Lung Cancer Drug Onartuzumab Fails Phase III Study
Trial halted because of lack of efficacy
An independent data-monitoring committee has recommended that the phase III METLung trial be stopped because of a lack of clinically meaningful efficacy.
The study was evaluating whether onartuzumab (MetMab, Roche) in combination with erlotinib (Tarceva, Genentech/Astellas Oncology) helped patients with previously treated, advanced non–small-cell lung cancer (NSCLC) whose tumors were identified as MET-positive live longer compared with patients treated with erlotinib alone.
Onartuzumab, an investigational monovalent (one-armed) monoclonal antibody designed to specifically target the MET receptor, is being studied in various cancers.
The METLung trial was a phase III, randomized, double-blind study evaluating the efficacy and safety profiles of onartuzumab in combination with erlotinib in patients with previously treated (second- or third-line) advanced NSCLC identified to be MET-positive. A total of 499 patients were randomly assigned to receive erlotinib 150 mg daily plus either intravenous (IV) onartuzumab 15 mg/kg or IV placebo every 3 weeks. The primary endpoint was overall survival.
MET is a cell-surface protein receptor that binds to another protein, hepatocyte growth factor (HGF). When HGF binds to MET, it causes the MET proteins to form pairs (dimerise). This, in turn, triggers a signaling 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 tumor growth and metastasis.
Source: Roche; March 3, 2014.