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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
RAHWAY, N.J., February 11, 2026--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peri
About this update from Merck & Company, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":217,"url":"https://media.zenfs.com/en/business-wire.com/f72da739c2e0b49c6898cb43374a6ce8"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/9fJ5dPgKQcUgzXd6ZrnZew--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQzNDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/f72da739c2e0b49c6898cb43374a6ce8","width":480,"height":217}},"lazy":false},{"type":"text","content":"KEYTRUDA and KEYTRUDA QLEX are the first and only PD-1 inhibitors approved for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma with PD-L1+ tumors","length":195,"tagName":"p","attribs":{}},{"type":"text","content":"Approvals based on Phase 3 KEYNOTE-B96 trial that demonstrated the KEYTRUDA regimen reduced the risk of disease progression or death by 28% and reduced the risk of death by 24% compared to placebo plus paclitaxel with or without bevacizumab","length":240,"tagName":"p","attribs":{}},{"type":"text","content":"RAHWAY, N.J., February 11, 2026--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens.","length":598,"tagName":"p"},{"type":"text","content":"These approvals are based on data from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), which were presented at the 2025 European Society for Medical Oncology (ESMO) Congress. Results from the trial showed that KEYTRUDA plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 28% (HR=0.72 [95% CI, 0.58-0.89]; p=0.0014) in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1) when compared to placebo plus paclitaxel with or without bevacizumab. In this s...