2024 World Conference on Lung Cancer (WCLC) - Posters-P3.12D.06 Beamion LUNG-1 And LUNG-2: The Zongertinib Clinical Program in Patients with Non-Small Cell Lung Cancer and HER2 Mutations

P3.12D.06 Beamion LUNG-1 And LUNG-2: The Zongertinib Clinical Program in Patients with Non-Small Cell Lung Cancer and HER2 Mutations

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The Beamion LUNG-1 and LUNG-2 clinical programs investigate the efficacy and safety of zongertinib, a novel, orally administered, HER2-selective tyrosine kinase inhibitor, in patients with advanced non-small cell lung cancer (NSCLC) harboring HER2 mutations. The program targets an unmet need for effective treatments, as traditional chemotherapy has shown limited effectiveness in this patient group.<br /><br />Beamion LUNG-1 consists of a phase 1a/1b, open-label dose-escalation study. The phase 1a trial aimed to determine the maximum tolerated dose (MTD) of zongertinib, enrolling 83 patients. Preliminary results showed promising efficacy, with a 44% objective response rate (ORR) and a 93% disease control rate (DCR) among patients with NSCLC. The MTD was not reached; thus, doses of 120 mg and 240 mg QD are considered for further phase 1b exploration, focusing on dose optimization in patients with HER2-mutant NSCLC.<br /><br />The Beamion LUNG-2 trial is a phase 3, randomized, active-controlled study comparing zongertinib to standard-of-care therapy, which includes pembrolizumab with platinum-pemetrexed chemotherapy. This trial aims to recruit 270 patients globally and evaluate endpoints such as progression-free survival and overall survival.<br /><br />Regarding safety, the phase 1a data showed zongertinib was generally well-tolerated with low-grade adverse events. Notably, only a single Grade 4 treatment-related adverse event (TRAE) of thrombocytopenia was reported with a 240 mg dose. The most common TRAEs included diarrhea and rash, with no Grade 5 events observed.<br /><br />In conclusion, zongertinib demonstrates a promising safety profile and antitumor activity, supporting its further investigation in ongoing trials. The phase 3 Beamion LUNG-2 trial aims to establish its efficacy compared to existing standard therapies for advanced HER2-mutant NSCLC.

Asset Subtitle

Yi-Long Wu

Meta Tag

Speaker Yi-Long Wu

Topic Metastatic NSCLC – Targeted Therapy

Keywords

zongertinib

HER2-selective

tyrosine kinase inhibitor

non-small cell lung cancer

NSCLC

Beamion LUNG-1

Beamion LUNG-2

clinical trial

chemotherapy

phase 3 study