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
Tuesday, October 1, 2013
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.
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*A new nonproprietary generic name for MK-3475 is under review by the United States Adopted Names Council.
Caroline Lappetito, 267-305-7639
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