Boehringer Ingelheim has reported promising outcomes from a Phase 1b primary analysis of Cohort 1 in the Beamion LUNG-1 trial, which investigated zongertinib (BI 1810631) for certain advanced lung cancer patients.
Zongertinib was being assessed in pre-treated patients with advanced non-small cell lung cancer (NSCLC) with activating HER2 mutations.
The experimental oral HER2 tyrosine kinase inhibitor (TKI) received fast track designation from the US Food and Drug Administration (FDA) in 2023.
Earlier this year, it was awarded breakthrough therapy designation by both the FDA and China’s Center for Drug Evaluation (CDE).
Currently, the Beamion LUNG-2 global Phase 3 trial is enrolling patients to compare zongertinib with standard treatments as a first-line therapy for advanced NSCLC with activating HER2 mutations.
In Phase 1b primary analysis, Zongertinib showed a significant objective response rate and was well tolerated by patients.
As of May 2024, 132 patients were treated with the experimental oral drug at doses of 120mg or 240mg daily.
The confirmed objective response rate (ORR) was 66.7% for Cohort 1, meeting the primary endpoint. Tumour shrinkage of any degree was observed in 94% of patients.
After an interim analysis, the 120mg dose was selected for further evaluation in Cohort 1, with 17 additional patients enrolled.
In this randomised part of the trial, the response rate was 72.4% for the 120mg group and 78.2% for the 240mg group, with disease control rates (DCRs) of 95% and 100%, respectively.
Phase 1b data from Cohort 1 also showed preliminary brain activity.
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.”
The biopharmaceutical company said that data is still maturing, with two-thirds of responding patients remaining on treatment at the data cut-off.
A recent pre-clinical study has indicated that the investigational asset may be promising for further clinical trials.
It shows potential as a monotherapy for HER2-dependent solid cancers and could also be effective when used alongside antibody-drug conjugates (ADC) therapy or KRAS-targeted drugs.
In July, Boehringer Ingelheim acquired US-based drug discovery and development company Nerio Therapeutics in a deal worth up to $1.3bn.
