Erlotinib plus Onartuzumab in advanced non-small cell lung cancer: METLung study stopped on lack of clinically efficacy
Roche has announced that an independent data monitoring Committee has recommended that the phase III METLung study be stopped due to a lack of clinically meaningful efficacy.
The study evaluated if Onartuzumab ( MetMab ) in combination with Erlotinib ( Tarceva ) helped patients with previously treated, advanced non-small cell lung cancer ( NSCLC ) whose tumours were identified as MET-positive live longer compared to Erlotinib alone. Overall adverse event rates were generally similar between the two groups.
Roche is evaluating the implications of the METLung study results across the ongoing Onartuzumab Clinical Programme.
METLung is a phase III, randomised, double-blind study evaluating the efficacy and safety profile of Onartuzumab in combination with Erlotinib in patients with previously treated ( second- or third-line ) advanced NSCLC identified to be MET-positive.
The METLung study included a companion diagnostic immunohistochemistry ( IHC ) test.
Four hundred and ninety-nine patients were randomized to receive 150 mg of Tarceva taken daily plus either: intravenous 15 mg/kg of Onartuzumab every three weeks, or intravenous placebo every three weeks.
The primary endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate and safety profile.
The current results announced are from a pre-specified interim analysis.
According to the World Health Organization ( WHO ), it is estimated that nearly 1.6 million people worldwide died of lung cancer in 2012; NSCLC accounts for 85% of all lung cancers.
MET is a protein found on the surface of cells and acts as a receptor that binds to another protein called Hepatocyte Growth Factor ( HGF ), also known as Scatter Factor. When HGF binds to MET, it causes MET proteins to form pairs ( dimerise ), which triggers a signalling cascade that tells cells to grow, divide, and spread to other parts of the body. Activation of the MET pathway has been proposed as a mechanism of tumour growth and spread ( metastasis ).
Onartuzumab is an investigational monovalent monoclonal antibody designed to specifically target the MET receptor. ( Xagena )
Source: Roche, 2014