Boehringer Ingelheim Unveils New Zongertinib and Obrixtamig Results Across Solid Tumors

At the 2026 American Society of Clinical Oncology Annual Meeting, Boehringer Ingelheim presented new patient-reported outcomes from the Phase Ib Beamion LUNG-1 study (NCT04886804) evaluating HERNEXEOS in first-line HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC).

Among 71 evaluable patients, zongertinib improved physical functioning and NSCLC-related symptoms within one week of treatment, with benefits sustained over time across patient-reported outcome measures. Patients also reported a low overall side effect burden, while adverse events remained consistent with previously reported safety findings.

Zongertinib selectively inhibits HER2 while sparing wild-type EGFR, a profile associated with reduced EGFR-related toxicities seen with broader HER-family inhibitors. The oral therapy is approved in the U.S., China, Hong Kong, and Japan for HER2-mutant advanced NSCLC and remains under evaluation across multiple HER2-driven solid tumors.

Activity Beyond Lung Cancer

Additional ASCO presentations highlighted expanding activity across HER2-driven cancers:

• Metastatic colorectal cancer (pooled Phase I/II): Zongertinib monotherapy achieved a confirmed objective response rate (ORR) of 42% and disease control rate (DCR) of 95%, with no grade 4 or 5 adverse events reported.
• Metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma: In combination with trastuzumab deruxtecan, confirmed responses were observed in 10 of 16 patients, including one complete response.
• Metastatic HER2-positive breast cancer: Early data showed encouraging disease stabilization and partial responses when zongertinib was combined with trastuzumab emtansine or trastuzumab deruxtecan in heavily pretreated patients.

Obrixtamig in Small Cell Lung Cancer

Boehringer also reported updated Phase I DAREON-8 (NCT06077500) data for obrixtamig, its investigational DLL3/CD3 bispecific T-cell engager, in first-line extensive-stage small cell lung cancer (ES-SCLC).

Combined with carboplatin, etoposide, and atezolizumab, obrixtamig achieved a confirmed ORR of 73% across 44 patients, including complete responses in 7% of patients. Median progression-free survival and duration of response were not reached at the time of analysis, while 6- and 9-month progression-free survival rates were 78% and 62%, respectively.

Cytokine release syndrome was the most common obrixtamig-related adverse event, occurring in 57% of patients. The safety profile was broadly consistent with the T-cell engager class, and treatment discontinuations related to obrixtamig were infrequent.

Late-Stage Development Programs

The expanding dataset supports Boehringer’s broader precision oncology strategy beyond HER2-mutant lung cancer. Ongoing Phase III programs include Beamion LUNG-2 in first-line HER2-mutant NSCLC, Beamion LUNG-3 in resectable early-stage disease, DAREON-LUNG-1 in first-line ES-SCLC, and DAREON-NEC-1 in DLL3-positive extrapulmonary neuroendocrine carcinoma.

Reference

Oncology portfolio across multiple cancers ASCO 2026 | Boehringer Ingelheim