Patients Treated with LYNPARZA and Bevacizumab Lived Without Disease Progression or Death for a Median of 37.2 Months vs. 17.7 Months with 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 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending LYNPARZA 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 BRCA1/2 mutation and/or genomic instability.

The positive opinion was based on a biomarker subgroup analysis of the Phase 3 PAOLA-1 trial, whichwas published in The New England Journal of Medicine.

The 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 progression-free survival (PFS) to a median of 37.2 months vs. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.

The most common adverse reactions (ARs) ≥10% 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.

For patients with advanced ovarian cancer, the primary aim of first-line maintenance treatment is to delay disease progression for as long as possible.

Dr. José Baselga, executive vice president, oncology R&D, AstraZeneca, said, “Half of all patients with advanced ovarian cancer have HRD-positive tumors. LYNPARZA together with bevacizumab has demonstrated a median progression-free survival benefit of more than three years vs. 17.7 months with bevacizumab alone, offering new hope for women in this setting. This recommendation is a vital step toward addressing a large and critical unmet need and could bring a new treatment option that significantly delays relapse in this difficult-to-treat disease.”

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “HRD is an important biomarker of advanced ovarian cancer that can inform how physicians in the EU treat this aggressive type of cancer. This recommendation and the results from the PAOLA-1 trial underscore the importance of HRD testing at diagnosis to determine treatment options for women with advanced ovarian cancer.”

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 data from the PAOLA-1 trial is currently under regulatory reviews in other countries.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

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