“Researchers from Genentech, Foundation Medicine, UC Davis, and other medical centers, have published a report on the development and early validation of Foundation’s planned blood-based tumor mutational burden test.
“Appearing today in Nature Medicine, the study describes the development of the test and its characteristics, and its retrospective validation in two cohorts. Investigators demonstrated, by applying the assay to samples from two clinical trials, that blood-based TMB (bTMB) could reproducibly identify lung cancer patients who respond to immunotherapy treatment with Roche/Genentech’s atezolizumab (Tecentriq).”
“Foundation Medicine, Inc. (NASDAQ: FMI) today announced that it has partnered with the Addario Lung Cancer Medical Institute (ALCMI) and Bonnie J. Addario Lung Cancer Foundation (ALCF) to launch a first of its kind, multi-center, international prospective study, the Genomics of Young Lung Cancer. This study aims to better inform treatment decisions in young adults with lung cancer by leveraging FoundationOne®, the only commercially available and validated comprehensive genomic profile, to look beyond the genomic alterations commonly associated with lung cancer and identify the novel and unique alterations that present in lung cancers in young adults. This insight, in combination with the expertise of leading academic institutions and peer-reviewed literature, will be applied to determine more effective treatment options and tailor therapies precisely for these distinct and underserved patients.
“In 2014, 224,000 new cases of lung cancer are expected to be diagnosed; 3,700 of these are expected to occur in patients under the age of 45. Eighty percent of new lung cancer diagnoses are made in former or never-smokers, and three percent of cancer diagnoses made in patients younger than 45 will be lung cancer1.
“ ‘Lung cancer presents in a unique manner in young adults, who often do not exhibit the characteristic symptoms and signs of a typical patient with lung cancer,’ said Steven Young, President and COO of ALCMI. ‘Despite an environment of rapidly expanding treatment options available for lung cancer, a lack of understanding of comprehensive testing for the molecular drivers of the disease specifically in young adults restricts the effective treatments available to patients at a tragically early stage in their lives. Through this initial study, we hope to address this gap in knowledge and access, and lay the groundwork to routinely identify more effective treatment options for these patients.’ ”
Clinical trials help determine whether new cancer treatments are safe and effective, and they provide access to cutting-edge drugs that patients wouldn’t otherwise be able to have. But the clinical trial system is notoriously inefficient, slow, expensive, and laborious. Now, a new and ambitious clinical trial design called the Lung Cancer Master Protocol seeks to overhaul the system, promising to benefit patients and drug companies alike. Continue reading…