New\u00a0patient-reported outcomes\u00a0(N=71)\u00a0from the Phase\u00a0Ib\u00a0Beamion\u00a0LUNG-1 trial (NCT04886804<\/a>) showed improvements within one week of treatment in\u00a0patients’ physical functioning with HERNEXEOS as\u00a0an initial treatment for adult patients with HER2 (ERBB2)-mutant advanced NSCLC, building on the\u00a0efficacy and safety\u00a0data that supported the recent U.S. FDA accelerated approval<\/a>.1 Results showed:<\/p>\n
Patients reported improvements in physical functioning and NSCLC\u2011related symptoms from baseline, which were sustained over time (as measured by\u00a0EORTC QLQ-C30 and NSCLC-SAQ total score).1
\n Patient-reported symptomatic adverse events (AEs) as assessed by PRO-CTCAE were in line with HERNEXEOS’s published safety data.1
\n HERNEXEOS\u00a0was\u00a0well tolerated, as reflected by the low\u00a0overall side effect burden (as assessed by EORTC IL46\/Q168) and the mild nature for most patient-reported symptomatic AEs (based on PRO-CTCAE measures).1\u00a0<\/p>\n
“For\u00a0people\u00a0living\u00a0with\u00a0HER2-mutant advanced NSCLC,\u00a0it’s especially\u00a0important to understand how treatment affects how they feel and function in daily life,” said\u00a0Dr. Joshua K. Sabari,\u00a0study investigator and\u00a0Associate Professor, Department of Medicine, New York University (NYU) Grossman School of Medicine; Medical Director, Thoracic Medical Oncology, NYU Langone Health’s Perlmutter Cancer Center. “These patient-reported outcomes showed that the patients who received treatment with zongertinib reported improvements in physical functioning and symptom\u00a0burden. These findings\u00a0build on previous clinical data to further support the use of zongertinib in the first-line setting for adult patients with HER2-mutant advanced NSCLC.”\u00a0<\/p>\n
Advancing research with\u00a0HERNEXEOS\u00ae\u00a0data\u00a0in\u00a0HER2-positive\u00a0colorectal, esophageal and breast cancers
Early data\u00a0to be presented\u00a0highlights the\u00a0potential\u00a0of\u00a0HERNEXEOS\u00a0in other HER2-driven cancers,\u00a0including metastatic colorectal cancer (mCRC),\u00a0metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC) and metastatic breast cancer (mBC). These data will inform continued clinical development across multiple tumor types.<\/p>\n
A pooled analysis\u00a0of\u00a0patients (N=19) with HER2-positive mCRC from\u00a0the\u00a0Phase Ia Beamion LUNG-1 trial (NCT04886804<\/a>)\u00a0and\u00a0the Phase II\u00a0Beamion\u00a0PANTUMOR-1 trial (NCT06581432<\/a>)\u00a0demonstrated early clinical activity and a manageable safety profile with HERNEXEOS as a monotherapy.\u00a0The\u00a0confirmed\u00a0objective response rate (ORR)\u00a0was\u00a042%\u00a0(n=8; all partial responses) and the disease\u00a0control rate\u00a0was\u00a095%. The most common\u00a0treatment-related AEs\u00a0were\u00a0diarrhea\u00a0(n=9), rash (n=3),\u00a0anemia (n=2),\u00a0and increased\u00a0AST\u00a0(n=2), dysgeusia (n=2) and paronychia (n=2).\u00a0No grade\u00a04 or 5\u00a0AEs\u00a0were reported.2 In patients with HER2-positive mGEAC (n=16) who had disease progression following prior trastuzumab-based therapy, confirmed responses with HERNEXEOS in combination with\u00a0trastuzumab deruxtecan were observed; 10 patients had a confirmed response (1 complete response and 9 partial responses), 5 patients had stable disease responses and 1 patient had progressive disease.3 HERNEXEOS-related AEs were reported in 85.7% of patients (n=18); the most common treatment-emergent AEs were diarrhea (n=12), nausea (n=10), and anemia (n=5). No grade 4 or 5 AEs were reported and no new safety signals were observed.3 These\u00a0initial\u00a0findings highlight the potential of\u00a0HERNEXEOS\u00a0beyond lung cancer and support its continued research and development\u00a0across multiple\u00a0HER2-driven\u00a0cancers.\u00a0<\/p>\n Exploring DLL3-directed therapy with obrixtamig\u00a0in ES-SCLC The confirmed ORR was 73%, with 7% of patients achieving a complete response and 66% achieving a partial response, and the disease control rate was 91%.\u00a0In the\u00a060 mg\u00a0cohort (n=29), the confirmed ORR was 76% (10% complete response, 66% partial response).5 “Given the longstanding\u00a0need for\u00a0innovative treatment options in\u00a0small cell lung cancer, DLL3\u2011directed approaches such as\u00a0obrixtamig\u00a0represent an important area of ongoing research,” said Dr. Solange Peters, Professor and Director of Oncology, University Hospital of Lausanne, Switzerland. “In a disease where delivery of later lines of treatment is often not feasible and where urgent disease control is critical, these findings support continued investigation of\u00a0obrixtamig\u00a0in\u00a0combination\u00a0with standard-of-care therapy as\u00a0initial treatment of\u00a0extensive-stage small cell lung cancer.”\u00a0<\/p>\n Presentations at ASCO 2026\u00a0from Boehringer\u00a0Ingelheim’s\u00a0diverse\u00a0oncology pipeline\u00a0reflect its ambition to reshape cancer care:\u00a0<\/p>\n Abstract\u00a0Title\u00a0<\/p>\n Presenter\u00a0<\/p>\n ASCO\u00a0Session\u00a0<\/p>\n Zongertinib\u00a0and HER2<\/p>\n PRO results from the\u00a0Beamion\u00a0LUNG-1 trial in treatment-na\u00efve patients with HER2-mutant advanced NSCLC\u00a0<\/p>\n Sabari, J. K.\u00a0<\/p>\n Poster\u00a0Presentation\u00a0406\u00a0<\/p>\n May 31, 9:00 AM \u2013 12:00 PM CDT\u00a0<\/p>\n Zongertinib\u00a0in HER2-altered colorectal cancer: a pooled analysis of colorectal cancer patients from two clinical trials\u00a0<\/p>\n Arnold, D.\u00a0<\/p>\n Poster\u00a0Presentation\u00a0292\u00a0<\/p>\n May 30,\u00a09:00 AM \u2013 12:00 PM CDT\u00a0<\/p>\n Zongertinib\u00a0combined with T-DXd\u00a0in HER2-positive metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC): first results from a Phase\u00a0Ib\/II dose-escalation trial\u00a0<\/p>\n Nakayama, I.\u00a0<\/p>\n Poster\u00a0Presentation\u00a0243\u00a0<\/p>\n May 30, 1:30 PM \u2013 4:30 PM CDT\u00a0<\/p>\n Beamion\u00a0BCGC-1: Four new phase\u00a0Ib\/II cohorts to evaluate oral\u00a0zongertinib\u00a0with other agents in HER2-positive metastatic breast cancer (mBC) and metastatic colorectal cancer (mCRC)\u00a0<\/p>\n Shitara, K.\u00a0<\/p>\n Poster\u00a0Presentation\u00a0303a\u00a0<\/p>\n May 30, 1:30 PM \u2013 4:30 PM CDT\u00a0<\/p>\n Zongertinib\u00a0combination therapy in HER2-positive metastatic breast cancer (mBC): first results from a phase\u00a0Ib\/II trial\u00a0<\/p>\n Kitano, S.\u00a0<\/p>\n Poster\u00a0Presentation\u00a0158\u00a0<\/p>\n June 1, 1:30 PM \u2013 4:30 PM CDT\u00a0<\/p>\n Overall Survival by Genomic Profile in HER2-Positive (HER2+) Metastatic Breast Cancer (mBC): A Large US\u00a0Clinico-Genomic Database Study\u00a0<\/p>\n Tarantino, P.\u00a0<\/p>\n Poster\u00a0Presentation\u00a0159\u00a0<\/p>\n June 1, 1:30 PM \u2013 4:30 PM CDT\u00a0<\/p>\n Beamion\u00a0LUNG-3:\u00a0Zongertinib\u00a0in\u00a0resectable\u00a0HER2-mutant NSCLC\u00a0<\/p>\n Cummings, A.<\/p>\n Poster\u00a0Presentation\u00a0600a\u00a0<\/p>\n May 31, 9:00 AM \u2013 12:00 PM CDT\u00a0<\/p>\n Zongertinib\u00a0in previously treated advanced HER2-mutant non-small cell lung cancer: A single-center study\u00a0<\/p>\n Kong, J.\u00a0<\/p>\n Publication Only: Lung Cancer\u2014Non-Small Cell Metastatic\u00a0<\/p>\n Obrixtamig and DLL3<\/p>\n DAREON\u00ae-8: updated efficacy and safety from a phase I dose-escalation\/expansion trial of\u00a0first-line\u00a0(1L)\u00a0obrixtamig\u00a0plus chemotherapy and atezolizumab in extensive-stage small cell lung carcinoma (ES-SCLC)\u00a0<\/p>\n Peters, S.\u00a0<\/p>\n Poster\u00a0Presentation\u00a0563\u00a0<\/p>\n May 31,\u00a09:00 AM \u2013 12:00 PM CDT\u00a0<\/p>\n Analysis of delta-like ligand 3 (DLL3) expression levels and characteristics of patients (pts) with advanced extrapulmonary neuroendocrine carcinomas (epNECs) from an ongoing phase I trial\u00a0<\/p>\n Gambardella, V.\u00a0<\/p>\n Poster\u00a0Presentation\u00a0432\u00a0<\/p>\n May 30,\u00a01:30 PM \u2013 4:30 PM CDT\u00a0<\/p>\n Real-world patient characteristics, treatment patterns and clinical outcomes in patients diagnosed with extra-pulmonary neuroendocrine carcinoma (epNEC): A non-interventional multimodal database analysis in the US.<\/p>\n Vijayvergia, N.<\/p>\n Publication Only: Gastrointestinal Cancer\u2014Gastroesophageal, Pancreatic, and Hepatobiliary<\/p>\n About HERNEXEOS\u00ae (zongertinib tablets)\u00a0<\/p>\n HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that inhibits HER2 (ERBB2).7,8\u00a0HERNEXEOS 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.7<\/p>\n Comprehensive biomarker testing using next generation sequencing determines a patient’s eligibility for treatment with HERNEXEOS by identifying HER2 (ERBB2)-mutant advanced NSCLC.7,9<\/p>\n The treatment\u00a0is 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 HERNEXEOS as a first-line treatment for patients with advanced NSCLC that\u00a0have HER2 tyrosine kinase domain mutations (NCT06151574<\/a>).10 Beamion LUNG-3 is a Phase III clinical trial investigating HERNEXEOS as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695)<\/a>.11<\/p>\n About\u00a0obrixtamig\u00a0<\/p>\n Obrixtamig\u00a0is an investigational novel Immunoglobin G (IgG)-like bispecific T-cell engager designed to bind concomitantly to DLL3 on tumor cells and CD3 on T-cells, potentially resulting in destruction of tumor cells by the body’s own immune system.12\u00a0Obrixtamig\u00a0is being evaluated in multiple, ongoing clinical trials, including a Phase I trial in combination with atezolizumab and chemotherapy in extensive-stage small-cell lung cancer (ES-SCLC) patients (DAREON\u00ae-8), a Phase\u00a0Ib\u00a0study in combination with topotecan in patients with advanced SCLC (DAREON\u00ae-9), and a Phase II trial in patients with relapsed\/refractory DLL3-high extrapulmonary neuroendocrine carcinomas (epNEC) (DAREON\u00ae-5).5,13,14 Obrixtamig in combination with atezolizumab plus standard-of-care (SOC) chemotherapy is being evaluated as a first-line treatment vs. atezolizumab plus SOC chemotherapy in a Phase III trial for patients with ES-SCLC (DAREON\u00ae-LUNG-1).15 Additionally, a Phase III trial is ongoing to evaluate obrixtamig in combination with SOC chemotherapy vs. chemotherapy alone as first-line treatment in patients with DLL3-positive unresectable locally advanced or metastatic epNEC (DAREON\u00ae-NEC-1).16<\/p>\n About Boehringer Ingelheim in oncology\u00a0<\/p>\n We have a clear aspiration \u2013 to transform the lives of people facing cancer by delivering unprecedented impact, with the\u00a0ultimate goal\u00a0to redefine standards of care. Boehringer Ingelheim’s long-term commitment to scientific innovation is reflected by the company’s robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as in smart combinations of these approaches. In everything we do, we focus on people \u2014 not just data \u2014 working alongside them to develop solutions that truly meet their needs and help move cancer into the background of their lives. This drives our research approach, drawing on diverse minds and a long-term perspective to address the needs of people facing cancer today and for generations to come.\u00a0Read more at\u00a0https:\/\/www.boehringer-ingelheim.com\/us\/human-health\/cancer<\/a>.<\/p>\n About Boehringer Ingelheim<\/p>\n 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.\u202fLearn more at\u00a0https:\/\/www.boehringer-ingelheim.com\/us<\/a>.\u00a0<\/p>\n What is HERNEXEOS (zongertinib tablets)?<\/p>\n HERNEXEOS is a prescription medicine used to treat adults with a type of lung cancer called non\u2013squamous non\u2013small cell lung cancer (NSCLC) that:<\/p>\n cannot be removed by surgery or that has spread to other parts of your body (metastatic), and Your healthcare provider will perform a test to make sure HERNEXEOS is right for you.<\/p>\n It is not known if HERNEXEOS is safe and effective in children.<\/p>\n IMPORTANT SAFETY INFORMATION<\/p>\n Before taking HERNEXEOS, tell your healthcare provider about all of your medical conditions, including if you:<\/p>\n have liver problems Females who are able to become pregnant:<\/p>\n Your healthcare provider will do a pregnancy test before you start 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<\/p>\n 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.<\/p>\n Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.<\/p>\n What are the possible side effects of HERNEXEOS? 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:<\/p>\n yellowing of your skin or the white part of your eyes (jaundice) heart problems that may affect your heart’s ability to pump blood. HERNEXEOS can cause severe 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:<\/p>\n feeling like your heart is pounding or racing 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<\/p>\n Your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with HERNEXEOS if you have serious side effects.<\/p>\n The most common side effects of HERNEXEOS include:<\/p>\n diarrhea. HERNEXEOS can cause severe diarrhea. Tell your healthcare provider right away if you have new or worsening diarrhea The most common severe abnormal blood tests include decreased white blood cell count, increased liver function tests, and decreased potassium levels.<\/p>\n 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.<\/p>\n 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.<\/p>\n
\n Data from Beamion\u00a0BCGC-1\u00a0(NCT06324357), an ongoing Phase\u00a0Ib\/II multicohort trial, showed evidence of clinical activity for HERNEXEOS\u00a0as a monotherapy and in combination with other agents.3,4 <\/p>\n
\n Encouraging clinical activity was observed in heavily pretreated patients with HER2-positive\u00a0mBC treated with HERNEXEOS in combination with trastuzumab emtansine (Cohort A) and trastuzumab deruxtecan (Cohort B).4 In Cohort A, of the 13 response-evaluable patients, 3 had partial responses and 9 had stable disease. In Cohort B, of the 15 response-evaluable patients, 4 had partial responses and 11 patients had stable disease.4 No new safety signals were observed with HERNEXEOS in combination with other medicines.4 In Cohort A (n=16), HERNEXEOS-related AEs were reported in 87.5% of patients (n=14); the most common treatment-emergent AEs were increased AST (n=6), increased ALT (n=5), and decreased platelet count (n=5).4 In Cohort B (n=16), HERNEXEOS-related AEs were reported in all patients; the most common treatment-emergent AEs were diarrhea (n=10), nausea (n=10), and anemia (n=7).4<\/p>\n
Updated efficacy and safety results\u00a0will also be presented\u00a0from the ongoing Phase I DAREON\u00ae\u20118 trial with obrixtamig, an investigational DLL3\/CD3 T-cell engager, in combination with standard-of-care induction therapy (carboplatin, etoposide and atezolizumab) followed by maintenance obrixtamig plus atezolizumab in the first-line treatment of ES-SCLC (N=44), demonstrating encouraging efficacy.5<\/p>\n
\n Median duration of response\u00a0(mDoR)\u00a0and median\u00a0progression\u2011free\u00a0survival\u00a0(PFS) were not yet reached, with 6\u2011 and 9\u2011month PFS\u00a0rates of 78% and 62%, respectively.5
\n Overall,\u00a0the\u00a0safety profile of the combination was\u00a0generally consistent\u00a0with the known profiles of the individual agents, with grade \u22653 AEs primarily related to chemotherapy. Cytokine release syndrome was the most common obrixtamig-related\u00a0AE (57%).5
\n Discontinuations due to obrixtamig\u2011related\u00a0AEs were infrequent (n=1).5<\/p>\n
\n has a certain mutation in the human epidermal growth factor receptor 2 (HER2) gene<\/p>\n
\n have heart problems
\n have lung or breathing problems other than lung cancer
\n are pregnant or plan to become pregnant. HERNEXEOS can harm your unborn baby<\/p>\n
\n Use an effective form of birth control (contraception) during treatment with HERNEXEOS and for 2 weeks after your last dose
\n Talk to your healthcare provider about birth control methods that might be right for you during this time
\n Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with HERNEXEOS<\/p>\n
HERNEXEOS may cause serious side effects, including:<\/p>\n
\n dark or brown (tea colored) urine
\n pain on the upper right side of your stomach area (abdomen)
\n bleeding or bruising more easily than normal
\n feeling very tired
\n loss of appetite
\n nausea or vomiting<\/p>\n
\n dizziness
\n tiredness
\n feeling lightheaded
\n shortness of breath
\n loss of consciousness
\n coughing
\n swelling of your legs, ankles, or feet<\/p>\n
\n rash
\n liver problems
\n feeling tired
\n nausea
\n muscle and joint pain
\n upper respiratory tract infection<\/p>\n
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