12/18/2013 9:13:46 AM
Merck Collaborates with GlaxoSmithKline to Evaluate Novel Combination Regimen for Advanced Renal Cell Carcinoma
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the initiation of a clinical trial to evaluate the combination of the company’s investigational anti-PD-1 immunotherapy, MK-3475, and GlaxoSmithKline’s orally administered kinase inhibitor, pazopanib, in advanced renal cell carcinoma.
“Collaborations like this are central to Merck’s strategy to evaluate the potential of MK-3475 for the treatment of cancer,” said Iain Dukes, senior vice president, Licensing and External Scientific Affairs, Merck Research Laboratories. “We look forward to initiating further collaborations to investigate MK-3475 in combination with other anti-cancer agents across a range of tumor types.”
Merck and GlaxoSmithKline entered a collaboration to study MK-3475 with pazopanib and other agents in the GlaxoSmithKline portfolio in the future. This Phase I/II clinical trial is designed to evaluate the safety and efficacy of a combination of MK-3475 and pazopanib in treatment naïve patients with advanced renal cell carcinoma. Further details of the collaboration were not disclosed.
Pazopanib was approved by the US Food and Drug Administration for the treatment of patients with advanced renal cell carcinoma in October 2009 and is marketed under the trade name Votrient®. It is now approved in more than 80 countries. For full US Prescribing Information including BOXED WARNING for hepatotoxicity and Medication Guide, please visit: http://www.gsk.com/products.html
Many tumors are able to evade the immune system through a mechanism that exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an investigational, highly selective anti-PD-1 immunotherapy designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system.
MK-3475 is being studied in 10 clinical trials estimated to enroll over 4,000 patients across a broad range of cancer types, including: bladder, colorectal, gastric, head and neck, melanoma, non-small cell lung, triple negative breast, pancreatic, hematological malignancies and renal cell carcinoma. Additional trials, as monotherapy and in combination with other cancer therapies, are planned in 2014. For information on Merck’s clinical trials please visit http://www.merck.com/clinical-trials/.
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.
Merck 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 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; 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 2012 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).
Ian McConnell, 908-423-3046
Claire Mulhearn, 908-423-7425
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088
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