- Erlotinib+bevacizumab extended median PFS vs erlotinib alone as first-line therapy for EGFR-positive NSCLC.
Why this matters
- These preliminary findings in this phase 3 trial confirm results reported from phase 2.
- Interim analysis of a randomized, open-label, phase 3 NEJ026 trial.
- 224 patients with stage IIIB-IV disease or recurrent, cytologically or histologically confirmed nonsquamous NSCLC with activating EGFR mutations received erlotinib+bevacizumab (n=112) or erlotinib alone (n=112).
- Funding: Chugai Pharmaceutical.
- Median PFS was 16.9 months with erlotinib plus bevacizumab and 13.3 months with the erlotinib-alone group (HR, 0.605; P=.016).
- The combination therapy group had a better objective response (72% vs 66%; P=.31) than the monotherapy group.
- The combination therapy group had significantly more grade ≥3 adverse events (AEs: 88% vs 46%) and serious AEs (8% vs 4%).
- Rash was the most common grade 3-4 AE.
- Grade 4 neutropenia and grade 4 hepatic dysfunction were the most common serious AEs.
- Small sample size.
- Underpowered for subgroup analysis.