Ruzaltatug Rezetecan Versus Chemotherapy for EGFR-Mutated Advanced NSCLC Post-EGFR TKI Therapy: Interim Phase 3 HERON-Lung01 Analysis

Highlights

  • Ruzaltatug rezetecan, a HER3-directed antibody-drug conjugate (ADC), demonstrates superior progression-free survival (PFS) compared to standard chemotherapy in EGFR-mutated advanced NSCLC patients resistant to EGFR tyrosine kinase inhibitors (TKIs).
  • The phase 3 HERON-Lung01 trial conducted in China enrolled 498 patients, showing a near 53% reduction in risk of progression or death with ruzaltatug rezetecan.
  • Adverse event profiles were manageable and comparable between treatment arms; hematologic toxicities predominated.
  • HER3 targeting provides a novel therapeutic avenue addressing EGFR-TKI resistance, with translational relevance supported by previous early-phase studies.

Background

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