RAHWAY - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that research spanning 16 different cancer types will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris, France from Sept. 9-13.

The breadth of data showcases the continued impact of Merck's portfolio of oncology medicines and the potential of Merck's innovative oncology pipeline.

'We are proud to present longer-term survival data in patients with lung, ovarian, melanoma and head and neck cancers, as well as findings that reinforce the impact of our medicines in earlier stages of certain cancers and in new combinations,' said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. 'Notably, we look forward to sharing five-year survival results from the pivotal KEYNOTE-189 study that has established the foundational role of KEYTRUDA in the first-line treatment setting for patients with metastatic nonsquamous non-small cell lung cancer, and results from EV-103/KEYNOTE-869, a study of KEYTRUDA in combination with the antibody-drug conjugate, enfortumab vedotin, in patients with locally advanced or metastatic urothelial cancer.'

Presentations will feature new or updated findings from Merck's growing pipeline and broad portfolio of cancer medicines: KEYTRUDA; WELIREG (belzutifan); LYNPARZA (in collaboration with AstraZeneca); LENVIMA (lenvatinib, in collaboration with Eisai) and ODM-208, an investigational steroid synthesis inhibitor (in collaboration with Orion).

Key Merck and collaborative data at ESMO 2022

Five-year overall survival (OS) data from the pivotal Phase 3 KEYNOTE-189 and KEYNOTE-407 trials evaluating KEYTRUDA in combination with chemotherapy as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) (Presentations #973MO and #974MO, respectively); Seven-year OS data from the Phase 3 SOLO-1 trial evaluating maintenance LYNPARZA in patients with advanced BRCA-mutated ovarian cancer, following first-line platinum-based chemotherapy (Presentation #517O) and final OS results from the Phase 3 PAOLA-1 trial evaluating maintenance LYNPARZA in combination with bevacizumab in patients with advanced ovarian cancer following first-line platinum-based chemotherapy and bevacizumab (Presentation #LBA29); First-time data from Cohort K of the Phase 1b/2 EV-103/KEYNOTE-869 trial evaluating PADCEV (enfortumab vedotin) in combination with KEYTRUDA as first-line treatment for patients with cisplatin-ineligible unresectable locally advanced or metastatic urothelial cancer (Presentation #LBA73), which reported positive topline results for the primary endpoint of objective response rate earlier this year; First-time data from NCI-sponsored SWOG S1801, a Phase 2 study of neoadjuvant versus adjuvant KEYTRUDA for clinically detectable and resectable stage III to IV melanoma, to be featured in Presidential Symposium II (Presentation #LBA6).

About Merck's early-stage cancer clinical program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

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.

About the Merck and Eisai strategic collaboration

In March 2018, Eisai and Merck, known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck's anti-PD-1 therapy KEYTRUDA.

In addition to ongoing clinical studies evaluating the KEYTRUDA plus LENVIMA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in multiple tumor types across more than 15+ clinical trials.

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

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2021 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

Contact:

Melissa Moody

Tel: (215) 407-3536

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