AstraZeneca, Merck present final results from Phase III PROpel trial

Results from the final prespecified overall survival analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer showed LYNPARZA, jointly developed and commercialized by AstraZeneca (AZN( and Merck & Co., (MRK) 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. 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 Genitourinary Cancers Symposium. 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, showing that LYNPARZA in combination with abiraterone significantly reduced the risk of disease progression or death by 34% versus abiraterone alone. The safety and tolerability of LYNPARZA plus abiraterone was in line with that observed in prior clinical trials and the known profiles of the individual medicines. At the time of this updated analysis, there were no new long-term safety issues identified. The most common adverse events in the LYNPARZA plus abiraterone arm were anemia, fatigue, nausea, back pain and diarrhea. Approximately 83% of patients treated with LYNPARZA plus abiraterone who experienced AEs remained on treatment at the time of data cut-off.