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    DRUG:

    Imdelltra (tarlatamab-dlle)

    i
    Other names: AMG 757, AMG757, AMG-757
    Company:
    Amgen, BeOne Medicines, Royalty
    Drug class:
    CD3 agonist, DLL3 inhibitor
    Related drugs:
    4d
    Rapid-onset Severe Cytokine Release Syndrome With Marked Interleukin-6 Increase and Acute Liver Injury After the First Tarlatamab Dose in SCLC: Case Report. (PubMed, JTO Clin Res Rep)
    Severe CRS and liver injury rapidly developed in the patient after the first tarlatamab dose, which led to treatment discontinuation. This report also presents the temporal changes in serum interleukin-6 levels, highlighting its potential utility as a biomarker for the onset and severity of CRS.
    Journal
    |
    IL6 (Interleukin 6)
    |
    Imdelltra (tarlatamab-dlle)
    9d
    Early Pseudoprogression Mimicking Pneumonitis After Tarlatamab Therapy: A Case Suggestive of Immune Cell-Associated Respiratory Syndrome (ICARS). (PubMed, Respirol Case Rep)
    High-dose methylprednisolone and tocilizumab produced prompt clinical and radiographic improvement; follow-up imaging showed resolution of infiltrates and tumour regression below baseline, consistent with pseudoprogression. We speculate that baseline carcinomatous lymphangitis may predispose to ICARS. Recognising ICARS may prevent misdiagnosis and avoid premature discontinuation of effective therapy.
    Journal
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    Imdelltra (tarlatamab-dlle) • Actemra IV (tocilizumab)
    18d
    TARLATEM: Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors (clinicaltrials.gov)
    P1/2, N=70, Recruiting, Centre Leon Berard
    New P1/2 trial
    |
    temozolomide • Imdelltra (tarlatamab-dlle)
    21d
    MERLIN: Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients (clinicaltrials.gov)
    P2, N=37, Not yet recruiting, Fundación GECP
    New P2 trial
    |
    Imdelltra (tarlatamab-dlle)
    21d
    Early trajectory of inflammatory cytokines following tarlatamab administration in three advanced SCLC patients. (PubMed, Cancer Immunol Immunother)
    This cytokine profiling highlights the complex pathophysiology of CRS and the involvement of diverse cytokine networks beyond the IL-6 axis. These findings may guide future biomarker development, disease classification, and therapeutic strategies beyond IL-6 inhibition, advancing personalized CRS management.
    Journal
    |
    IFNG (Interferon, gamma) • HGF (Hepatocyte growth factor) • IL10 (Interleukin 10) • IFNA1 (Interferon Alpha 1) • IL1R1 (Interleukin 1 receptor, type I)
    |
    Imdelltra (tarlatamab-dlle)
    23d
    DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov)
    P1, N=269, Active, not recruiting, Amgen | Trial completion date: Oct 2026 --> Dec 2027 | Trial primary completion date: Oct 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Imdelltra (tarlatamab-dlle)
    24d
    DLL3 Immunohistochemical Expression in Neuroendocrine-Transformed EGFR-Mutant Lung Cancer and Two Cases of Tarlatamab Therapy. (PubMed, JTO Clin Res Rep)
    Tarlatamab appeared effective when added to osimertinib. Further analysis of the combination of bispecific DLL3 T-cell engager and EGFR tyrosine kinase inhibitor is warranted to confirm these findings.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53) • RB1 (RB Transcriptional Corepressor 1) • DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    TP53 mutation • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • RB1 mutation • DLL3 expression
    |
    VENTANA DLL3 (SP347) Assay
    |
    Tagrisso (osimertinib) • Imdelltra (tarlatamab-dlle)
    1m
    DeLLphi-307: Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, Amgen | Trial completion date: May 2026 --> Jan 2027
    Trial completion date
    |
    Imdelltra (tarlatamab-dlle)
    1m
    Bridging Knowledge Gaps in Small Cell Lung Cancer: Data, Challenges and Priorities. (PubMed, Curr Oncol)
    Novel agents such as tarlatamab (DLL3-targeting) and ifinatamab deruxtecan (B7-H3-targeting) have shown encouraging efficacy in early-phase trials, though predictive markers remain elusive. A multi-dimensional approach combining tissue, blood, and immune profiling is essential to advance precision oncology in SCLC and improve patient selection for emerging therapies.
    Review • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • DLL3 (Delta Like Canonical Notch Ligand 3) • YAP1 (Yes associated protein 1) • POU2F3 (POU Class 2 Homeobox 3) • ASCL1 (Achaete-Scute Family BHLH Transcription Factor 1) • NEUROD1 (Neuronal Differentiation 1)
    |
    ifinatamab deruxtecan (DS-7300) • Imdelltra (tarlatamab-dlle)
    2ms
    Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308) (clinicaltrials.gov)
    P1, N=220, Recruiting, Amgen | N=100 --> 220
    Enrollment change
    |
    Imdelltra (tarlatamab-dlle)
    2ms
    DeLLphi-305: Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab (clinicaltrials.gov)
    P3, N=563, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Imfinzi (durvalumab) • etoposide IV • Imdelltra (tarlatamab-dlle)