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Final results of key secondary overall survival endpoint from phase III PROpel trial presented at ASCO GU Cancers Symposium

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Published: 17th Feb 2023

Results from the final prespecified overall survival (OS) analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer (mCRPC) showed AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone demonstrated median overall survival (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 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,(previously cited) 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).

Noel Clarke, Urological Surgeon and Professor of Urological Oncology at Manchester’s Christie/Salford Royal Hospitals and Manchester University, and a senior investigator in the PROpel trial, said: “From the primary radiographic progression-free survival analysis presented at ASCO GU last year to the updated overall survival data presented today, the data reinforce the therapeutic potential of olaparib plus abiraterone and prednisone for patients with metastatic castration-resistant prostate cancer in the overall trial population and across subgroups. The results of PROpel are important for patients and the oncology community alike, providing support for this combination as a potential and critically needed new treatment option in metastatic castration-resistant prostate cancer.”

Condition: Prostate Cancer
Type: drug
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