Patients Treated with LYNPARZA and Bevacizumab Lived Without Disease Progression or Death for a Median of 37.2 Months vs. 17.7 Months for Bevacizumab Alone Following Response to Platinum-Based Chemotherapy

Approximately One in Two Women with Advanced Ovarian Cancer Has an HRD-Positive Tumor

KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that LYNPARZA in combination with bevacizumab has been approved in the European Union (EU) for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic instability.

The approval by the European Commission was based on a biomarker subgroup analysis of the PAOLA-1 Phase 3 trial showing LYNPARZA in combination with bevacizumab maintenance treatment demonstrated progression-free survival (PFS) benefit versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumors. Women treated with LYNPARZA in combination with bevacizumab in the PAOLA-1 Phase 3 trial lived progression free for a median of more than three years, showing that HRD testing should be an essential component of clinical diagnosis. HRD status can help physicians select a personalized first-line treatment regimen for patients to substantially delay relapse in this devastating disease.”

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “Biomarker testing has rapidly enhanced our understanding of how PARP inhibition can help target this devastating disease. The EU approval reinforces that HRD-positive tumors represent a distinct subset of advanced ovarian cancer and HRD testing is critical for women in this setting.”

The PAOLA-1 trial showed that LYNPARZA in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (HR 0.33 [95% CI, 0.25-0.45]). The addition of LYNPARZA to bevacizumab improved PFS to a median of 37.2 months vs. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer. These results were published in The New England Journal of Medicine in 2019.

The most common adverse reactions (ARs) occurring in ≥10% of subjects in the overall trial population for PAOLA-1 when treated with LYNPARZA in combination with bevacizumab (N=535) and at a ≥5% frequency compared to bevacizumab alone (N=267) were fatigue (53% vs. 32%), nausea (53% vs. 22%), anemia (41% vs. 10%), lymphopenia (24% vs. 9%), vomiting (22% vs. 11%) and leukopenia (18% vs. 10%). Grade 3 or above ARs were anemia (17% vs. 5% of patients included hypertension (19%) and anemia (17%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA in combination with bevacizumab (5%) than in those receiving bevacizumab alone (1.9%). ARs led to dose interruption in 54% of patients on LYNPARZA in combination with bevacizumab, while 41% of patients on LYNPARZA in combination with bevacizumab had a dose reduction. Discontinuation of treatment due to ARs occurred in 20% of patients on LYNPARZA in combination with bevacizumab.

LYNPARZA in combination with bevacizumab is approved in the U.S. as a maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with HRD-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. In the U.S., patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. The combination is currently under regulatory review in other countries around the world.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

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