German pharmaceutical company Boehringer Ingelheim has reported positive outcomes from the first cohort of Beamion LUNG-1, a two-part trial analysing zongertinib for treating non-small cell lung cancer (NSCLC).
The Phase Ib primary analysis assessed zongertinib’s efficacy in previously treated patients with advanced NSCLC with activating HER2 mutations.
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Zongertinib is an oral HER2 tyrosine kinase inhibitor designed to minimise toxicity by sparing wild-type EGFR.
The first part of the trial includes adults with various advanced cancers, specifically solid tumours with HER2 gene alterations, who have not responded to previous treatments.
The second part is tailored to NSCLC patients who exhibit specific HER2 gene mutations.
As of May this year, 132 patients in the trial have been treated with zongertinib at doses of either 120mg or 240mg daily.
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By GlobalDataThe trial met its primary endpoint, with the drug showing a meaningful objective response rate and a tolerable safety profile.
The confirmed objective response rate for the 120mg cohort was 66.7%, with tumour shrinkage observed in 94% of patients across both dose groups.
The trial included a dose expansion to determine the optimal zongertinib dosage. After an interim analysis, the 120mg dose was chosen for further evaluation.
Data from the first cohort also suggest that zongertinib may have activity against brain metastases, a common and serious complication in NSCLC.
The drug was generally well-tolerated at both doses, with no treatment-related deaths reported.
Boehringer Ingelheim Innovation Unit head Paola Casarosa said: “Zongertinib’s efficacy and tolerability profile has the potential to become part of the future treatment landscape for patients with HER2-mutated lung tumours.
“Zongertinib is a perfect example of our approach to science in the discovery and development of novel treatments.”
Earlier this year, Boehringer Ingelheim began a Phase I clinical trial of BI 3034701, a long-acting triple agonist peptide designed to treat obesity, in partnership with Gubra.
