On December 21, 2015 Foundation Medicine, Inc. (NASDAQ: FMI) and Mirati Therapeutics, Inc. ("Mirati") (NASDAQ: MRTX), a targeted oncology company focusing on genetic and epigenetic drivers of cancer, reported that they have entered into a collaboration for the development of a companion diagnostic test for glesatinib (Press release, Foundation Medicine, DEC 21, 2015, View Source [SID:1234508622]). The test, designed for use by physicians, will be used to identify NSCLC patients most likely to respond to Mirati’s kinase inhibitor, glesatinib. Schedule your 30 min Free 1stOncology Demo! The companion diagnostic is part of a coordinated regulatory strategy and is being developed in parallel with the clinical development of glesatinib. The coordinated regulatory strategy is expected to facilitate a submission to the U.S. Food and Drug Administration (FDA) of a Premarket Approval (PMA) for the companion diagnostic, concurrent with the New Drug Application (NDA) for glesatinib. Patients with MET gene amplification and MET mutations are currently being enrolled in a Phase 2 trial of glesatinib. FoundationOne, Foundation Medicine’s comprehensive genomic profiling assay for solid tumors, is being used in the trial to identify those patients most likely to benefit from glesatinib based on patient genomic profiles, which will enable targeted recruitment of patient populations.
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"We’re pleased to work with Mirati as they advance glesatinib through the clinic, and to contribute to Mirati’s efforts to advance patient care through precision medicine," said Steven Kafka, Ph.D., president and COO, Foundation Medicine. "Our collaboration with Mirati is an example of the growing demand for companion diagnostics that rely upon comprehensive genomic profiling. Importantly, this collaboration also represents significant progress in advancing Foundation Medicine’s development of a universal companion diagnostic, a validated assay that streamlines and simplifies clinical decisions by providing all the necessary genomic information to help physicians target relevant cancer therapeutics with a single assay."
"Mirati treats cancer as a genetic disease. Often referred to as targeted oncology, this approach means we must find the genetic alterations responsible for driving cancer growth, like MET and Axl alterations, and block the activity of those targets. An effective patient selection strategy is a critical part of this process," said Charles M. Baum, M.D., Ph.D., president and CEO, Mirati. "In collaboration with Foundation Medicine, we expect to develop a companion diagnostic based upon their comprehensive genomic profiling assay that will detect all the relevant mutations in a single assay from a single biopsy, and provide patients with data to make the best treatment decisions. Identifying and treating the more than 15,000 non-small cell lung cancer patients in the U.S. who are most likely to respond to glesatinib may result in significantly improved patient outcomes."
About Glesatinib (MGCD265)
Glesatinib (MGCD265) is a tyrosine kinase inhibitor that is expected to potently and selectively target tumors in patients with driver alterations in MET (mutations and gene amplification) and Axl (rearrangements) that occur in approximately 8% of patients with non-small cell lung cancer (NSCLC). Glesatinib is being evaluated in a Phase 1b study in patients with solid tumors that have genetic alterations in MET or AXL genes. The Phase 2 trial in NSCLC patients with MET genetic alterations is underway to confirm and extend the data that supports the clinical benefit of glesatinib in patients with driver mutations in MET. Genetic alterations in these targets have been implicated as drivers of tumor growth and disease progression in NSCLC, gastroesophageal cancer and other solid tumors. MET and Axl are also implicated as drivers of tumor progression in patients whose tumors have become resistant to EGFR inhibitors. Therefore, Mirati believes that the combination of glesatinib with an EGFR inhibitor could potentially treat patients who have become resistant to agents targeting EGFR. Mirati retains worldwide rights to glesatinib.