Merck’s Keytruda in combination approved in EU for ovarian carcinoma

Merck (MRK) announced that Keytruda – pembrolizumab -, in combination with paclitaxel, with or without bevacizumab, is approved in the European Union, or EU, for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 with a Combined Positive Score greater than or equal to 1 and who have received one or two prior systemic treatment regimens. This approval, which also covers Keytruda SC, known as Keytruda Qlex – pembrolizumab and berahyaluronidase alfa-pmph – in the U.S., makes this regimen the first and only PD-1 inhibitor-based treatment option for eligible patients with platinum-resistant ovarian cancer in the EU. This approval is based on results from the Phase 3 KEYNOTE-B96 trial in which Keytruda plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, the trial’s primary endpoint, and overall survival, a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 vs. placebo plus paclitaxel, with or without bevacizumab. The approval follows a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use, received in February. In the trial, Keytruda plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in PFS, reducing the risk of disease progression or death by 28%. The Keytruda-based regimen also demonstrated a statistically significant and clinically meaningful improvement in OS, reducing the risk of death by 24%.