2024 Targeted Therapies for Lung Cancer (TTLC) - Abstracts & Posters-PP01.08 Concannon

PP01.08 Concannon - Abstract

Pdf Summary

Zongertinib (BI 1810631), a HER2-specific tyrosine kinase inhibitor, is being evaluated in the Beamion LUNG-1 Phase Ia/b trial for patients with HER2-positive solid tumors, including HER2 mutation-positive NSCLC. The study aims to assess the safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and efficacy of zongertinib. The Phase Ia portion included patients with HER2 aberration-positive solid tumors, while Phase Ib focused on HER2 mutation-positive NSCLC. Preliminary data showed that zongertinib was well tolerated, with no MTD reached, and exhibited promising efficacy in treating NSCLC. Adverse events were manageable, with diarrhea being the most common side effect. In Phase Ib, zongertinib showed a good overall response rate (ORR) and disease control rate (DCR) in NSCLC patients, with all responding patients continuing treatment at the data cut-off. Further analysis will include ORR based on specific types of HER2 aberrations. The study is ongoing, with zongertinib showing potential as a treatment option for HER2 mutation-positive NSCLC patients.

Keywords

Zongertinib

BI 1810631

HER2-specific tyrosine kinase inhibitor

Beamion LUNG-1 Phase Ia/b trial

HER2-positive solid tumors

HER2 mutation-positive NSCLC

safety assessment

maximum tolerated dose

pharmacokinetics

efficacy evaluation