Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic MCC. No Duty to Update John Cummins Policy media relations

This news release of Merck & Co., Inc., Kenilworth, 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.

Cookie Policy. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

By continuing, you will be directed to a site intended only for residents of the United States and Canada. In the US, BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

This release contains forward-looking information about BAVENCIO (avelumab), including an indication for first-line maintenance therapy for BAVENCIO for the treatment of patients with locally advanced or metastatic urothelial carcinoma, the alliance between Merck and Pfizer involving BAVENCIO and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. Merck, based in Kenilworth, N.J., is a longtime maker of vaccines and antivirals, including human papillomavirus shot Gardasil. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia. The company assumes no duty to update the information to reflect subsequent developments.

We are called MSD everywhere, except in the United States and Canada where we are known as Merck & Co Inc, Kenilworth, NJ USA. This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S.

Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications may be filed in any other jurisdictions for BAVENCIO for first-line maintenance therapy for locally advanced or metastatic urothelial carcinoma in any jurisdictions or for any other potential indications for BAVENCIO or combination therapies in any jurisdictions; whether and when regulatory authorities in any jurisdictions where any applications are pending or may be submitted for BAVENCIO or combination therapies, including BAVENCIO for locally advanced or metastatic urothelial carcinoma may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BAVENCIO, including BAVENCIO for locally advanced or metastatic urothelial carcinoma; the impact of COVID-19 on our business, operations and financial results; and competitive developments.

and need information about Merck, please feel free to get in touch with our media contacts below. Corporate media relations, John Cummins Dahan R, Sega E, Engelhardt J, et al. Production is based on GMP standards. (908) 740-1037, Merck to Hold Third-Quarter 2020 Sales and Earnings Conference Call on October 27, https://www.merck.com/investor-relations/events-and-presentations/.

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 recent 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 assumes no duty to update the information to reflect subsequent developments.

Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. Avelumab 1L maintenance + best supportive care (BSC) vs BSC alone with 1L chemotherapy for advanced urothelial carcinoma: subgroup analyses from JAVELIN Bladder 100. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Get a glimpse of what it's like on the inside through our stories.

At one year, 71.3% of patients (95% CI, 66.0% to 76.0%) in the BAVENCIO arm were alive vs 58.4% (95% CI, 52.7% to 63.7%) of patients who received BSC alone.

About Merck. Jessica Fine. Overall survival, costs, and healthcare resource use by line of therapy in Medicare patients with newly diagnosed metastatic urothelial carcinoma. You can change which cookies are set at any time - and find out more about them in our cookie policy.

Fisher MD, et al. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Merck & Co., Inc., Kenilworth, New Jersey, USA is known as MSD outside of the United States and Canada ... General media inquiries +1 908-740-5633. mediarelations@msd.com. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. Pfizer Inc.: Breakthroughs that change patients' livesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Merck.

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The information contained in this website was current as of the date presented. John Cummins Policy media relations ... Merck Patient Assistance Program provides certain Merck medicines and adult vaccines for free to qualified patients;

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Accessed. All primary and secondary endpoints are measured from the time of randomization. Bladder cancer: introduction. Safety No new safety signals were identified in the JAVELIN Bladder 100 study, and the safety profile was consistent with previous studies of BAVENCIO monotherapy.1 Treatment-related adverse events of grade 3 or higher occurred in 57 patients (16.6%) treated with BAVENCIO plus BSC; no grade 3 or higher treatment-related events occurred in the control arm.1 No grade 4 or fatal immune-related adverse events occurred.1 Investigators attributed two patient deaths in the BAVENCIO plus BSC arm (0.6%), due to sepsis and ischemic stroke, to study treatment toxicity.1. General media inquiries, Pamela Eisele Everything we do, in and out of the laboratory, is based on our deep appreciation for life.

Grivas P, Park SE, Voog E, et al. Share Icons revealed to the left Cancer stat facts: bladder cancer. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. https://seer.cancer.gov/statfacts/html/urinb.html. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Countries outside of the United States and Canada. Merck's online newsroom offers real-time news about Merck's prescription medicines, vaccines and consumer care products.

For more than 150 years, we have worked to make a difference for all who rely on us. Countries outside of the United States and Canada. Assets intended for use by media professionals. In 2019, Merck generated sales of € 16.2 billion in 66 countries.

Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call. 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.

Bray F, et al. About BAVENCIO® (avelumab)BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody.

Access videos, logos, photos and infographics. Our mission is to discover, develop and provide innovative products and services that save and improve lives around the world. Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA. A real-world data study to evaluate treatment patterns, clinical characteristics and survival outcomes for first- and second-line treatment in locally advanced and metastatic urothelial cancer patients in, Flannery K, et al.

Registration on or use of this site constitutes acceptance of our Terms of Service and Privacy Policy. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.

CANCERMPACT – treatment architecture. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.16-18 In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

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