- Adding cetuximab to afatinib as first-line treatment for advanced NSCLC with epidermal growth factor receptor (EGFR) mutations offered no PFS benefit compared with afatinib alone.
Why this matters
- A previous study found that the combination therapy of afatinib plus cetuximab offered a 29% response rate in patients with acquired tyrosine kinase inhibitor (TKI) resistance.
- Randomized, multicenter phase 2 trial.
- 168 patients with previously untreated advanced EGFR-positive NSCLC received afatinib plus cetuximab (n=83) or afatinib alone (n=85).
- Funding: NIH; Boehringer Ingelheim Pharmaceuticals; Eli Lilly; others.
- No significant difference in PFS in the combination therapy group compared with monotherapy (11.9 vs 13.4 months, respectively; HR, 1.01; P=.94), regardless of clinical or tumor characteristic.
- Median duration of treatment was not significantly different between combination therapy and monotherapy (12.7 vs 12.2 months, respectively; HR, 0.90; P=.54).
- No significant difference in 2-year OS between combination therapy and monotherapy (67% vs 70%, respectively; HR, 0.82; P=.44).
- Grade ≥3 adverse events were more significantly common with combination therapy (72% vs 40%, respectively; P<.0001>
- Primary endpoint not achieved.