AstraZeneca and MSD have announced that the companies’ joint drug, Lynparza (olaparib), has met the primary endpoint in a Phase III prostate cancer trial.
The primary endpoint was significantly increasing the time patients selected for BRCA1/2 or ATM mutations live without radiographic disease progression vs. standard of care treatment, which the drug achieved in men with metastatic castration-resistant prostate cancer (mCRPC). Specifically, those who have a homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal anticancer treatments (e.g. enzalutamide and abiraterone).
The results showed a statistically-significant and clinically-meaningful improvement in radiographic progression-free survival (rPFS) with Lynparza, meaning that the treatment is now the only PARP inhibitor with positive Phase III results in four different cancer types - ovarian, breast, pancreatic and prostate.
Lynparza is currently already approved in 64 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status
For men with metastatic castration-resistant prostate cancer “the disease remains deadly, especially in those who have failed on a new hormonal anticancer treatment” commented José Baselga, executive vice president, Oncology R&D.
He continued to explain that the trial is the “only positive Phase III 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.”
Prostate cancer is the second-most common cancer in men, with an estimated 1.3 million new cases diagnosed worldwide in 2018 and is associated with a significant mortality rate.