LYNPARZA® (olaparib) Approved in the EU for Treatment of BRCA1/2-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that LYNPARZA has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) who have progressed following a prior therapy that included a new hormonal agent.

The approval by the European Commission was based on a subgroup analysis from the Phase 3 PROfound trial showing LYNPARZA demonstrated an improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1/2 mutations. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.

Prostate cancer is the second-most common type of cancer in men, with an estimated 1.3 million new patients diagnosed worldwide in 2018. Approximately 10% of men with mCRPC have a BRCA mutation.

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “LYNPARZA more than tripled radiographic progression-free survival and is the only PARP inhibitor to demonstrate overall survival versus enzalutamide or abiraterone for men with BRCA-mutated metastatic castration-resistant prostate cancer. BRCA testing should now become a critical step in the diagnosis and determination of treatment for men with advanced prostate cancer in the EU.”

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “The PROfound trial showed LYNPARZA provided a clinical benefit for men living with BRCA1/2-mutated metastatic castration-resistant prostate cancer, offering an important option to improve overall survival for these patients in the EU. Merck, along with our collaborator AstraZeneca, looks forward to making this targeted treatment available for patients across the EU as quickly as possible.”

Results from the subgroup analysis from the PROfound trial showed LYNPARZA reduced the risk of disease progression or death by 78% (HR 0.22 [95% CI, 0.15-0.32], p<0.0001) and improved rPFS to a median of 9.8 months vs. 3.0 months with enzalutamide or abiraterone in men with mCRPC with BRCA1/2 mutations. LYNPARZA reduced the risk of death by 37% (HR 0.63 [95% CI, 0.42-0.95]) with median OS of 20.1 months vs. 14.4 months with enzalutamide or abiraterone. The primary results and OS results from the trial were each published in The New England Journal of Medicine earlier this year.

The most common adverse reactions (ARs) in the PROfound trial, occurring in ≥10% of subjects, for LYNPARZA compared to enzalutamide or abiraterone were anemia (46% vs.15%), nausea (41% vs. 19%), fatigue (including asthenia) (41% vs. 32%), decreased appetite (30% vs. 18%), diarrhea (21% vs. 7%), vomiting (18% vs. 12%), thrombocytopenia (12% vs. 3%), cough (11% vs. 2%) and dyspnea (10% vs. 3%). Dose interruptions due to an AR occurred in 45% of patients receiving LYNPARZA and dose reductions due to an AR occurred in 22% of LYNPARZA patients. Discontinuation due to ARs occurred in 18% of LYNPARZA patients.

LYNPARZA is approved in the U.S. for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone. In the U.S., patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer, including the ongoing Phase 3 PROpel trial evaluating LYNPARZA as a first-line therapy in combination with abiraterone acetate for patients with mCRPC versus abiraterone acetate alone.

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