MANILA, Philippines - Roche announced this week the final results from a randomized, multi-center, double-blind Phase II study with its investigational personalized medicine, MetMAb, in people with previously treated advanced non-small cell lung cancer (NSCLC).
MetMAb is a unique one-armed investigational antibody designed to target Met, a protein (or receptor) associated with a poor outcome in many cancers.
The study showed that people whose tumors had high levels of Met, as determined by a companion diagnostic, lived twice as long without their disease getting worse when they received MetMAb plus erlotinib compared to erlotinib alone.
Overall survival was evaluated as an exploratory endpoint and the study showed MetMAb plus erlotinib tripled the time people with this form of advanced NSCLC lived compared with erlotinib alone.
There were no unexpected safety signals from the combination of MetMAb with erlotinib and the safety profile of erlotinib was consistent with previous studies of the medicine in people with solid tumors.
“The unique design of MetMAb and the development of a companion diagnostic test allowed us to target a specific pathway that may be driving cancer growth,” said Dr. Hal Barron, chief medical officer and head of global product development.
“These results support further investigation of MetMAb as a potential personalized medicine for people with lung cancer and we plan to start a Phase III study later this year,” Barron added.
In the Phase II MetMAb study, people with previously treated NSCLC had their tumors analyzed for Met protein levels using an immunohistochemistry (IHC) test developed by Roche’s Tissue Diagnostics Co., Ventana Medical Systems.
Tumors with high Met protein levels were classified as Met diagnostic-positive, and with low Met protein levels as Met diagnostic-negative.
Although progression-free survival and overall survival were improved in people classified as having high Met tumors, those with low Met tumors had worse outcomes when given MetMAb plus erlotinib as compared to erlotinib alone.
This result highlights the importance of a companion diagnostic in evaluating the efficacy of experimental therapeutics to distinguish between the people who may potentially benefit from a new medicine as well as those who may not.
Full results of the study will be presented during an oral abstract session at the 47th annual meeting of the American Society of Clinical Oncology on June 5 by Dr. David Spigel, the principal investigator and program director of Lung Cancer Research at the Sarah Cannon Research Institute in Nashville, Tennessee.