On May 21, 2026 Boehringer Ingelheim reported it 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 HERNEXEOS in other types of cancer driven by HER2 alterations. 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).
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"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 (Free ASCO Whitepaper), 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 HERNEXEOS 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 HERNEXEOS 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 HERNEXEOS’s published safety data.1
HERNEXEOS was well tolerated, as reflected by the low overall 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
"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 HERNEXEOS data in HER2-positive colorectal, esophageal and breast cancers
Early data to be presented highlights the potential of HERNEXEOS in other HER2-driven cancers, including metastatic colorectal cancer (mCRC), metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC) and metastatic breast cancer (mBC). 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 HERNEXEOS 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 HERNEXEOS 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 HERNEXEOS 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 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
Encouraging clinical activity was observed in heavily pretreated patients with HER2-positive mBC 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
These initial findings highlight the potential of HERNEXEOS 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 (Free ASCO Whitepaper) 2026 from Boehringer Ingelheim’s diverse oncology pipeline reflect its ambition to reshape cancer care:
Abstract Title
Presenter
ASCO Session
Zongertinib and HER2
PRO results from the Beamion LUNG-1 trial in treatment-naïve patients with HER2-mutant advanced NSCLC
Sabari, J. K.
Poster Presentation 406
May 31, 9:00 AM – 12:00 PM CDT
Zongertinib in HER2-altered colorectal cancer: a pooled analysis of colorectal cancer patients from two clinical trials
Arnold, D.
Poster Presentation 292
May 30, 9:00 AM – 12:00 PM CDT
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
Nakayama, I.
Poster Presentation 243
May 30, 1:30 PM – 4:30 PM CDT
Beamion BCGC-1: Four new phase Ib/II cohorts to evaluate oral zongertinib with other agents in HER2-positive metastatic breast cancer (mBC) and metastatic colorectal cancer (mCRC)
Shitara, K.
Poster Presentation 303a
May 30, 1:30 PM – 4:30 PM CDT
Zongertinib combination therapy in HER2-positive metastatic breast cancer (mBC): first results from a phase Ib/II trial
Kitano, S.
Poster Presentation 158
June 1, 1:30 PM – 4:30 PM CDT
Overall Survival by Genomic Profile in HER2-Positive (HER2+) Metastatic Breast Cancer (mBC): A Large US Clinico-Genomic Database Study
Tarantino, P.
Poster Presentation 159
June 1, 1:30 PM – 4:30 PM CDT
Beamion LUNG-3: Zongertinib in resectable HER2-mutant NSCLC
Cummings, A.
Poster Presentation 600a
May 31, 9:00 AM – 12:00 PM CDT
Zongertinib in previously treated advanced HER2-mutant non-small cell lung cancer: A single-center study
Kong, J.
Publication Only: Lung Cancer—Non-Small Cell Metastatic
Obrixtamig and DLL3
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)
Peters, S.
Poster Presentation 563
May 31, 9:00 AM – 12:00 PM CDT
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
Gambardella, V.
Poster Presentation 432
May 30, 1:30 PM – 4:30 PM CDT
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.
Vijayvergia, N.
Publication Only: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that inhibits HER2 (ERBB2).7,8 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.7
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
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 HERNEXEOS as a first-line treatment for patients with advanced NSCLC that have HER2 tyrosine kinase domain mutations (NCT06151574).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).11
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.12 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).5,13,14 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-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-NEC-1).
(Press release, Boehringer Ingelheim, MAY 21, 2026, View Source [SID1234665961])