On June 25, Merck announced that its PD-1 inhibitor pembrolizumab has been approved by the NMPA for use in combination with paclitaxel (with or without bevacizumab) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received prior first- or second-line systemic therapy and whose tumors express PD-L1 (CPS≥1) as assessed by a validated test. The press release stated that this is the first and only PD-1 inhibitor in China approved with an immunotherapy combination regimen for platinum-resistant ovarian cancer.
The approval of this new indication is based on data from the Phase III KEYNOTE-B96 (ENGOT-ov65) study. This was a randomized, double-blind, global multicenter Phase III trial designed to evaluate the efficacy and safety of pembrolizumab in combination with paclitaxel (with or without bevacizumab) in patients with recurrent platinum-resistant epithelial ovarian cancer. A total of 643 subjects were enrolled, including 61 from China. The results showed that the study met both its primary and secondary endpoints. In the overall population, the median PFS was 8.3 months in the pembrolizumab plus paclitaxel group compared with 6.4 months in the control group (HR=0.73; 95% CI: 0.62-0.87). The median OS was 17.7 months in the pembrolizumab group versus 14.0 months in the control group (HR=0.82; P=0.0115). In terms of safety, the incidence of Grade ≥3 treatment-related adverse events (TRAEs) was 67.8% in the pembrolizumab plus paclitaxel group, compared with 55.3% in the control group.
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