Pembrolizumab Combination Approved for Platinum-Resistant Ovarian Cancer
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On 10 February 2026, the US Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck), as well as the combination of pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck), with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1), as determined by an FDA-approved test, and who have received one or two prior systemic treatment regimens.
The FDA also approved PD-L1 IHC 22C3 pharmDx (Agilent Technologies, Inc.) as a companion diagnostic device to identify patients with PD-L1-expressing (CPS≥1) epithelial ovarian, fallopian tube or primary peritoneal carcinoma for pembrolizumab treatment.
Scope of Approval and Patient Selection
On 10 February 2026, the FDA approved pembrolizumab (Keytruda) and a new formulation, pembrolizumab + berahyaluronidase alfa-pmph (Keytruda Qlex) . This approval applies, in combination with paclitaxel (with or without bevacizumab), to patients meeting the following criteria:
- Platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
- Tumor expression confirmed by an FDA-approved test: PD-L1 expression (CPS ≥ 1).
- The requirement to have received 1 or 2 prior lines of systemic treatment.
- Radiological progression within 6 months after the last platinum treatment.
The KEYNOTE-B96 Trial: Efficacy Data
Efficacy was evaluated in KEYNOTE-B96 (NCT05116189), a multicenter, randomized, double-blind, placebo-controlled trial involving 643 patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma who had received one or two prior lines of systemic treatment for ovarian carcinoma. Patients were required to have received at least one line of platinum-based chemotherapy for ovarian cancer, with evidence of radiographic disease progression within six months after the last dose. Patients were randomized (1:1) to pembrolizumab plus paclitaxel (with or without bevacizumab) or placebo plus paclitaxel (with or without bevacizumab).
The primary efficacy measure was progression-free survival (PFS), assessed by the investigator according to RECIST v1.1. An additional efficacy measure was overall survival (OS).
In the phase III trial involving 643 patients, results from 466 patients with PD-L1 CPS ≥ 1 clearly demonstrated a survival benefit in the arm receiving immunotherapy.
18.2 Months
Pembrolizumab Arm
14.0 Months
Control (Placebo) Arm
Recommended Dosing Schedule and Administration
The new approval offers patients both standard intravenous and subcutaneous administration options.
| Drug Form | Dose Options | Duration |
|---|---|---|
| Pembrolizumab (IV) | 200 mg (every 3 weeks) or 400 mg (every 6 weeks) | Maximum 24 months |
| Keytruda Qlex (Subcutaneous) | 395 mg (every 3 weeks) or 790 mg (every 6 weeks) | Maximum 24 months |
*If given on the same day, the pembrolizumab formulations should be administered before paclitaxel and bevacizumab.
Safety Profile
The combination's safety profile is consistent with the known profile of pembrolizumab in other indications. However, the following risks should be monitored during treatment:
- Immune-mediated adverse reactions (affecting the lungs, liver, kidneys, etc.).
- Infusion reactions and reactions at the subcutaneous administration site.
- Embryo-fetal toxicity (risk in pregnancy).
Platinum-resistant ovarian cancer is one of the most challenging areas to manage in oncology. The most important advances brought by this approval are:
- A Specific Biomarker: The role of PD-L1 (CPS ≥ 1) status in predicting treatment success has been established.
- Ease of Administration: The Qlex formulation (subcutaneous administration) may reduce patient congestion in oncology clinics and will improve patient comfort.
- A Clear Survival Benefit: The increase in median overall survival from 14 to 18 months is a meaningful gain for this patient group.
Personalized medicine is opening a new door in ovarian cancer treatment with the right biomarker and easier administration methods.
Sources
- FDA approves pembrolizumab with paclitaxel for platinum-resistant ovarian cancer. 10 February 2026.
- KEYNOTE-B96 (NCT05116189) Phase III Trial Data.
- Merck & Co. Keytruda Qlex Prescribing Information.
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