FDA Approves Pembrolizumab Combination for Platinum-Resistant Ovarian Cancer

FDA approved pembrolizumab in combination with paclitaxel, with or without bevacizumab, for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS greater than or equal to 1). The approval also includes pembrolizumab and berahyaluronidase alfa-pmph in combination with paclitaxel, with or without bevacizumab, for the same indication in patients who have received one or two prior systemic treatment regimens.

The approval was based on results from the phase 3 KEYNOTE-B96 trial, which demonstrated improvements in overall survival and progression-free survival compared with chemotherapy alone. Platinum-resistant ovarian cancer has historically been difficult to treat, and options in this setting are often limited.

FDA has approved PD-L1 IHC 22C3 pharmDx, Code SK006m as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, whose tumors express PD-L1 and who may be eligible for treatment with pembrolizumab.

The addition of an immunotherapy-based regimen offers a new approach for eligible patients and underscores the growing role of biomarker testing in guiding care decisions. Tumors must be determined to express PD-L1 (CPS≥1) by an FDA-authorized test for patients to be eligible for the treatment.