Keytruda Combo Approved for Platinum-Resistant Ovarian Cancer

The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with paclitaxel, with or without Avastin (bevacizumab), for adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 and who have received one or two prior systemic treatments.

Clinical trial data showed the regimen helped patients live longer without their cancer growing and extended overall survival, according to the FDA announcement.

The approval also includes use of the PD-L1 IHC 22C3 pharmDx test as a companion diagnostic to identify eligible patients whose tumors have PD-L1 expression with a combined positive score of at least 1.

Main data that support the findings

Efficacy was evaluated in the KEYNOTE-B96 study. Researchers focused on progression-free survival, which measures how long patients live without their cancer growing or spreading, and overall survival.

Among 466 patients whose tumors expressed PD-L1 with a combined positive score of at least 1, those who received Keytruda plus paclitaxel with or without Avastin had a median progression-free survival of 8.3 months compared with 7.2 months for those who received placebo plus paclitaxel with or without Avastin. This reflected a 28% lower risk of the cancer growing or spreading during the study period.

Median overall survival was also longer with the Keytruda regimen. Patients lived a median of 18.2 months compared with 14 months in the placebo group, representing a 24% lower risk of death during the study period.

These results showed improvements both in delaying disease progression and in length of life for patients whose tumors tested positive for PD-L1.

What side effects and warnings patients and caregivers should know

The overall safety profile of Keytruda in combination with paclitaxel, with or without Avastin, was reported to be similar to what has been seen in prior trials in cancer.

The prescribing information includes warnings and precautions for immune-mediated side effects, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation and embryo-fetal toxicity.

Full prescribing information will be posted on Drugs@FDA.

Who participated in KEYNOTE-B96 and how treatment was given?

KEYNOTE-B96 was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 643 patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. All participants had received one or two prior lines of systemic therapy for ovarian carcinoma.

Patients must have previously received at least one platinum-based chemotherapy regimen and had radiographic evidence that their disease progressed within six months after the last dose.

Participants were randomly assigned in a 1:1 ratio to receive either Keytruda plus paclitaxel with or without Avastin or placebo plus paclitaxel with or without Avastin.

The recommended dose of Keytruda is 200 mg every three weeks or 400 mg every six weeks. Treatment continues until disease progression, unacceptable toxicity or up to 24 months.

For Keytruda Qlex, the recommended dose is 395 mg/4,800 units every three weeks or 790 mg/9,600 units every six weeks on the same schedule.

When given on the same day, Keytruda or Keytruda Qlex should be administered before paclitaxel with or without Avastin.

The FDA conducted the review under Project Orbis, an Oncology Center of Excellence initiative that allows concurrent submission and review of oncology drugs among international partners. For this application, the FDA collaborated with regulatory agencies in Australia, Canada and Switzerland. The review was granted priority status.

Reference

1. “FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.” FDA. Feb 10, 2026.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI and reviewed by a human editor.

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