FDA approves Keytruda regimens for PD-L1-positive platinum-resistant ovarian cancer
The FDA approved Keytruda and Keytruda Qlex with paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian-related cancers. The Phase III KEYNOTE-B96 trial showed improved progression-free and overall survival versus placebo.
The US Food and Drug Administration has approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), along with paclitaxel, with or without bevacizumab, for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express programmed death-ligand 1 (PD-L1) (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorised test. The therapies are approved as second or third line treatment, and the approvals introduce the first PD-1 inhibitors for platinum-resistant ovarian cancer.
The approvals stem from the Phase III KEYNOTE-B96 trial (ENGOT-ov65). Results demonstrated statistically significant improvements in progression-free survival and overall survival compared to placebo plus paclitaxel with or without bevacizumab for patients whose tumours express PD-L1 (CPS ≥1).
In patients with PD-L1+ tumors, Keytruda plus paclitaxel, with or without bevacizumab, reduced the risk of disease progression or death by 28% compared to placebo and improved overall survival by 24%. Patients receiving Keytruda regimens saw a median progression-free survival of 8.3 months, compared to 7.2 months with placebo, and a median overall survival of 18.2 months, versus 14.0 months for placebo.
The study enrolled 643 patients, with 72% expressing PD-L1, 73% receiving bevacizumab, and 46% having received prior bevacizumab. Almost half had a platinum-free interval of less than three months.
The approval of Keytruda Qlex for its indications is supported by data from well-controlled studies of Keytruda and additional results from MK-3475A-D77, which compared the efficacy, safety, and pharmacokinetic profiles of Keytruda Qlex and Keytruda.
Keytruda Qlex is contraindicated in patients with known hypersensitivity to its components. Both Keytruda and Keytruda Qlex carry warnings for severe immune-mediated reactions, infusion-related reactions, transplant complications, embryo-fetal toxicity, and increased mortality in multiple myeloma patients.
In June 2025, MSD received FDA approval for its anti-PD-1 therapy, Keytruda, for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).