Merck, AstraZeneca present final results from Phase 3 PROpel trial

AstraZeneca (AZN) and Merck (MRK) announced results from the final analysis of the key secondary endpoint of overall survival from the Phase 3 PROpel trial evaluating LYNPARZA in combination with abiraterone and prednisone or prednisolone, compared to placebo plus abi/pred. Median OS was 42.1 months for the LYNPARZA plus abi/pred arm versus 34.7 months for the placebo plus abi/pred arm, representing a 7.4-month absolute difference in median OS versus a standard of care. This OS trend did not reach statistical significance. Results from the primary endpoint of investigator-assessed radiographic progression-free survival, which showed that LYNPARZA in combination with abi/pred significantly reduced the risk of disease progression or death by 34% compared to placebo plus abi/pred, were previously presented at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium and published in NEJM Evidence. The final OS results from PROpel will be presented today at ASCO GU 2023. In this updated analysis, the most common adverse events were anemia, fatigue, nausea, back pain and diarrhea. Grade greater than or equal to3 AEs were anemia, hypertension, urinary tract infection, fatigue, vomiting, diarrhea, decreased appetite, back pain and nausea. Approximately 17% of patients who received LYNPARZA in combination with abi/pred discontinued treatment due to an AE. LYNPARZA in combination with abi/pred was approved by the European Commission in December 2022 for the treatment of mCRPC in adult men for whom chemotherapy is not clinically indicated and is currently undergoing regulatory review by the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency for this indication. LYNPARZA is currently approved in the U.S. for patients with HRR gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone, based on the Phase 3 PROfound trial. For this indication, patients are selected for therapy based on an FDA approved companion diagnostic for LYNPARZA.