AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US has presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with Lynparza (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a standard of care, in metastatic castration-resistant prostate cancer (mCRPC).
The results of Study 08, a randomised, double-blinded, multi-centre Phase II trial, comparing Lynparza in combination with abiraterone (n=71) to abiraterone monotherapy (n=71) in patients with previously-treated mCRPC, regardless of homologous recombination repair (HRR) mutation status, were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The primary endpoint was rPFS. Secondary endpoints included time to second progression or death (PFS2), overall survival (OS) and health-related quality of life.
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “There is a significant unmet medical need for patients with metastatic castration-resistant prostate cancer as they are a high-risk group with limited treatment options. Lynparza is the first PARP inhibitor to demonstrate activity in combination with standard-of-care treatment in prostate cancer.”
The safety profile of Lynparza and abiraterone was generally manageable, with no detrimental effect on quality of life compared to abiraterone alone.
In addition to Study 08, other studies are underway to explore the potential of Lynparza as a monotherapy for HRR-mutated mCRPC, including PROfound, which is testing Lynparza monotherapy vs. enzalutamide or abiraterone in patients with previously-untreated mCRPC. Additional trials are planned to explore Lynparza in combination for the treatment of mCRPC regardless of HRR status.