New Zongertinib Data from Boehringer Shows Sustained, Clinically Meaningful Results in Advanced NSCLC Patients
In the Phase Ib Beamion LUNG-1 clinical trial, zongertinib, an investigational irreversible tyrosine kinase inhibitor, demonstrated a median duration of response of 14.1 months.
Boehringer Ingelheim has shared new data from the Phase Ib Beamion LUNG-1 clinical trial (NCT04886804) of zongertinib, an investigational irreversible tyrosine kinase inhibitor, in previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC). Zongertinib demonstrated clinically meaningful and sustainable results, with a median duration of response (DoR) of 14.1 months.1
In addition to the median DoR mark, this most recent analysis of the Beamion LUNG-1 study showed an objective response rate (ORR) of 71%, with 7% complete response, 64% partial response, and 96% disease control in previously treated patients. Zongertinib also demonstrated intracranial activity in previously treated patients with brain metastases, with 41% achieving response and 81% disease control.
The median DoR of 14.1 months plus the median progression-free survival of 12.4 months were presented for the first time at the American Association for Cancer Research (AACR) Annual Meeting 2025.
In a press release, John Heymach, MD, PhD, chair of thoracic/head and neck medical oncology at the University of Texas MD Anderson Cancer Center, and the trial’s coordinating investigator, said: “These data presented at AACR 2025 suggest that zongertinib may offer a new approach to treating patients with non-small cell lung cancer with activating HER2 mutations. Notably, more than 70% of patients experienced a tumor response, which is highly meaningful for those with this subtype of lung cancer. If approved by the FDA, zongertinib would be the first oral, targeted treatment option that addresses an unmet need for these patients.”
Boehringer initially shared outcomes from the Beamion LUNG-1 trial in September 2024. The trial met its primary endpoint of ORR and was generally well tolerated in Cohort 1. As of May 2024, 132 patients were treated with 120/240 mg of zongertinib once a day. Across all doses, 94% of patients experienced tumor shrinkage of any magnitude.2
In a press release from the time, Heymach said: “These new data could represent positive news in the future treatment of non-small cell lung cancer patients with activating HER2 mutations. While these mutations are rare, they are critical drivers in a subset of non-small cell lung cancer cases, and current treatment options are severely limited. Patients with this type of cancer typically face a poor prognosis, with approximately 50% responding to first-line treatment and only 20% responding to second-line therapy.”
Paola Casarosa, board of managing directors, head of innovation unit at Boehringer Ingelheim, added: “Zongertinib’s efficacy and tolerability profile has the potential to become part of the future treatment landscape for patients with HER2 mutated lung tumors. Zongertinib is a perfect example of our approach to science in the discovery and development of novel treatments. Boehringer is committed to providing breakthrough therapies for cancer patients, and we look forward to advancing the zongertinib clinical program.”
The Beamion LUNG-1 trial is an open-label, dose escalation study with dose confirmation and expansion, of zongertinib as monotherapy. The study features two parts, with the first being open to adults with different types of advanced cancer for whom previous treatment was unsuccessful. The second part is open to patients with advanced NSCLC with a specific mutation in the HER2 gene. The Beamion study program also includes Beamion LUNG-2, a Phase III study evaluating zongertinib compared with standard of care in patients with unresectable, locally advanced, or metastatic non-squamous NSCLC harboring HER2 TKD mutations.
References
1. Boehringer’s new zongertinib data demonstrates durable and clinically meaningful results in patients with HER2 (ERBB2)-mutant advanced NSCLC. News release. Boehringer Ingelheim. April 28, 2025. Accessed April 29, 2025. https://www.boehringer-ingelheim.com/us/results-announced-boehringers-beamion-lung-1-study
2. Boehringer’s zongertinib shows encouraging efficacy and tolerability profile in previously treated HER2 mutated lung cancer patients. News release. Boehringer Ingelheim. September 9, 2024. Accessed April 29, 2025. https://www.boehringer-ingelheim.com/us/positive-results-reported-her2-mutated-lung-cancer
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