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Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
AstraZeneca and Merck announced long-term results from the Phase 3 PAOLA-1 and SOLO-1 trials for LYNPARZA in advanced ovarian cancer. The PAOLA-1 trial showed that, in HRD-positive patients, overall survival was 65.5% for LYNPARZA plus bevacizumab versus 48.4% for bevacizumab alone. In the SOLO-1 trial, 67% of patients with BRCA mutations treated with LYNPARZA were alive at seven years compared to 47% on placebo. Both trials highlighted the importance of biomarker testing in treatment decisions. While the OS results were not statistically significant for the PAOLA-1 trial overall, HRD-positive subgroup showed a 38% reduced risk of death.
The Merck Foundation has launched the Alliance for Equity in Cancer Care, a $20 million, five-year initiative aimed at improving cancer care for underserved communities in the United States. The program addresses disparities in cancer access and treatment, providing grants to non-profit organizations to implement innovative programs. Nearly 40% of Americans are expected to be diagnosed with cancer, with minority and low-income groups disproportionately affected. The Foundation aims to improve coordination of care and patient engagement, enhancing overall health outcomes.
Merck (NYSE: MRK) announced that CEO Robert M. Davis and Dr. Dean Li will participate in a virtual fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 12, 2022, at 2:15 p.m. EDT. The session invites investors, analysts, and the public to listen via a live audio webcast. Merck, known as MSD internationally, focuses on leading-edge science to improve global health and has been a key player in pharmaceuticals for over 130 years.
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Merck (NYSE: MRK) announced extensive research on cancer treatments to be presented at the ESMO Congress 2022 in Paris from September 9-13. Key highlights include:
- Long-term survival data for KEYTRUDA® in advanced lung cancer.
- Seven-year overall survival results for LYNPARZA® in ovarian cancer.
- First-time data combining KEYTRUDA with enfortumab vedotin for advanced urothelial cancer.
Dr. Eliav Barr emphasized the importance of these findings in enhancing treatment options across various cancer types.
Merck and AstraZeneca announced the approval of LYNPARZA by Japan's Pharmaceuticals and Medical Devices Agency for treating patients with high-risk, HER2-negative breast cancer with BRCA mutations.
This drug, a PARP inhibitor, shows a 42% reduced risk of invasive disease recurrence and a 32% lower risk of death, based on the OlympiA trial. Approximately 10% of patients experienced treatment discontinuation due to adverse reactions. The approval marks an important treatment advance for breast cancer patients in Japan.
Merck (NYSE: MRK) announced that the FDA has granted Fast Track designation for its investigational anticoagulant therapy, MK-2060, aimed at reducing major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). This designation allows more frequent FDA interactions and potential eligibility for Accelerated Approval. MK-2060 is a monoclonal antibody targeting Factor XI and is currently in a Phase 2 study for patients on hemodialysis. Merck emphasizes the urgent need for effective anticoagulation medicines for ESRD patients.
AstraZeneca and Merck (NYSE: MRK) announced that the FDA has accepted their supplemental New Drug Application for LYNPARZA in combination with abiraterone and prednisone for treating metastatic castration-resistant prostate cancer (mCRPC). The FDA granted priority review status, with a decision expected in Q4 2022. In the PROpel trial, the combination showed a 34% reduction in disease progression risk, with median radiographic progression-free survival of 24.8 months compared to 16.6 months for placebo. Merck aims to address significant unmet needs in mCRPC treatment.
Merck (NYSE: MRK) and Orna Therapeutics have entered a strategic collaboration to develop vaccines and therapeutics targeting infectious diseases and oncology. Merck will pay Orna $150 million upfront and an additional $3.5 billion in potential milestones, plus royalties on approved products. Merck will also invest $100 million in Orna's Series B financing. Orna retains rights to its innovative oRNA technology platform, which has shown stability and effectiveness in therapeutic applications, promising advancements in RNA-based treatments.
The European Commission has approved LYNPARZA as the first PARP inhibitor for adjuvant treatment in adults with germline BRCA mutations and HER2-negative early breast cancer, based on the Phase 3 OlympiA trial results. LYNPARZA showed a 42% reduction in the risk of invasive disease recurrence and a 32% reduction in mortality compared to placebo. AstraZeneca will receive a $75 million payment from Merck due to this approval. This milestone indicates a shift in treatment options for high-risk patients, aiming to decrease recurrence rates.