According to a new study published in the journal Annals of Oncology, researchers have found that the addition of figitumumab to erlotinib did not improve overall survival in patients with advanced, non-adenocarcinoma non-small cell lung cancer (NSCLC) who have received prior therapy.
For the multicenter, open-label, phase 3 study, 583 patients with stage 3B/4 non-adenocarcinoma NSCLC or recurrent disease with non-adenocarcinoma histology who had previously received at least one platinum-based therapy were randomly assigned to receive erlotinib 150mg daily with or without figitumumab 20mg/kg.
The study was stopped early by an independent data safety monitoring committee due to nine treatment-related deaths, specifically three related to both drugs, four attributed to erlotinib alone, and two related to figitumumab.
Results showed a median overall survival of 5.7 months for the combination group compared with 6.2 months for the erlotinib alone group (HR = 1.09, 95% CI: 0.91 - 1.31; P = 0.35). Median progression-free survival was 2.1 months and 2.6 months for the combination group and erlotinib alone group, respectively (HR = 1.08, 95% CI: 0.90 - 1.29; P = 0.43).
As a result of the safety concerns and the early study closure, the clinical development of figitumumab has been discontinued.
This multicenter, randomized, phase III study investigated the efficacy of figitumumab plus erlotinib compared with erlotinib alone in patients with pretreated, non–small cell lung cancer (NSCLC).
The addition of figitumumab to erlotinib did not improve OS in patients with advanced, pretreated, non–adenocarcinoma NSCLC. Clinical development of figitumumab has been discontinued.