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- New patient-reported outcomes data shows improved function and reduced symptom burden with HERNEXEOS\u00ae<\/sup> (zongertinib\u00a0tablets) as an initial treatment option in HER2 (ERBB2<\/i>)-mutant advanced\u00a0non-small cell lung cancer (NSCLC)1<\/sup><\/li>\n
- Data for zongertinib monotherapy and in combination in\u00a0other HER2-altered solid tumors, including breast, colorectal and esophageal\u00a0cancers, shows encouraging early signals2-4<\/sup><\/li>\n
- Updated data adds to the growing evidence base\u00a0of\u00a0obrixtamig\u00a0in extensive\u2011stage\u00a0small cell lung cancer (ES\u2011SCLC)\u00a0and extrapulmonary neuroendocrine carcinoma (epNEC)5,6<\/sup><\/li>\n<\/ul>\n
Ingelheim, Germany and Ridgefield, Conn., US<\/b>\u00a0\u2013\u00a0<\/b>At\u00a0the 2026\u00a0American\u00a0Society of Clinical Oncology (ASCO)\u00a0Annual Meeting, Boehringer Ingelheim will present new data from across its robust oncology clinical development program.\u00a0Key data includes patient-reported outcomes with HERNEXEOS\u00ae<\/sup> (zongertinib\u00a0tablets) as an initial\u00a0orally administered\u00a0treatment option for\u00a0HER2 (ERBB2<\/i>)-mutant advanced non-small cell lung cancer (NSCLC) and\u00a0early results evaluating zongertinib in other\u00a0types of cancer driven by\u00a0HER2 alterations.1-4 <\/sup>Updated data\u00a0for obrixtamig, an investigational DLL3\/CD3-targeting T-cell engager,\u00a0will also be presented in extensive-stage small cell lung cancer (ES-SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC).5-6<\/sup>\u00a0<\/b><\/p>\n
\u201cIn the past year, Boehringer has meaningfully advanced the NSCLC treatment landscape through multiple regulatory approvals of zongertinib across markets. These new patient-reported outcomes for zongertinib further add to the growing body of evidence characterizing its clinical profile,\u201d\u00a0said Itziar\u00a0Canamasas, Ph.D., Global Head of Oncology at Boehringer Ingelheim. \u201cBuilding on this progress, our ambition is to advance precision cancer care across tumor types and modalities by exploring zongertinib\u2019s potential in other HER2-driven cancers as well as next-generation approaches such as T-cell engagers. At ASCO, these data reflect our commitment to understanding what truly matters to patients, as we continue to shape an innovative oncology portfolio designed to deliver meaningful, unprecedented impact for people facing cancer.\u201d<\/p>\n
Showcasing\u00a0patient-reported outcomes\u00a0for\u00a0zongertinib\u00a0in HER2-mutant NSCLC<\/b><\/h3>\n
New patient-reported outcomes (N=71) from the Phase Ib Beamion LUNG-1 trial (NCT04886804<\/a>) showed improvements within one week of treatment in\u00a0patients\u2019 physical functioning with zongertinib as\u00a0an initial treatment for adult patients with HER2 (ERBB2<\/i>)-mutant advanced NSCLC, building on the\u00a0efficacy and safety\u00a0data that supported the recent U.S. FDA accelerated approval<\/a>.1<\/sup> Results showed:<\/p>\n
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- Patients reported improvements in\u00a0physical functioning and\u00a0NSCLC\u2011related\u00a0symptoms\u00a0from baseline, which were sustained over time (as measured by EORTC QLQ-C30 and NSCLC-SAQ total score).1<\/sup><\/li>\n
- Patient-reported symptomatic adverse events (AEs) as assessed by PRO-CTCAE were in line with zongertinib\u2019s published safety data.1<\/sup><\/li>\n<\/ul>\n
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- Zongertinib\u00a0was\u00a0well tolerated, as reflected by the low\u00a0overall side effect burden (assessed by EORTC IL46\/Q168) and the mild nature for most patient-reported symptomatic AEs (based on PRO-CTCAE measures).1<\/sup><\/li>\n<\/ul>\n
\u201cFor\u00a0people\u00a0living\u00a0with\u00a0HER2-mutant advanced NSCLC,\u00a0it\u2019s especially\u00a0important to understand how treatment affects how they feel and function in daily life,\u201d 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\u2019s Perlmutter Cancer Center. \u201cThese 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.\u201d<\/p>\n
Advancing research with zongertinib data in HER2-positive colorectal, esophageal and breast cancers<\/b><\/h3>\n
Early data to be presented highlights the potential of zongertinib in other HER2-driven cancers, including metastatic colorectal cancer (mCRC), metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC) and metastatic breast cancer (mBC).2-4<\/sup> These data will inform continued clinical development across multiple tumor types.<\/p>\n
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- 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 zongertinib 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<\/sup><\/li>\n
- Data from Beamion\u00a0BCGC-1\u00a0(NCT06324357), an ongoing Phase\u00a0Ib\/II multicohort trial, showed evidence of clinical activity for zongertinib\u00a0as a monotherapy and in combination with other agents.3-4<\/sup>\n
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- In patients with HER2-positive mGEAC (n=16) who had disease progression following prior trastuzumab-based therapy, confirmed responses with\u00a0zongertinib\u00a0in combination with trastuzumab 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<\/sup> Zongertinib-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<\/sup><\/li>\n
- Encouraging clinical activity was observed in heavily pretreated patients with HER2-positive mBC treated with zongertinib in combination with trastuzumab emtansine (Cohort A) and trastuzumab deruxtecan (Cohort B).4<\/sup> 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. No new safety signals were observed with zongertinib in combination with other medicines.4<\/sup> In Cohort A (n=16), zongertinib-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<\/sup> In Cohort B (n=16), zongertinib-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<\/sup><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
These\u00a0initial\u00a0findings highlight the potential of\u00a0zongertinib\u00a0beyond lung cancer and support its continued research and development\u00a0across multiple\u00a0HER2-driven\u00a0cancers.<\/p>\n
Exploring DLL3-directed therapy with obrixtamig in ES-SCLC<\/b><\/h3>\n
Updated efficacy and safety results will also be presented from the ongoing Phase I DAREON\u00ae<\/sup>\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.\u00a05<\/sup><\/p>\n
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- 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<\/sup><\/li>\n
- Median duration of response\u00a0(mDoR)\u00a0and median\u00a0progression\u2011free\u00a0survival\u00a0(PFS)\u00a0were not yet reached, with 6\u2011\u00a0and 9\u2011month\u00a0PFS\u00a0rates of 78% and 62%, respectively.5<\/sup><\/li>\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<\/sup><\/li>\n
- Discontinuations due to obrixtamig\u2011related\u00a0AEs were infrequent (n=1).5<\/sup><\/li>\n<\/ul>\n
\u201cGiven 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,\u201d said Dr. Solange Peters, Professor and Director of Oncology, University Hospital of Lausanne, Switzerland. \u201cIn 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.\u201d<\/p>\n
Presentations at ASCO 2026\u00a0from Boehringer\u00a0Ingelheim\u2019s\u00a0diverse\u00a0oncology pipeline\u00a0<\/b>reflect its ambition to reshape cancer care:<\/b><\/p>\n
- Median duration of response\u00a0(mDoR)\u00a0and median\u00a0progression\u2011free\u00a0survival\u00a0(PFS)\u00a0were not yet reached, with 6\u2011\u00a0and 9\u2011month\u00a0PFS\u00a0rates of 78% and 62%, respectively.5<\/sup><\/li>\n
- Encouraging clinical activity was observed in heavily pretreated patients with HER2-positive mBC treated with zongertinib in combination with trastuzumab emtansine (Cohort A) and trastuzumab deruxtecan (Cohort B).4<\/sup> 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. No new safety signals were observed with zongertinib in combination with other medicines.4<\/sup> In Cohort A (n=16), zongertinib-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<\/sup> In Cohort B (n=16), zongertinib-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<\/sup><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
- Data from Beamion\u00a0BCGC-1\u00a0(NCT06324357), an ongoing Phase\u00a0Ib\/II multicohort trial, showed evidence of clinical activity for zongertinib\u00a0as a monotherapy and in combination with other agents.3-4<\/sup>\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 zongertinib 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<\/sup><\/li>\n
- Patient-reported symptomatic adverse events (AEs) as assessed by PRO-CTCAE were in line with zongertinib\u2019s published safety data.1<\/sup><\/li>\n<\/ul>\n
- Data for zongertinib monotherapy and in combination in\u00a0other HER2-altered solid tumors, including breast, colorectal and esophageal\u00a0cancers, shows encouraging early signals2-4<\/sup><\/li>\n