Imdelltra (tarlatamab-dlle) / Amgen 
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  • ||||||||||  Review, Journal, Adverse events, IO biomarker:  Bispecific immunotherapy based on antibodies, T-cell receptors, and aptamers: mechanisms of action, adverse effects, and future perspectives. (Pubmed Central) -  Nov 20, 2025   
    TCR-based constructs broaden the repertoire of actionable targets by recognizing intracellular antigens presented on MHC molecules, as exemplified by the approval of tebentafusp for uveal melanoma...The integrated evidence indicates that continued progress in bispecific immunotherapy will depend on the incorporation of predictive molecular biomarkers, dynamic monitoring of the evolving antigenic landscape, and the standardization of biomanufacturing processes. These advances are expected to accelerate the clinical deployment of next-generation, multipurpose bispecific constructs.
  • ||||||||||  Journal:  Brain Atrophy and Leukoencephalopathy Following Tarlatamab: Case Report. (Pubmed Central) -  Oct 27, 2025   
    The early-onset cerebral atrophy and leukoencephalopathy in the current case was attributed to whole brain radiotherapy and tarlatamab. Patients with brain metastases may be at increased risk of neurological events associated with tarlatamab.
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen
    Tarlatamab versus chemotherapy as second-line treatment for small cell lung cancer (SCLC): primary analysis of the phase 3 DeLLphi-304 study (Prince George's Exhibit Hall AB) -  Oct 24, 2025 - Abstract #JADPRO2025JADPRO_198;    
    Patients with brain metastases may be at increased risk of neurological events associated with tarlatamab. BACKGROUNDTarlatamab is a bispecific T-cell engager immunotherapy that targets delta-like ligand 3 (DLL3) on tumor cells and CD3 on T cells.Tarlatamab demonstrated durable antitumor activity in patients with previously treated SCLC.The DLL3 expression in SCLC is nearly uniform in nature and is also associated with a poorer hematological malignancy.The DeLPhi-304 study was conducted to assess whether tarlatamab monotherapy versus chemotherapy as second-line treatment for SCLC will be positioned as becoming a second-line of this platform-based treatment in SCLC.We present results from the first planned patient-analysis of the Phase 3 DeLPhi-304 study comparing tarlatamab versus chemotherapy in second-line treatment of SCLC.KEY TAKEAWAYSThe DeLPhi-304 study ultimately positions tarlatamab as the new standard of care in patients with previously treated SCLC.In the Phase 3 DeLPhi-304 study, tarlatamab significantly improved OS and PFS, reducing the risk of death by 30% versus chemotherapy.Tarlatamab compared with chemotherapy significantly improved patient-reported outcomes of dyspnea and cough.Tarlatamab had a lower rate of high-grade AEs and severity of AEs than that of chemotherapy treatment.CRS and iCANS were mostly Grade 1 or 2 severity and generally manageable.METHODSKey Inclusion criteria
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen
    Enrollment closed:  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) -  Oct 20, 2025   
    P3,  N=563, Active, not recruiting, 
    BACKGROUNDTarlatamab is a bispecific T-cell engager immunotherapy that targets delta-like ligand 3 (DLL3) on tumor cells and CD3 on T cells.Tarlatamab demonstrated durable antitumor activity in patients with previously treated SCLC.The DLL3 expression in SCLC is nearly uniform in nature and is also associated with a poorer hematological malignancy.The DeLPhi-304 study was conducted to assess whether tarlatamab monotherapy versus chemotherapy as second-line treatment for SCLC will be positioned as becoming a second-line of this platform-based treatment in SCLC.We present results from the first planned patient-analysis of the Phase 3 DeLPhi-304 study comparing tarlatamab versus chemotherapy in second-line treatment of SCLC.KEY TAKEAWAYSThe DeLPhi-304 study ultimately positions tarlatamab as the new standard of care in patients with previously treated SCLC.In the Phase 3 DeLPhi-304 study, tarlatamab significantly improved OS and PFS, reducing the risk of death by 30% versus chemotherapy.Tarlatamab compared with chemotherapy significantly improved patient-reported outcomes of dyspnea and cough.Tarlatamab had a lower rate of high-grade AEs and severity of AEs than that of chemotherapy treatment.CRS and iCANS were mostly Grade 1 or 2 severity and generally manageable.METHODSKey Inclusion criteria Recruiting --> Active, not recruiting
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen, Talvey (talquetamab-tgvs) / J&J
    Integrated platforms for the preclinical evaluation of T-Cell engagers (Poster Hall (Exhibit Halls AB); Virtual) -  Oct 3, 2025 - Abstract #SITC2025SITC_1500;    
    We evaluated the efficacy of CD3/CD20 bispecific-antibody using BALB/c-hCD3EDG mouse inoculated with the humanized mouse lymphoma A20-hCD20 cell lines.Results Both Talquetamab and Tarlatamab effectively inhibited tumor growth in huPBMC-NCG-MHC-dKO mice, with animals demonstrating good health conditions throughout the study. Mice bearing SHP-77 and NCI-H929 tumors demonstrated a complete response to Tarlatamab and Talquetamab following two weeks of treatment.In the BALB/c-hCD3EDG mice model, the CD3/CD20 bispecific antibody suppressed tumor growth, with tumor inhibition at 81.46% was following 18 days of treatment.Conclusions GemPharmatech's integrated in vitro and in vivo platforms, including our NGC-MHC-dKO and CD3-humanized mouse models provide a powerful, scalable framework for the rapid and comprehensive evaluation of T-cell engagers.
  • ||||||||||  VIB193 / Vibrant Therapeutics
    VIB193, the first TCE prodrug targeting CAIX for the treatment of solid cancer (Poster Hall (Exhibit Halls AB); Virtual) -  Oct 3, 2025 - Abstract #SITC2025SITC_1270;    
    However, over the following 15 years, efforts to develop TCEs for solid tumors have led to the approval of only two additional drugs: the TCR-based Tebentafusp and the antibody-based Tarlatamab...These rendered VIB193 a high therapeutic window not observed with conventional TCEs. It is noteworthy that, due to high TCE's high potency, VIB193 was able to achieve complete responses (per mRECIST criteria) at low doses.Conclusions VIB193 holds promise for the treatment of a wide range of solid tumors and represents a significant step forward toward overcoming the challenges traditionally associated with TCEs for solid tumors.Ethics Approval Ethical committee approval ID number for the animal work 20250206C02, Guangzhou, China.
  • ||||||||||  DLL3xB7H3 bsADC / Biocytogen, DLL3xSEZ6 bsADC / Biocytogen
    Bispecific antibody-drug conjugates targeting DLL3 (Poster Hall (Exhibit Halls AB); Virtual) -  Oct 3, 2025 - Abstract #SITC2025SITC_1243;    
    Bispecific treatment duration by clinical trial eligibility status Despite the approval of tarlatamab and ongoing development of DLL3- or B7-H3-targeted ADCs, tumor relapse and heterogeneity in target expression continue to pose challenges...We used in vitro internalization activity, in vivo anti-tumor efficacy in SCLC CDX or PDX models, and developability screening as primary selection criteria.Results The DLL3
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen
    Immune cell profile changes in patients treated with tarlatamab for extensive-stage small cell lung cancer in real world practice (Poster Hall (Exhibit Halls AB); Virtual) -  Oct 3, 2025 - Abstract #SITC2025SITC_1140;    
    Despite the approval of tarlatamab and ongoing development of DLL3- or B7-H3-targeted ADCs, tumor relapse and heterogeneity in target expression continue to pose challenges...We used in vitro internalization activity, in vivo anti-tumor efficacy in SCLC CDX or PDX models, and developability screening as primary selection criteria.Results The DLL3 In addition, the no-PD group had a statistically significant decrease from baseline to day 7 in intermediate monocytes (32.5
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen, Imfinzi (durvalumab) / AstraZeneca, Tecentriq (atezolizumab) / Roche
    Treatment patterns of systemic therapies in extensive-stage small-cell lung cancer (ES-SCLC): a real-world observational study (Poster Hall (Exhibit Halls AB); Virtual) -  Oct 3, 2025 - Abstract #SITC2025SITC_770;    
    Multicolor flow cytometry analysis of serial PBMCs showing tarlatamab treatment increased the number of total CD3+ T cells, cytotoxic CD8+ T cells and CD19+ B cells, and decreased the number of CD4+ T cells and CD56+NK cells Background Despite poor prognosis, there were no advances in treatment options that improved outcomes for patients with ES-SCLC beyond chemotherapy1 until the approval of immune checkpoint inhibitors (ICIs) as first-line treatment for ES-SCLC in 2019 and the approval of tarlatamab (a DLL3-targeting T-cell engager) in the second-line setting or beyond in 2024.2
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen
    Journal:  Tarlatamab in Small-Cell Lung Cancer. Reply. (Pubmed Central) -  Oct 1, 2025   
    Tarlatamab plus a PD-L1 inhibitor as maintenance after first-line chemo-immunotherapy showed a manageable safety profile with promising anticancer activity, supporting the ongoing phase 3 trial (NCT06211036). No abstract available
  • ||||||||||  Journal, PD(L)-1 Biomarker, IO biomarker:  Small (Pubmed Central) -  Sep 26, 2025   
    For decades, outcomes stagnated: most patients present with extensive-stage disease, screening rarely detects early tumors, surgery is seldom feasible, and platinum-etoposide remained the first-line standard with median overall survival (OS) 80% of SCLC, enables T-cell-redirecting therapy: the bispecific T-cell engager tarlatamab improved OS to 13.6 vs 8.3 months over standard second-line chemotherapy, with manageable cytokine release syndrome and occasional ICANS. B7 homolog 3 (B7-H3, CD276), uniformly expressed across SCLC subtypes and linked to poor prognosis, is another compelling target: the antibody-drug conjugate ifinatamab deruxtecan achieved a 54.8% response rate and meaningful survival in heavily pretreated patients, earning FDA Breakthrough designation.
  • ||||||||||  Review, Journal, Tumor mutational burden, PD(L)-1 Biomarker, IO biomarker:  State of the art in treatment of small cell lung cancer. (Pubmed Central) -  Sep 18, 2025   
    The delta-like ligand 3-targeting bispecific T-cell engager (BiTE), tarlatamab, has been approved by the FDA for ES-SCLC with disease progression on or after platinum-based chemotherapy and is being evaluated in earlier lines of treatment...Several antibody-drug conjugates, including sacituzumab govitecan, are being tested in clinical trials and have demonstrated encouraging efficacy...Circulating tumour DNA and circulating tumour cells have demonstrated potential for prognostication, molecular subtyping and tumour monitoring. Further research remains essential to support treatment stratification, prolong treatment responses, overcome resistance and ultimately improve outcomes for this devastating disease.
  • ||||||||||  Journal, Adverse events:  Neurologic Adverse Events Associated With T-cell Engager Therapy in Multiple Myeloma: A Pharmacovigilance Study. (Pubmed Central) -  Aug 18, 2025   
    T-cell engager (TCE) therapies, such as teclistamab (TL), talquetamab (TQ), and elranatamab (ER), have emerged as promising options...Conclusion NAEs are a substantial part of the toxicity profile of TCEs in RRMM, particularly in the context of TL. These findings underscore the need for proactive neurologic monitoring and further research to identify predictive markers and improve management strategies.
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen
    Journal, Real-world evidence:  Rapid Intracranial Response With Tarlatamab in Patients With Untreated Brain Metastases From SCLC-A Real-World Case Series: Case Report. (Pubmed Central) -  Aug 6, 2025   
    In our cohort of 10 patients with relapsed SCLC and untreated brain metastases, including those with symptomatic intracranial disease and one with suspected leptomeningeal disease, clinical response or stability was seen in 90% of patients. We present several cases in which rapid, dramatic radiographic responses and clinical improvement were observed in patients with innumerable growing brain metastases (>20 lesions) who would otherwise require whole brain radiation, suggesting that tarlatamab can control intracranial metastases as monotherapy, potentially sparing or deferring the need for brain radiation.
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen
    Trial completion date, Trial primary completion date:  DeLLphi-306: Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) (clinicaltrials.gov) -  Jul 25, 2025   
    P3,  N=400, Recruiting, 
    We present several cases in which rapid, dramatic radiographic responses and clinical improvement were observed in patients with innumerable growing brain metastases (>20 lesions) who would otherwise require whole brain radiation, suggesting that tarlatamab can control intracranial metastases as monotherapy, potentially sparing or deferring the need for brain radiation. Trial completion date: Oct 2029 --> Mar 2030 | Trial primary completion date: Oct 2029 --> Mar 2030
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen
    Trial completion date, Trial primary completion date:  DeLLphi-301: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) -  Jul 25, 2025   
    P2,  N=222, Active, not recruiting, 
    Trial completion date: Oct 2029 --> Mar 2030 | Trial primary completion date: Oct 2029 --> Mar 2030 Trial completion date: Oct 2026 --> Apr 2027 | Trial primary completion date: Oct 2025 --> Apr 2026
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen, Rova-T (rovalpituzumab tesirine) / AbbVie
    Impact of DLL3 isoforms on DLL3-targeting antibody therapies (Hall 25) -  Jul 24, 2025 - Abstract #ESMO2025ESMO_3816;    
    Previous efforts to target DLL3 with the antibody drug conjugate rovalpituzumab tesirine (Rova-T) were not successful...The effects of isoforms on epitope retention and target affinity are underappreciated and may contribute to failure of antibody-based therapies. Legal entity responsible for the study The authors.