On March 16, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) and its collaborators reported new data in a variety of tumor types at the 2016 United States and Canadian Academy of Pathology (USCAP) Annual Meeting taking place March 12-18 in Seattle (Press release, Foundation Medicine, MAR 16, 2016, View Source [SID:1234509585]). The data further strengthens the growing body of evidence across various cancers in support of integrating comprehensive genomic profiling with FoundationOne into the clinical pathology assessments of cancer patients to help inform targeted therapy utilization and improve patient care. The data presented underscore an urgent need for innovative solutions capable of accurately informing therapeutic options based on unique genomic alterations found within each patient’s tumor. Oncology case reports and series have indicated positive responses to targeted therapies for certain rare tumor types, and additional evidence supporting clinical utility is evolving to support payor coverage.

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"We are encouraged by the latest data presented amongst the global leaders and top minds in the pathology field at USCAP," said Jeffrey S. Ross M.D., medical director of Foundation Medicine, chair of pathology at the Albany Medical Center and lead author of two of the studies. "The pathology community is essential to advancing the next generation of novel therapies and personalized treatment for cancer patients worldwide. We are honored to provide an evidence-based platform to help the oncology community identify clinically relevant genomic alterations that hold the potential to influence patient treatment options, both for therapies that are FDA approved and therapies that are being investigated in clinical trials."

Three of the posters presented at the event focused on cancers with diverse, clinically relevant alterations, many of which are undetectable with standard screening, and represent indications with unmet clinical need, including refractory and metastatic breast cancer, triple negative breast cancer (TNBC) and adult and pediatric brain tumors. Results from all three data sets point to the importance of comprehensive genomic profiling to potentially influence and personalize treatment and guide the selection of approved targeted therapies or access to novel therapies that are being investigated in clinical trials.

Key Data Highlights:

The poster presentation titled, "Pangenomic Analysis of BRAF Genomic Alterations Across All Types of Brain Tumors Reveals Expanded Opportunities for Targeted Therapies," by Zachary R. Chalmers, lead researcher, senior research associate with Foundation Medicine, and presented by Dr. Ross demonstrates the need for additional basket-type clinical trials aimed to identify BRAF genomic alterations in various types of non-melanoma cancers to further understand targeted therapy choice and efficacy. Comprehensive genomic profiling using FoundationOne was performed to search for all classes of BRAF alterations in a large series of intracranial neoplasms including adult and pediatric brain tumors, and key findings include:

142 (4.8 percent) brain tumors featured BRAF alterations including base substitutions (70 percent), fusions (25 percent) and rare amplifications and other alterations types (5 percent). Genomic alterations in BRAF are widely distributed in brain tumors with base substitutions primarily seen in high-grade gliomas and BRAF fusions in low grade gliomas

The presentation demonstrated that BRAF base substitutions and fusions can be successfully targeted with anti-BRAF and anti-MEK targeted therapies

Preliminary findings outlined in the poster presentation titled, "Genomic Alterations of MCL1 is a Predictive Biomarker of Triple Negative Status and Therapy Response in Breast Cancer," led and presented by Dr. Ross, draw attention to the vital need for comprehensive analysis of breast cancer genes and the inherent limitations of hotspot testing in uncovering potential therapy options. Two hundred patients with breast cancer underwent comprehensive genomic profiling using FoundationOne, and key findings include:

MCL1 amplification is a frequent feature in advanced stage and high grade breast cancer, and MCL1 amplified breast cancer is very seldom ERBB2 co-amplified

Of the MCL1 amplified breast cancer cases, 88 percent were high grade and 98 percent were stage IV at the time of sequencing

Of the 200 MCL1 amplified breast cancer patients, 12 (6 percent) were ERBB2 (HER2) amplified

Clinical observation across several case studies suggest that treatment with targeted therapies including sorafenib and vorinostat in heavily pre-treated MCL1 amplified breast cancer may be correlated with clinical benefit

These preliminary findings suggest that MCL1 amplified TNBC may benefit from combination targeted therapy, and warrant further investigation in a prospective clinical trial

Consistent with the other two data sets, the findings in the poster presentation titled, "The Detection of IHC-/FISH- ERBB2 Non-Amplification Mutations in 5,606 Cases of Refractory and Metastatic Breast Cancer: an Emerging Opportunity for anti-HER2 Targeted Therapies," led by Siddhartha Dalvi, MBBS, lead researcher, Albany Medical College, and presented by Dr. Ross, demonstrate the potential for missing critical information with routine hotspot sequencing tests and thus the need for comprehensive profiling with FoundationOne. Comprehensive genomic profiling was performed on 5,606 metastatic breast cancer patients, and key findings include:

ERBB2mut are responsible for nearly 20 percent of ERBB2 alterations in metastatic breast cancer, though such mutations are not detectable by routine IHC and FISH slide-based HER2 tests

698 (12.5 percent) featured ERBB2 alterations, 596 (10.6 percent) featured ERBB2 amplifications (ERBB2amp) and 137 (2.4 percent) featured ERBB2mut

Evidence that ERBB2mut driven mBC are responsive to anti-HER2 targeted therapies is steadily accumulating