ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025
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.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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Who cites it
25 citing papers in PubMed.
- Review
- Perspectives on 10 years of Immune Checkpoint Inhibitors in Merkel Cell Carcinoma: A Podcast.Targeted oncology · 2026Article
- Brief Report: Proposed Clinical Trial Guidelines Based on Clinicopathologic Heterogeneity of Metastatic Pulmonary Large Cell Neuroendocrine Carcinoma.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026Article
- What are the Unmet Needs in Managing Digestive Neuroendocrine Carcinomas?Current oncology reports · 2026Review
- DLL3-Targeted Strategies in Advanced Prostate Cancer: Current Evidence and Future Perspectives.Drugs · 2026Review
- Review
- T-Cell Engagers in Lung Cancer: A Comprehensive Literature Review from Tarlatamab Approval to Next-Generation Strategies.Cancers · 2026Review
- Palliative Systemic Therapy in Advanced Thymic Epithelial Tumors in 2026-A Narrative Review.Cancers · 2026Review
- [Expert Consensus on Immunotherapy for Extensive-stage Small Cell Lung Cancer Based on Molecular Subtyping].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2026Review
- [Advances in Systemic Therapy for Extensive-stage Small Cell Lung Cancer in the Era of Precision Treatment].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2026Review
- Clinical practice review of systemic treatment in large cell neuroendocrine carcinoma.Translational lung cancer research · 2026Review
- Research progress on immune microenvironment and biomarkers of small cell lung cancer.Journal of thoracic disease · 2026Review
- IAR025, a novel anti-DLL3 x CD3-bispecific antibody, displays high antitumor efficacy in preclinical models of small-cell lung cancer.Cancer immunology, immunotherapy : CII · 2026Article
- [Chinese Expert Consensus on Delta-like Ligand 3-T Cell Engager Therapy for SCLC].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2026Review
- Real World Outcomes With Chemotherapy and Immunotherapy in Metastatic Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinomas.Cancer medicine · 2026Article
- Advances in Systemic Therapy for Metastatic Pancreatic Neuroendocrine Neoplasms.Current treatment options in oncology · 2026Review
- Updates on Antibody Drug Conjugates and Bispecific T-Cell Engagers in SCLC.Antibodies (Basel, Switzerland) · 2026Review
- Immune cell engagers in lung cancer.Frontiers in immunology · 2026Review
- Association of salvage radiotherapy with survival outcomes in extracranial oligoprogression after first-line therapy for extensive-stage small-cell lung cancer: a multicenter retrospective cohort study.Therapeutic advances in medical oncology · 2026Article
- Systemic therapy for gastroenteropancreatic neuroendocrine neoplasms: current landscape and future directions.Therapeutic advances in medical oncology · 2026Review
Corrections and comments
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Authors and funding
15 authors.
Funding
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Abstract
purposeWe report phase I results for obrixtamig (BI 764532), a delta-like ligand 3 (DLL3)/CD3 IgG-like T-cell engager, in patients with previously treated DLL3-positive small cell lung cancer (SCLC), extrapulmonary neuroendocrine carcinomas (epNECs), or large cell neuroendocrine carcinoma of the lung (LCNEC-L).
methodsPatients received escalating intravenous obrixtamig doses using four regimens: a fixed dose once every 3 weeks (A); a fixed dose once weekly (B1); a step-up dose once weekly for two weeks and target dose once weekly (B2); and a step-up dose once weekly for 3 weeks, target dose once weekly for 3 weeks, and once every 3 weeks thereafter (B3). The primary objective was maximum tolerated dose (MTD). Secondary objectives included safety, pharmacokinetics, and tumor response (RECIST v1.1).
resultsAs of February 21, 2024, 168 patients received obrixtamig, 72% received ≥2 lines of previous anticancer therapy, and 51% received previous anti-PD-1/PD-L1 therapy. Seven dose-limiting toxicities occurred during MTD evaluation (Regimen A, n = 1; Regimen B2, n = 6). MTD was not reached. The most common treatment-related adverse event was cytokine release syndrome (any grade: 57%; grade ≥3: 3%); most cases occurred early and were reversible. Across all doses, regimens, and tumor types, the overall response rate (ORR) was 23% (95% CI, 17.4% to 30.2%), the median duration of response (DoR) was 8.5 months (95% CI, 6.2 to not reached), and the 6-month DoR rate was 70% (95% CI, 53% to 88%). All patients in Regimens B2/B3 received the minimum effective dose (≥90 μg/kg once weekly or once every 3 weeks), achieving an ORR of 28% (95% CI, 20.7% to 35.9%). With Regimens B2/B3, ORRs were 21% (95% CI, 12.9% to 33.1%), 27% (95% CI, 17.4% to 39.6%), and 70% (95% CI, 39.7% to 89.2%) for SCLC, epNECs, and LCNEC-L, respectively.
conclusionThe 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.
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