up of 26.6 months, pembrolizumab demonstrated statistically significant and clinically meaningful improvement in OS in patients with PD-L1 expression (24%). The 12-month OS rates were 69.1% in the pembrolizumab arm vs 59.3% in the placebo arm; 18-month OS rates were 51.5% vs 38.9%, respectively.

Immune-mediated adverse events (AEs) and infusion reactions of any grade occurred in 39.1% of patients in the pembrolizumab arm vs 18.9% of patients in the placebo arm. The most common AE was hypothyroidism (17.8%) in patients in the pembrolizumab arm.

Treatment-related AEs (TRAEs) occurred in 97.8% of patients in the pembrolizumab arm vs 95.3% of patients in the placebo arm. Grade 3 to 5 TRAEs occurred in 67.5% of patients in the pembrolizumab arm vs 55.3% of patients in the placebo arm. No new safety concerns were identified.

Patients in the pembrolizumab arm received 400 mg intravenously every 6 weeks for approximately 2 years.³

“These results build upon the success of [pembrolizumab] in gynecologic cancers and support the potential use of [pembrolizumab] for patients with platinum-resistant ovarian cancer,” said Gursel Aktan, MD, vice president of Global Clinical Development at Merck Research Laboratories, in a news release. “As the first immunotherapy with data demonstrating improved survival in certain patients with platinum-resistant recurrent ovarian cancer, this [pembrolizumab]-based regimen underscores our commitment to helping provide patients with more treatment options to meet their unique needs. These data have the potential to change the treatment paradigm for patients like these with platinum-resistant recurrent ovarian cancer.”

REFERENCES

1. FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. News release. US FDA. February 10, 2026. Accessed February 10, 2026. https://tinyurl.com/yy5vzf7z

2. KEYTRUDA (pembrolizumab) plus chemotherapy with or without bevacizumab reduced risk of disease progression or death versus chemotherapy with or without bevacizumab in certain patients with platinum-resistant recurrent ovarian cancer. News release. Merck. Published October 18, 2025. Accessed January 15, 2026. https://tinyurl.com/ywxr7m2w

3. Pembrolizumab/placebo plus paclitaxel with or without bevacizumab for platinum-resistant recurrent ovarian cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). ClinicalTrials.gov. Updated July 14, 2025. Accessed January 15, 2026. https://clinicaltrials.gov/study/NCT05116189