AstraZeneca and Merck Receive EC’s Approval of Lynparza (olaparib) for Metastatic Castration-Resistant Prostate Cancer
Shots:
- The approval was based on the P-III trial (PROpel) results evaluating Lynparza vs PBO when given in addition to abiraterone, prednisone, or prednisolone in men with mCRPC who had not received prior CT or NHAs in the mCRPC setting
- The combination therapy showed a 34% reduction in risk of disease progression or death, m-rPFS (24.8 vs 16.6mos.). The planned sensitivity analysis was consistent with the investigator-based analysis with an m-rPFS of 27.6 vs 16.4mos.
- The interim results for 2EPs of OS did not reach statistical significance, the event rate (37.1% vs 43.1%), safety & tolerability were consistent with individual therapies, and AEs leading to treatment discontinuation (~16%). The therapy was approved in the US as monotx. for HRR gene-mutated mCRPC
Ref: Merck | Image: AstraZeneca
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
