CHICAGO, IL— Adding onartuzumab to erlotinib in previously treated advanced, MET-positive non-small cell lung cancer (NSCLC) did not improve patient survival, suggest findings from the pivotal phase 3 randomized, multicenter, placebo-controlled METLung trial presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting.

The study “unfortunately did not confirm efficacy results observed in the previous phase 2 trial,” reported lead author David R. Spigel, MD, of the Sarah Cannon Research Institute in Nashville, TN, and coauthors. The study found “no differences in overall survival, progression-free survival, objective response rate, or by MET FISH status.”

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Nor was there evidence of benefit for patients with epidermal growth factor receptor (EGFR) mutation-positive NSCLC, Dr. Spigel reported.

Onartuzumab is a humanized monoclonal antibody that targets c-MET. A total of 499 patients with stage IIIb or IV NSCLC were enrolled in the phase 3 trial between January 2012 and August 2013.

Despite a trend toward improved overall survival (OS), at a median follow-up of 7.7 months, neither OS nor progression-free survival (PFS) was significantly improved with the addition of onartuzumab to erlotinib (OS, 6.8 months vs. 9.1 months; hazard radio [HR], 1.27; 95% CI: 0.98-1.65; P = 0.07, not statistically significant; PFS, 2.7 vs. 2.6 months; HR,  0.99; P = 0.92).

“Unfortunately, there were no subgroups for which we saw a benefit,” Dr. Spigel added. Frequent adverse events that were more common in the combined-agents arm included peripheral edema, hypoalbuminemia, back pain, dyspnea, nausea, acneiform dermatitis, and rash, Dr. Spigel reported.

The authors halted continued enrollment in the study because of futility.


  1. Spigel DR, Edelman MJ, O’Byrne K et al. Abstract 8000. Presented at: 2014 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2014; Chicago, IL.