Olaparib significantly extended radiographic PFS compared with standard-of-care treatment among a specific subset of men with advanced prostate cancer, according to the agent’s manufacturers.
The randomized phase 3 PROfound trial evaluated the efficacy and safety of the PARP inhibitor olaparib (Lynparza; AstraZeneca, Merck) compared with enzalutamide (Xtandi; Astellas, Pfizer) or abiraterone (Zytiga, Janssen) for men with metastatic castration-resistant prostate cancer whose disease progressed on or prior treatment with new hormonal anticancer treatments. All trial participants also had homologous recombination repair (HRR) gene mutations.
The trial met its primary endpoint, showing significantly improved radiographic PFS with olaparib compared with standard-of-care treatment for men selected for BRCA1/BRCA2 or ATM gene mutations, a subgroup of HRR mutations.
Olaparib exhibited a safety profile consistent with that observed in prior studies.
“For men with metastatic castration-resistant prostate cancer, the disease remains deadly, especially in those who have failed on a new hormonal anticancer treatment,” José Baselga, MD, PhD, executive vice president for oncology research and development at AstraZeneca, said in a company-issued press release. “This trial is the only positive phase 3 trial of any PARP inhibitor in metastatic castration-resistant prostate cancer, where the need for new, effective therapies is high. The PROfound trial also demonstrates the potential value of genomic testing in this at-risk patient population. We look forward to discussing these results with global health authorities soon.”
Full results from PROfound will be presented at an upcoming medical meeting.
“Metastatic castration-resistant prostate cancer is a deadly disease and represents an area of critical unmet medical need,” Roy Baynes, MD, PhD, senior vice president, head of global clinical development and chief medical officer for MSD Research Laboratories, said in the release. “These results represent the potential for a new, oral targeted treatment option for this patient population.”