Multi-drug Lung-MAP cancer trial launches with private, public support
BETHESDA, Md.—An innovative public-private collaboration is now underway that will seek to evaluate a multi-drug approach in patients with lung cancer. The National Cancer Institute (NCI), SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), Amgen, Genentech, Pfizer, AstraZeneca, MedImmune (the global biologics R&D arm of AstraZeneca) and Foundation Medicine will all take part in the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer.
Lung-MAP will utilize genomic profiling to match patients to one of a number of different investigational treatments designed to target the genomic alterations driving their cancer growth. It is thought that this novel approach will improve patient access to promising drugs and alleviate the recruitment and infrastructure burdens researchers face in traditional clinical trials.
“Lung-MAP represents the first of several planned large, genomically driven treatment trials that will be conducted by NCI’s newly formed National Clinical Trials Network (NCTN),” Dr. Jeff Abrams, associate director of NCI’s Cancer Therapy Evaluation Program. “The restructuring and consolidation of NCI’s large trial treatment program, resulting in the formation of the NCTN, is quite timely, as it now can offer an ideal platform for bringing the benefits of more precise molecular diagnostics to cancer patients in communities large and small.”
The trial will involve five experimental drugs to begin with—four targeted therapies and one anti-PD-L1 immunotherapy—and it is expected that 500 to 1,000 patients will be screened each year for more than 200 cancer-related genes for genomic alterations. The results of that screening will determine which trial arm each patient is assigned. Unlike traditional trials, Lung-MAP will test for multiple biomarkers simultaneously, including selected base substitutions and small in/dels, gene fusions and amplifications, to determine which of the five trial arms offers the most compatibility.
The American Cancer Society reports that roughly 25 percent to 30 percent of all lung cancers are squamous cell carcinomas, which are a subset of non-small cell lung cancer. Squamous cells, as noted by the NCI, are “thin, flat cells that look like fish scales, and are found in the tissue that forms the surface of the skin, the lining of the hollow organs of the body and the lining of the respiratory and digestive tracts.”
Dr. Charles Blanke, chair of SWOG Cancer Research, noted in a statement that “Squamous cell lung cancer, like many other neoplasms, is increasingly recognized as consisting of a host of relatively rare genomic subsets, each of which may require treatment with a different targeted drug. The Lung-MAP S1400 trial models a way to efficiently study a large number of these rare squamous cell subsets under one master protocol.”
“Squamous cell carcinoma of the lung is a deadly cancer killer, and like many common solid tumors, analysis of no one or even several genes provides a sufficiently comprehensive characterization of the actionable alterations present in a population of patients to ensure a high screen hit rate when evaluating patients for a targeted therapy approach,” added Dr. Vincent Miller, chief medical officer of Foundation Medicine. “Rather, multiple genes often altered by one or more classes of DNA changes and often co-occurring are unpredictably altered in any given patient. The comprehensive, broad based nature of FoundationOne testing allowed us to be uniquely suited to provide reliable results across an unprecedented broad swath of predictive biomarkers in a clinically relevant turnaround time to attract multiple interested pharma partners with distinct therapeutic targets.”
SWOG will be leading the trial, which will be conducted at more than 200 medical centers by the NCTN, with NCI partly funding the work through its Cancer Therapy Evaluation Program. The participating companies will provide additional funding as part of a partnership, which is managed by FNIH and includes Friends of Cancer Research, the U.S. Food and Drug Administration and other patient advocacy organizations. Lung-MAP’s infrastructure will be able to test as many as five to seven additional drugs over the next five years, with an expected cost of up to $160 million.
SOURCE: Foundation Medicine press release