AstraZeneca and Merck’s Lynparza (olaparib) Receive NMPA’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer


The approval was based on the P-III (PAOLA-1) trial evaluating Lynparza + bevacizumab vs bevacizumab alone in patients with newly diagnosed advanced FIGO stage III-IV high-grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer
The results showed an improvement in PFS while the safety & tolerability profile was consistent with prior clinical trials with no new safety signals
The 5yr. analysis of the (PAOLA-1) trial showed m-OS (56.5mos. vs 51.6mos.). In an exploratory subgroup analysis of HRD+ patients, improvement in OS with a 38% reduction in risk of death. The therapy was approved in the US, EU & multiple other countries for the same indication & is currently under regulatory review in other countries globally

Ref: Businesswire | Image: AstraZeneca