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Boehringer's HERNEXEOS® Demonstrated a 77% Objective Response Rate in Treatment-Naïve Patients with Advanced HER2 (ERBB2)-Mutant NSCLC
Boehringer Ingelheim's HERNEXEOS showed a 77% objective response rate and 96% disease control in first-line HER2-mutant NSCLC with manageable safety in a 74-patient trial.
- On Oct. 17, 2025, Boehringer Ingelheim reported Beamion LUNG‑1 data showing a 77% confirmed objective response rate and 96% disease control in treatment‑naïve HER2 TKD‑mutant NSCLC.
- With high unmet need in HER2‑mutant disease, regulatory agencies granted Breakthrough Therapy Designations after recent advancements in HER2 ‑mutant NSCLC treatment, which accounts for up to 4% of lung cancers.
- At data cut-off, median DoR and PFS were not mature, with 47% of patients remaining on treatment, 6-month DoR of 80%, PFS of 79%, and dose reductions in 11 patients.
- Under the accelerated pathway, continued approval may depend on verification in confirmatory Phase III trials, aligning with the Beamion Phase III program for previously treated adult patients with unresectable or metastatic non‑squamous NSCLC whose tumors have HER2 TKD activating mutations.
- Beamion Phase III trials will enroll 416 patients in LUNG‑2 and 400 in LUNG‑3, with Shashank Deshpande saying `We see a significant unmet need in the first-line setting for patients with HER2-mutant advanced NSCLC where there are currently no targeted treatments approved.
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Boehringer’s zongertinib demonstrated a 77% objective response rate in treatment-naïve patients with advanced HER2 (ERBB2)-mutant NSCLC
Ingelheim, Germany / Ridgefield, Connecticut, U.S. Data from the Phase Ib Beamion LUNG-1 trial evaluating zongertinib in treatment-naïve patients with...
Boehringer's HERNEXEOS® demonstrated a 77% objective response rate in treatment-naïve patients with advanced HER2 (ERBB2)-mutant NSCLC
Data from the Phase Ib Beamion LUNG-1 trial evaluating HERNEXEOS® (zongertinib tablets) in treatment-naïve patients with advanced HER2 (ERBB2)-mutant NSCLC was...
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Boehringer, Bayer are neck-and-neck in front-line HER2-mutant lung cancer
BERLIN — Bayer and Boehringer Ingelheim provided the first glimpses of how each of their targeted therapies fare as a front-line treatment for HER2-mutant lung cancer patients. Boehringer Ingelheim's Hernexeos, also known as zongertinib, shrank tumors ...
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Total News Sources12
Leaning Left4Leaning Right1Center3Last UpdatedBias Distribution50% Left
Bias Distribution
- 50% of the sources lean Left
50% Left
L 50%
C 38%
12%
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