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Merck & Co., Inc. (MRK)’s Investigational Anti-PD1 Antibody, MK-3475, Active In Three Different Tumor Types: New Data To Be Presented At The 2014 American Society of Clinical Oncology Annual Meeting


5/14/2014 7:21:05 AM

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Six oral presentations report MK-3475 monotherapy data across three different tumor types and multiple lines of therapy

Late-breaker presentation of long-term findings of MK-3475 in advanced melanoma, including ipilimumab-naïve and treated settings; data included in ASCO Press Program

First presentation of findings evaluating MK-3475 as initial treatment of patients with advanced non-small cell lung cancer

First presentation of findings of MK-3475 in recurrent/metastatic head and neck cancer


WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data for the company’s investigational anti-PD-1 antibody, MK-3475, in advanced melanoma, non-small cell lung cancer (NSCLC), and head and neck cancer, are scheduled to be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago on May 30 – June 3, 2014. The first presentation of data for MK-3475 as initial treatment in advanced NSCLC (Abstract #8007) – where chemotherapy is currently the standard of care -- and for the treatment of advanced head and neck cancer (Abstract #6011) will be part of oral sessions at ASCO 2014. The broad MK-3475 dataset to be highlighted across multiple tumors and lines of therapy comprises 16 abstracts, with half being oral presentations or poster discussions.

“Through our broad immuno-oncology-focused development program Merck is striving to help improve survival for people with advanced malignancies,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “The data to be presented expands our understanding of the effects of monotherapy with MK-3475, and will serve as a foundation for future studies of combination therapies in an even broader set of malignancies.”

Presentations in Advanced Melanoma

Merck has a broad development program in advanced melanoma evaluating MK-3475 across multiple stages of disease, lines of therapy and in combination with other anti-cancer agents. The company currently has two Phase 3 studies ongoing in advanced melanoma, and one planned for adjuvant treatment in the same indication.

Data evaluating MK-3475 in advanced melanoma will be the subject of four oral presentations and a poster discussion, including long-term data from Merck’s large ongoing Phase 1b trial (KEYNOTE-001).

On Monday, June 2, as part of a late-breaker abstract session, data from a study of 411 patients with advanced melanoma treated with MK-3475 will be presented; these data will also be highlighted in the ASCO Press Program (embargoed until 6:30 AM CDT) (Abstract #LBA9000). This study evaluated MK-3475 in patients across all lines of therapy including those previously-treated with ipilimumab.

On Monday, June 2, a study evaluating baseline factors including tumor size as an independent predictor for overall survival (OS) in patients with advanced melanoma treated with MK-3475 will be presented as a poster discussion (Abstract #3015).

On Tuesday, June 3, data in patients with advanced melanoma will be presented in three separate oral presentations: one evaluating durability of response and OS from the longest ongoing MK-3475 melanoma cohort of KEYNOTE-001 (Abstract #3005), another on the effect of different doses of MK-3475 (Abstract #3000) across different patient populations; and a third on observations of unique response patterns to MK-3475 based on immune-related response criteria (irRC) (Abstract #3006).

Presentations in Advanced Lung Cancer

Merck is advancing a clinical program in NSCLC evaluating MK-3475 as monotherapy and in combination across lines of therapy, and is exploring different tumor characteristics such as PD-L1 expression as predictors of responsiveness. Phase 3 studies with MK-3475 are currently ongoing in previously-treated advanced NSCLC patients, and Merck plans to initiate a Phase 3 trial in first-line treatment in 2014.

On Monday, June 2, the first presentation of data for MK-3475 as initial therapy for advanced NSCLC (KEYNOTE-001) will be the subject of an oral session (Abstract #8007). On Tuesday, June 3, updated results including durability of response in patients with previously-treated advanced NSCLC (KEYNOTE-001) will be presented as a poster discussion (Abstract #8020).

Presentation in Head and Neck Cancer

On Sunday, June 1, the first presentation of a study evaluating MK-3475 in patients with recurrent and metastatic head and neck cancer (KEYNOTE-012) expressing PD-L1 will be featured in an oral session (Abstract #6011). The company announced recently that a new Phase 3 study is planned in advanced head and neck cancer in 2014.

Full session information on MK-3475 data and other findings on Merck’s marketed anti-cancer and supportive care products can be accessed through the ASCO iplanner: https://iplanner.asco.org/am2014/AM2014.aspx.

Regulatory Status of MK-3475

On May 6, 2014, Merck announced that the Biologics License Application (BLA) for MK-3475 has been accepted for priority review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced melanoma previously-treated with ipilimumab; the PDUFA date is October 28, 2014. The company also announced plans to file a Marketing Authorization Application for MK-3475 for advanced melanoma in Europe by the end of 2014.

Merck’s Research Focus on Immuno-Oncology

Harnessing immune mechanisms to fight cancer is the priority focus of Merck’s oncology research and development program. Today, MK-3475, an investigational anti-PD-1 antibody, is being evaluated across more than 30 types of cancers, as monotherapy and in combination. More than 24 trials including seven Phase 3 studies are either ongoing or anticipated to start in 2014. The company is advancing Phase 1 studies with MK-4166, an investigational anti-GITR antibody, clinical studies of immunomodulatory combination regimens, and preclinical evaluation of other immunotherapy candidates for the treatment of cancer. For information about Merck’s oncology clinical studies, please visit www.MerckClinicalTrials.com.

About Merck Oncology

At Merck Oncology, our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. Cancer is one of the world's most urgent unmet medical needs. Helping to empower people to fight cancer is our passion. For more information about Merck’s commitment to Oncology please visit the Oncology Information Center at http://www.mercknewsroom.com/oncology-infocenter.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. 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. 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 pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’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 Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck 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 Merck’s 2013 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).

Contact:

Merck

Media:
Ian McConnell, 908-423-3046
or
Claire Mulhearn, 908-423-7425
or
Investors:
Carol Ferguson, 908-423-4465
or
Justin Holko, 908-423-5088

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