AstraZeneca and MSD have reported positive results from the Phase III PROfound trial evaluating the safety and efficacy of Lynparza (olaparib) in men with metastatic castration-resistant prostate cancer (mCRPC).
The trial results showed a statistically-significant and clinically-meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) with Lynparza versus enzalutamide or abiraterone in men with mCRPC.
The prospective, multi-centre, randomised, open-label, Phase III PROfound trial evaluated Lynparza versus enzalutamide or abiraterone in patients with mCRPC.
MSD Research Laboratories senior vice-president and Global Clinical Development head Roy Baynes said: “Metastatic castration-resistant prostate cancer is a deadly disease and represents an area of critical unmet medical need.
“The Phase III PROfound trial is another example of MSD and AstraZeneca’s shared commitment to improving long-term outcomes for people living with cancer. These results represent the potential for a new, oral targeted treatment option for this patient population.”
AstraZeneca and MSD are planning to conduct trials in prostate cancer, including the Phase III PROpel trial, which is currently testing Lynparza in combination with abiraterone as a first-line therapy in mCRPC.
AstraZeneca Oncology R&D executive vice-president José Baselga said: “This 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.”
Lynparza (olaparib) is being jointly developed and commercialised by AstraZeneca and MSD.
It is a first-in-class PARP inhibitor that is currently approved in 64 countries for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status.