On January 13, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported a three-way collaboration with Horizon Healthcare Services, Inc., New Jersey’s oldest and largest health insurer, and Clinical Outcomes Tracking and Analysis (COTA) to advance precision medicine, improve clinical outcomes and deliver enhanced value to the healthcare system in the treatment of patients with metastatic, non-small cell lung cancer (NSCLC) (Press release, Foundation Medicine, JAN 13, 2016, View Source [SID:1234508781]). The organizations initiated a prospective clinical study measuring changes in survival benefit and total cost savings achieved among patients with previously untreated metastatic NSCLC who undergo comprehensive genomic profiling with FoundationOne. Based on the outcomes, the study enables Horizon to provide its members with coverage for FoundationOne as a critical component of clinical care pathways in the evaluation of patients with metastatic lung cancer.
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As thought leaders and innovators in cancer care, the organizations designed the study to support guidelines from the National Comprehensive Cancer Network (NCCN) that specifically recommend broad molecular profiling for patients with NSCLC. These guidelines enable the identification of cancer-driving genomic alterations for which effective targeted therapies may already be approved and available commercially or to enable physicians to appropriately counsel patients regarding the availability of clinical trials. This recommendation by NCCN and the genesis of this trial supports the widespread understanding that cancer is a disease of the genome and that tumors may harbor specific genomic alterations likely to respond to "matched" therapies regardless of its anatomic site of origin.
FoundationOne is a comprehensive genomic profile (CGP) that enables physicians to make treatment decisions for patients with cancer by identifying the molecular growth drivers of their cancers and by helping oncologists match the identified drivers with relevant targeted therapeutic options. Requiring only a small amount of tumor tissue, FoundationOne interrogates the entire coding sequence of 315 cancer-related genes plus select introns from 28 genes that are known to be altered in solid tumors.
"We believe this study design, which embraces the importance of data sharing in molecular information, represents an innovative model of collaboration that will catalyze the consistent integration of comprehensive genomic profiling in clinical care for the treatment of metastatic lung cancer," stated Vincent Miller, M.D., chief medical officer for Foundation Medicine. "We fully expect the study to demonstrate the clinical and health economic benefits of a comprehensive approach versus the use of more limited testing panels and importantly, that these results will support broad reimbursement in this patient population with advanced disease," Miller added.
"Gene-by-gene testing, as is common practice today in metastatic NSCLC, presents clinical and logistical challenges, including missing alterations, insufficient tissue for testing, and a significant loss of precious time in identifying a clinical course of care," said Andrew Pecora, M.D., F.A.C.P., C.P.E., member of Regional Cancer Care Associates and chief innovation officer, Professor and vice president of Cancer Services, John Theurer Cancer Center at HackensackUMC. "The availability of a single CGP assay to accurately identify all known variants from a single sample and to accommodate the expanding list of genomic markers in metastatic NSCLC without necessitating new biopsies is a medical necessity."
"Horizon believes in investigating whether a comprehensive genomic approach could yield the most robust information to guide clinical treatment options – either to approved or investigational therapies – through clinical trials," said Glenn D. Pomerantz, M.D., JD, vice president and chief medical officer with Horizon. "Ultimately, we hope that working with Foundation Medicine on this approach will optimize outcomes for metastatic lung cancer patients."
Patients will be enrolled at Regional Cancer Care Associates (RCCA) and Hackensack Medical University in New Jersey. Patient outcomes will be tracked by Clinical Outcomes Tracking and Analysis (COTA). Horizon Blue Cross of New Jersey will pay for enrolled patients to receive FoundationOne assays as part of the study.