- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Enrollment open: DeLLphi-312: A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) (clinicaltrials.gov) - Aug 18, 2025 P3, N=330, Recruiting, This analysis underscores the potential of tarlatamab to become a new therapeutic option for previously treated SCLC, a disease that has historically been associated with extremely poor outcomes and limited treatment options. Not yet recruiting --> Recruiting
- |||||||||| 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
Journal: Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. (Pubmed Central) - Jul 23, 2025 P3 Treatment with tarlatamab led to longer overall survival than chemotherapy among patients with small-cell lung cancer whose disease had progressed during or after platinum-based chemotherapy. (Funded by Amgen; DeLLphi-304 ClinicalTrials.gov number, NCT05740566.).
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Multi-Institution Analysis Evaluating Safety, Efficacy and ctDNA Dynamics Following Tarlatamab in ES-SCLC and LCNEC Patients (Exhibit Hall) - Jul 22, 2025 - Abstract #IASLCWCLC2025IASLC_WCLC_1894; However, in this non-trial setting, rates and timing of CRS/ICANS differed from previous reports, highlighting the need for careful observation and care coordination as this therapy is utilized in real-world practice. Novel biomarkers of response and resistance are needed in this setting, with longitudinal ctDNA dynamics showing potential promise, though larger, prospective studies are needed.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen, Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
HER2- and TROP2-Directed Antibody Drug Conjugates Show Potent Antitumor Activities in Small Cell Lung Cancer (Exhibit Hall) - Jul 22, 2025 - Abstract #IASLCWCLC2025IASLC_WCLC_1893; TROP2-ADC similarly demonstrated significant antitumor activity. Conclusions : These findings demonstrate that targeting cell surface HER2 and TROP2 using ADCs is effective in SCLC, including the SCLC-P subtype, which typically is resistant to standard of care therapies and likely to tarlatamab, due to low DLL3 expression.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Surface Targeting Strategies to Overcome Heterogeneity Associated With Treatment Resistance in Small Cell Lung Cancer (SCLC) (Exhibit Hall) - Jul 22, 2025 - Abstract #IASLCWCLC2025IASLC_WCLC_1891; Single-agent surface targeting strategies are effective in preclinical models, including those resistant to other common SCLC therapies (i.e., platinum chemotherapy). Notably, single-cell transcriptional profiling of relapsed SCLC patient biopsies revealed mutually exclusive expression of surface genes in distinct cell populations (i.e., DLL3/SEZ6 vs. TROP2/HER2/B7-H3), including senescent, drug tolerant persister cells (DTPCs), representing a unique opportunity to target heterogeneous populations.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Tracking Ctc Phenotypes in SCLC Liquid Biopsies as a Diagnostic and Therapy Response Assessment Tool (Exhibit Hall) - Jul 22, 2025 - Abstract #IASLCWCLC2025IASLC_WCLC_1559; Notably, single-cell transcriptional profiling of relapsed SCLC patient biopsies revealed mutually exclusive expression of surface genes in distinct cell populations (i.e., DLL3/SEZ6 vs. TROP2/HER2/B7-H3), including senescent, drug tolerant persister cells (DTPCs), representing a unique opportunity to target heterogeneous populations. Computational analysis was performed to assess intra- and inter- patient CTC heterogeneity, phenotypic differences between treatment-na
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Real-World Multi-Institution Analysis of Patients With Small Cell Lung Cancer Treated With Tarlatamab (E-Poster Lounge Station 4) - Jul 22, 2025 - Abstract #IASLCWCLC2025IASLC_WCLC_1170; These patients had comparable CRS rates but higher rates of ICANS, lower objective response rate, and more frequent primary progression. Detailed analyses are warranted to understand patient and disease characteristics predictive of toxicity and response to optimize patient selection.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Review, Journal: Bispecific T-cell engagers (BiTE): a review of tarlatamab in small cell lung cancer. (Pubmed Central) - Jul 5, 2025 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.
- |||||||||| Review, Journal: Bispecific Antibodies in Solid Tumors: Advances and Challenges. (Pubmed Central) - Jun 26, 2025
Currently, several BsAbs are under clinical development for solid tumors, but are mostly in early phase I and II trials. This review provides an overview of the basic mechanism of action of BsAbs, current FDA-approved BsAbs, and current BsAbs under clinical development, their challenges in clinical use, the management of toxicities, and future directions.
- |||||||||| Review, Journal, PD(L)-1 Biomarker, IO biomarker: Treatment of small cell lung cancer; advances and future prospects. (Pubmed Central) - Jun 12, 2025
Two randomized phase III studies (IMpower 133 and CASPIAN) demonstrated that addition of atezolizumab or durvalumab to platinum plus etoposide prolonged the overall survival in ES-SCLC patients...Tarlatamab is a bispecific antibody that targets DLL3 and CD3...Further development of effective treatments and additional biomarkers to predict efficacy is needed. Bispecific antibodies and/or antibody-drug conjugate could be the next candidates for breakthroughs in the treatment of SCLC.
- |||||||||| Journal: Small Cell Lung Cancer: A Review. (Pubmed Central) - Jun 3, 2025
First-line treatment for ES-SCLC is combined treatment with platinum-etoposide chemotherapy and immunotherapy with the programmed cell death 1 ligand 1 (PD-L1) inhibitors durvalumab or atezolizumab followed by maintenance immunotherapy until disease progression or toxicity...Second-line therapy for patients with ES-SCLC includes the DNA-alkylating agent lurbinectedin (35% overall response rate; median progression-free survival, 3.7 months) and a bispecific T-cell engager against delta-like ligand 3, tarlatamab (40% overall response rate; median progression-free survival, 4.9 months)...First-line treatment for LS-SCLC is radiation targeting the tumor given concurrently with chemotherapy and followed by consolidation immunotherapy. For ES-SCLC, first-line treatment is chemotherapy and immunotherapy followed by maintenance immunotherapy.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Review, Journal, IO biomarker: Taking a Bite Out of Small Cell Lung Cancer By Leveraging Precision-Directed Delta-Like Ligand-3 Therapies. (Pubmed Central) - May 29, 2025 The therapeutic landscape of small cell lung cancer (SCLC) is undergoing a paradigm shift with the emergence of delta-like ligand-3 (DLL3)-directed therapies, particularly tarlatamab, a first-in-class bispecific T-cell engager designed to bind to cluster of differentiation-3 on T cells and DLL3 on tumors cells, demonstrating promising efficacy, including potential intracranial activity, and a manageable safety profile...Importantly, the thoughtful incorporation of toxicity mitigation strategies, equitable access, and multidisciplinary care models will be critical to ensure that clinical advances translate into meaningful, real-world benefits. The challenge ahead lies in balancing efficacy with patient quality of life, financial burden, and time toxicity, an effort that requires continuous innovation, collaboration, and a patient-centered approach.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen, ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD), Trodelvy (sacituzumab govitecan-hziy) / Gilead
Review, Journal: ADCs and TCE in SCLC Therapy: The Beginning of a New Era? (Pubmed Central) - May 27, 2025 These therapies represent a paradigm shift from traditional monoclonal antibody (mAb) and chemotherapy regimens, allowing direct engagement of multiple targets associated with tumor progression. In this review, we provide an overview of current drug development in SCLC, specifically focusing on these new agents, summarizing available evidence, and tracking future directions.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
PK/PD data, Journal: Population Pharmacokinetics of Tarlatamab, a Half-Life Extended DLL3-Directed Bispecific T-Cell Engager in Patients with Previously Treated Small Cell Lung Cancer. (Pubmed Central) - May 10, 2025 No clinically significant differences were observed on the basis of age, sex, bodyweight, race, ethnicity, estimates of renal and hepatic function, prior lines of therapy, baseline disease status, or emergence of ADA. These results support that no dose adjustment is required on the basis of any of the evaluated covariates.
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