AstraZeneca and MSD’s Lynparza (olaparib) has demonstrated an overall survival benefit in a late-stage trial for BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer.
The Phase III PROfound trial tested Lynparza in men with metastatic castration-resistant prostate cancer (mCRPC) who have a homologous recombination repair gene mutation (HRRm) and have progressed on prior hormonal treatment.
Results from the trial showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) with Lynparza versus enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations.
The study had already met its primary endpoint, back in August last year, showing significantly improved radiographic progression-free survival (rPFS) in men with mutations in BRCA1/2 or ATM genes, and had met a key secondary endpoint of rPFS in the overall HRRm population.
“Overall survival in metastatic castration-resistant prostate cancer has remained extremely challenging to achieve,” noted José Baselga, executive vice president, Oncology R&D at AZ. “We are thrilled by these results for Lynparza and we are working with regulatory authorities to bring this medicine to patients as soon as possible.”
The data will be presented at a forthcoming medical meeting.
Lynparza was awarded a priority review in the US for patients with HRRm mCRPC in January 2020, with regulatory reviews ongoing in the EU and other jurisdictions.
