- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Journal, Circulating tumor cells: Circulating Tumor Cells Predict Response to the DLL3-targeting Bispecific Antibody Tarlatamab. (Pubmed Central) - Jan 14, 2026
Acquired resistance to tarlatamab is associated in some cases with loss of DLL3 expression, but persistence of other targetable neuro-endocrine epitopes; in other patients, DLL3 is retained on CTCs, but accompanied by systemic markers of T cell dysfunction. Quantitation of DLL3-positive CTCs identifies patients likely to benefit from tarlatamab, and longitudinal monitoring may guide therapeutic decision-making at the time of acquired resistance.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Real-World Time Toxicity of Tarlatamab in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) () - Jan 14, 2026 - Abstract #IASLCTTLC2026IASLC_TTLC_150;
RW patients face an early upfront time investment with minimal increase in Home Days. These findings highlight the need for careful patient selection and improved outpatient monitoring to optimize time-toxicity of tarlatamab, particularly for vulnerable populations.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Real-World Safety and Outcomes of Tarlatamab in Extensive-Stage Small Cell Lung Cancer () - Jan 14, 2026 - Abstract #IASLCTTLC2026IASLC_TTLC_148;
These findings highlight the need for careful patient selection and improved outpatient monitoring to optimize time-toxicity of tarlatamab, particularly for vulnerable populations. Primary endpoints included the 15-day incidence of cytokine release syndrome (CRS), immune effector cell
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Review, Journal: Bispecific T-cell engagers (BiTE): a review of tarlatamab in small cell lung cancer. (Pubmed Central) - Jan 10, 2026
Tarlatamab's use must be evaluated in a more heterogeneous population with different demographics, comorbidities, and a larger patient population. The possibility of combination therapy studies should also be evaluated in future studies to increase the efficacy of tarlatamab.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Journal: A multi-institutional perspective on tarlatamab administration and management of CRS/ICANS. (Pubmed Central) - Jan 2, 2026
The possibility of combination therapy studies should also be evaluated in future studies to increase the efficacy of tarlatamab. This perspective highlights current best practices and suggests future directions to improve on our current approaches for tarlatamab administration and CRS/ICANS management.
- |||||||||| Review, Journal: Advances in the clinical application of bispecific antibodies in cancer therapy. (Pubmed Central) - Jan 1, 2026
Several BsAbs, such as blinatumomab, mosunetuzumab, teclistamab, glofitamab, epcoritamab, talquetamab, ivonescimab, cadonilimab, tarlatamab, zenocutuzumab, and catumaxomab, have achieved notable success in clinical trials. This review highlights clinically approved BsAbs and provides a comprehensive summary of their therapeutic applications in cancer treatment.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Review, Journal: Tarlatamab for small-cell lung cancer. (Pubmed Central) - Dec 30, 2025
Most data come from SCLC; in the other two diseases, tarlatamab is in early clinical development. Tarlatamab is an effective therapy mainly in relapsed/progressed SCLC, and its assessment in limited SCLC alone or combined with other therapies is supported by the existing data.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Tarlatamab () - Dec 15, 2025 - Abstract #IASLCTTLC2026IASLC_TTLC_7;
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Journal: Rapid disease progression and hydrocephalus following tarlatamab therapy initiation: A case report. (Pubmed Central) - Nov 28, 2025
This case highlights the need to consider the possibility of rapid disease progression following tarlatamab administration and underscores the importance of adequate assessment to exclude ICANS. Since rapid tumor progression may lead to a decline in the patient's general condition, careful follow-up is advised.
- |||||||||| 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
UNLOCK TARLATAMAB: A phase 2, multicenter, open-label, Study Investigating Tarlatamab in Patients with Metastatic/Locally Advanced Small-Cell Lung Cancer and Other Poorly Differentiated Neuroendocrine Carcinomas with Integrated Biomarker Analyses (Churchill Room) - Oct 26, 2025 - Abstract #ESMOIO2025ESMO_IO_213;
P2
Analyses include DLL3 expression dynamics, genomic and transcriptomic profiling, epigenetic characterization, tumor microenvironment mapping, ctDNA kinetics, and establishment of patient-derived xenografts. This study aims to uncover mechanisms driving response and resistance to tarlatamab, ultimately informing next-generation therapeutic strategies.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
DLL3 Expression by Immunohistochemistry in Rare Neuroendocrine Neoplasms and Associated Response to Off Label Tarlatamab (Churchill Room) - Oct 26, 2025 - Abstract #ESMOIO2025ESMO_IO_201;
Tarlatamab was well tolerated with only one case (7.7%) of grade 3 or higher cytokine release syndrome or immune effector cell associated neurotoxicity syndrome.Conclusions Tarlatamab demonstrated promising activity in DLL3-expressing rare NENs, supporting its use as a precision medicine strategy in patients with rare NENs other than small cell lung cancer. Prospective studies and standardized DLL3 testing are warranted across all tumor types.
- |||||||||| 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;
Prospective studies and standardized DLL3 testing are warranted across all tumor types. 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.
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