Beamion LUNG-1 study results for zongertinib in treatment-naïve patients with HER2-mutant advanced NSCLC published in The New England of Journal of Medicine

RIDGEFIELD, Conn. and INGELHEIM, Germany, April 16, 2026 /PRNewswire/ -- 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:

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."

HERNEXEOS 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.

About HERNEXEOS ® (zongertinib tablets)

HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that inhibits HER2 (ERBB2). 1,2 HERNEXEOS has been approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer.

Comprehensive biomarker testing using next generation sequencing determines a patient's eligibility for treatment with HERNEXEOS by identifying HER2 (ERBB2)-mutant advanced NSCLC. 1,3

The orally administered treatment 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. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations ( NCT06151574). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations ( NCT07195695 ).

About HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC)

Lung cancer claims more lives than any other cancer type 3 and the incidence is set to increase to over 3 million cases worldwide by 2040. 4 NSCLC is the most common type of lung cancer. 3 The condition is often diagnosed at a late stage, and fewer than 3 in 10 patients are alive five years after diagnosis. 5,6 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives. 7,8,9 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). 3 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. 10

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 Boehringer-Ingelheim.com/US.

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 Boehringer-Ingelheim.com/US.

What is HERNEXEOS (zongertinib tablets)?

HERNEXEOS is a prescription medicine used to treat adults with a type of lung cancer called non–squamous non–small cell lung cancer (NSCLC) that:

Your healthcare provider will perform a test to make sure HERNEXEOS is right for you.

It is not known if HERNEXEOS is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Before taking HERNEXEOS, tell your healthcare provider about all of your medical conditions, including if you:

Females who are able to become pregnant:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HERNEXEOS may affect the way other medicines work, and other medicines may affect how HERNEXEOS works.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

What are the possible side effects of HERNEXEOS?

HERNEXEOS may cause serious side effects, including:

Your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with HERNEXEOS if you have serious side effects.

The most common side effects of HERNEXEOS include:

The most common severe abnormal blood tests include decreased white blood cell count, increased liver function tests, and decreased potassium levels.

HERNEXEOS may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of HERNEXEOS. Call your doctor for medical advice about side effects. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CL-HER-100001 02.2026

For U.S. Audiences, please see full Prescribing Information and Patient Information.

MPR-US-104011

References:

SOURCE Boehringer Ingelheim