Boehringer Ingelheim has announced positive results from the first cohort of the Beamion LUNG-1 trial, evaluating zongertinib in patients with HER2-mutated non-small cell lung cancer (NSCLC). The Phase Ib trial assessed the efficacy and safety of zongertinib, an oral HER2 tyrosine kinase inhibitor, in previously treated patients with advanced NSCLC harboring activating HER2 mutations.
The primary analysis of the Beamion LUNG-1 trial focused on patients with advanced NSCLC who had progressed on prior therapies and harbored activating HER2 mutations. Zongertinib is designed to minimize toxicity by selectively targeting HER2 while sparing wild-type EGFR.
Objective Response and Tolerability
The trial met its primary endpoint, demonstrating a meaningful objective response rate and a tolerable safety profile. Specifically, the confirmed objective response rate for the 120mg cohort was 66.7%. Tumor shrinkage was observed in 94% of patients across both the 120mg and 240mg dose groups.
Paola Casarosa, Head of Boehringer Ingelheim Innovation Unit, stated, "Zongertinib's efficacy and tolerability profile has the potential to become part of the future treatment landscape for patients with HER2-mutated lung tumors."
Trial Design and Patient Population
The Beamion LUNG-1 trial is a two-part study. The first part included adults with various advanced cancers, specifically solid tumors with HER2 gene alterations, who had not responded to previous treatments. The second part is specifically focused on NSCLC patients with defined HER2 gene mutations. As of May of this year, 132 patients have been treated with zongertinib at doses of 120mg or 240mg daily.
Potential Activity Against Brain Metastases
Data from the first cohort suggest that zongertinib may have activity against brain metastases, a common and serious complication in NSCLC. This is a particularly encouraging finding, as brain metastases often present a significant therapeutic challenge.
Dose Selection and Safety
Following an interim analysis, the 120mg dose was chosen for further evaluation in the dose expansion phase of the trial, aiming to optimize the balance between efficacy and safety. The drug was generally well-tolerated at both doses, with no treatment-related deaths reported.
