Foundation Medicine (FMI) announced the publication of the results of a large study demonstrating that its novel, investigational assay to measure blood tumor mutational burden can help predict response to the anti-PD-L1 immunotherapy, atezolizumab, in patients with previously treated non-small cell lung cancer. The study, published in the journal Nature Medicine, was the result of a collaboration between Foundation Medicine and Genentech, a member of the Roche Group (RHHBY), and demonstrates the potential of bTMB to expand precision oncology approaches for patients with advanced cancers, including metastatic lung cancer. In addition, these results show that bTMB may be an independent predictor of clinical benefit, regardless of PD-L1 expression as assessed by immunohistochemistry. In the study, clinical data for the novel bTMB assay was reported from a retrospective analysis of more than 1,000 samples from patients with previously treated, advanced NSCLC who participated in Genentech’s Phase II POPLAR and Phase III OAK clinical trials. The study used samples from the POPLAR trial to identify a range of bTMB thresholds that correlated with clinically meaningful outcomes, which were then confirmed using samples from the OAK study. Within the OAK study, patients with bTMB greater than or equal to 16 total mutations showed significantly improved progression-free survival when treated with atezolizumab as compared to those patients with bTMB greater than or equal to 16 total mutations treated with docetaxel chemotherapy. This bTMB assay is being prospectively evaluated in two Genentech studies: in the Phase III Blood First Assay Screening Trial as a companion diagnostic assay to validate bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients, and in the single arm Phase II Blood First-Line Ready Screening Trial evaluating atezolizumab monotherapy in first-line NSCLC. In April 2018, the U.S. Food and Drug Administration granted a Breakthrough Device designation for Foundation Medicine’s new liquid biopsy assay, which will expand upon its current liquid biopsy assay to include genomic biomarkers for microsatellite instability and bTMB. If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.
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