Genome-driven lung cancer trial launches
pharmafile | June 18, 2014 | News story | Research and Development, Sales and Marketing | AstraZeneca, Cancer, Genentech, MedImmune, Pfizer, genome, lung cancer
Amgen, Genentech, Pfizer, AstraZeneca and MedImmune – AstraZeneca’s global biologics R&D arm – have each put investigative treatments into a new trial for patients with advanced squamous cell lung cancer.
Launched this week, the Lung Cancer Master Protocol (Lung-MAP) is a public-private venture led by the National Cancer Institute (NCI), which is part of the US National Institutes of Health.
The biomarker-driven trial aims to use genomic profiling to match patients to one of the treatments, in an attempt to target the genomic alterations driving the growth of each patient’s cancer.
Between 500 and 1,000 people will be screened annually for more than 200 cancer-related genes for these alterations – they will then be put into the arm of the trial which best matches their tumour’s genomic profile.
“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),” says Jeff Abrams, associate director of NCI’s Cancer Therapy Evaluation Program.
“The restructuring and consolidation of NCI’s large trial treatment programme, 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,” he adds.
Other groups involved in Lung-MAP include SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH) and Foundation Medicine.
Traditional clinical trials can produce ‘frustratingly slow results’ because of recruitment and infrastructure problems, says Maria Freire, executive director of the FNIH.
“This master protocol will allow multiple enrollees to be tested once and assigned to a treatment most likely to work for them, rather than separate tests for separate trials with most patients ineligible,” she goes on. “This strategy will validate biomarkers and facilitate drug development in one infrastructure, to more rapidly provide safer and more effective treatments to patients.”
Lung cancer is the leading cause of cancer death in the US and the second most common cancer: around 25-30% of non-small cell lung cancers – the most common form of lung cancer – are squamous cell carcinomas but there are currently few treatment options beyond surgery.
“This latest collaboration can significantly speed our understanding of targeted approaches for this complex and underserved form of lung cancer, while demonstrating how genomic testing can drive the evolution of clinical trial design,” says Sean Harper, executive VP of R&D at Amgen.
“It may ultimately tell us more about how best to match patients to the right treatments,” he adds.
The five investigational drugs used in the trial are:
- MedImmune’s anti-PD-L1 monoclonal antibody MEDI4736
- AstraZeneca’s FGFR tyrosine kinase inhibitor AZD4547
- Amgen’s hepatocyte growth factor receptor c-MET inhibitor rilotumumab
- Genentech/Roche’s PI3 kinase inhibitor GDC0032
- Pfizer’s CDK4/6 kinase inhibitor palbociclib.
Adam Hill
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