Pembrolizumab combo approved in ovarian cancer

The FDA approved pembrolizumab on February 10, 2026, in combination with paclitaxel, with or without bevacizumab, for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors are PD-L1 positive and who have already had one or two prior systemic regimens. The agency approved the regimen alongside Agilent’s PD-L1 IHC 22C3 companion test, so this is not a blanket ovarian cancer approval. It is a biomarker-gated one in a disease that has chewed through many promising ideas without giving much back (fda.gov, agilent.com). That setting matters. “Platinum-resistant” means the cancer came back or progressed within six months of platinum chemotherapy, which is the backbone of initial treatment for most ovarian cancers. Once that happens, the disease is harder to control and survival gains are rare. Weekly paclitaxel, sometimes paired with bevacizumab, became a common standard after the AURELIA trial showed that bevacizumab could improve progression-free survival and response rate, but it did not clearly extend overall survival (clinicaltrials.gov, annalsofoncology.org). Pembrolizumab changes that story because it finally pushed survival in a place where ovarian cancer trials usually stall out. The approval rests on KEYNOTE-B96, a randomized, double-blind phase 3 trial that enrolled 643 patients with platinum-resistant ovarian-type cancers after one or two prior lines of therapy. In the 466 patients whose tumors had PD-L1 combined positive score of at least 1, median progression-free survival was 8.3 months with pembrolizumab versus 7.2 months with placebo, and median overall survival was 18.2 months versus 14.0 months. That is not a miracle. It is a few months. But in this disease, a few months of overall survival is exactly the kind of result that gets a regimen over the line (fda.gov, merck.com). The more surprising detail came after the approval package was already set. At the final analysis presented in late February 2026, Merck said the regimen also improved overall survival in the all-comers population regardless of PD-L1 status, with median overall survival of 17.7 months versus 14.0 months and a hazard ratio of 0.82. That result does not widen the U.S. label, which still requires PD-L1 positivity, but it does make the trial harder to dismiss as a narrow biomarker win. It suggests the chemotherapy and anti-angiogenic backbone may be doing more than carrying pembrolizumab along for the ride (merck.com, esmo.org). That is why the label details matter as much as the headline. Pembrolizumab brings the usual immune-mediated risks, including pneumonitis, colitis, hepatitis, endocrinopathies, severe skin reactions, infusion reactions, and embryo-fetal toxicity. Paclitaxel adds neuropathy and myelosuppression. Bevacizumab adds hypertension, bleeding, clotting, impaired wound healing, proteinuria, and the small but feared risk of gastrointestinal perforation. The FDA said the overall safety profile in KEYNOTE-B96 looked consistent with prior experience, which is another way of saying clinicians are now responsible for tracking three different toxicity logics inside one regimen (accessdata.fda.gov, fda.gov). Merck also won U.S. approval for the subcutaneous version, Keytruda Qlex, on the same indication, and the European Commission followed with its own approval on April 2, 2026. So this is no longer just a conference result with a hopeful Kaplan-Meier curve attached. It is a real treatment option for a specific slice of ovarian cancer, selected by a PD-L1 test, delivered with weekly paclitaxel, and sometimes with bevacizumab layered on top (merck.com, merck.com)