FDA Approves Pembrolizumab Plus Paclitaxel for Platinum-Resistant Ovarian Cancer
The FDA approved pembrolizumab plus paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian cancer based on phase 3 KEYNOTE-B96 trial results showing improved survival outcomes.
The FDA approved pembrolizumab (Keytruda) and pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex) plus paclitaxel, with or without bevacizumab (Avastin), for PD-L1-positive (combined positive score of 1 or higher) platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma following 1 to 2 previous therapies. The decision was supported by findings from the phase 3 KEYNOTE-B96 trial (NCT05116189).
In PD-L1-positive tumors, pembrolizumab significantly improved median progression-free survival versus placebo, at a median of 8.3 months (95% CI, 7.0-9.4) and 7.2 months (95% CI, 6.2-8.1), respectively (HR, 0.72; 95% CI, 0.58-0.89; P = .0014). Pembrolizumab also significantly improved overall survival over placebo, at a median of 18.2 months (95% CI, 15.3-21.0) and 14.0 months (95% CI, 12.5-16.1), respectively (HR, 0.76; 95% CI, 0.61-0.94; P = .0053).
The approval represents a new treatment standard for patients with platinum-resistant ovarian cancer whose tumors express PD-L1 at a combined positive score of 1 or higher. The KEYNOTE-B96 trial evaluated the immunotherapy regimen in patients with recurrent ovarian cancers that express PD-L1.