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Ingelheim, Germany and Ridgefield, Conn.
Boehringer Ingelheim today announced that The New England Journal of Medicine (NEJM) published results from the Phase 1b Beamion LUNG-1 trial of HERNEXEOS (zongertinib tablets) in treatment-naïve patients with advanced non-small cell lung cancer (NSCLC) who have HER2 activating mutations in the tyrosine kinase domain (TKD). The data in the manuscript, titled “First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer,” demonstrated durable efficacy in this patient population (N=74). As of August 21, 2025:
- The confirmed objective response rate (ORR) was 76%, with 11% of patients achieving a complete response and 65% of patients achieving a partial response.
- The median duration of response (mDoR) was 15.2 months, and the median progression free survival (mPFS) was 14.4 months.
- Treatment-related adverse events (AEs) were predominantly low-grade. AEs led to dose reductions in 12 patients (16%) and dose discontinuations in 7 patients (9%).
Additionally, the NEJM manuscript reported findings from 30 patients with HER2-mutant advanced NSCLC with active brain metastases, of which, 47% experienced a confirmed intracranial objective response (iORR) by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).
The data builds on results presented at the ESMO Annual Meeting in October 2025 and was presented at the European Lung Cancer Congress (ELCC 2026) that took place in Copenhagen, Denmark, March 25-28, 2026.
“This data shows zongertinib demonstrated durable efficacy as first-line therapy in treatment-naïve patients with HER2-mutant advanced non-small cell lung cancer, a setting where there are currently limited options with durable responses,” said coordinating investigator for the Beamion LUNG-1 trial, Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. “These findings, now published in The New England Journal of Medicine, may help healthcare providers make informed decisions on HER2 targeted treatment choices.”
Zongertinib was recently granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERRB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication is contingent upon verification in a confirmatory trial.
Accelerated approval follows Breakthrough Therapy Designation and selection for the FDA Commissioner’s National Priority Voucher pilot program, in recognition of the medicine’s ability to address critical unmet need for this rare and aggressive cancer. This builds upon the FDA accelerated approval for use in previously treated patients in August 2025.
Why it matters
- NSCLC with HER2 activating mutations is a highly heterogeneous and aggressive disease which in the past has made it hard to find a targeted treatment offering significant clinical benefit.
- HER2 mutations are found in approximately 2-4% of NSCLC cases and are linked to poor prognosis.1
- There remains a high unmet need for patients as they may respond poorly to chemotherapy with or without immunotherapy (the current standard of care).
About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby minimizing associated toxicities. It has been approved in several countries:
HERNEXEOS is approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with HER2-mutant advanced non-small cell lung cancer.
The therapy has been conditionally approved by China’s NMPA as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have activating HER2 mutations and who have received at least one line of prior systemic therapy. China’s CDE also granted Breakthrough Therapy Designation for zongertinib for use in a first-line setting.
Zongertinib, a first-in-class orally administered targeted therapy for HER2-mutant NSCLC, received approval for manufacturing and marketing in Japan. This approval makes zongertinib the first orally administered molecularly targeted therapy available in Japan for previously treated, unresectable, advanced, or recurrent HER2-mutant NSCLC.
This orally administered targeted therapy is not approved in other markets and is being evaluated in ongoing trials, across a range of earlier stages and advanced solid tumors with HER2 alterations.
About non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type1 and the incidence is set to increase to over 3 million cases worldwide by 2040.5 NSCLC is the most common type of lung cancer.1 The condition is often diagnosed at a late stage,2 and fewer than 3 in 10 patients are alive five years after diagnosis.2,3 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.5,6,7 There remains a high unmet need for additional treatment options for people living with advanced NSCLC. Up to 4% of lung cancers are driven by HER2 mutations (or gene alterations).1 Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.8
About Boehringer Ingelheim in oncology
We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Boehringer Ingelheim’s generational commitment to driving scientific innovation is reflected by the company’s robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer’s ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research. Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations. Read more at www.boehringer-ingelheim.com.
About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.
References:
Zeng J, Ma W, Young RB, Li T. Targeting HER2 genomic alterations in non-small cell lung cancer. J Natl Cancer Cent. 2021 May 3;1(2):58-73.National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). 5-Year Survival Rates. https://www.seer.cancer.gov/csr/1975_2016/results_merged/topic_survival.pdf (Accessed: February 2026).Casal-Mouriño, A. et al. Epidemiology of stage III lung cancer: frequency, diagnostic characteristics, and survival. Transl Lung Cancer Res. 2021;10(1):506-518.International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: https://gco.iarc.fr/tomorrow/en (Accessed: February 2026).Valentine, T. R. et al. Illness Perceptions and Psychological and Physical Symptoms in Newly Diagnosed Lung Cancer. Health Psychol. 2022 Jun; 41(6): 379–388.Andersen, B. L. et al. Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms. Lung Cancer. 2020 Jul;145:195-204.Presley, C. J. et al. Functional Disability Among Older Versus Younger Adults With Advanced Non–Small-Cell Lung Cancer. JCO Oncol Pract. 2021 May 3;17(6):e848–e858.Galogre M, et al. A review of HER2 overexpression and somatic mutations in cancers, Critical Reviews in Oncology/Hematology, Volume 186, 2023, 103997.
