Tivantinib plus erlotinib might improve progression-free survival compared with erlotinib alone in patients with non-squamous non-small cell lung cancer (NSCLC) with wild-type EGFR, a new study published online ahead of print in the journal Annals of Oncology has shown.
For the double-blind, placebo-controlled, phase 3 ATTENTION trial, researchers sought to compare the overall survival between Asian patients with non-squamous NSCLC with wild-type EGFR who received tivantinib or placebo, in combination with erlotinib.
Researchers planned to enroll 460 patients but enrollment was terminated after enrollment of only 307 patients due to a higher incidence of interstitial lung disease observed in the tivantinib group.
Results showed that median overall survival was 12.7 months in the tinvantinib group compared with 11.1 months in the placebo group (HR = 0.892; P=0.427). Researchers found that median progression-free survival was 2.9 and 2.0 months in the tivantinib and placebo groups, respectively (HR = 0.719; P=0.019).
In regard to safety, 14 patients in the tivantinib group developed interstitial lung disease and three patients died as a result versus six patients in the placebo group who developed interstitial lung disease and no deaths. The most frequently reported adverse events in the tivantinib group were neutropenia, leukopenia, febrile neutropenia, and anemia.
- Yoskioka H, Azuma K, Yamamoto N, et al. A randomized, double-blind, placebo-controlled, phase III trial of erlotinib with or without a c-Met inhibitor tivantinib (ARQ 197) in Asian patients with previously treated stage IIIB/IV non-squamous non-small-cell lung cancer harboring wild-type epidermal growth factor receptor (ATTENTION study). Ann Oncol. 2015. [epub ahead of print]. doi: 10.1093/annonc/mdv288.