KENILWORTH - AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the Phase 3 OlympiA trial for LYNPARZA will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC).
Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) versus placebo in the adjuvant treatment of germline BRCA-mutated (gBRCAm), high-risk human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer following definitive local treatment and neoadjuvant or adjuvant chemotherapy.
The OlympiA Phase 3 trial is a partnership between Breast International Group (BIG), NRG Oncology, the U.S. National Cancer Institute (NCI), Frontier Science & Technology Research Foundation (FSTRF), AstraZeneca and Merck. The trial is sponsored by NRG Oncology in the U.S. and by AstraZeneca outside the U.S.
An estimated 2.3 million women were diagnosed with breast cancer worldwide in 2020, and BRCA mutations are found in approximately 5% of breast cancer patients. Around 55-65% of women with a BRCA1 mutation and approximately 45% with a BRCA2 mutation are estimated to develop breast cancer before the age of 70.
Andrew Tutt, global chair of the OlympiA Phase 3 trial and professor, Institute of Cancer Research and Kings College London, said, 'We are delighted that our global academic and industry partnership has been able to help investigate a possible personalized treatment for women with hereditary breast cancer. The most common cause of hereditary breast cancer is an inherited mutation in the BRCA1 or BRCA2 genes, which also may cause the disease to develop at a significantly earlier age than is usual. The OlympiA trial has allowed us to go beyond using genetic testing to identify patients who are at risk of this disease and explore the potential of LYNPARZA to prevent disease recurrence for these patients. We look forward to analyzing and presenting the full results of the trial at a forthcoming medical meeting.'
Dr. Jose Baselga, executive vice president, oncology R&D, AstraZeneca, said, 'Breast cancer remains one of the most common cancers globally and despite advances in treatment, many patients with high-risk disease will unfortunately develop a recurrence. We look forward to reviewing the results.'
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, 'Analysis of the OlympiA trial, based upon the IDMC recommendation, could represent a potential step forward for patients with early-stage, high-risk primary breast cancer with a germline BRCA mutation.'
In its communication on the planned interim analysis, the IDMC did not raise any new safety concerns. The trial will continue to assess the key secondary endpoints of overall survival and distant disease-free survival.
About Breast Cancer
Breast cancer is the most common cancer among women worldwide. The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease, and one of the most biologically diverse tumor types with various factors fueling its development and progression.
About BRCA Mutations
BRCA1 and BRCA2 (breast cancer susceptibility genes 1/2) are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.
About OlympiA
OlympiA is a Phase 3, double-blind, parallel group, placebo-controlled, multicenter trial testing the efficacy and safety of LYNPARZA tablets versus placebo as adjuvant treatment in patients with gBRCAm high-risk HER2-negative early breast cancer, who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. The primary endpoint of the trial is iDFS defined as time from randomization to date of first treatment failure that is loco-regional or distant recurrence or new cancer or death from any cause.
About NRG Oncology
NRG Oncology is a network group funded by the NCI, a part of the National Institutes of Health. All of the NCI funded network groups participated in the trial. The NCI and AstraZeneca are collaborating under a Cooperative Research and Development Agreement.
NRG Oncology brings together the National Surgical Adjuvant Breast and Bowel Project, the Radiation Therapy Oncology Group, and the Gynaecologic Oncology Group, with the mission to improve the lives of cancer patients by conducting practice-changing multi-institutional clinical and translational research.
About BIG
The Breast International Group (BIG) is an international not-for-profit organization for academic breast cancer research groups from around the world, based in Brussels, Belgium.
Founded by leading European opinions leaders in 1999, the organization aims to address fragmentation in European breast cancer research and now represents a network of over 55 like-minded research groups affiliated with specialized hospitals, research centers and leading experts across approximately 70 countries on six continents.
BIG's research is supported in part by its philanthropy unit, known as BIG against breast cancer, which is used to interact with the general public and donors, and to raise funds for BIG's purely academic breast cancer trials and research programs.
About FSTRF
Frontier Science & Technology Research Foundation (FSTRF) is a non-profit, research organization which supports research networks, pharmaceutical companies and investigators to conduct scientifically meaningful, high-quality clinical trials. The OlympiA trial involved research staff in the U.S. and in the Affiliate office in Scotland.
FSTRF works with scientists and technicians in more than 800 laboratories, universities and medical centers around the world to provide a comprehensive range of research services throughout the clinical trial process including design, analysis and reporting.
Through its work, FSTRF aims to advance the application of statistical science and practice and data management techniques in science, healthcare and education.
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 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 certain oncology products including 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.
Merck's Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.
About Merck
For 130 years, Merck, known as MSD outside of 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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