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Merck & Co., Inc. (MRK)’s MK-3475 Works in 24 Percent of Lung Cancer Patients
10/2/2013 6:20:27 AM
Interim Data for Merck’s MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Previously Treated Patients with Non-Small Cell Lung Cancer to be Presented at 15th World Conference on Lung Cancer
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, confirmed today that interim data from the company’s Phase IB expansion study (PN 001) evaluating the efficacy and safety of *MK-3475 in patients with refractory non-small cell lung cancer (NSCLC) is scheduled for presentation at the 15th World Conference on Lung Cancer on Oct. 29 at 4:15 p.m., (1:15 a.m. EDT), in Sydney, Australia.
An abstract (# 2416) published today summarized preliminary findings from 38 patients with NSCLC treated with MK-3475. Data from additional patients and an analysis of tumor PD-L1 expression is scheduled to be presented by Dr. Edward Garon, Director of Thoracic Oncology, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, during the conference.
“These early data in lung cancer patients were the basis for Merck’s decision to rapidly advance MK-3475 into a Phase II/III clinical trial in NSCLC,” said Dr. Eric H. Rubin, vice president, Oncology, Merck Research Laboratories. “We look forward to further discussion of the data following its presentation at the conference.”
The published abstract describes early data for 38 patients with NSCLC treated with MK-3475 as a single agent dosed at 10mg/kg every three weeks. The preliminary objective response rate (confirmed and unconfirmed) was 24 percent as measured using investigator-assessed immune related response criteria (irRC) and 21 percent, (confirmed and unconfirmed), by RECIST v1.1. The most common treatment-related adverse events observed were fatigue, rash, and pruritus (16 percent each); diarrhea grade 1 or 2 occurred in 13 percent of patients. One case of a drug-related grade 3 pulmonary edema was reported.
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 currently being studied in seven clinical trials estimated to enroll over 3,000 patients across a broad range of cancer types including: bladder, colorectal, head and neck, melanoma, non-small cell lung and triple negative breast. The expansion of MK-3475 clinical development program is based on preliminary clinical evidence from Merck’s large foundational Phase IB trial (PN 001) evaluating MK-3475 monotherapy in over 1,000 patients with diverse late stage cancers (metastatic carcinoma).
About Lung Cancer
Lung cancer is the leading cause of cancer death worldwide in both men and women, with an estimated 1.4 million deaths worldwide each year, according to the American Cancer Society. NSCLC is the most common type of lung cancer representing about 85 percent of all lung cancer diagnoses.
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).
*A new nonproprietary generic name for MK-3475 is under review by the United States Adopted Names Council.
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