CHICAGO — Phase 3 data from the NEJ026 trial showed that a combination regimen of bevacizumab plus erlotinib prolonged PFS compared with erlotinib alone in chemotherapy-naive patients with EGFR-mutated non-small cell lung cancer.
The results build on previous findings from a phase 2 trial that demonstrated improvements in PFS among patients with EGFR-mutated non-small cell lung cancer (NSCLC) who received bevacizumab (Avastin, Genentech) plus erlotinib vs. erlotinib (Tarceva, Roche) monotherapy (16 months vs. 9.7 months).
During a presentation at ASCO, Naoki Furuya MD, PhD, of the St. Marianna University School of Medicine, reported that tyrosine kinase inhibitor monotherapy has been the standard treatment for EGFR-mutated advanced NSCLC. However, the median PFS associated with this therapy is 1 year, which Furuya said is “not so long.” As a result, combination regimens are currently being investigated.
For the phase 3 NEJ026 trial, Furuya and colleagues randomly assigned patients with advanced nonsquamous, EGFR-positive NSCLC in a 1:1 ratio to receive 15 mg/kg of IV bevacizumab every 3 weeks plus 150 mg of erlotinib daily or 150 mg of erlotinib alone daily. The primary endpoint was the median duration of PFS.
The interim analysis included data on 224 patients who were enrolled between June 3, 2015 and Aug. 31, 2016. Furuya said bevacizumab plus erlotinib met its primary endpoint of prolonged PFS compared with erlotinib alone (HR = 0.605; 95% CI, 0.417-0.877). As of Sept. 21, 2017, the median PFS was 16.9 months (95% CI, 14.2-21) among patients who received combination therapy and 13.3 months (95% CI, 11.1-15.3) among patients who received monotherapy.
In a safety analysis, bevacizumab plus erlotinib was generally well tolerated, according to Furuya. Serious adverse events occurred in nine patients who received combination therapy. No treatment-related deaths were reported.
“There are statistically more hypertension, proteinuria and hemorrhage in the combination arm,” he said. “However, these adverse events were manageable.”
The added efficacy benefit of bevacizumab plus erlotinib was largely consistent across subgroup analyses adjusted for gender, age, smoking status and disease stage, Furuya noted.
“Biomarker analysis and OS follow-up are still ongoing,” he concluded. “Bevacizumab plus erlotinib combination is considered as a new standard therapy in patients with untreated EGFR-mutated NSCLC.” – by Stephanie Viguers
Furuya N, et al. Abstract 9006. Presented at: ASCO Annual Meeting; June 1-5, 2018; Chicago.
Disclosures: Furuya reports no relevant financial disclosures.