Foundation Medicine and Collaborators to Present New Data at ASCO 2019 Further Supporting the Utility of Comprehensive Genomic Profiling (CGP) to Inform Precision Medicine in Advanced Cancer

CAMBRIDGE, Mass. – May 16, 2019 – Foundation Medicine, Inc. today announced that new data informed by the use of its portfolio of comprehensive genomic profiling (CGP) tests will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago. The company and its collaborators will present a total of 18 studies, including two poster discussions.

Highlights of these presentations include: 

• New data that provides additional insights into the utility of tumor mutational burden (TMB) as a pan-tumor genomic biomarker across a variety of cancers, including metastatic breast cancer and non-small cell lung cancer (NSCLC), and how it impacts response to immunotherapy;
• Studies demonstrating the utility of known and novel biomarkers, including results in cancers that have not traditionally been treated with targeted therapies, such as urothelial cancer and cholangiocarcinoma; and
• Results from analysis of data within Foundation Medicine and Flatiron Health’s clinico-genomic database demonstrating that combining measures of TMB and PD-L1 can better predict response to immunotherapy in advanced NSCLC patients than either biomarker alone.

Data to be presented support the clinical use of tissue and liquid CGP tests and demonstrate the importance of genomic biomarkers to help inform selection of targeted therapies, including immunotherapies, across a variety of advanced tumor types.

“We are excited to share new data derived from the use of comprehensive genomic profiling to further characterize the molecular underpinnings of cancer and provide additional evidence of the role of biomarkers in optimizing precision medicine approaches,” said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. “Given the continued pace of innovation for targeted and immunotherapies, the clinically relevant insights derived from comprehensive genomic profiling, including those from Foundation Medicine and Flatiron Health’s unique database of clinico-genomic information, are a vital source of information to support the development of such therapies and can help improve clinical decision-making and patient care.” 

Tumor Mutational Burden (TMB) as Predictor of Response to Immunotherapy

In one study, more than 3,800 metastatic breast cancer samples were classified as HER2 negative (ER+/HER2-), HER2 amplified and triple negative breast cancer. The study showed that TMB can help predict responsiveness to immunotherapy, which has been difficult to show in metastatic breast cancer patients, across all three subtypes.

[Immunotherapy predictive biomarkers in metastatic breast cancer (MBC). Poster discussion. Abstract 1023, Poster #104. June 2, 8:00am – 11:00am, Hall A. Poster Discussion –  June 2, 11:15am – 12:45pm, Hall D2.]

Another study to be presented by Friends of Cancer Research found it is feasible to standardize the measurement of TMB across different CGP testing platforms, including FoundationOne^®CDx. These data were drawn from the findings of the organization’s TMB Harmonization Project, which aims to establish best practices to improve consistency and reliability of TMB estimation across platforms in the interest of optimizing the clinical utility of TMB in cancer care through engaging a coalition of research and industry organizations, including Foundation Medicine.

[TMB standardization by alignment to reference standards: Phase II of the Friends of Cancer Research TMB Harmonization Project. Abstract 2624, Poster #268. June 1, 8:00am – 11:00am, Hall A. Presented by Friends of Cancer Research.]

Utility of Comprehensive Genomic Profiling

In a retrospective analysis, more than 200,000 relapsed or refractory cancers were evaluated to determine how pan-tumor FGFR2 genomic alterations co-occur with other genomic alterations including TMB, microsatellite instability (MSI), and PD-L1 expression. Cancers with an FGFR2 receptor tyrosine kinase (RTK) alteration were shown to have higher frequency of elevated TMB than cancers with other RTK alterations, suggesting potential immunotherapy responsiveness.

[FGFR2: A pan-genomic target. Abstract 3099, Poster #91. June 1, 8:00am – 11:00am, Hall A.]

In another retrospective analysis, researchers evaluated more than 2,000 primary and metastatic urothelial cancer cases, the largest analysis of its kind. All classes of genomic alterations were evaluated in two subtypes of the cancer: upper tract and bladder tumors. FGFR3 was found more frequently in upper tract tumors (26 percent of cases) than in bladder tumors (19 percent of cases). Overall, 48 percent of all tumors harbored genomic alterations that could benefit from approved or investigational targeted therapies, suggesting CGP should be incorporated into routine evaluation of metastatic urothelial cancer before initiating treatment.

[Comprehensive genomic profiling (CGP) of upper-tract (UTUC) and bladder (BUC) urothelial carcinoma reveals opportunities for therapeutic and biomarker development. Abstract 4581, Poster #346. June 3, 1:15pm – 4:15pm, Hall A. Poster Discussion –  June 3, 4:30pm – 6:00pm, Hall D2.]

A study characterizing NSCLC cases found HER2 exon 20 insertion mutations in 1.5 percent (n=648) of NSCLC cases analyzed and noted that these are generally mutually exclusive of other known drivers. Detection of these alterations using tissue or liquid CGP may be critical to identify matched targeted therapy options, which have recently shown efficacy in the clinic, for this subset of patients.

[Characterization of 648 non-small cell lung cancer (NSCLC) cases with 28 unique HER2 exon 20 insertions. Abstract 9063. Poster #386. June 2, 8:00am – 11:00am, Hall A.]

Using Data to Advance Precision Medicine

Another ASCO presentation will share data from a clinico-genomic database, which includes more than 50,000 de-identified matched profiles linking comprehensive genomic profiling results from Foundation Medicine with patient outcomes data from Flatiron Health’s electronic health records database. The study evaluated more than 400 advanced NSCLC patients and showed that combining the biomarkers TMB and PD-L1 expression can predict response to immunotherapy better than either of these markers alone, reinforcing the importance of testing patients for both biomarkers to inform treatment strategies.

[Tumor mutational burden (TMB) and PD-L1 expression as predictors of response to immunotherapy (IO) in NSCLC. Abstract 2630, Poster #274. June 1, 8:00am – 11:00am, Hall A. Presented by Flatiron Health.]

The following is a list of select abstracts that will be presented at the meeting. For a full list of the data being presented by Foundation Medicine and its collaborators, please visit: http://info.foundationmedicine.com/asco2019

About Foundation Medicine
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine^® and FoundationOne^®CDx are registered trademarks of Foundation Medicine, Inc.

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