The European Commission has approved pembrolizumab (Keytruda) and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for use in combination with paclitaxel, with or without bevacizumab (Avastin), in the European Union (EU) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 with a combined positive score of 1 or greater (CPS ≥1) and who have received 1 or 2 prior systemic therapies.1
The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in February 2026. The indication is supported by data from the phase 3 KEYNOTE-B96/ENGOT-ov65 trial (NCT05116189), in which the regimen led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS), respectively, vs placebo plus paclitaxel, with or without bevacizumab (PFS: HR, 0.72; 95% CI, 0.58-0.89; P = .0014; OS: HR, 0.76; 95% CI, 0.61-0.94; P = .0053).2
With this approval, the regimen will become available for use in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
“Despite recent advances, patients with ovarian cancer face a significant unmet need when their disease progresses and becomes resistant to standard platinum-based therapy,” Nicoletta Colombo, MD, PhD, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy, said in a news release.1 “The approval of this pembrolizumab-based regimen is an important advance that provides a crucial new treatment option and represents a welcome addition to the treatment landscape for appropriate patients with PD-L1–positive platinum-resistant ovarian cancer across Europe.”
EC Approves Pembrolizumab Combo for Platinum-Resistant Ovarian Cancer
- The European Commission approved pembrolizumab-based regimens (Keytruda ± Keytruda Qlex) with paclitaxel ± bevacizumab for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer (CPS ≥1) after 1 to 2 prior therapies.
- In KEYNOTE-B96, the combination significantly improved progression-free survival (HR, 0.72) and overall survival (HR, 0.76) vs standard therapy.
- The same regimen received FDA approval in February 2026, expanding access across both the EU and United States.
Is the regimen also approved in the United States?
The regimen first received approval from the FDA on February 10, 2026, in the same patient population based on data from KEYNOTE-B96.2
The multicenter, randomized, double-blind, placebo-controlled phase 3 trial evaluated the PD-1 inhibitor pembrolizumab or placebo, plus paclitaxel, with or without bevacizumab, in patients with platinum-resistant recurrent ovarian cancer.
A total of 643 patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma were enrolled, irrespective of PD-L1 expression level, who received 1 or 2 prior lines of therapy, including at least 1 line of platinum-based chemotherapy. Most patients (72%) had PD-L1–positive tumors.
Patients were randomly assigned 1:1 to receive 400 mg of pembrolizumab plus 80 mg/m2 paclitaxel, with or without bevacizumab, or placebo plus paclitaxel, with or without 10 mg/kg of bevacizumab. Pembrolizumab and placebo were administered on day 1 of each 6-week cycle, and paclitaxel was administered on days 1, 8, and 15 of each 3-week cycle. Bevacizumab was administered on day 1 of every 2-week cycle according to physician’s choice prior to randomization.
Investigator-assessed PFS per RECIST 1.1 criteria served as the primary end point of the trial. OS was a key secondary end point.
What do new efficacy data from KEYNOTE-B96 reveal?
The regimen’s median PFS was 8.3 months (95% CI, 7.0-9.4) vs 7.2 months (95% CI, 6.2-8.1) with the placebo regimen. Median OS was 18.2 months (95% CI, 15.3-21.0) with the pembrolizumab- and placebo-containing regimens, respectively.
The regimen was also shown to improve PFS and OS in the all-comer population, irrespective of PD-L1 expression level, in findings shared during the 2026 European Society of Gynaecological Oncology Congress.3
What were the most common adverse effects of the pembrolizumab-based regimen?
Adverse effects that occurred in at least 20% of patients were diarrhea (45%), fatigue (43%), nausea (41%), alopecia (38%), peripheral neuropathy (38%), epistaxis (31%), urinary tract infection (27%), constipation (25%), abdominal pain (24%), decreased appetite (24%), vomiting (24%), hypothyroidism (21%), cough (20%), hypertension (20%), and rash (20%).4
Laboratory abnormalities that worsened from baseline and occurred in at least 20% of patients were anemia (85%), leukopenia (82%), decreased neutrophil count (71%), lymphopenia (60%), hypoalbuminemia (50%), hyponatremia (53%), hypomagnesemia (45%), increased aspartate aminotransferase level (43%), increased alanine aminotransferase level (40%), hypocalcemia (40%), increased alkaline phosphatase (31%), increased creatinine (29%), hypokalemia (27%), and neutropenia (21%).
What is Merck’s view on the approval?
“We’re proud to bring this [pembrolizumab]-based regimen to appropriate patients in Europe with PD-L1–positive platinum-resistant ovarian cancer, giving this community access to the region’s first PD-1 inhibitor treatment approach for this disease,” Gursel Aktan, MD, PhD, vice president, global clinical development, Merck Research Laboratories, added in a news release. “This milestone marks real progress for patients and advances our broader mission of expanding access to effective options for women’s cancers globally.”
References
- European Commission approves KEYTRUDA (pembrolizumab) plus paclitaxel ± bevacizumab for the treatment of adults with PD-L1 (CPS ≥1) platinum-resistant recurrent ovarian carcinoma who have received one or two prior systemic treatment regimens. News release. Merck. April 2, 2026. Accessed April 2, 2026. https://www.merck.com/news/european-commission-approves-keytruda-pembrolizumab-plus-paclitaxel-%C2%B1-bevacizumab-for-the-treatment-of-adults-with-pd-l1-cps-%E2%89%A51-platinum-resistant-recurrent-ovarian-carcinoma-wh/
- FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. FDA. February 10, 2026. Accessed April 2, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
- Colombo N, Zsiros E, Sebastianelli A, et al. Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: final analysis results from the randomized double-blind phase 3 ENGOT-ov65/KEYNOTE-B96 study. Abstract presented at: 2026 European Society of Gynaecological Oncology Congress; February 26-28, 2026; Copenhagen, Denmark. Abstract BO2-1 /526.
