KeytrudaTreatment for Melanoma - Metastatic
Update: Keytruda (pembrolizumab) Now FDA Approved - September 4, 2014
Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab
WHITEHOUSE STATION, N.J. Sept. 2, 2014 --(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from ongoing clinical trials evaluating the anti-tumor activity of pembrolizumab, the company’s investigational anti-PD-1 antibody, at the European Society of Medical Oncology (ESMO) 2014 in Madrid, Spain, September 26 – 30. Data on pembrolizumab are planned to be presented in five advanced solid tumor types, including the first presentation of data evaluating pembrolizumab for the treatment of gastric and bladder (urothelial tract) cancers. Three late-breaking abstracts have been accepted for oral presentation.
“We are pleased to present the first data for our investigational anti-PD-1 antibody pembrolizumab in gastric and bladder cancers at ESMO 2014,” said Dr. Roy Baynes, senior vice president, Global Clinical Development, Merck Research Laboratories. “The presentation of data for five advanced tumor types underscores the breadth of Merck’s immuno-oncology development program evaluating pembrolizumab in diverse tumor types, different stages of disease and multiple lines of therapy.”
Abstracts involving Merck Oncology-sponsored studies at ESMO 2014 include:
Bladder and Gastric Cancers
- (Abstract #LBA23) Late-Breaker (Oral presentation): A Phase 1b Study of Pembrolizumab (Pembro; MK-3475) in Patients (Pts) With Advanced Urothelial Tract Cancer. E. Plimack. Monday, September 29, 11:00 AM-11:15 AM CEST. Location: Sevilla.
- (Abstract #LBA15) Late-Breaker (Oral presentation): A Phase 1b Study of Pembrolizumab (Pembro; MK-3475) in Patients (Pts) With Advanced Gastric Cancer. K. Muro. Sunday, September 28. 09:15 AM-09:30 AM CEST. Location: Madrid.
- (Abstract #LBA34) Late-Breaker (Poster discussion): Pembrolizumab (Pembro; MK-3475) for Advanced Melanoma (MEL): Randomized Comparison of Two Dosing Schedules. C. Robert, Monday, September 29. 1:00 PM-2:00 PM CEST. Location: Valencia.
- (Abstract #1075TiP) Poster: KEYNOTE-029: Phase 1/2 Study of MK-3475 in Combination With Pegylated Interferon Alfa-2b (PEG-IFN) or Ipilimumab (IPI) in Patients (Pts) With Advanced Melanoma (MEL) or Renal Cell Carcinoma (RCC). T.K. Choueiri. Monday, September 29; 12:45 PM-1:45 PM CEST. Location: Poster Area.
- (Abstract #1097P) Poster: PD-L1 Expression and Overall Survival Among Patients With Melanoma. T. Steiniche. Sunday, September 28; 12:45 PM-1:45 PM CEST. Location: Poster Area.
- (Abstract #LBA43) Late-Breaker (Oral presentation): Antitumor Activity of Pembrolizumab (Pembro; MK-3475) and Correlation With Programmed Death Ligand 1 (PD-L1) Expression in a Pooled Analysis of Patients (pts) With Advanced Non–Small Cell Lung Carcinoma (NSCLC). E. Garon. Sunday, September 28; 09:15 AM-10:30 AM CEST. Location: Barcelona.
- (Abstract #1328P) Poster: PD-L1 Expression and Survival Among Advanced Non–Small Cell Lung Cancer (NSCLC) Patients Treated With Chemotherapy. S. Sorensen. Saturday, September 27; 12:45 PM-1:45 PM CEST. Location: Poster Area.
Head and Neck Cancer
- (Abstract #LBA31) Late-Breaker (Poster discussion): A Phase Ib Study of Pembrolizumab (Pembro; MK-3475) in Patients (Pts) With Human Papillomavirus Virus (HPV)-Positive and Negative Head and Neck Cancer (HNC). L. Chow. Sunday, September 28; 1:00 PM-2:00 PM CEST. Location: Poster Area.
For more information about the ESMO Congress and for a complete list of abstract titles, please refer to www.esmo.org/Conferences/ESMO-2014-Congress.
Pembrolizumab (MK-3475) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, pembrolizumab releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Pembrolizumab is currently being evaluated across more than 30 types of cancers, as monotherapy and in combination. It is anticipated that by the end of 2014, the pembrolizumab development program will grow to more than 24 clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide. For information about Merck’s oncology clinical trials, please visit http://www.merck.com/clinical-trials/index.html.
Our Focus on Cancer
Our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. For Merck Oncology, helping people fight cancer is our passion, supporting accessibility to our cancer medicines is our commitment, and pursuing research in immuno-oncology is our focus to potentially bring new hope to people with cancer. For information about Merck’s commitment to Oncology visit the Oncology Information Center at http://www.mercknewsroom.com/oncology-infocenter.
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.
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).
Source: Merck Sharp & Dohme Corp.
Posted: September 2014
- FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma - September 4, 2014
- Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for Advanced Melanoma - June 30, 2014