- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Journal: Expression of antibody drug conjugate target antigens in ovarian sex cord stromal Tumors. (Pubmed Central) - Feb 22, 2026
The pervasive absence of HER2, folate receptor alpha, DLL3, TROP-2, and nectin-4 expression in SCSTs suggests ADCs targeting these antigens may be of limited clinical benefit. The design of clinical trials investigating the use of tissue factor-targeting ADCs for the treatment of adult GCTs warrants future consideration.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
P4 data, Journal, Adverse events, Real-world evidence: Post-marketing safety surveillance of tarlatamab: a real-world pharmacovigilance study based on the FAERS database. (Pubmed Central) - Jan 29, 2026
Leveraging FAERS, this first comprehensive real-world characterization of tarlatamab safety confirms core immune-related toxicities (CRS, ICANS) and identifies new signals (TLS, respiratory failure), with sex- and age-associated risk differences. As spontaneous-report signals are inherently hypothesis-generating, causality requires validation in robust pharmacoepidemiologic studies; meanwhile, early detection and supportive care are essential to optimize the benefit-risk profile as use expands.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
FDA event, Journal: FDA Approval Summary: Tarlatamab for the Treatment of Extensive Stage Small Cell Lung Cancer. (Pubmed Central) - Jan 26, 2026
P2
The most common adverse reactions (?20%) were cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia and nausea. Product labeling includes a Boxed Warning for serious or life-threatening CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen, Lorbrena (lorlatinib) / Pfizer
Journal: First Report of Response to Tarlatamab in a Patient With Histologic-Transformed SCLC From ALK-Rearranged NSCLC: Case Report. (Pubmed Central) - Jan 26, 2026
Given lack of standard-of-care treatments for patients with actionable oncogenic alteration NSCLC transformed to SCLC, this remains a challenge and unmet need for treating these patients. Here, we present a case of a patient with ALK-rearranged NSCLC with transformation to SCLC, who has progressed on several lines of therapies and successfully treated with tarlatamab to elicit and maintain clinical benefit, including intracranial response.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Review, Journal, IO biomarker: Updates on Antibody Drug Conjugates and Bispecific T-Cell Engagers in SCLC. (Pubmed Central) - Jan 21, 2026
Collectively, these emerging immunotherapies illustrate a shift toward antigen-specific targeting in a disease historically defined by limited therapeutic innovation. Continued optimization of antigen selection, payload and linker engineering, and biomarker-driven trial design will be critical for translating early promise into durable clinical benefit and reshaping the treatment landscape for SCLC.
- |||||||||| 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
SCLC Outcomes and Real-World Insight with Tarlatamab, a Multi-Center Experience (Salon ABC) - Jan 14, 2026 - Abstract #IASLCTTLC2026IASLC_TTLC_178;
Conclusion Tarlatamab was overall well-tolerated in this real-world cohort and demonstrated preliminary efficacy for active CNS metastases. Real world efficacy appears similar to clinical trial results.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Real-World Time Toxicity of Tarlatamab in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (Salon ABC) - 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 (Salon ABC) - 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.
- |||||||||| Outpatient Administration of Bispecific Therapies in a Community Oncology Setting (Room 255 A-G (Salt Palace Convention Center)) - Dec 15, 2025 - Abstract #TCTASTCTCIBMTR2026TCT_ASTCT_CIBMTR_554;
Findings & Interpretation Between March 2023 and July 2025, the TCT clinic treated 61 patients with outpatient BiTEs including Teclistamab, Talquetamab, Epcoritamab, Mosunetuzumab, Glofitamab, and Tarlatamab...Discussion & Implications This model demonstrates that outpatient BiTE therapy is feasible and safe in a community setting. With structured protocols, nursing support, and caregiver engagement, complex therapies can be delivered outside the hospital, expanding access and reinforcing the vital role of oncology nurses in advanced outpatient care.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Tarlatamab (Salon DEFG) - 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.
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