Bevacizumab Plus Erlotinib in EGFR-Mutant NSCLC: Phase 2 Trial Results

On August 8, 2019, Thomas E. Stinchcombe and colleagues published the results of a Phase 2 clinical trial in JAMA Oncology. The study investigated whether adding Bevacizumab (Avastin), an anti-VEGF antibody, to Erlotinib (Tarceva), an EGFR inhibitor, would improve outcomes for patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC).

Study Design

The trial enrolled 88 patients with advanced EGFR-mutant NSCLC. Participants were randomized into two groups:

1. Combination Group: Bevacizumab (15 mg/kg every 3 weeks) + Erlotinib (150 mg daily).
2. Monotherapy Group: Erlotinib (150 mg daily) alone.

The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and overall survival (OS).

Key Efficacy Results

• Progression-Free Survival (PFS):
  • Combination Group: 17.9 months
  • Monotherapy Group: 13.5 months
  • While there was a 19% reduction in the risk of progression (Hazard Ratio [HR] = 0.81), the difference was not statistically significant.
• Objective Response Rate (ORR): 81% (Combination) vs. 83% (Monotherapy).
• Overall Survival (OS):
  • Combination Group: 32.4 months
  • Monotherapy Group: 50.6 months
  • The combination group showed a higher risk of death (HR = 1.41), though again, this was not statistically significant.

Safety Profile

The combination group experienced more Grade 3 or higher adverse events, primarily skin-related reactions (26%), hypertension (40%), and proteinuria (12%). There were no Grade 5 toxicities reported in the combination arm.

Conclusion

The authors concluded that adding Bevacizumab to Erlotinib did not significantly improve PFS or OS in patients with advanced EGFR-mutant NSCLC compared to Erlotinib alone. These findings suggest that the combination may not provide a substantial benefit over the current standard of care in this setting.

Source: JAMA Oncology - Erlotinib Plus Bevacizumab Trial Results

#LungCancer #NSCLC #EGFRMutation #Bevacizumab #Avastin #Erlotinib #Tarceva #CancerResearch

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