Largest of its kind initiative to test effectiveness of biomarker-targeted cancer treatment combinations to seek improvement in patient outcomes

Foundation Medicine is one of the largest contributors of potential participants to ComboMATCH; results will help determine trial eligibility for patients

Foundation Medicine, Inc., today announced its participation in the National Cancer Institute’s (NCI) Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH) initiative to test new therapy combinations in select groups of adults and children with cancer. NCI is part of the National Institutes of Health. Foundation Medicine is one of nearly 40 participating Designated Laboratories, meaning that oncologists at participating ComboMATCH clinical sites may utilize their patients' FoundationOne®CDx commercial testing results to help determine their eligibility for ComboMATCH treatment trials.

The initiative aims to identify promising treatments that can advance to larger, more definitive clinical trials outside of ComboMATCH¹ and improve patient outcomes. Each selected combination has strong pre-clinical or clinical evidence that it could be more effective than either of the single agents alone. ComboMATCH tests whether therapy selected in this manner to treat cancer may provide better patient outcomes than the current standard of care. Since the study opened to enrollment in June 2023, Foundation Medicine has been a key contributor of the patients screened and enrolled onto treatment trials.

From 2017 to 2023, Foundation Medicine was involved in the NCI’s MATCH study, a precursor to ComboMATCH, which evaluated the benefit of genomically-guided treatments targeting specific alterations within a patient’s tumor, regardless of cancer type. Through this longstanding partnership, Foundation Medicine was the most-used lab to enroll patients in the trial to help the NCI and other partners cast a wide net to evaluate patients who might have been eligible for treatment on NCI-MATCH.

“The ComboMATCH initiative is key to unlocking advancements in precision oncology care, and NCI’s leadership and resources are paramount in identifying more promising treatments for patients,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “We believe this next step in our ongoing collaboration with NCI will inform more targeted treatment options for advanced, complex cancer cases and is critical in understanding molecular insights to build the next level of cancer treatment.”

For individuals interested in joining a ComboMATCH treatment trial, the first step is to enroll in the patient registration trial through their oncologist. This protocol, managed by the ECOG-ACRIN Cancer Research Group, contains the rules for assigning patients to various treatment trials and other guidelines. Patients' tumor test results must show abnormalities being targeted by the drug combinations in the study. During registration, a patient's oncologist will review the FoundationOne®CDx test results, along with other clinical information, to determine if they are eligible for one of the treatment trials.

ComboMATCH treatment trials are conducted under an NCI-sponsored Investigational New Drug Application, and led by NCI network groups in the U.S. The groups are the Alliance for Clinical Trials in Oncology, Children’s Oncology Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG Cancer Research Network. Many pharmaceutical companies are providing their agents for evaluation in these treatment trials.

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

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.

Source: Foundation Medicine

¹ https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative

View source version on businesswire.com: https://www.businesswire.com/news/home/20231026710567/en/