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Phase I Expansion Supports 2.5 mg/kg Iza-bren Dose for Phase III in EGFR-Mutated NSCLC

Phase I Expansion Supports 2.5 mg/kg Iza-bren Dose for Phase III in EGFR-Mutated NSCLC

Phase I data for iza-bren show 33% ORR and 6.9-month PFS at 2.5 mg/kg in heavily pretreated EGFR-mutated NSCLC, supporting Phase III entry. The dose-expansion design confirms tolerability with G-CSF support but lacks randomization. Next trial will test clinical benefit against standard care.

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The 2.5 mg/kg regimen now advances into the registrational IZABRIGHT-Lung01 Phase III trial. That study must demonstrate superiority in progression-free or overall survival versus investigator-choice chemotherapy to change practice; early single-arm data cannot establish this.

⚡ Prediction

IZABRIGHT-Lung01: Phase III PFS hazard ratio <0.70 versus chemotherapy reported by Q4 2028

Sources (3)

  • [1]
    Primary Source(https://medicalxpress.com/news/2026-09-egfr-her3-therapy-phase-iii.html)
  • [2]
    Supporting Source(https://www.iaslc.org/conferences/wclc-2026)
  • [3]
    Supporting Source(https://www.nejm.org/doi/full/10.1056/NEJMoa2304714)