By VETTAPHARMA reporter: Merck Group has recently announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with paclitaxel, with or without bevacizumab, for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥ 1 and who have received one or two prior systemic treatment regimens. These therapies are the first and only PD-1 inhibitors approved for this patient population.
The approvals were based on data from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), presented at the 2025 European Society for Medical Oncology (ESMO) Congress. The results showed that the KEYTRUDA regimen reduced the risk of disease progression or death by 28 % (hazard ratio [HR] = 0.72; 95 % confidence interval [CI], 0.58–0.89; p = 0.0014) compared with placebo plus paclitaxel with or without bevacizumab. In the same population, the regimen also demonstrated a 24 % reduction in the risk of death (HR = 0.76; 95 % CI, 0.61–0.94; p = 0.0053).
In the KEYNOTE-B96 study, 643 patients were enrolled, with 72 % of patients having tumors expressing PD-L1 (CPS ≥ 1). Among those evaluated, median progression-free survival (PFS) for the KEYTRUDA regimen was 8.3 months (95 % CI, 7.0–9.4) compared with 7.2 months (95 % CI, 6.2–8.1) for the placebo regimen. Median overall survival (OS) was 18.2 months (95 % CI, 15.3–21.0) versus 14.0 months (95 % CI, 12.5–16.1).
Merck noted that the effectiveness of KEYTRUDA QLEX for its approved indications was established based on evidence from controlled studies conducted with KEYTRUDA and additional pharmacokinetic, efficacy, and safety data from study MK-3475A-D77 comparing the two formulations.
The introduction of these PD-1 inhibitor regimens expands treatment options for patients with PD-L1 positive platinum-resistant ovarian cancer, a subgroup that has historically had limited effective therapies following platinum-based treatments.
Source credit:
- Merck. (2026, February 11). KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), plus paclitaxel ± bevacizumab, approved for certain adults with PD-L1+ (CPS ≥ 1) platinum-resistant ovarian carcinoma as second or third line treatment. Click here
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