AstraZeneca and Merck present final results of key secondary overall survival endpoint from Phase III PROpel trial at ASCO GU Cancers Symposium

Results showed an absolute difference of an additional 7.4 months in median overall survival for LYNPARZA® (olaparib) plus abiraterone in this setting vs. abiraterone alone

Excerpt from the Press Release:

WILMINGTON, Del.–(BUSINESS WIRE)–Results from the final prespecified overall survival (OS) analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer (mCRPC) showed LYNPARZA^® (olaparib), jointly developed and commercialized by AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada in combination with abiraterone and prednisone or prednisolone demonstrated median OS of 42.1 months versus 34.7 months for abiraterone plus placebo. This result represents a 7.4-month absolute difference in median OS versus a standard of care (47.9% maturity, hazard ratio [HR] of 0.81, 95% confidence interval [CI] 0.67-1.00; p=0.0544).

While this numerical increase in median OS did not achieve statistical significance, this clinical activity builds on the meaningful survival gains achieved for patients in this setting treated with abiraterone alone, a current standard of care. Results will be presented today in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (#LBA16).

In the primary analysis presented at ASCO GU 2022, and published in The New England Journal of Medicine Evidence, PROpel met its primary endpoint of radiographic progression-free survival (rPFS), showing that LYNPARZA in combination with abiraterone significantly reduced the risk of disease progression or death by 34% versus abiraterone alone (HR 0.66; 95% CI 0.54-0.81; p<0.0001).

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