Foundation Medicine to Present Validation Data for Its Assay Measuring Tumor Mutational Burden in Blood (bTMB), a New, Non-Invasive Predictor of Response to Immunotherapy
--Data Supports Inclusion of the bTMB Assay into a Phase III Clinical Trial of Atezolizumab Immunotherapy in Individuals with Advanced
Based on these findings,
"Foundation Medicine has previously shown that measuring tumor mutational burden from tissue samples can help reliably predict responses to immunotherapies. However, a critical need exists for measuring TMB via a non-invasive solution for cancer patients for whom tissue is not available or when a biopsy is not feasible," said
In the studies presented at ESMO, Foundation Medicine's bTMB assay was analytically validated to determine TMB with high precision and accuracy from as little as one percent tumor content in a blood sample. The assay was used to retrospectively analyze a total of 794 plasma samples from the Phase II POPLAR and Phase III OAK clinical trials. The analysis showed that atezolizumab demonstrated a clear benefit for overall survival. Additionally, there was a correlation between patients with high bTMB in those studies and longer progression-free survival (PFS) when treated with atezolizumab. In addition, bTMB was not found to correlate with PD-L1 expression levels as measured by tissue-based immunohistochemistry, suggesting that bTMB, like tissue TMB, provides independent and critical predictive information in addition to the information furnished by PD-L1 testing.
The bTMB assay validation presentations will take place during the following times:
Abstract #1295O -- Blood-based biomarkers for cancer immunotherapy: Tumor mutational burden in blood (bTMB) is associated with improved atezolizumab (atezo) efficacy in 2L+ NSCLC (POPLAR and OAK),
Abstract #102P -- Analytic validation of a next generation sequencing assay to identify tumor mutational burden from blood (bTMB) to support investigation of an anti-PD-L1 agent, atezolizumab, in a first line non-small cell lung cancer trial (BFAST),
In totality, the company and its collaborators will present a total of 19 studies at the ESMO Annual Meeting, including three oral presentations, seven poster discussions and nine posters, which support the integration of comprehensive genomic profiling (CGP) and biomarkers such as tissue- and blood-based TMB to help guide personalized cancer care. These new data include insights into the landscape of tissue-based TMB across various types of cancer, which may help further stratify molecular subtypes of disease and guide more personalized treatment. Results will be presented from a study of more than 80,000 solid tumors, a study of more than 22,000 gastrointestinal cancers and a study of more than 2,000 melanoma cases (the largest known cohort of metastatic melanoma cases with comprehensive genomic profiling released to date). Together these results reveal pan-tumor and disease-specific alterations that may inform rational selection of immunotherapy.
Furthermore, new studies show the prevalence of TMB in subtypes of certain cancers where immunotherapy is not often considered, such as breast and thymic cancers. These findings may help expand the utility of TMB into new indications.
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Cautionary Note Regarding Forward-Looking Statements for
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the ability of tissue and blood based TMB to predict responses to certain types of cancer, including NSCLC; the validation of bTMB as a biomarker in first-line immunotherapy; the development of bTMB as a companion diagnostic assay, the correlation of improvement in PFS for patients with NSCLC who have high bTMB treated with atezolizumab; the ability of CGP to improve patient outcomes; and the continuation of the
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