LYNPARZA® (olaparib) Reduced Risk of Death by 32% in Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer in Phase 3 OlympiA Trial

First and Only PARP Inhibitor to Demonstrate Overall Survival Benefit in Certain Patients With Early Breast Cancer, A Key Secondary Endpoint

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced additional positive results from the Phase 3 OlympiA trial. In OlympiA, LYNPARZA demonstrated a statistically significant improvement in overall survival (OS) versus placebo for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.

These updated results will be presented today at the European Society for Medical Oncology Virtual Plenary. The OlympiA trial is led by the Breast International Group (BIG) in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, AstraZeneca and Merck.

In the key secondary endpoint of OS, LYNPARZA reduced the risk of death by 32% (HR=0.68 [98.5% CI, 0.47-0.97]; p=0.009) versus placebo. The three-year survival rate was 92.8% (95% CI, 90.8-94.4) versus 89.1% (95% CI, 86.7-91) for those on placebo. At four years, the survival rate was 89.8% (95% CI, 87.2-91.9) for patients treated with LYNPARZA versus 86.4% (95% CI, 83.6-88.7) for those on placebo. The analyses at three and four years are based on Kaplan-Meier estimates and are descriptive only. The OlympiA study was not powered to assess a statistical difference between treatment groups at these timepoints.

The safety and tolerability profile of LYNPARZA in this trial was in line with that observed in prior clinical trials. The most common adverse reactions (ARs) ≥10% for LYNPARZA were nausea (57%), fatigue (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%) and stomatitis (10%). Approximately 10% of patients treated with LYNPARZA discontinued treatment due to an AR. The most common Grade ≥3 ARs for LYNPARZA were anemia (9%), neutropenia (5%), leukopenia (3%) and fatigue (1.8%).

Breast cancer is the most commonly diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020. Almost 91% of all breast cancer patients in the U.S. are diagnosed at an early stage of disease, and germline BRCA mutations are found in approximately 5-10% of all breast cancer patients.

About OlympiA

OlympiA is a Phase 3, double-blind, parallel group, placebo-controlled, international trial evaluating the efficacy and safety of LYNPARZAversus placebo as adjuvant treatment in patients with gBRCAm, HER2-negative high-risk early breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. The primary endpoint was IDFS, defined as the time from randomization to the date of the first loco-regional or distant recurrence or new cancer or death from any cause. A key secondary efficacy outcome measure was OS.

The OlympiA trial is led by BIG in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, AstraZeneca and Merck.

About LYNPARZA® (olaparib)

LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.

About Breast Cancer

Early breast cancer is defined as disease confined to the breast with or without regional lymph node involvement and the absence of distant metastatic disease.For women in the U.S., the five-year survival rate is 99% for localized breast cancer (cancer that is found only in the breast area) and 86% for regional breast cancer (cancer that has spread outside the breast to nearby structures or lymph nodes).Breast cancer is one of the most biologically diverse tumor types with various factors fueling its development and progression.The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease.
About the AstraZeneca and Merck Strategic Oncology Collaboration

In July 2017, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world’s first PARP inhibitor, for multiple cancer types. Working together, the companies will develop these products in combination with other potential new medicines and as monotherapies. Independently, the companies will develop these oncology products in combination with their respective PD-L1 and PD-1 medicines.
About Merck

For over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world.

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