Boehringer Ingelheim has initiated three Phase III clinical trials targeting hard-to-treat cancers, advancing biomarker-informed precision oncology approaches. The DAREON®-Lung-1 and DAREON®-NEC-1 trials evaluate obrixtamig, a DLL3/CD3 T-cell engager, in small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC). Separately, the Beamion LUNG-3 trial explores zongertinib in earlier stages of resectable HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC).
Biomarker-informed approaches target aggressive neuroendocrine carcinomas
Delta-like canonical Notch ligand 3 (DLL3) is expressed on tumor cells in SCLC and epNEC but largely absent from non-cancerous cells, making it a potential predictive biomarker. DAREON®-Lung-1 and DAREON®-NEC-1 are designed to test whether adding obrixtamig improves outcomes in biomarker-informed patient populations versus current standard of care. SCLC is the most aggressive type of lung cancer, often with short-lived therapeutic benefit and poor survival. EpNEC is historically under-researched, with survival outcomes unchanged for decades.
Expanding precision care in HER2-mutant NSCLC
Beamion LUNG-3 investigates zongertinib in resectable HER2-mutant NSCLC, where new targeted treatment options are still needed. This trial moves targeted therapy into earlier disease stages, aiming to improve long-term outcomes where unmet need remains high.
“People living with aggressive cancers often face a shortage of treatment choices,” said Lykke Hinsch Gylvin, MD, Chief Medical Officer, Boehringer Ingelheim. “With the launch of these trials, we are advancing our precision oncology ambitions to move targeted therapies into earlier treatment lines and bring biomarker-informed science into late-stage development. By focusing on the biology of each tumor, we aim to give patients facing cancer more precise treatment options with the goal of improving outcomes where the need is greatest.”
Commitment to unprecedented impact in high-unmet-need cancers
Boehringer Ingelheim reinforces its ambition to bring unprecedented impact and improve long-term outcomes across multiple cancers and stages of disease. The company is committed to improving outcomes for people facing aggressive cancers where few treatment options currently exist. According to the company, the DAREON® and Beamion programs represent a shift toward more personalized and potentially transformative treatment approaches in these aggressive neuroendocrine carcinomas and lung cancers.
