Landmark lung cancer study will use genomics to match patients with 5 experimental drugs
MedImmune, the biologics unit of Anglo-Swedish AstraZeneca (LON:AZN, STO:AZN), said yesterday that it, together with several leading pharma and diagnostics companies, and institutions had launched a multi-drug clinical study in advanced squamous cell lung cancer.
Besides MedImmune, the other parties in the public-private partnership include Amgen Inc (NASDAQ:AMGN), Genentech, part of Swiss Roche (VTX:ROG), Pfizer Inc (NYSE:PFE), AstraZeneca, Foundation Medicine Inc (NASDAQ:FMI), as well as the National Cancer Institute (NCI), part of the National Institutes of Health, SWOG Cancer Research, Friends of Cancer Research (Friends), and the Foundation for the National Institutes of Health (FNIH).
The multi-arm, biomarker-driven clinical study, dubbed Lung Cancer Master Protocol (Lung-MAP), will utilise genomic profiling to match patients with advanced squamous cell lung cancer to one of several different investigational drugs intended to target the genomic alterations that promote the growth of their cancer. This novel approach to clinical testing is expected to enhance access to promising therapies for patients and help tackle the enrollment and infrastructure challenges that researchers face in traditional clinical studies.
At first, the study will investigate five investigational therapies, including four targeted drugs and an anti-PD-L1 immunotherapy. It is expected that between 500 and 1,000 patients will be screened annually for more than 200 cancer-related genes for genomic alterations. The findings of the test will be utilised to assign each participant to one of the trial’s five arms that is best matched to the genomic profile of their tumour.
The goal of the trial is to create a model of clinical testing that more efficiently meets the needs of both patients and drug makers. While a typical clinical study for a targeted treatment tests each potential patient for a single biomarker and recruits only a fraction of patients tested, Lung-MAP will test at the same time patients for a number of biomarkers, including selected base substitutions and small in/dels, gene fusions, and amplifications to evaluate compatibility with several different investigational drugs.
Lung-MAP will be carried out at more than 200 medical centres by NCI’s newly created National Clinical Trials Network (NCTN), led by SWOG, and partially financed by NCI under its Cancer Therapy Evaluation Program. The participating firms will also provide significant additional funding under a collaboration managed by FNIH, that also involves the US FDA, Friends, and other patient advocacy organisations. The study infrastructure is capable of testing up to 5-7 additional therapies over the next five years, and will cost up to USD 160 million (EUR 118m).
This trial is the first of several planned large, genomically- driven treatment studies that will be carried out by NCTN, noted Dr. Jeff Abrams, associate director of NCI’s Cancer Therapy Evaluation Program.
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