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ESMO 2025 | Beamion LUNG-1: first-line zongertinib in advanced HER2-mutant NSCLC
Sanjay Popat, MBBS, FRCP, PhD, Royal Marsden Hospital, London, UK, discusses the Phase Ib Beamion LUNG-1 study (NCT04886804) of zongertinib, an irreversible HER2-selective TKI, as first-line therapy in treatment-naïve patients with advanced HER2-mutant non-small cell lung cancer (NSCLC). Zongertinib demonstrated high response rates, durable disease control, and favorable progression-free survival, with a manageable safety profile. Most treatment-related adverse events were low-grade, with few grade 3 events and no grade 4/5 events reported. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
So at the ESMO 2025 Congress, I was delighted to present the efficacy and safety data of zongertinibin HER2 mutant advanced non-small cell lung cancer. \ongertinib, as you remember, is the irreversible TKI that inhibits HER2 and is actually quite sparing of EGFRs thereby limiting and minimizing the EGFR-associated toxicities. It’s been evaluated in the ongoing phase one trial with dose escalation and the optimized dose moving forward is 120 milligrams once daily...
So at the ESMO 2025 Congress, I was delighted to present the efficacy and safety data of zongertinibin HER2 mutant advanced non-small cell lung cancer. \ongertinib, as you remember, is the irreversible TKI that inhibits HER2 and is actually quite sparing of EGFRs thereby limiting and minimizing the EGFR-associated toxicities. It’s been evaluated in the ongoing phase one trial with dose escalation and the optimized dose moving forward is 120 milligrams once daily. I presented results of cohort two which is patients that were untreated previously who had metastatic HER2 tyrosine kinase domain mutant non-small cell lung cancer. This is an important group of patients because they have no targeted therapies approved for use and the standard of care is currently chemotherapy with or without immunotherapy. A total of 74 patients were enrolled in the study and the primary endpoint was ORR, a confirmed objective response rate and indeed the primary endpoint was met with a response rate of 77% with over 90% of patients achieving disease control. When we looked at the waterfall plot every single patient had some form of tumour shrinkage and the clinical benefit of tumour shrinkage was not restricted to whether the patients had a YVMA mutation or not. When we looked at time to event endpoints a median duration of response had not been met yet and neither had median progression-free survival so we need more data for that. And the toxicity profile was very similar to that previously reported with mostly grade one or grade two adverse events.
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