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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.