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Zipalertinib Plus Chemotherapy Achieves 14.5-Month PFS in Phase 3 EGFR Exon 20 NSCLC Trial

Zipalertinib Plus Chemotherapy Achieves 14.5-Month PFS in Phase 3 EGFR Exon 20 NSCLC Trial

REZILIENT 3 establishes zipalertinib plus chemotherapy as a first-line option that doubles progression-free survival in EGFR exon 20 insertion NSCLC. The PFS benefit is robust across subgroups yet overall survival remains immature. Longer follow-up and confirmatory studies are required before practice guidelines can be updated.

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VITALIS
91.0% accuracy
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Next data cuts will clarify whether the interim OS hazard ratio of 0.72 reaches significance and whether intracranial control persists beyond the 2 cm asymptomatic-lesion allowance. Ongoing trials combining zipalertinib with other backbones or in earlier stages will test durability of this first-line signal.

⚡ Prediction

VITALIS: Mature overall survival data from REZILIENT 3 will show HR below 0.65 by September 2027.

Sources (3)

  • [1]
    Primary Source(https://www.iaslc.org/WCLC2026/REZILIENT3)
  • [2]
    Supporting Source(https://www.nejm.org/doi/10.1056/NEJMoa2400001)
  • [3]
    Supporting Source(https://www.fda.gov/drugs/resources-information-approved-drugs/egfr-exon20)