Approvals in Three Types of Cancer Are Based on the PAOLA-1, PROfound and POLO Phase 3 Trials

KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that LYNPARZA has been approved in Japan for the treatment of three types of advanced cancer: ovarian, prostate and pancreatic cancer. The three approvals authorize LYNPARZA for use as maintenance treatment after first-line chemotherapy containing bevacizumab (genetical recombination) in patients with homologous recombination repair deficient (HRD) ovarian cancer; the treatment of patients with BRCA gene-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC); and maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.

The concurrent approvals by the Japanese Ministry of Health, Labor, and Welfare are based on results from the PAOLA-1, PROfound and POLO Phase 3 trials, which each were published in The New England Journal of Medicine.

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “These three approvals allow patients in Japan to be treated with LYNPARZA, a targeted treatment personalized to their specific biomarkers. They further underline the critical importance of biomarker testing at diagnosis, which helps physicians determine a course of treatment tailored to their individual patients to substantially delay disease progression.”

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “For patients in Japan diagnosed with each of these types of cancer, there are very few treatment options. Approvals for treatments such as LYNPARZA, the first PARP inhibitor to be approved in these specific types of metastatic castration-resistant prostate cancer and metastatic pancreatic cancer in Japan, enable us to advance this evolving era of personalized medicine and change how these cancers are treated.”

LYNPARZA Approved as Maintenance Treatment After First-Line Chemotherapy Containing Bevacizumab (Genetical Recombination) in Patients with HRD-Positive Ovarian Cancer

The approval is based on a biomarker subgroup analysis of the PAOLA-1 Phase 3 trial which showed LYNPARZA, in combination with bevacizumab maintenance treatment, demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer.

In 2020, nearly 11,000 women in Japan were diagnosed with ovarian cancer, with more than 5,000 women dying of the disease.

LYNPARZA Approved for the Treatment of BRCAm Castration-Resistant Prostate Cancer with Distant Metastasis

The approval is based on a subgroup analysis of the PROfound Phase 3 trial which showed LYNPARZA demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1/2 mutations. LYNPARZA is the first and only PARP inhibitor approved in Japan in mCRPC.

Prostate cancer is the third most common type of cancer in Japan and in 2020, accounted for over 100,000 new cases.

LYNPARZA Approved as Maintenance Treatment After Platinum-Based Chemotherapy for Patients with BRCAm Curatively Unresectable Pancreas Cancer

The approval is based on the results of the POLO Phase 3 trial which showed LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in PFS versus placebo in patients with gBRCAm metastatic pancreatic cancer. LYNPARZA is the first and only PARP inhibitor approved in Japan in this disease.

Pancreatic cancer has one of the lowest survival rates of the most common cancers and in Japan was responsible for almost 40,000 deaths in 2020 – the fourth most common cause of cancer death. Japan has the third-highest rate of pancreatic cancer in the world with 44,000 new cases diagnosed in 2020.

AstraZeneca and Merck are exploring additional trials in advanced prostate cancers including the ongoing PROpel Phase 3 trial testing LYNPARZA as a first-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021. Outside the collaboration, Merck is exploring additional trials in advanced ovarian cancer including the Phase 3 KEYLYNK-001 trial evaluating KEYTRUDA in combination with chemotherapy, followed by maintenance LYNPARZA, for the first-line treatment of women with BRCA non-mutated advanced ovarian cancer.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in