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- HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 75% (N=71), as demonstrated in the Beamion-LUNG 1 clinical trial1
- Accelerated approval follows Priority Review and Breakthrough Therapy Designation granted by the U.S. FDA for the treatment of patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer
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Ridgefield, Conn. U.S. and Ingelheim, Germany – Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.1
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This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1
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“With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant non-small cell lung cancer in the U.S. that not only elicits a durable response but, importantly, has a manageable safety profile,” said Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, and coordinating investigator for the Beamion-LUNG 1 trial. “In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care.”
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Accelerated approval is based on data from the Phase Ib Beamion-LUNG 1 trial, demonstrating an objective response rate of 75% (N=71), 6% of patients had a complete response and 69% of patients had a partial response and a duration of response of ≥6 months in 58% of patients (n=53).1 Positive results from the Beamion-LUNG 1 trial were previously presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 and simultaneously published in The New England Journal of Medicine.2Zongertinib demonstrated a manageable safety profile with a 2.9% discontinuation rate. In the pooled safety population, the most common (> 20%) adverse reactions were diarrhea (53%), hepatotoxicity (27%), rash (27%), fatigue (22%), and nausea (21%).1
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“We are grateful to be able to bring forward HERNEXEOS, which has the potential to reset the benchmark for those living with HER2-mutant advanced non-small cell lung cancer, a condition associated with a particularly poor prognosis,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “Believing in the power of scientific innovation, we aim to provide meaningful improvements to this patient population. Recognizing its potential, we accelerated development to deliver this new treatment option to patients within four years of starting the first clinical trial.”
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Harnessing the power of precision medicine by targeting HER2 mutations in lung cancer
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HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.3,4,5 Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.3,5 Comprehensive biomarker testing using next generation sequencing determines a patient’s eligibility for treatment with zongertinib by identifying HER2 (ERBB2)-mutant advanced NSCLC.1,5
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“The advocacy community is thrilled about the approval of zongertinib, as it is another testament to the importance of personalized options for lung cancer that allow for a much more targeted approach for a subgroup of patients who have been waiting many years for innovative treatments,” said Marcia Horn, President and CEO, International Cancer Advocacy Network and Executive Director of the Exon 20 Group/HER2 Warriors. “Understanding your cancer’s unique biomarkers, including HER2, through comprehensive testing is critical for all patients with NSCLC, as it can unlock targeted treatment options.”
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About non-small cell lung cancer (NSCLC)
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Lung cancer claims more lives than any other cancer type and the incidence is set to increase to over 3 million cases worldwide by 2040.5,6 NSCLC is the most common type of lung cancer.3 Due to a lack of symptoms and misdiagnoses,7 most patients with NSCLC present at stage III or IV, where the disease has metastasized locally or to other organs.8 The estimated 5-year survival rate historically has been less than 10% for metastatic disease.9,10,11 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.12,13,14
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About zongertinib
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Zongertinib is a tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2).1 This orally administered, targeted therapy was approved as HERNEXEOS® (zongertinib tablets) under the FDA’s Accelerated Approval Program, after securing Priority Review as well as Breakthrough Therapy and Fast Track Designations.1
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The treatment is being evaluated in ongoing trials, across a range of advanced solid tumors with HER2 alterations.
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About Boehringer Ingelheim in oncology
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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 and, Boehringer-Ingelheim.com/US.
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About Boehringer Ingelheim
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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 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at Boehringer-Ingelheim.com and Boehringer-Ingelheim.com/US.
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The following information is intended for U.S. audiences only:
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About HERNEXEOS®
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HERNEXEOS® (zongertinib tablets) is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
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Boehringer Ingelheim’s CareConnect4Me patient support program
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Boehringer’s goal is to make HERNEXEOS® (zongertinib tablets) easily accessible in the U.S. through a comprehensive patient support program, CareConnect4MeTM, that provides a broad range of access and clinical support solutions, including financial support services. For those in the U.S., visit www.HERNEXEOS.com or call 1-855-297-5903 to learn more.
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What is HERNEXEOS (zongertinib tablets)?
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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:
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- cannot be removed by surgery or that has spread to other parts of your body (metastatic), an
- has a certain mutation in the human epidermal growth factor receptor 2 (HER2) gene, and
- who have previously received treatment by mouth or injection (systemic therapy).
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Your healthcare provider will perform a test to make sure HERNEXEOS is right for you.
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It is not known if HERNEXEOS is safe and effective in children.
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IMPORTANT SAFETY INFORMATION
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Before taking HERNEXEOS, tell your healthcare provider about all of your medical conditions, including if you:
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- have liver problems.
- have heart problems.
- have lung or breathing problems other than lung cancer.
- are pregnant or plan to become pregnant. HERNEXEOS can harm your unborn baby.
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Females who are able to become pregnant:
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- Your healthcare provider will do a pregnancy test before you start treatment with HERNEXEOS.
- Use an effective form of birth control (contraception) during treatment with HERNEXEOS and for 2 weeks after your last dose.
- Talk to your healthcare provider about birth control methods that might be right for you during this time.
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with HERNEXEOS.
- are breastfeeding or plan to breastfeed. It is not known if HERNEXEOS passes into your breastmilk. Do not breastfeed during treatment and for 2 weeks after your last dose of HERNEXEOS.
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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.
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Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
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What are the possible side effects of HERNEXEOS?
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HERNEXEOS may cause serious side effects, including:
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- liver problems. Liver problems are common with HERNEXEOS and can be severe and life threatening. Your healthcare provider will do blood tests to check your liver function before you start taking HERNEXEOS and during your treatment. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark or brown (tea colored) urine
- pain on the upper right side of your stomach area (abdomen)
- bleeding or bruising more easily than normal
- feeling very tired
- loss of appetite
- nausea or vomiting
- heart problems that may affect your heart’s ability to pump blood. HERNEXEOS can cause heart problems. Your healthcare provider will do tests to check your heart function before you start taking HERNEXEOS and during treatment. Tell your healthcare provider right away if you have any new or worsening symptoms of heart problems, including:
- feeling like your heart is pounding or racing
- Dizziness
- Tiredness
- feeling lightheaded
- shortness of breath
- loss of consciousness
- coughing
- swelling of your legs, ankles, or feet
- lung problems. HERNEXEOS can cause lung problems that are severe or life-threatening. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever.
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Your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with HERNEXEOS if you have serious side effects.
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The most common side effects of HERNEXEOS include:
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- diarrhea. HERNEXEOS can cause severe diarrhea. Tell your healthcare provider right away if you have diarrhea.
- liver problems
- Rash
- feeling tired
- nausea
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The most common severe abnormal blood tests include decreased white blood cell count, increased liver function tests, and decreased potassium levels.
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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.
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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.
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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.
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For U.S. Healthcare Professionals, please see full Prescribing Information.
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CL–100065 07.28.2025
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References:
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1HERNEXEOS Prescribing Information
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2Heymach, J. et al. Zongertinib in previously treated HER2-mutant non-small cell lung cancer. N Engl J Med. 2025;01-13.
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3Baraibar I, et al. Novel drugs targeting EGFR and HER2 exon 20 mutations in metastatic NSCLC. Crit Rev Oncol Hematol. 2020;148:102906.
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4Li, B.T. et al. Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer. N Engl J Med. 2022;386:241–51
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5Zeng 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.
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6International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: https://gco.iarc.fr/tomorrow/en (Accessed: January 2025).
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7American Cancer Society. Lung Cancer Early Detection, Diagnosis, and Staging. Available at: https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/signs-symptoms.html (Accessed: January 2025).
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8Casal-Mouriño, A. et al. Epidemiology of stage III lung cancer: frequency, diagnostic characteristics, and survival. Transl Lung Cancer Res. 2021;10(1):506-518.
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9National 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 July 2025).
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10Belaroussi, Y. et al. Survival outcomes of patients with metastatic non-small cell lung cancer receiving chemotherapy or immunotherapy as first-line in a real-life setting. Sci Rep. 2023.13, 9584.
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11Simeone, J. C. et al. Treatment patterns and overall survival in metastatic non-small-cell lung cancer in a real-world US setting. Fut. Oncol. Lond. Engl. 2019. 15(30), 3491–3502.
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12Valentine, T. R. et al. Illness Perceptions and Psychological and Physical Symptoms in Newly Diagnosed Lung Cancer. Health Psychol. 2022 Jun; 41(6): 379–388.
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13Andersen, 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.
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14Presley, 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.
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English (US)