# Tarlatamab

Source: https://onco.cc/drugs/tarlatamab/  
OnCo record `tarlatamab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first T-cell engager to improve survival in a common solid tumour, small-cell lung cancer.

## Summary

Accelerated approval May 2024 (DeLLphi-301, ORR 40%); DeLLphi-304 phase 3 (2025) showed OS 13.6 vs 8.3 months versus chemotherapy in second-line SCLC, converting to full approval. First-line combination with PD-L1 (DeLLphi-305) and limited-stage trials ongoing. CRS in ~50% (mostly grade 1-2); step-up dosing with monitoring.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Imdelltra
- Modality: Bispecific T-cell engager (DLL3×CD3)
- Mechanism: Half-life-extended BiTE binding DLL3 on tumour and CD3 on T cells.
- Approvals: US 2024: Extensive-stage SCLC after platinum chemotherapy; EU 2026: ES-SCLC after platinum-based chemotherapy; 29 May 2026; England (NICE) 2025: Extensive-stage small-cell lung cancer progressing after two or more lines of treatment including platinum-based chemotherapy: not recommended
- Dosing: IV infusion over 1 hour; Step-up: 1 mg on cycle 1 day 1, then 10 mg on day 8 and every 2 weeks thereafter
- Toxicity (grade 3+): Cytokine release syndrome 1.6%; Haemoglobin decreased 5%; Fatigue 10%; Dysgeusia 0%; Pyrexia 0%; Decreased appetite 2.7%; Musculoskeletal pain 1.1%; Constipation 0.5%; Nausea 1.6%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Tarlatamab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Tarlatamab
- NICE TA1091: tarlatamab for extensive-stage small-cell lung cancer after 2 or more treatments (not recommended): https://www.nice.org.uk/guidance/ta1091

## Connected records

- cancers: [Extensive-stage small-cell lung cancer](https://onco.cc/cancers/extensive-stage-sclc/), [Extrapulmonary neuroendocrine carcinoma](https://onco.cc/cancers/extrapulmonary-nec/), [Limited-stage small-cell lung cancer](https://onco.cc/cancers/limited-stage-sclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Neuroendocrine and small-cell prostate cancer](https://onco.cc/cancers/prostate-nepc/), [Neuroendocrine tumours](https://onco.cc/cancers/neuroendocrine/), [Prostate cancer](https://onco.cc/cancers/prostate/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [CD3](https://onco.cc/targets/cd3/), [DLL3](https://onco.cc/targets/dll3/)
- companies: [Amgen](https://onco.cc/companies/amgen/)
- terms: [Cancer stem cell theory and phenotypic plasticity](https://onco.cc/terms/cancer-stem-cell-theory/), [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [Limited-stage vs extensive-stage (small-cell lung cancer)](https://onco.cc/terms/limited-extensive-stage/), [Lung cancer drugs in England: what NICE has recommended](https://onco.cc/terms/lung-uk-drug-access/), [Lung cancer: the failed and stopped programmes, and why](https://onco.cc/terms/lung-failed-programmes/), [Small-cell lung cancer transcription-factor subtypes (SCLC-A, SCLC-N, SCLC-P, SCLC-I) and SLFN11](https://onco.cc/terms/sclc-molecular-subtypes/), [Step-up dosing (T-cell engagers)](https://onco.cc/terms/step-up-dosing/)
- trials: [A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)](https://onco.cc/trials/nct05060016/), [A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC](https://onco.cc/trials/nct06745323/), [A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small](https://onco.cc/trials/nct07005128/), [A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2](https://onco.cc/trials/nct07203053/), [DeLLphi-304](https://onco.cc/trials/dellphi-304/), [DeLLphi-305](https://onco.cc/trials/dellphi-305/), [Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)](https://onco.cc/trials/nct07778316/), [Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors](https://onco.cc/trials/nct06814496/), [Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)](https://onco.cc/trials/nct06117774/), [Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment](https://onco.cc/trials/nct06502977/), [Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocri](https://onco.cc/trials/nct07016230/), [Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer](https://onco.cc/trials/nct07637513/), [Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer](https://onco.cc/trials/nct07423585/)
- key papers: [DeLLphi-301: tarlatamab, a DLL3-targeting T-cell engager, in previously treated small-cell lung cancer](https://onco.cc/key-papers/paper-dellphi-301-nejm-2023/)
- pairings: [Chemo-immunotherapy induction → maintenance intensification (SCLC)](https://onco.cc/pairings/chemo-io-then-maintenance-sclc/), [Sequencing DLL3 engager and B7-H3 ADC in relapsed SCLC](https://onco.cc/pairings/tarlatamab-vs-idxd-sequence/)
- ideas: [Detect tumours changing cell type from RNA in the blood](https://onco.cc/ideas/idea-bio1-cfrna-plasticity-tracking/), [Subtype-directed therapy for SCLC (ASCL1 / NEUROD1 / POU2F3 / inflamed)](https://onco.cc/ideas/idea-sclc-subtype-directed/)
- roadmaps: [Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity](https://onco.cc/roadmaps/immunotherapy-roadmap/)
- drugs: [Obrixtamig](https://onco.cc/drugs/obrixtamig/), [Rovalpituzumab tesirine](https://onco.cc/drugs/rovalpituzumab-tesirine/)
- people: [Charles M. Rudin](https://onco.cc/people/charles-rudin/), [Se-Hoon Lee](https://onco.cc/people/lee-se-hoon/)
- bottlenecks: [Cold tumours and the immunosuppressive microenvironment](https://onco.cc/bottlenecks/b-tme-immunosuppression/)
- pathways: [Cancer stem cells & phenotypic plasticity](https://onco.cc/pathways/cancer-stem-cells-plasticity/), [Lineage plasticity & neuroendocrine transformation](https://onco.cc/pathways/lineage-plasticity-neuroendocrine/), [Notch signalling](https://onco.cc/pathways/notch/), [Resistance routes: how a blocked pathway comes back](https://onco.cc/pathways/resistance-routes-map/), [Small cell lung cancer (KEGG map)](https://onco.cc/pathways/sclc-signalling/)
- institutions: [Hospital Universitario 12 de Octubre](https://onco.cc/institutions/12-de-octubre/)
- biomarkers: [DLL3 expression](https://onco.cc/biomarkers/dll3-expression/)

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