CHMP Recommends Pembrolizumab Regimen For Approval in Pretreated PROC

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) in combination with paclitaxel with or without bevacizumab (Avastin) for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (PROC) with PD-L1 expressing tumors and who have received 1 or 2 prior systemic regimens.¹

The decision was announced in a Merck press release that also highlighted the recent release of new overall survival (OS) data for this regimen in the phase 2 KEYNOTE-B96/ENGOT-ov65 trial (NCT05116189). These results were shared at the European Society of Gynaecological Oncology (ESGO) 2026 Congress.

With a median follow-up of 32.7 months (range, 26.1-44.1), pembrolizumab plus paclitaxel with or without bevacizumab improved OS in all comers, achieving a median OS of 17.7 months compared with 14.0 months in patients who received a placebo regimen. The risk of death was reduced by 18% with the pembrolizumab regimen compared with standard of care (HR, 0.82; 95% CI, 0.69-0.97; P = .0115). According to the developer, this is the longest OS reported in any clinical trial among patients with PROC. An OS benefit with pembrolizumab was also observed in patients with a PD-L1 combined positive score (CPS) of at least 1, with a reduction in the risk of death of 24% (HR, 0.76; 95% CI, 0.62-0.93).

Additionally, it was reported that this treatment combination elicited a statistically significant improvement in progression-free survival (PFS). The pembrolizumab regimen reduced the risk of disease progression or death by 27% (HR, 0.73; 95% CI, 0.62-0.87). Among patients with PROC and a PD-L1 combined positive score (CPS) of at least 1, the pembrolizumab regimen reduced the risk of progression or death by 24% (HR, 0.76; 95% CI, 0.62-0.93).

Previously, it was reported that the 12-month PFS rate was 33.1% (95% CI, 27.7%-38.5%) with the pembrolizumab regimen vs 21.3% (95% CI, 16.6%-26.4%) with the placebo regimen.² Across patients with a PD-L1 combined positive score (CPS) of at least 1, the risk of disease progression or death was reduced by 28% (HR, 0.72; 95% CI, 0.58-0.89; P = .0014); the 12-month PFS rates were 35.2% (95% CI, 28.8%-41.7%) vs 22.6% (95% CI, 17.0%-28.7%), respectively.

“Patients with PROC show reduced responses to traditional treatment regimens and may experience poor OS,” stated Nicoletta Colombo, MD, PhD, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy, in the press release.¹ “These results build on prior data from the KEYNOTE-B96 trial and further define the clinical impact of this pembrolizumab-based regimen in appropriate patients with platinum-resistant recurrent ovarian cancer.”

A total of 643 patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who received 1 or 2 prior lines of systemic therapy, including at least 1 platinum-based therapy, were enrolled in the trial, regardless of PD-L1 status. Of the patients, 72% had tumors expressing PD-L1.

All patients were randomly assigned 1:1 to receive pembrolizumab at 400 mg or placebo on day 1 of each 6-week cycle. Paclitaxel was given at 80 mg/m² on days 1, 8, and 15 of each 3-week cycle, and bevacizumab was given at 10 mg/kg on day 1 of a 2-week treatment cycle if deemed necessary by the investigator.

Grade 3 or higher treatment-related adverse events (TRAEs) were observed in 67.8% of patients who received pembrolizumab vs 55.3% who received placebo. TRAEs led to death in 1.3% vs 1.6% of patients, respectively. Any grade immune-mediated AEs and infusion reactions occurred in 39.4% and 18.9%, respectively; immune-mediated AEs led to death in 0.6% of the pembrolizumab arm.

Previously, in February 2026, the FDA approved pembrolizumab plus paclitaxel with or without bevacizumab in the same patient population based on previous data from the KEYNOTE-B96 trial.³

“Results from the final analysis of KEYNOTE-B96, including [OS] data in the all comers population, demonstrate the continued clinical benefit of [pembrolizumab] plus paclitaxel with or without bevacizumab for certain patients with platinum-resistant recurrent ovarian cancer,” added Gursel Aktan, MD, PhD, vice president of global clinical development at Merck Research Laboratories.¹ “Taken together, the recent FDA approval and CHMP positive opinion underscore our commitment to the ovarian cancer community and our ongoing focus on delivering therapies that can help patients with unmet needs across women’s cancers.”

References

1. KEYTRUDA® (pembrolizumab) plus paclitaxel with or without bevacizumab significantly improved key secondary endpoint of overall survival (OS) versus paclitaxel with or without bevacizumab in patients with platinum-resistant recurrent ovarian cancer. News release. Merck. February 27, 2026. Accessed March 2, 2026. https://tinyurl.com/443ewvbc
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. October 18, 2025. Accessed March 2, 2026. https://tinyurl.com/5prjpndb
3. FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. News release. FDA. February 10, 2026. Accessed March 2, 2026. https://tinyurl.com/ydzhnzha