AstraZeneca PLC (AZN.L,AZN) Tuesday announced positive results from the PROpel Phase III trial of Lynparza (olaparib) plus abiraterone in 1st-line metastatic castration-resistant prostate cancer or mCRPC.
The trial data showed that Lynparza plus abiraterone reduced risk of disease progression by 34%, compared to standard-of-care in 1st-line mCRPC.
In the trial, Lynparza in combination with abiraterone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival or rPFS versus current standard-of-care abiraterone as a 1st-line treatment for patients with mCRPC with or without homologous recombination repair or HRR gene mutations.
The company noted that the combination was well tolerated and allowed patients to maintain their quality of life, compared to patients treated with abiraterone alone.
Prostate cancer is the second most common cancer in male patients, causing approximately 375,000 deaths in 2020. In a predefined interim analysis, Lynparza in combination with abiraterone reduced the risk of disease progression or death by 34% versus abiraterone alone. Results also showed a favourable trend towards improved overall survival with Lynparza plus abiraterone versus abiraterone alone. However, the difference did not reach statistical significance at the time of this data cut-off.
The trial will continue to assess OS as a key secondary endpoint.
The results will be presented on February 17 at the 2022 American Society of Clinical Oncology or ASCO Genitourinary Cancers Symposium.
Lynparza is co-developed and co-commercialised by AstraZeneca and Merck & Co., Inc.
Fred Saad, the principal investigator in the trial, said, "The results of the PROpel trial, which showed that olaparib in combination with abiraterone significantly delayed disease progression versus abiraterone by more than eight months, demonstrate the potential for this combination to become a new standard of care option in mCRPC if approved."
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