ASCO 2026 | Beamion LUNG-1: PROs with zongertinib in HER2-mutant advanced NSCLC

The HER2 mutations in non-small cell lung cancer occur in about 2% to 4% of patients, and we know there’s a significant unmet need for this patient population. Until the approval of zanatinib, there were no FDA approvals in the frontline setting for HER2-targeted therapies. So, zongertinib is a HER2-selective tyrosine kinase inhibitor. It has no EGFR activity and is very selective for HER2. And it showed phenomenal activity in the MONARCH Lung 1 study in the frontline setting, 77% response rate, you know, median progression-free survival, now of 14 months. So a really exciting opportunity. It’s the frontline therapy that is standard of care now in my clinical practice setting. There are other TKIs available in this space in the second-line setting, such as poziotinib, an EGFR and HER2-exon 20 inhibitor, as well as an ADC, trastuzumab deruxtecan. Here at ASCO, we’re reporting an update on the patient-reported outcomes. Now, why are patient-reported outcomes important? It’s important that we improve PFS and overall survival, but it’s also important that we improve the outcomes for our patients. Quality of life, we know, is critical. So in this study, we showed that all patients had dramatic symptom improvement with therapy, with zongertinib , and it was sustained, right? So we don’t see any long-term toxicity with zongertinib . Most common side effect from zongertinib , again, a HER2-selective TKI, is diarrhea, mostly grade 1. Only 1% of patients had grade 3 diarrhea. When you compare and contrast that to a therapy like poziotinib, poziotinib being an EGFR and HER2 therapy, so non-selective for HER2, much higher rates of diarrhea, upwards of 80%, with a grade 3 rate in that 15% to 20% range. So looking at patient-reported outcomes, we did see an improvement in quality of life for patients, as well as an improvement in their symptom management and control. We had very high response to our questionnaires on this study, with very long-term follow-up in a group of 70-plus patients in the MONARCH Lung 1 study. And what we saw early on was improvement in the patient-reported outcome metrics, but this could just be related to symptom improvement from cancer control, right? The time to response for zanatinib is 1.5 months. But what we want to see is more durability long-term, and that’s what we’re presenting here at ASCO 2024, that we saw improvement in the patient-reported outcomes that sustained throughout the therapy, and we saw no new significant adverse events as patients remained on treatment. I have patients now coming up on three years in my clinical practice setting, and really the tolerability is durable in the sense that we don’t see new adverse events that occur later on in their therapy journey.

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