PROpel Is the First Phase 3 Trial to Show Clinical Benefit in Radiographic Progression-Free Survival With a PARP Inhibitor in This Setting
KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that positive results from the Phase 3 PROpel trial showed LYNPARZA in combination with abiraterone plus prednisone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) versus abiraterone plus prednisone, a standard of care, as a first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations.
Results from the trial will be presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium on Feb. 17, 2022 (Abstract 11).
Globally, prostate cancer is the second most common cancer in patients assigned as male at birth, with an estimated 1.4 million patients diagnosed worldwide in 2020. Approximately 10-20% of men with advanced prostate cancer are estimated to develop CRPC within five years, and at least 84% of these men may develop metastases at the time of CRPC diagnosis. Patients with advanced prostate cancer have a particularly poor prognosis, and the five-year survival rate remains low.
PROpel is a randomized, double-blind, multi-center Phase 3 trial. In Sept. 2021, at a planned interim analysis, the Independent Data Monitoring Committee concluded that the PROpel trial met the primary endpoint of rPFS. LYNPARZA in combination with abiraterone plus prednisone (n=399) reduced the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.54-0.81]; p