FDA Approves Pembrolizumab-Based Regimens for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Key Clinical Summary:

• Design/Population: On February 10, 2026, the US FDA approved pembrolizumab, including pembrolizumab plus berahyaluronidase alfa-pmph, in combination with paclitaxel with or without bevacizumab, for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with PD-L1 CPS ≥1 after 1 to 2 prior systemic regimens, based on the phase 3 KEYNOTE-B96 trial (NCT05116189).
• Key Outcomes: Among 466 PD-L1–positive patients (CPS ≥1), pembrolizumab-based therapy significantly improved PFS (8.3 vs 7.2 months; HR, 0.72; P = .0014) and OS (18.2 vs 14.0 months; HR, 0.76; P = .0053) versus placebo plus chemotherapy. Benefit was observed with paclitaxel with or without bevacizumab, supporting broad applicability across standard backbones.
• Clinical Relevance: This approval establishes immune checkpoint inhibition plus chemotherapy as a new option for PD-L1-positive, platinum-resistant ovarian cancer, a setting with limited effective therapies. Routine PD-L1 testing (22C3 pharmDx) is now clinically actionable, and the availability of IV and hyaluronidase-enabled formulations offers flexibility in delivery while maintaining established pembrolizumab safety expectations.

On February 10, 2026, the US Food and Drug Administration (FDA) approved pembrolizumab as well as pembrolizumab plus berahyaluronidase alfa-pmph combined with paclitaxel, with or without bevacizumab, for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have received 1 or 2 prior systemic treatment regimens and whose tumors express PD-L1 as determined by an FDA-authorized test.

The FDA has also approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic tool for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (combined positive score [CPS] ≥ 1) and may be eligible for treatment with pembrolizumab.

For this approval, efficacy was evaluated in KEYNOTE-B96, a multicenter, randomized, double-blind, placebo-controlled trial of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who had received 1 or 2 prior lines of systemic therapy. Eligible patients were required to have received at least 1 prior line of platinum-based chemotherapy and to have experienced radiographic disease progression within 6 months of the last platinum dose. Patients were randomized 1:1 to receive pembrolizumab plus paclitaxel with or without bevacizumab or placebo plus paclitaxel with or without bevacizumab.

The primary efficacy end point was progression-free survival (PFS) as assessed by the investigator according to RECIST v1.1, with overall survival (OS) as an additional efficacy endpoint. 

Among 466 patients whose tumors expressed PD-L1 with CPS ≥ 1, the median PFS was 8.3 months (95% confidence interval [CI], 7.0 to 9.4) in the pembrolizumab arm and 7.2 months (95% CI, 6.2 to 8.1) in the placebo arm (hazard ratio [HR], 0.72; 95% CI, 0.58 to 0.89; P = 0.0014). The median OS was 18.2 months (95% CI, 15.3 to 21.0) and 14.0 months (95% CI, 12.5 to 16.1; HR, 0.76; 95% CI, 0.61 to 0.94; P = 0.0053), respectively.

In terms of safety, pembrolizumab in combination with paclitaxel, with or without bevacizumab, was consistent with prior clinical experience with pembrolizumab. The prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.

The recommended dose of pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks, administered until disease progression, unacceptable toxicity, or for up to 24 months. The recommended dose of pembrolizumab and berahyaluronidase alfa-pmph is 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks, given for the same duration. When administered on the same day, pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph should be given prior to paclitaxel, with or without bevacizumab. Refer to the prescribing information for agents used in combination with pembrolizumab for additional dosing guidance.

Source:

US Food and Drug Administration. FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Accessed February 10, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or