On June 6, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported new data in two presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2016 that underscore the critical importance of integrating comprehensive genomic profiling into clinical care programs for the treatment of advanced breast cancer (Press release, Foundation Medicine, JUN 6, 2016, View Source [SID:1234513069]). Data presented from two separate studies showed:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Molecular information elucidated from FoundationOne led physicians to change their recommended course of therapy for 41 percent of patient cases;
77 percent of patients profiled with FoundationOne harbored an alteration matched to an FDA-approved therapy;
98 percent of patients with advanced breast cancer had genomic alterations that matched therapeutics being studied in clinical trials; and
20 percent of advanced breast cancers possess high tumor mutational burden, suggesting a potential role for FoundationOne as a predictive biomarker for immune checkpoint inhibition.
"It’s no longer sufficient to classify or treat breast cancer as a single disease, and we must continue to acknowledge and understand its vast, complex genomic variability in order to provide individuals with every opportunity for improved outcomes," said Vincent Miller, M.D., chief medical officer, Foundation Medicine. "In a striking example of the importance of genomic information in breast cancer treatment, data presented at ASCO (Free ASCO Whitepaper) show that comprehensive genomic profiling led to physician-recommended therapy changes, matches with FDA-approved therapeutic agents that otherwise may have been overlooked or missed, and links to clinical trials for investigational targeted agents. This data is significant for the approximately 40,000 individuals in the United States who present with metastatic breast cancer annually, and it underscores opportunity with precision medicine to improve outcomes by matching patients with the right therapies."

Key Data Highlights:

The poster "Decision impact analysis of comprehensive genomic profiling (CGP) in advanced breast cancer: A prospective study," presented by Raquel E. Reinbolt, M.D., assistant professor, internal medicine, college of medicine, The Ohio State University, presented data that demonstrated that comprehensive genomic profiling in advanced breast cancer provides therapy or clinical trial recommendations for more than 70 percent of patients screened. A prospective, single center, single arm study enrolled advanced breast cancer patients who were within 10 weeks of starting therapy and who had an estimated survival of ≥ 3 months. Key findings include:

Comprehensive genomic profiling noted the existence of an FDA approved drug for 77 of 83 patients, with everolimus (n=72), temsirolimus (n=70), ponatinib (n=23) and pazopanib (n=20) being the most frequently selected by physicians
At least one clinical trial was identified for 98 percent of patients
A change in therapy was recommended by the treating physician for 34 of 83 patients (41 percent), and of these, 17 patients (50 percent) pursued the suggested treatment
A second poster "Biomarkers of Immune Checkpoint Inhibitor Response in Metastatic Breast Cancer: PD-L1 Protein Expression, PD-L1 Gene Amplification and Total Mutational Burden," presented by Jeffrey S. Ross, M.D., medical director, Foundation Medicine and Chair of the Department of Pathology, Albany Medical College, studied potential predictive biomarkers for immune checkpoint inhibitors in more than 6,000 breast cancer tumor samples at Foundation Medicine, and 84 breast cancer cases at Albany Medical Center. In the study, comprehensive genomic profiling using FoundationOne was performed on a cohort of 6,751 metastatic breast cancer tumor samples which were also evaluated for tumor mutational burden. PD-L1 expression detected by immunohistochemistry was used to predict patient survival in the 84 case Albany Medical Center cohort.

Key findings include:

PD-L1 protein expression in infiltrating immunocytes was found to be a significant favorable prognostic factor, which significantly correlated with increased overall survival whereas lack of PD-L1 staining in both tumor cells and immunocytes was a significant adverse prognostic factor associated with decreased patient survival
PD-L1 gene amplification was identified in only 57 of 6,751 (0.1 percent) metastatic breast cancer tumor samples, correlating with the potential for response to immune checkpoint inhibitors
High tumor mutational burden was found in 1,351 of 6,643 (20 percent) metastatic breast cancer cases underscoring the potential for further studies measuring tumor mutational burden with FoundationOne to identify breast cancer patients as candidates for immunotherapy
Breast cancer is the most common type of cancer among women in the United States, excluding non-melanoma cancers of the skin. The American Cancer Society estimates that approximately 246,660 women will be diagnosed with breast cancer in 20161. Although the majority of these patients will be cured of their disease in the primary treatment setting, the more than 40,000 cases of relapsed and metastatic breast cancer make this disease the second leading cause of death from cancer in American women2. The matching of patients with advanced breast cancer to personalized therapies holds significant promise to improving clinical outcomes for these patients.