Mirati announces initiation of glesatinib Phase 2 clinical trial in NSCLC patients

Mirati Therapeutics, Inc.Dec 21 2015

Mirati Therapeutics, Inc. (NASDAQ: MRTX) today announced that the Phase 2 clinical trial of glesatinib (MGCD265) has commenced. The Company also announced that "glesatinib" is the proposed generic name for MGCD265. Glesatinib is an inhibitor of the MET and Axl receptor tyrosine kinase pathways which, when altered, are drivers of tumor growth. The Phase 2 clinical trial will evaluate glesatinib in NSCLC patients with activating genetic alterations of the MET gene, including MET gene amplification and MET mutations.

"MET is a proto-oncogene that is widely recognized as an important mediator of uncontrolled growth in certain types of cancer. Alterations involving the MET gene locus, such as gene amplification and mutations, are implicated in the pathogenesis of non-small cell lung cancer and other solid tumors," said Pasi Janne, M.D., Ph.D., director, Lowe Center for Thoracic Oncology, Dana Farber Cancer Institute. "Glesatinib has demonstrated early signs of clinical activity in MET- or Axl-positive patients and warrants further study. I look forward to being the principal investigator for the Phase 2 glesatinib trial that could lead to improved treatment options for the significant number of non-small cell lung cancer patients with these MET alterations."

"In the ongoing Phase 1b dose expansion trial, glesatinib has demonstrated confirmed partial responses and significant tumor regressions in heavily pre-treated non-small cell lung cancer patients with MET or Axl gene amplification and MET mutations," said Charles M. Baum, M.D., Ph.D., president and CEO of Mirati. "The initiation of this Phase 2 trial is a significant milestone for Mirati and we look forward to demonstrating the potential therapeutic benefit to lung cancer patients with MET-driven tumors."

Glesatinib (MGCD265) Phase 2 Trial
The Phase 2 open-label, single-agent, multi-national trial will be conducted at up to 140 clinical trial sites. The purpose is to evaluate the safety and efficacy of glesatinib in NSCLC patients with MET gene alterations, which are known oncogenic drivers. Eligible patients must have failed at least one prior treatment with a platinum-based chemotherapy regimen. The trial will enroll patients with MET gene amplification or MET mutations (including exon-14 deletion mutations). The primary endpoint of the study is Objective Response Rate and the secondary endpoint is Progression Free Survival. Additional information about this Phase 2 clinical trial of glesatinib is available at www.clinicaltrials.gov using identifier: NCT02544633.

In separate press releases issued today, Mirati announced collaboration agreements with two advanced molecular diagnostic companies for the glesatinib development program.

Mirati anticipates providing a detailed update on the ongoing glesatinib Phase 1b dose expansion cohort at a scientific/medical conference taking place in the first half of 2016.