Foundation Medicine Presents New Data at ASCO 2016 Demonstrating that FoundationOne® May Help Predict Response to Cancer Immunotherapy Across a Variety of Advanced Cancers
Molecular Information on Tumor Mutational Burden Supports Improved Outcomes and Drives Care Efficiencies
"Successful application of cancer immunotherapy in the clinic is one of the most important advances in cancer treatment in decades," said
Cancer immunotherapy works by helping the immune system mount an effective anti-cancer response, a process that depends in part on the recognition of cancer-specific proteins called neoantigens. Tumor mutational burden has been shown to correlate well with the number of neoantigens, and therefore it may help identify patients most likely to respond to cancer immunotherapies. By combining comprehensive genomic profiling of 315 genes utilizing the FoundationOne assay, with Foundation Medicine's advanced and proprietary algorithm that filters out normal individual genomic variants, FoundationOne can reliably and accurately measure tumor mutational burden without the need for whole exome sequencing.
Overview of Data Presentations
The IMvigor 210 study of TecentriqTM (atezolizumab; anti-PD-L1;
- "PD-L1 Expression, Cancer Genome Atlas (TCGA) Subtype and Mutational Load are Independent Predictors of Response to Atezolizumab (atezo) in Metastatic Urothelial Carcinoma (mUC; Imvigor210)", by Jonathan E. Rosenberg, M.D.,
Memorial Sloan Kettering Cancer Center [Abstract #104, Clinical Science Symposium,Sunday June 5 ,9:57-10:09 AM ].
"These results are particularly exciting given the amount of variability inherent to using immunohistochemistry (IHC) to measure biomarkers. There are many different PD-L1 IHC tests, for example, and pathologists often do not see agreement between them," stated Vamsidhar Velcheti, M.D., assistant professor, Solid Tumor Oncology,
In a separate melanoma study, higher mutational burden as measured by FoundationOne was associated with a greater likelihood of response and a more durable response to pembrolizumab; anti-PD-1; Merck, nivolumab; anti-PD-1; Bristol Myers Squibb, and Tecentriq, thereby providing oncologists with greater confidence in the potential for clinical benefit from a host of newly approved immunotherapies.
- "Hybrid Capture-Based Next Generation Sequencing (HC NGS) in Melanoma Identifies Markers of Response to Anti-PD1/PD-L1", by
Douglas Buckner Johnson, M.D., M.S.C.I.,Vanderbilt-Ingram Cancer Center [Abstract #105, Clinical Science Symposium,Sunday June 5 ,10:21-10:33 AM ]
These conclusions were further supported by two additional presentations at ASCO 2016 that demonstrated that total mutational burden could also predict response to cancer immunotherapy in lung and colorectal cancers:
- "Total Mutational Burden (TMB) in
Lung Cancer and Relationship with Response to PD-1/PD-L1 Targeted Therapies", byDavid R. Spigel , M.D.,Sarah Cannon Research Institute [Abstract #9017, Poster Session,Saturday June 4 ,8:00-11:30 AM ]. - "Tumor Mutational Burden as a Potential Biomarker for PD1/PD-L1 Therapy in Colorectal Cancer", by
Thomas J. George , M.D., F.A.C.P.,University of Florida [Abstract #3587, Poster Session,Saturday June 4 ,8:00-11:30 AM ].
About
Cautionary Note Regarding Forward-Looking Statements
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 comprehensive genomic profiling, including FoundationOne, to identify genomic alterations, approved therapies or therapies in clinical trials and to estimate tumor mutational burden; the ability of tumor mutational burden to predict the likelihood or longevity of response to immunotherapies by patients with certain types of cancer; the ability of FoundationOne to inform therapeutic choices and improve patient outcomes; and the relevance of tumor mutational burden and comprehensive genomic profiling in oncology clinical care, including the ability to increase efficiencies in clinical care. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risk that the results presented are found to lack scientific, medical or clinical utility or that subsequent research renders the results presented less useful or not useful in clinical practice; Foundation Medicine's services and molecular information platform will not be able to identify genomic alterations or tumor mutational burden in the same manner as prior clinical data; and the risks described under the caption "Risk Factors" in
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