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The New England Journal of MedicineAmivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions

Amivantamab-Chemotherapy Combo Shows Promise in Advanced NSCLC Patients with EGFR Exon 20 Insertions

A recent phase 3, international, randomized trial has demonstrated the superior efficacy of amivantamab combined with chemotherapy over chemotherapy alone in treating patients with advanced non-small-cell lung cancer (NSCLC) with EGFR exon 20 insertions. This study provides valuable insights into the potential of amivantamab as a first-line treatment option for this patient population.

Study Design

  • The study involved 308 patients with advanced NSCLC with EGFR exon 20 insertions who had not received previous systemic therapy.
  • Patients were randomly assigned in a 1:1 ratio to receive intravenous amivantamab plus chemotherapy (amivantamab–chemotherapy) or chemotherapy alone.
  • Patients in the chemotherapy group who had disease progression were allowed to cross over to receive amivantamab monotherapy.

Key Findings

  • Progression-free survival was significantly longer in the amivantamab–chemotherapy group than in the chemotherapy group (median, 11.4 months and 6.7 months, respectively).
  • At 18 months, progression-free survival was reported in 31% of the patients in the amivantamab–chemotherapy group and in 3% in the chemotherapy group.
  • A complete or partial response at data cutoff was reported in 73% and 47%, respectively.
  • In the interim overall survival analysis (33% maturity), the hazard ratio for death for amivantamab–chemotherapy as compared with chemotherapy was 0.67.
  • The predominant adverse events associated with amivantamab–chemotherapy were reversible hematologic and EGFR-related toxic effects; 7% of patients discontinued amivantamab owing to adverse reactions.

According to the World Health Organization, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths.

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