Britisdh drug major AstraZeneca Plc (AZN.L,AZN) announced Friday positive high-level results from the PROpel Phase III trial of Lynparza (olaparib), which met primary endpoint.
AstraZeneca and Merck & Co., Inc. (MRK) co-develop and co-commercialise Lynparza.
The results of the trial showed that Lynparza in combination with abiraterone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival or rPFS versus standard-of-care abiraterone as a 1st-line treatment for men with metastatic castration-resistant prostate cancer or mCRPC with or without homologous recombination repair (HRR) gene mutations.
At a planned interim analysis, the Independent Data Monitoring Committee or IDMC concluded that the trial met the primary endpoint of rPFS in men with mCRPC who had not received treatment in the 1st-line setting including with new hormonal agents (NHAs) or chemotherapy.
Lynparza in combination with abiraterone significantly delayed disease progression in all-comers in PROpel Phase III trial in 1st-line mCRPC.
Prostate cancer is the second-most common cancer in men and despite an increase in the number of available treatments for men with mCRPC, five-year survival remains low.
The study also showed a trend towards improved overall survival or OS.
However, the company said the data are still immature and the trial will continue to assess OS as a key secondary endpoint. The safety and tolerability were consistent with the known profiles of each medicine.
The companies will present the data at an upcoming medical meeting.
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