Roche, the world’s largest biotech company,  announced that an independent data monitoring committee has recommended that the phase III METLung study to be stopped due to a lack of clinically meaningful efficacy.

The study evaluated if onartuzumab (MetMab) in combination with Tarceva (erlotinib) helped patients with previously treated, advanced non-small cell lung cancer (NSCLC) whose tumours were identified as MET-positive live longer compared to Tarceva alone.

Overall adverse event rates were generally similar between the two groups. Data will be submitted for presentation at a forthcoming medical meeting.

"These results are disappointing because new options are needed for patients with lung cancer, the most common and deadly cancer worldwide,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. "We remain committed to helping patients with lung cancer and are studying several investigational medicines in this disease.”

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 Tarceva 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 that was co-developed with Ventana Medical Systems, Inc., a member of the Roche Group. 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; intravenous placebo every three weeks; the primary endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate and safety profile. The results announced today are from a pre-specified interim analysis.

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, an investigational monovalent (one-armed) monoclonal antibody designed to specifically target the MET receptor, is being studied in various cancers.

Tarceva is a once-daily, oral non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit epidermal growth factor receptor (EGFR), a protein involved in the growth and development of cancers. Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas global group of companies.

Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics.