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ASCO 2025 | Beamion LUNG-1: zongertinib for pre-treated HER2-mutant NSCLC

Joshua Sabari, MD, New York University Langone Health, New York, NY, discusses patient-reported outcomes from the Phase Ia/Ib Beamion LUNG-1 trial (NCT04886804) of zongertinib in previously treated HER2-mutant advanced non-small cell lung cancer (NSCLC). Patients reported rapid and sustained improvements in physical functioning and symptom burden. Side effect burden remained low throughout treatment, with adverse event profiles consistent with known toxicities. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

So the Beamion LUNG-1 study is a study of a medicine called zongertinib, it’s a BI 181. It’s a specific HER2 inhibitor that spares EGFR. Now this is an exciting space, HER2 occurs in about 2 to 4 percent of patients with non-small cell lung cancer, the most common mutation being a YVMA insertion mutation. So the Beamion LUNG-1 study, we had a Phase I escalation, this is the expansion into patients who have previous treatment, as well as patients who are newly diagnosed...

So the Beamion LUNG-1 study is a study of a medicine called zongertinib, it’s a BI 181. It’s a specific HER2 inhibitor that spares EGFR. Now this is an exciting space, HER2 occurs in about 2 to 4 percent of patients with non-small cell lung cancer, the most common mutation being a YVMA insertion mutation. So the Beamion LUNG-1 study, we had a Phase I escalation, this is the expansion into patients who have previous treatment, as well as patients who are newly diagnosed. The overall response rate in patients was 71%. We saw a progression-free survival median of 12.9 months. And we’re seeing exciting, durable responses as well as CNS, central nervous system responses. So a very exciting agent with a very clean toxicity profile, very low rates of diarrhea and rash when you compare it to some of the other prior HER2 tyrosine kinase inhibitors in this space.

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Disclosures

Consulting or Advisory Role – Abbvie; AstraZeneca; Genentech/Roche; Janssen; Janssen (Inst); Loxo/Lilly; Loxo/Lilly (Inst); Medscape; Mirati Therapeutics; Mirati Therapeutics (Inst); Pfizer; Regeneron; Regeneron (Inst); Sanofi; Takeda