Disappointing results from cetuximab plus afatinib for EGFR-positive NSCLC

  • Goldberg SB & al.
  • J Clin Oncol
  • 6 Oct 2020

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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>

Limitations

  • Primary endpoint not achieved.