Boehringer Ingelheim is advancing biomarker-informed approaches and extending precision care across multiple cancers and stages of disease, reinforcing its ambition to bring unprecedented impact and improve long-term outcomes where unmet need remains high.

The company has initiated 2 phase 3 clinical trials within the DAREON program: DAREON-Lung-1 in Small Cell Lung Cancer (SCLC) and DAREON-NEC-1 in extrapulmonary neuroendocrine carcinoma (epNEC).

In parallel, the phase 3 Beamion LUNG-3 trial has been initiated in HER2 (ERBB2)-mutant Non-Small Cell Lung Cancer (NSCLC).

Lykke Hinsch Gylvin, MD, Chief Medical Officer (CMO), Boehringer Ingelheim, said, “People living with aggressive cancers often face a shortage of treatment choices. 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.”

The two DAREON phase 3 trials mark a pivotal step for obrixtamig, Boehringer’s investigational DLL3/CD3 T-cell engager, and for the company’s broader biomarker strategy in aggressive neuroendocrine carcinomas (NECs) such as SCLC and epNEC.

People with SCLC often face short-lived therapeutic benefit and poor survival with existing approaches. EpNEC is a historically under-researched cancer for which survival outcomes have not improved in decades. For those living with these cancers, treatment options are limited and significant unmet needs persist.

Delta-like canonical Notch ligand 3 is expressed on tumor cells in SCLC and epNEC while largely absent from non-cancerous cells. This makes it a potential predictive biomarker that could help to redefine treatment strategies for these aggressive cancers.

DAREON-Lung-1 and DAREON-NEC-1 are designed to test whether the addition of obrixtamig, a DLL3 targeted T-cell engager, can improve outcomes in biomarker-informed patient populations versus the current standard of care. Together, the studies aim to position obrixtamig as part of a broader shift toward more personalised and potentially more transformative treatment approaches in these aggressive NECs.

In addition, the company is investigating zongertinib in earlier stages of disease with the initiation of Beamion LUNG-3. This global, randomised phase 3 trial will study the efficacy and safety of zongertinib as adjuvant monotherapy compared with physician's choice Standard of Care (SoC) in patients with stage 2-3B HER2 (ERBB2)-mutant NSCLC who have undergone complete surgical resection and have received either neoadjuvant or adjuvant therapy.

The study is designed to evaluate whether zongertinib can improve disease-free survival compared to SoC following surgery, addressing the significant risk of recurrence after curative-intent treatment.

Beamion LUNG-3 reflects the company’s focus on advancing targeted therapies earlier in the treatment pathway, where effective targeted adjuvant treatment options are not available. This trial extends the investigation of zongertinib to early stage disease.