obrixtamig (BI 764532) / Boehringer Ingelheim, Oxford BioTherapeutics - LARVOL DELTA

Subgroup analysis of the ongoing Phase Ib DAREON®-7 study: Outcomes with first-line (1L) obrixtamig plus standard of care (SoC) in neuroendocrine carcinomas (NECs) by DLL3 expression status (ESMO 2026) - No abstract available

Clinical • P1 data • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

DAREON®-9: a Phase Ib open-label dose escalation/confirmation study of obrixtamig (BI 764532) plus topotecan in patients (pts) with extensive-stage small-cell lung cancer (ES-SCLC) ‒ topotecan use analysis (ESMO 2026) - No abstract available

Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

DAREON®-NEC-1: Phase III trial of first-line (1L) obrixtamig plus carboplatin and etoposide (SoC) vs SoC in patients (pts) with delta-like ligand 3 (DLL3)-positive extrapulmonary neuroendocrine carcinoma (epNEC) (ESMO 2026) - No abstract available

Clinical • P3 data • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

A phase I dose escalation trial of obrixtamig + ezabenlimab in patients (pts) with small cell lung cancer (SCLC) or other neuroendocrine carcinomas (NECs) expressing DLL3 (ELCC 2026) - P1 | "Legal entity responsible for the study Boehringer Ingelheim. Funding Boehringer Ingelheim."

Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

DAREON®-8: A phase I trial of first-line obrixtamig plus chemotherapy and atezolizumab in extensive-stage small cell lung carcinoma (ES-SCLC) (ESMO 2025) - P1 | "We report the first safety and efficacy data for the dose escalation part of the Phase I DAREON®-8 (NCT06077500) trial investigating obrixtamig + first-line (1L) SoC (carboplatin + etoposide + atezolizumab) in patients (pts) with ES-SCLC. The frequency and severity of AEs reported for the combination were consistent with the expected safety findings of the individual treatments. The combinability of obrixtamig with chemotherapy and an anti-PDL1 antibody observed in this trial warrant further development of this combination in 1L ES-SCLC."

Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

DAREON-8: DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Sep 2026 ➔ Mar 2027

Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

DAREON®-Lung-1: Phase III Trial of First-Line Obrixtamig + SoC (Atezolizumab + Carboplatin + Etoposide) Versus SoC in ES-SCLC (IASLC-WCLC 2026) - P3 | "Further endpoints include objective response rate, duration of response, safety, and patient-reported outcomes. Recruitment is expected to begin in April 2026; planned recruitment is approximately 670 patients across Asia, Africa, Europe, North America, South America, and Oceania."

Clinical • IO biomarker • P3 data • CNS Disorders • Endocrine Cancer • Infectious Disease • Lung Cancer • Neuroendocrine Carcinoma • Pulmonary Disease • Small Cell Lung Cancer • Solid Tumor • 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). (ASCO 2026) - P1 | "We report updated efficacy and safety data from the ongoing Phase I DAREON-8 (NCT06077500) dose-escalation/expansion trial investigating 1L obrixtamig + induction SoC (carboplatin + etoposide + atezolizumab) and maintenance obrixtamig + atezolizumab in pts with ES-SCLC. Obrixtamig + SoC demonstrated encouraging efficacy, supporting obrixtamig as a combination partner for 1L SoC. The combination showed a safety profile consistent with individual agents, supporting the favorable tolerability of obrixtamig in combination regimens. Updated safety data are consistent with previous findings (Peters S et al, Ann Oncol 2025; 36: S1466–7), and results warrant further development in Phase III trials."

Clinical • P1 data • Hematological Disorders • Inflammation • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

DAREON®-7: Phase I open-label dose-escalation/expansion study of first-line obrixtamig (BI 764532) plus platinum-doublet chemotherapy in patients with DLL3-positive neuroendocrine carcinomas (ENETS 2026) - P1 | "OBJECTIVES: We assessed the safety and efficacy of obrixtamig + carboplatin (or cisplatin) + etoposide in patients with DLL3-po - sitive NECs and report data from the ongoing dose-escalation/ expansion Phase I DAREON®-7 trial (NCT06132113). Obrixtamig with platinum + etoposide had a safety profile consistent with the individual treatments, supporting the tolerability of obrixtamig in combination regimens. Encouraging efficacy warrants the prioritized development of first-line obrixta - mig + platinum-doublet chemotherapy in these settings of high unmet need."

Clinical • P1 data • Endocrine Cancer • Hematological Disorders • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

DAREON®-9: A phase Ib open-label dose escalation and dose confirmation study of obrixtamig (BI 764532) plus topotecan in patients (pts) with advanced small-cell lung cancer (SCLC): Updated results (ESMO 2025) - P1 | "Conclusions Obrixtamig + topotecan was tolerable with no indicators of overlapping toxicity. Preliminary efficacy data for the combination show encouraging short- and long-term efficacy in 2L+ SCLC, warranting further investigation of the combination treatment."

Clinical • Metastases • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

DAREONTM-9, a phase Ib study of obrixtamig plus topotecan in patients (pts) with advanced small cell lung cancer (SCLC): Interim analysis results. (ASCO 2025) - P1 | "The obrixtamig plus topotecan combination was tolerable with no unexpected toxicities. AE frequency and severity reported for the combination were consistent with the expected safety findings for obrixtamig and topotecan as monotherapy. Preliminary efficacy data for the combination are encouraging and indicate an improvement on top of topotecan monotherapy."

Clinical • Metastases • P1 data • Anemia • Fatigue • Febrile Neutropenia • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • DLL3

First-in-human dose-escalation trial of BI 764532, a delta-like ligand 3 (DLL3)/CD3 IgG-like T-cell engager in patients (pts) with DLL3-positive (DLL3+) small-cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC). (ASCO 2023) - P1 | "BI 764532 showed clinically manageable tolerability and MTD has not been reached at the doses administered to date. Promising efficacy has been observed, not only in SCLC but also in difficult to treat entities such as NEC and LCNEC. The study is ongoing; updated data will be presented."

Clinical • P1 data • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3 • PD-1 • PD-L1 • RB1

Phase I Dose Escalation Trial Of The DLL3/CD3 Igg-Like T Cell Engager BI 764532 In Patients with DLL3+ Tumors: Focus on SCLC (IASLC-WCLC 2023) - P1 | "BI 764532 showed clinically manageable tolerability and MTD has not been reached at the doses administered to date. Promising efficacy has been observed in patients with heavily pre-treated SCLC. The study is ongoing; updated data will be presented."

Clinical • P1 data • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Efficacy and safety of the DLL3/CD3 T-cell engager obrixtamig in patients with extrapulmonary neuroendocrine carcinomas with high or low DLL3 expression: Results from an ongoing phase I trial. (ASCO 2025) - P1 | "Analyses from this ongoing Ph I study show greater obrixtamig efficacy in patients with epNEC with high DLL3 expression compared with low DLL3 expression, with a manageable safety profile that is comparable across both groups. The ORR of 40.0% and median DoR of 7.9 months in heavily pretreated epNEC tumors with DLL3 high expression are encouraging, and support further development of obrixtamig for this subgroup. *Evaluated with a customised MedDRA query."

Clinical • P1 data • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • DLL3 • RB1

Efficacy and safety of the DLL3/CD3 T-cell engager obrixtamig in patients with genitourinary extrapulmonary neuroendocrine carcinomas with high or low DLL3 expression: Results from an ongoing phase I trial. (ASCO-GU 2026) - P1 | "Obrixtamig showed preliminary efficacy and durable responses in heavily pretreated patients with DLL3-high epNEC GU, with a manageable safety profile. These data support further development of obrixtamig in this setting. *Kaplan−Meier estimate."

Clinical • P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • DLL3 • RB1

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. (ASCO 2026) - P1, P2 | "In the largest prospectively screened cohort of pts with epNEC, high (83.3%) prevalence of DLL3 expression was seen, underscoring DLL3 as a promising target for clinical development of DLL3-targeted therapies such as obrixtamig. Obrixtamig safety and efficacy in pts with DLL3-positive epNEC are being assessed in several ongoing trials, including DAREON-5 (NCT05882058), with the data expected to inform and support Phase III development."

Biomarker • Clinical • First-in-human • Metastases • P1 data • Endocrine Cancer • Genito-urinary Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas. (PubMed, J Clin Oncol) - "The demonstrated tolerability and efficacy of obrixtamig regimens, administered as step-up followed by target doses of 90-1,080 μg/kg (once weekly or once every 3 weeks), in patients with heavily pretreated DLL3-positive tumors support further exploration in SCLC, epNEC, and LCNEC-L."

Journal • P1 data • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Phase I Trial of DLL3/CD3 IgG-Like T-Cell Engager BI 764532 in Patients with DLL3-Positive Tumors: Patients with LCNEC (IASLC-WCLC 2024) - P1 | "At data cut-off, 5 of 7 responding patients (71%) were still on treatment. Conclusions : BI 764532 showed promising efficacy and safety in patients with LCNEC, with an ORR of 70% at active dose levels."

Clinical • P1 data • Endocrine Cancer • Eosinophilia • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • DLL3

Phase I, non-randomised, open-label, multi-centre dose escalation trial of BI 764532 (DLL3/CD3 IgG-like T cell engager [TcE]) + ezabenlimab (anti-PD-1 antibody) in patients (pts) with small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NECs) expressing DLL3 (ESMO 2023) - P1 | "In the dose escalation part, the primary endpoint is dose-limiting toxicity (DLT) occurrence in the MTD evaluation period; secondary endpoints include DLT occurrence in the on-treatment period, objective response and pharmacokinetics. Enrolment is ongoing."

Clinical • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study to Test Different Doses of Obrixtamig in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 (clinicaltrials.gov) - P1 | N=300 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3 (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Recruiting

Enrollment open • Monotherapy • Brain Cancer • Glioma • Oncology • Solid Tumor • DLL3

A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 (clinicaltrials.gov) - P1 | N=45 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2026 ➔ Mar 2027

Trial completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study to Test Different Doses of Obrixtamig in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 (clinicaltrials.gov) - P1 | N=300 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: May 2027 ➔ Sep 2027

First-in-human • Trial completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

DAREON-5: DAREON-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Feb 2028 ➔ Jun 2028 | Trial primary completion date: Sep 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma • DLL3 • PD-L1

DAREON-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy (clinicaltrials.gov) - P3 | N=390 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3