(SEOUL, Republic of Korea —September 12 th , 6:15 p.m. Korea Standard Time) — An investigational EGFR x HER3 antibody-drug conjugate demonstrated promising efficacy with a tolerable safety profile in patients with previously treated EGFR-mutated non-small cell lung cancer (NSCLC), supporting selection of the 2.5 mg/kg dose for evaluation in the global Phase 3 IZABRIGHT-Lung01 registrational study.
These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) in Seoul, Republic of Korea.
Results from the randomized dose-expansion cohort of the global Phase 1 study showed increasing clinical activity with higher dose levels. At the recommended Phase 3 dose of 2.5 mg/kg, the objective response rate reached 33.3%, the confirmed objective response rate was 29.6%, and median progression-free survival was 6.9 months.
All enrolled patients had previously progressed on a third-generation EGFR inhibitor, and nearly two-thirds had also received platinum-based chemotherapy. Mandatory primary G-CSF prophylaxis was associated with an improved hematologic safety profile compared with previously reported experience.
Overall, the investigational therapy demonstrated a manageable safety profile. No treatment-related deaths were observed, and only one patient discontinued treatment because of a treatment-related adverse event.
“These findings support continued development of iza-bren and provide the rationale for advancing the 2.5 mg/kg regimen into the global Phase 3 IZABRIGHT-Lung01 trial for patients with previously treated EGFR-mutated NSCLC,” said Alexander Spira, M.D., NEXT Oncology Virginia and Virginia Cancer Specialists, Fairfax, Va.
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About the IASLC
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information.
About the WCLC
The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc.iaslc.org/.