Erlotinib plus tivantinib was well tolerated and increased progression-free survival but did not improve overall survival in the overall population of previously treated patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), a new study published online ahead of print in the Journal of Clinical Oncology has shown.
For the study, researchers enrolled 1,048 patients with advanced nonsquamous NSCLC previously treated with one or two systemic regimens.
One regimen must have been a platinum doublet. Patients were randomly assigned 1:1 to receive erlotinib 150 mg orally daily plus tivantinib 360 mg orally twice daily or erlotinib plus placebo. Patients were treated until disease progression.
An interim analysis showed that there was no improvement in overall survival with the addition of tivantinib (HR = 0.98; 95% CI: 0.84, 1.15;P=0.81); however, researchers found that progression-free survival was improved in the tivantinib group (HR = 0.74; 95% CI: 0.62, 0.89; P<0.001).
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The study was therefore discontinued for futility.
Subgroup analyses demonstrated an improvement in overall survival in patients with high MET expression (HR = 0.70; 95% CI: 0.49, 1.01). The most common adverse events in the erlotinib-tivantinib arm were rash, diarrhea, asthenia, and neutropenia.
Scagliotti G, von Pawel J, Novello S, et al. Phase III multinational, randomized, double-blind, placebo-controlled study of tivantinib (ARQ 197) plus erlotinib versus erlotinib alone in previously treated patients with locally advanced or metastatic nonsquamous non-small cell lung cancer. J Clin Oncol. 2015. [epub ahead of print]. doi: 10.1200/JCO.2014.60.7317.