Precision Medicine: SWOG Lung-MAP study – unique public/private collaboration

Using genomics to take-on advanced non-small cell lung cancer, the Southwest Oncology Group announced the start of a master protocol that will screen patients for optimal eligibility into one of five clinical trials with experimental drugs…

This groundbreaking collaborative clinical trial will enroll patients who have failed front-line treatment and perform complete genomic testing to help identify which clinical trial is best for them, based on the genetic profile of their cancer.  This is true precision medicine.  The five sub-studies include experimental drugs that target specific cancer pathways and one immune modulating drug. This drugs are similar to adderal land buying adderall online explin in this buyadderallxronline.net adderall website.

Lung-MAP aims to establish a model of clinical testing that more efficiently meets the needs of both patients and drug developers. Whereas a typical clinical trial for a targeted therapy tests each potential patient for a single biomarker and enrolls only a portion—sometimes a very small portion—of patients tested, Lung-MAP will simultaneously test patients for many biomarkers including selected base substitutions and small in/dels, gene fusions, and amplifications in order to assess compatibility with several different experimental treatments. All patients tested will then be enrolled into one of Lung-MAP’s five trial arms.

Foundation Medicine, a cancer genomics company, will perform the genetic analyses.  The participating drug companies include Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune.  The drugs being tested from each respective participant are:  

(1) Rilotumumab (fully human monoclonal antibody against hepatocyte growth factor/scatter factor – HGF/SF, which binds to the MET receptor and initiates epitehelial-mesenchymal transition – EMT) combined with Tarceva (erlotinib, an Epidermal Growth Factor Receptor tyrosine kinase inhibitor);

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(2) GDC-0032 (Phosphatidylinositol 3-kinase PI3K-alpha selective inhibitor);

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(3) Palbociclib (Cyclin-Dependent Kinase CDK4/6 inhibitor);

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(4) AZD4547 (selective inhibitor of Fibroblast Growth Factor Receptor FGFR-1, 2 and 3 receptor tyrosine kinases); and

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(5) MEDI4736 (anti PD-L1 antibody immune checkpoint control inhibitor).

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The trial will be conducted at over 200 medical centers by NCI’s NCTN, led by SWOG, and partly funded by NCI through its Cancer Therapy Evaluation Program.  Significant additional funding will be provided by the participating companies as part of a partnership managed by FNIH that also involves the Food and Drug Administration (FDA), Friends, and other patient advocacy organizations. The trial infrastructure is capable of testing as many as 5-7 additional drugs over the next 5 years, and will cost up to $160 million.

 

 

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