US-based Mirati Therapeutics has started a Phase II clinical trial of glesatinib (MGCD265) in patients with non-small cell lung cancer (NSCLC).

Glesatinib is an inhibitor of the MET and Axl receptor tyrosine kinase pathways, which drive tumour growth when altered.

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The trial is designed to evaluate glesatinib in NSCLC patients with activating genetic alterations of the MET gene, including gene amplification and mutations.

"Glesatinib has demonstrated early signs of clinical activity in MET or Axl-positive patients and warrants further study."

Dana Farber Cancer Institute Lowe Center for Thoracic Oncology director Pasi Janne said: "MET is a proto-oncogene that is widely recognised 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 tumours.

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"Glesatinib has demonstrated early signs of clinical activity in MET or Axl-positive patients and warrants further study.

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"I look forward to being the principal investigator for the Phase II glesatinib trial that could lead to improved treatment options for the significant number of non-small cell lung cancer patients with these MET alterations."

The trial will be conducted at up to 140 clinical trial sites to evaluate the safety and efficacy of glesatinib in NSCLC patients with MET gene alterations.

The company noted that eligible patients must have failed at least one prior treatment with a platinum-based chemotherapy regimen.

Patients with MET gene amplification or MET mutations including exon-14 deletion mutations will be enroled in the trial.

The primary endpoint is objective response rate (ORR), while the secondary endpoint is progression free survival (PFS).

Mirati president and CEO Charles Baum said: "In the ongoing Phase Ib 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.

"The initiation of this Phase II trial is a significant milestone for Mirati, and we look forward to demonstrating the potential therapeutic benefit to lung cancer patients with MET-driven tumours."