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Zongertinib elicited meaningful results in previously treated patients with HER2-mutated, advanced non–small cell lung cancer.
Among previously treated patients with HER2-mutated, advanced non-small cell lung cancer (NSCLC), treatment with zongertinib showed durable responses and clinically meaningful results, according to data published in a news release from the biopharmaceutical company Boehringer Ingelheim.
The findings were also featured in the official press program of the American Association for Cancer Research (AACR) Annual Meeting and published in The New England Journal of Medicine.
New and updated data from the dose escalation, phase 1 Beamion LUNG-1 trial showed that, among 75 patients, the objective response rate was 71%. There was also a 7% complete response rate, 64% partial response and 96% disease control rate among previously treated patients, according to the news release.
Objective response rate: patients who responded partially or completely to treatment.
Complete response: the disappearance of cancer.
Partial response: a decrease in the extent of cancer in the body.
Disease control rate: patients who have achieved a complete response, partial response or stable disease.
Progression-free survival: the time a patient lives without their disease spreading or worsening.
Interstitial lung disease: inflammation and scarring of lung tissue.
Furthermore, zongertinib showed intracranial activity among 27 evaluable patients with brain metastases, with 41% achieving response and 81% experiencing disease control. The news release noted that the median duration of response of 14.1 months and progression-free survival of 12.4 months were presented for the first time at the 2025 AACR Annual Meeting.
"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," said the trial's coordinating investigator, Dr. John Heymach. "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."
Heymach is the chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, in the news release
Zongertinib, as defined by the National Cancer Institute on its website, is an oral inhibitor of HER2 which prevents HER2-mediated signaling and may lead to cell death in HER2-expressing tumor cells. HER2, the National Cancer Institute explained, is overexpressed on a variety of tumor cell types and plays an important role in tumor cell proliferation and tumor blood vessel formation.
"Zongertinib has the potential to reset the benchmark for patients with HER2-mutant advanced non-small cell lung cancer, a patient population that has historically faced a poor prognosis,” Itziar Canamasas, global head of Oncology at Boehringer Ingelheim, said in the news release. “At Boehringer, we take cancer care personally; these updated data reaffirm our approach of addressing areas with high unmet need and letting our research guide us to where we can have the biggest impact for patients."
Based on the results of the Beamion LUNG-1 trial, the United States Food and Drug Administration (FDA) granted priority review to zongertinib for previously treated patients with HER2-mutant advanced NSCLC earlier this year.
Priority review designation, according to the FDA’s website, prioritizes the evaluation of certain drug applications. After approval, these drugs would significantly improve the safety or effectiveness of treatment, diagnosis or prevention of serious conditions compared with standard applications.
Initial study results among patients with advanced NSCLC with HER2 mutations who were previously treated with platinum-based chemotherapy and subsequent HER2-directed antibody-drug conjugates (31 patients) showed an objective response rate of 48% with a disease control rate of 97%. Additionally, an exploratory cohort of 20 patients that included HER2 mutations outside of the tyrosine kinase domain showed an objective response rate of 30% and a disease control rate of 65%, the news release reported.
The company reported that the data presented at AACR showed a manageable safety profile, with no drug-related deaths, cases of interstitial lung disease or cardiotoxicity reported, with the most commonly reported side effect being grade 1 (mild) diarrhea and a 17% incidence of grade 3 (severe) or higher drug-related side effects in patients with tyrosine kinase domain mutations.
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