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.”
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.
- 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.