Oncology Drug Approval News Flash: Pembrolizumab plus paclitaxel with or without bevacizumab approved for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

FDA approval summary

On February 10, 2026, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 with a combined positive score (CPS) ≥ 1 as determined by an FDA-authorized test, and who have received one or two prior lines of systemic therapy.

FDA simultaneously approved the PD-L1 IHC 22C3 pharmDx assay (Agilent Technologies, Inc.) as a companion diagnostic device to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥ 1) for treatment with pembrolizumab.

Full prescribing information for Keytruda and Keytruda Qlex will be available on Drugs@FDA.

KEYNOTE-B96 trial (NCT05116189)

Efficacy was evaluated in KEYNOTE-B96 (NCT05116189), a multicenter, randomized, double-blind, placebo-controlled trial in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

• Key eligibility criteria:
  • Radiographic evidence of platinum-resistant disease following at least one line of platinum-based chemotherapy
  • Disease progression within six months of the last dose of platinum-based therapy
  • One or two prior lines of systemic therapy for ovarian carcinoma
• Randomization: 643 patients were randomized 1:1 to:
  • Pembrolizumab plus paclitaxel with or without bevacizumab
  • Placebo plus paclitaxel with or without bevacizumab

The major efficacy outcome measure was investigator-assessed progression-free survival (PFS) per RECIST v1.1. Overall survival (OS) was an additional efficacy outcome measure. The primary analysis was conducted in the subset of patients whose tumors expressed PD-L1 with CPS ≥ 1 (n = 466).

Efficacy in PD-L1 CPS ≥1 tumors: PFS and OS benefit

• PFS (PD-L1 CPS ≥1, n = 466):
  • Median PFS:
    • Pembrolizumab arm: 8.3 months (95% CI: 7.0, 9.4)
    • Placebo arm: 7.2 months (95% CI: 6.2, 8.1)
  • Hazard ratio (HR): 0.72 (95% CI: 0.58, 0.89); p = 0.0014
• OS (PD-L1 CPS ≥1, n = 466):
  • Median OS:
    • Pembrolizumab arm: 18.2 months (95% CI: 15.3, 21.0)
    • Placebo arm: 14.0 months (95% CI: 12.5, 16.1)
  • HR: 0.76 (95% CI: 0.61, 0.94); p = 0.0053

In this poor-prognosis, platinum-resistant population, the addition of pembrolizumab to paclitaxel ± bevacizumab led to statistically significant improvements in both PFS and OS among patients with PD-L1 CPS ≥ 1 tumors.

Safety profile and key warnings

In KEYNOTE-B96, the safety profile of pembrolizumab in combination with paclitaxel, with or without bevacizumab, was generally consistent with that observed in prior pembrolizumab trials across tumor types. The prescribing information includes warnings and precautions for:

• Immune-mediated adverse reactions (e.g., pneumonitis, colitis, hepatitis, endocrinopathies, severe skin reactions)
• Infusion-related reactions
• Complications of allogeneic hematopoietic stem cell transplantation (allo-HSCT)
• Embryo-fetal toxicity

Given the overlapping toxicities of paclitaxel (myelosuppression, neuropathy), bevacizumab (hypertension, thromboembolism, GI perforation, wound-healing complications), and immune checkpoint blockade, close monitoring and proactive management of adverse events are essential.

Recommended dosing

Pembrolizumab (IV):

• 200 mg intravenously every 3 weeks, or
• 400 mg intravenously every 6 weeks
• Treatment is continued until disease progression, unacceptable toxicity, or up to 24 months

Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, SC):

• 395 mg/4,800 units subcutaneously every 3 weeks, or
• 790 mg/9,600 units subcutaneously every 6 weeks
• Treatment is continued until disease progression, unacceptable toxicity, or up to 24 months

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 paclitaxel and bevacizumab for recommended dosing schedules.

Regulatory considerations: Project Orbis and expedited review

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international partners.

• For this application, FDA collaborated with:
  • Australia’s Therapeutic Goods Administration (TGA)
  • Health Canada (HC)
  • Switzerland’s Swissmedic (SMC)
• The review used the Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment.
• The application received priority review. FDA’s expedited programs are described in the guidance “Expedited Programs for Serious Conditions – Drugs and Biologics.”

Editorial perspective (Morningglorysciences)

Platinum-resistant ovarian cancer remains a therapeutic challenge, with limited options and modest survival outcomes. Standard therapies such as weekly paclitaxel, pegylated liposomal doxorubicin, topotecan, and bevacizumab-containing regimens often yield short-lived responses. In this context, a regimen that offers a statistically significant OS benefit is noteworthy, even if absolute gains are measured in months rather than years.

KEYNOTE-B96 introduces a biomarker-driven approach—restricting treatment to PD-L1 CPS ≥1 tumors—and demonstrates that adding pembrolizumab to a paclitaxel ± bevacizumab backbone can improve both PFS and OS. However, the absolute PFS gain (~1 month) and OS gain (~4 months) underscore the need for realistic expectations and careful weighing of toxicity, cost, and patient burden.

Key questions for clinical practice and future research include:

• Whether higher PD-L1 cutoffs (e.g., CPS ≥10) identify patients with more pronounced benefit
• How this regimen should be positioned relative to existing bevacizumab-based combinations in platinum-resistant disease
• How molecular features such as homologous recombination deficiency (HRD) or BRCA status should be integrated into treatment sequencing decisions

Ultimately, pembrolizumab plus paclitaxel ± bevacizumab