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*New patient-reported outcomes data shows improved function and reduced symptom burden with HERNEXEOS (zongertinib tablets) as an initial treatment option in HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC)1

*Data for zongertinib monotherapy and in combination in other HER2-altered solid tumors, including breast, colorectal and esophageal cancers, shows encouraging early signals2-4

*Updated data adds to the growing evidence base of obrixtamig in extensive‑stage small cell lung cancer (ES‑SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC)5,6

Ingelheim, Germany and Ridgefield, Conn., US - At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, Boehringer Ingelheim will present new data from across its robust oncology clinical development program. Key data includes patient-reported outcomes with HERNEXEOS (zongertinib tablets) as an initial orally administered treatment option for HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) and early results evaluating zongertinib in other types of cancer driven by HER2 alterations.1-4 Updated data for obrixtamig, an investigational DLL3/CD3-targeting T-cell engager, will also be presented in extensive-stage small cell lung cancer (ES-SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC).5-6 

"In 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," said Itziar Canamasas, Ph.D., Global Head of Oncology at Boehringer Ingelheim. "Building on this progress, our ambition is to advance precision cancer care across tumor types and modalities by exploring zongertinib's 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." 

Showcasing patient-reported outcomes for zongertinib in HER2-mutant NSCLC

New patient-reported outcomes (N=71) from the Phase Ib Beamion LUNG-1 trial (NCT04886804) showed improvements within one week of treatment in patients' physical functioning with zongertinib as an initial treatment for adult patients with HER2 (ERBB2)-mutant advanced NSCLC, building on the efficacy and safety data that supported the recent U.S. FDA accelerated approval.1 Results showed:

Patients reported improvements in physical functioning and NSCLC‑related symptoms from baseline, which were sustained over time (as measured by EORTC QLQ-C30 and NSCLC-SAQ total score).1

Patient-reported symptomatic adverse events (AEs) as assessed by PRO-CTCAE were in line with zongertinib's published safety data.1

Zongertinib was well tolerated, as reflected by the low overall side effect burden (assessed by EORTC IL46/Q168) and the mild nature for most patient-reported symptomatic AEs (based on PRO-CTCAE measures).1

"For people living with HER2-mutant advanced NSCLC, it's especially important to understand how treatment affects how they feel and function in daily life," said Dr. Joshua K. Sabari, study investigator and Associate 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 burden. These findings build on previous clinical data to further support the use of zongertinib in the first-line setting for adult patients with HER2-mutant advanced NSCLC." 

Advancing research with zongertinib data in HER2-positive colorectal, esophageal and breast cancers

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 These data will inform continued clinical development across multiple tumor types.

A pooled analysis of patients (N=19) with HER2-positive mCRC from the Phase Ia Beamion LUNG-1 trial (NCT04886804) and the Phase II Beamion PANTUMOR-1 trial (NCT06581432) demonstrated early clinical activity and a manageable safety profile with zongertinib as a monotherapy. The confirmed objective response rate (ORR) was 42% (n=8; all partial responses) and the disease control rate was 95%. The most common treatment-related AEs were diarrhea (n=9), rash (n=3), anemia (n=2), and increased AST (n=2), dysgeusia (n=2) and paronychia (n=2). No grade 4 or 5 AEs were reported.2

Data from Beamion BCGC-1 (NCT06324357), an ongoing Phase Ib/II multicohort trial, showed evidence of clinical activity for zongertinib as a monotherapy and in combination with other agents.3-4

In patients with HER2-positive mGEAC (n=16) who had disease progression following prior trastuzumab-based therapy, confirmed responses with zongertinib in 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 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

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 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 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 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

These initial findings highlight the potential of zongertinib beyond lung cancer and support its continued research and development across multiple HER2-driven cancers. 

Exploring DLL3-directed therapy with obrixtamig in ES-SCLC

Updated efficacy and safety results will also be presented from the ongoing Phase I DAREON?‑8 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

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%. In the 60 mg cohort (n=29), the confirmed ORR was 76% (10% complete response, 66% partial response).5

Median duration of response (mDoR) and median progression‑free survival (PFS) were not yet reached, with 6‑ and 9‑month PFS rates of 78% and 62%, respectively.5

Overall, the safety profile of the combination was generally consistent with the known profiles of the individual agents, with grade ≥3 AEs primarily related to chemotherapy. Cytokine release syndrome was the most common obrixtamig-related AE (57%).5

Discontinuations due to obrixtamig‑related AEs were infrequent (n=1).5

"Given the longstanding need for innovative treatment options in small cell lung cancer, DLL3‑directed approaches such as obrixtamig represent 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 obrixtamig in combination with standard-of-care therapy as initial treatment of extensive-stage small cell lung cancer." 

Presentations at ASCO 2026 from Boehringer Ingelheim's diverse oncology pipeline reflect its ambition to reshape cancer 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.7,8 HERNEXEOS is approved in the U.S., China, Hong Kong and Japan as the first orally administered targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer. Zongertinib is not approved in other markets. 

The treatment 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 have HER2 tyrosine kinase domain mutations (NCT06151574).9 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).10

About obrixtamig 

Obrixtamig is 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.11 Obrixtamig is 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-8), a Phase Ib study in combination with topotecan in patients with advanced SCLC (DAREON-9), and a Phase II trial in patients with relapsed/refractory DLL3-high extrapulmonary neuroendocrine carcinomas (epNEC) (DAREON-5).5,12,13 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-LUNG-1).14 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-NEC-1).15

About Boehringer Ingelheim in oncology 

We have a clear aspiration - to transform the lives of people facing cancer by delivering unprecedented impact, with the ultimate goal to 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 - not just data - 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. Read more at https://www.boehringer-ingelheim.com/human-health/cancer.

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

Sabari, JK, et al. PRO results from the Beamion LUNG-1 trial in treatment-na?ve patients with HER2-mutant advanced NSCLC. Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 - June 2, 2026; Chicago, IL.

Arnold, D, et al. Zongertinib in HER2-altered colorectal cancer: a pooled analysis of colorectal cancer patients from two clinical trials . Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 - June 2, 2026; Chicago, IL.

Nakayama, I, et al. Zongertinib combined with T-DXd in HER2-positive metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC): first results from a Phase Ib/II dose-escalation trial . Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 - June 2, 2026; Chicago, IL.

Kitano, S, et al. Zongertinib combination therapy in HER2-positive metastatic breast cancer (mBC): first results from a phase Ib/II trial. Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 - June 2, 2026; Chicago, IL.

Peters, S, et al. DAREON?-8: updated efficacy and safety from a phase I dose-escalation/expansion trial of first-line (1L) obrixtamig plus chemotherapy and atezolizumab in extensive-stage small cell lung carcinoma (ES-SCLC). Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 - June 2, 2026; Chicago, IL.

Gambardella, V.  et al. 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. Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 - June 2, 2026; Chicago, IL.

HERNEXEOS Prescribing Information.

Wilding B, Woelflingseder L, Baum A, et al. Zongertinib (BI 1810631), an Irreversible HER2 TKI, Spares EGFR Signaling and Improves Therapeutic Response in Preclinical Models and Patients with HER2-Driven Cancers. Cancer Discov. 2025;15(1):119-138. doi:10.1158/2159-8290.CD-24-0306

ClinicalTrials.gov. Beamion LUNG-2 (NCT06151574). Accessed May 2026.

ClinicalTrials.gov. Beamion LUNG-3 (NCT07195695). Accessed May 2026.

Wermke M, Gambardella V, Kuboki Y, et al. Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas. J Clin Oncol. 2025;43(27):3021-3031.

ClinicalTrials.gov. DAREON-9 (NCT05990738). Accessed May 2026.

ClinicalTrials.gov. DAREON-5 (NCT05882058). Accessed May 2026.

ClinicalTrials.gov. DAREON-Lung-1 (NCT07472517). Accessed May 2026.

ClinicalTrials.gov. DAREON-NEC-1 (NCT07544654). Accessed May 2026.

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