On May 24, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported a collaboration with Merck, known as MSD outside the United States and Canada, to develop companion diagnostic tests for use with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability (MSI) high or mismatch repair deficient solid tumors (Press release, Foundation Medicine, MAY 24, 2018, View Source [SID1234526886]). The companion diagnostic tests will leverage FoundationOne CDx, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating multiple companion diagnostics. The companies will collaborate on the development of a pan-cancer companion diagnostic to measure MSI. In addition, they plan to develop companion diagnostics for tumor mutational burden (TMB), as well as additional potential novel biomarkers of response.
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"By collaborating, Merck and Foundation Medicine can continue to push the frontier on innovation in immuno-oncology and personalized cancer care, making a positive difference in the lives of individuals with cancer," said Melanie Nallicheri, chief business officer and head, biopharma for Foundation Medicine. "The addition of MSI and TMB companion diagnostics to FoundationOne CDx re-affirms the validity and clinical utility of these critical immuno-oncology biomarkers, can simplify diagnostic testing through the use of one test that provides physicians with necessary information to both rule-in and rule-out potential treatment options based on each patient’s genomic and biomarker status, and can help accelerate patient access to personalized healthcare."
"Rapidly evolving knowledge of cancer biology and immuno-oncology continues to improve understanding of how to deploy our medicines to identify those patients most likely to respond effectively," said Dr. Eric Rubin senior vice president oncology clinical development, Merck Research Laboratories. "We look forward to working with Foundation Medicine on this companion diagnostics strategy."
FoundationOne CDx, an FDA-approved CGP assay for all solid tumors, assesses genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment options. FoundationOne CDx is also FDA-approved as a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, 12 of which are approved as first line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as MSI and TMB, that can help inform the use of other targeted oncology therapies, including immunotherapies and relevant clinical trial information. In all of these ways, FoundationOne CDx is available to biopharma companies as an FDA-approved platform for clinical research and as a CGP platform for biopharma companies seeking to develop companion diagnostics for their precision therapeutics.
FoundationOne CDx is available to order online at www.foundationmedicine.com/genomic-testing/order, or visit View Source to sign up for an account.