Precision medicine drug developer, Mirati Therapeutics, Inc., recently announced it has treated the first patient volunteer in a Phase Ib clinical study of MGCD265 for Non-Small Cell Lung Cancer (NSCLC) with genetic mutations of MET or Axl. The study will have two cohorts: one involving NSCLC patients, and another involving patients with various other solid tumors. Both groups will be composed only of patients carrying certain MET driver alterations, including MET gene point mutations, gene amplification, and MET or Axl gene rearrangements.
MGCD265 is an oral tyrosine kinase inhibitor that works to selectively target these two genetic aberrations, known to drive disease progression and tumor growth in NSCLC and in other types of cancer with solid tumors. MET and Axl tumor growth drivers are commonly found in patients who have developed resistance to EGFR inhibitors such as Tarceva, Iressa and Erbitux. Combining MGCD265 with these EGFR inhibitors may address resistance to treatment.
The Phase Ib, open-label clinical study of MGCD265 aims to treat around 60 patients with NSCLC and other advanced solid tumors with known MET or Axl genetic alterations. The study will be evaluating the drug’s safety and efficacy profile when administered to patients with specific activating MET driver mutations, MET gene amplification, and MET or Axl gene rearrangements.
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Charles M. Baum, M.D., Ph.D., the company’s president and Chief Executive Officer, said, “In the dose escalation phase of this trial, we identified an optimal dose that achieved serum levels that we believe will result in greater than 90% inhibition of MET and Axl. We are focused on patients whose tumors harbor the specific MET and Axl genetic alterations that MGCD265 is designed to treat. By selecting and treating only those patients who carry the targeted mutations, there is strong rationale that we’ll see proof of concept based on a high overall response rate in early 2015 that supports accelerated drug development.”
The clinical trial for MGCD265 is still ongoing. Those interested in learning more about the trial and how to participate or recommend someone who may be interested, visit www.clinicaltrials.gov, and use the identifier: NCT00697632.