FDA Approves Keytruda Combination Therapy for Platinum-Resistant Ovarian Cancer
The Food and Drug Administration has approved Merck’s Keytruda (pembrolizumab), both as a standalone therapy and in combination with Keytruda Qlex (pembrolizumab plus berahyaluronidase alfa-pmph), alongside paclitaxel, with or without bevacizumab, for adult patients battling platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. This approval marks a significant advancement for individuals whose tumors express PD-L1 (Combined Positive Score ≥ 1), offering a new treatment option after initial chemotherapy has ceased to be effective.
The decision, announced on February 10, 2026, is based on compelling data from the phase 3 KEYNOTE-B96 trial (NCT05116189). The trial’s findings demonstrate clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) for patients receiving the pembrolizumab combination. A companion diagnostic device, the PD-L1 IHC 22C3 pharmDx from Agilent Technologies, Inc., is also included with the approval to identify eligible patients.
KEYNOTE-B96 Trial: A Detailed Look at the Results
The KEYNOTE-B96 study was a randomized, double-blind, multicenter, placebo-controlled trial designed to rigorously assess the safety and efficacy of pembrolizumab. Researchers compared the effects of pembrolizumab plus paclitaxel, with or without bevacizumab, against a placebo plus the same chemotherapy regimen. The trial enrolled 643 patients with platinum-resistant disease who had previously undergone one or two lines of platinum-based chemotherapy, experiencing disease progression within six months.
Patients were randomly assigned in a 1:1 ratio to receive either the pembrolizumab combination or the placebo combination. Those in the pembrolizumab arm received 400 mg of pembrolizumab intravenously every six weeks for approximately two years, alongside paclitaxel administered intravenously on days 1, 8, and 15 of each three-week cycle. Bevacizumab was given to some patients in both arms, at a dosage of 10 mg/kg intravenously every two weeks.
According to trial data, in the PD-L1–positive population (CPS ≥ 1; n = 466), the median PFS for patients treated with pembrolizumab was 8.3 months (95% CI, 7.0–9.4), a notable improvement compared to the 7.2 months (95% CI, 6.2–8.1) observed in the placebo group (HR, 0.72; 95% CI, 0.58–0.89; P = .0014). Furthermore, median OS favored the pembrolizumab arm, reaching 18.2 months (95% CI, 15.3–21.0) versus 14.0 months (95% CI, 12.5–16.1) with placebo (HR, 0.76; 95% CI, 0.61–0.94; P = .0053).
Safety and Tolerability Profile
The KEYNOTE-B96 trial also evaluated the safety of the pembrolizumab combination. Findings indicated a tolerability profile consistent with previous studies of pembrolizumab, with no previously unreported adverse events. In the event of a severe hypersensitivity reaction to paclitaxel or an adverse event necessitating its discontinuation, treatment with docetaxel was administered (75 mg/m2 every three weeks).
Pembrolizumab Dosing and Administration
Pembrolizumab is typically administered at a recommended dose of 200 mg every three weeks or 400 mg every six weeks, continuing until disease progression, unacceptable toxicity, or for up to 24 months. When combined with berahyaluronidase, the recommended dosage is 395 mg/4800 units every three weeks or 790 mg/9600 units every six weeks, also continuing until disease progression, unacceptable toxicity, or for up to 24 months. When administered on the same day, pembrolizumab or the pembrolizumab/berahyaluronidase combination should precede paclitaxel, with or without bevacizumab.
Prescribing information details warnings related to immune-mediated adverse reactions, infusion-related reactions, potential complications from allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
This approval represents a crucial step forward in the treatment of platinum-resistant ovarian cancer, offering renewed hope and improved outcomes for patients with this challenging disease.
https://clinicaltrials.gov/study/NCT05116189
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or?utm_medium=email&utm_source=govdelivery
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