Combination therapy treat patients with metastatic castration-resistant prostate cancer
AstraZeneca and MSD have announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Lynparza. The therapy – also known as olaparib – will be for use in the UK with both abiraterone and prednisone or prednisolone.
The combination therapy treats adult patients with metastatic castration-resistant prostate cancer (mCRPC) when chemotherapy is not clinically indicated.
The verdict from the MHRA followed results from the PROpel phase 3 trial which showed that AstraZeneca and MSD’s olaparib in combination with abiraterone clearly improved radiographic progression-free survival in contrast to abiraterone alone as a first-line treatment for patients with mCRPC. This would be irrespective of their biomarker status.
Data also demonstrated that the combination therapy cut the risk of disease progression or death by 34% against abiraterone alone. At the time of the results cut off point, analysis of overall survival (OS) was at 40% maturity. The study will continue to assess OS as a key secondary endpoint.
David Long, head of oncology at MSD UK, was optimistic about the results: “Prostate cancer is the most common cancer in men in the UK and advanced prostate cancer is associated with a significant mortality rate. This approval from the MHRA marks important progress in advancing a new treatment option to address the significant unmet need of patients with mCRPC.”
Professor Noel Clarke, professor of urological oncology at The Christie and Salford Royal Hospitals, concluded: “This approval by the MHRA is an important next step for healthcare professionals and their patients in the UK with this specific type of prostate cancer.
“This data from the PROpel phase 3 trial underlines the therapeutic potential of new first-line treatment options for patients with mCRPC, especially given that many have a much-shortened life-span when their disease becomes castrate resistant.”
Prostate cancer is a significant cause of disease and mortality among men and has become fifth most common cause of cancer death across the world. In the UK alone, more than 52,000 men are diagnosed with prostate cancer every year – accounting for more than 140 cases every day.
Roughly 10-20% of patients with advanced prostate cancer will develop castration-resistant prostate cancer within five years.