"Tarlatamab"

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                            1
                            2024FDA - Drug Approval Package
                            Tarlatamab dlle (Imdelltra) - small cell lung cancer Drug Approval Package: IMDELLTRA * Skip to main content * Skip to FDA Search * Skip to footer links An official website of the United States governmentHere's how you know The .gov means it's official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site
                            2
                            2025CADTH - Reimbursement Review
                            Review Analysis
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                            Tarlatamab (Imdelltra) - small cell lung cancer View of Tarlatamab (Imdelltra) | Canadian Journal of Health Technologies Return to Article DetailsTarlatamab (Imdelltra)
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                            3
                            2025Cancer
                            Practical management of adverse events in patients receiving tarlatamab, a delta-like ligand 3-targeted bispecific T-cell engager immunotherapy, for previously treated small cell lung cancer. Tarlatamab is a bispecific T-cell engager immunotherapy targeting delta-like ligand 3 (DLL3) and the cluster of differentiation 3 (CD3) molecule. In the phase 2 DeLLphi-301 trial of tarlatamab for patients with previously treated small cell lung cancer, tarlatamab 10 mg every 2 weeks achieved durable responses and encouraging survival outcomes. Analyses of updated safety data from the DeLLphi-301 trial demonstrated that the most common treatment-emergent adverse events were cytokine release syndrome (53%), pyrexia (38%), decreased appetite (36%), dysgeusia (32%), and an emia (30%). Cytokine release syndrome
                            4
                            2025Journal of Thoracic Oncology
                            Rapid Intracranial Response With Tarlatamab in Patients With Untreated Brain Metastases From SCLC-A Real-World Case Series: Case Report. SCLC has the highest propensity for brain metastases among all malignancies. Systemic treatment for SCLC, particularly in the setting of brain metastases, is very limited. Tarlatamab, the CD3/delta-like ligand 3 bispecific T-cell engager, has changed the treatment landscape of relapsed SCLC since its Food and Drug Administration approval in May 2024. Patients with treated and stable brain metastases were included in the phase 1 DeLLphi-300 trial and phase 2 DeLLphi-301 trials of tarlatamab. Nevertheless, it remains unknown if tarlatamab is safe and efficacious in the setting of untreated, active or symptomatic brain metastases. Our case series provides
                            5
                            2023NEJM
                            Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. Tarlatamab, a bispecific T-cell engager immunotherapy targeting delta-like ligand 3 and CD3, showed promising antitumor activity in a phase 1 trial in patients with previously treated small-cell lung cancer. In this phase 2 trial, we evaluated the antitumor activity and safety of tarlatamab, administered intravenously every 2 weeks at a dose of 10 mg or 100 mg, in patients with previously treated small-cell lung cancer. The primary end point was objective response (complete or partial response), as assessed by blinded independent central review according to the Response Evaluation Criteria in Solid Tumors, version 1.1. Overall, 220 patients received tarlatamab; patients had previously received a median of two lines
                            6
                            2024Journal of Clinical Oncology
                            Sustained Clinical Benefit and Intracranial Activity of Tarlatamab in Previously Treated Small Cell Lung Cancer: DeLLphi-300 Trial Update. JCO .Tarlatamab, a bispecific T-cell engager immunotherapy targeting delta-like ligand 3, has shown durable anticancer activity and manageable safety in previously treated small cell lung cancer (SCLC) in DeLLphi-300 phase I and DeLLphi-301 phase II trials . Here, we report extended follow-up of DeLLphi-300 (median follow-up, 12.1 months [range, 0.2-34.3]) in fully enrolled cohorts treated with tarlatamab ≥10 mg dose administered once every two weeks, once every three weeks, or once on day 1 and once on day 8 of a 21-day cycle (N = 152). Overall, the objective response rate (ORR) was 25.0%; the median duration of response (mDOR) was 11.2 months (95% CI
                            7
                            2023Journal of Clinical Oncology
                            Tarlatamab, a first-in-class DLL3-targeted bispecific T cell engager, in recurrent small-cell lung cancer: an open-label, phase 1 study. Small cell lung cancer (SCLC) is an aggressive malignancy with limited treatments. Delta-like ligand 3 (DLL3) is aberrantly expressed in most SCLC. Tarlatamab (AMG 757), a bispecific T cell engager molecule, binds both DLL3 and CD3 leading to T cell-mediated tumor lysis. Herein, we report phase 1 results of tarlatamab in patients with SCLC. This study evaluated tarlatamab in patients with relapsed/refractory SCLC. The primary endpoint was safety. Secondary endpoints included antitumor activity by modified RECIST 1.1, overall survival (OS), and pharmacokinetics. By July 19, 2022, 107 patients received tarlatamab in dose exploration (0.003 to 100 mg; n=73
                            8
                            2025Clinical Trials
                            A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC The primary objective of this study is to describe the antitumor activity of tarlatamab in participants with small cell lung cancer (SCLC).
                            9
                            2025Clinical Trials
                            Study of How Safe and Effective Tarlatamab is in Brain Cancers This is a phase 2 study to assess how useful study drug tarlatamab is for the treatment of patients with recurrent/refractory oligodendroglioma or astrocytoma with a mutation in the IDH gene. There will be 2 cohorts in the study. * Cohort 1, patients whose disease is amendable for resection will be treated with up to 3 cycles of tarlatamab prior to surgical resection. These patients can resume tarlatamab treatment post-operatively until disease progression at the discretion of the investigator. Up to 10 patients may be enrolled to Cohort 1.* Cohort 2, patients with progressive/refractory disease are eligible to receive tarlatamab at Q2W 10 mg dosing in 28 day cycles until documented disease progression, intolerable toxicity
                            10
                            2025Clinical Trials
                            Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms This study is being done to learn more about the drug tarlatamab in people with your condition. The purpose of this study is to see the efficacy (how well something works) of study treatment (tarlatamab) and whether it causes any side effects. Tarlatamab is being developed as an anti-cancer drug for tumors and is FDA-approved for extensive-stage small cell lung cancer. Tarlatamab is investigational for the purpose of this study. This is a phase II, multicenter, basket trial to evaluate the safety, tolerability, and efficacy of tarlatamab in DLL3-expressing tumors. The study will enroll patients with advanced tumors, other than small cell lung cancer or neuroendocrine prostate cancer
                            11
                            2025Clinical Trials
                            Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS) Extrapulmonary small cell carcinoma (EPSCC) or neuroendocrine carcinoma (NEC) is a rare but fatal disease. The prognosis of patients with advanced EPSCC or NEC failed platinum-etoposide chemotherapy is poor with median overall survival ranged 6 to 9 months. High expression levels of DLL3 has been demonstrated in many EPSCC or NEC. As tarlatamab, a bispecific T-cell engager with dual affinity for DLL3 on tumor cells and CD3 on T cells, has demonstrated clinically meaningful activity for patients with advanced small cell lung cancer. We thus hypothesize that tarlatamab also has clinically activity for patients with advanced EPSCC and NECs.
                            12
                            2025Clinical Trials
                            Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) with Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients from Adenocarcinoma After EGFR TKI Treatment The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma (ADC) with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase study was only 5.2 months and 5.1 months, despite the objective response rate showing 60.2% and 79%. This finding suggest further development of maintenance treatment strategy to prolonged longer duration of response to the treatment. In addition to the conventional treatment, Tarlatamab (AMG757), bispecific t-cell engager (BiTE), designed to engage DLL3 on SCLC and CD3 on T-cell has been tested
                            13
                            2025Clinical Trials
                            Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC) The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.
                            14
                            2025Clinical Trials
                            Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients This is a phase 2 single-arm, open-label clinical trial designed to evaluate the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma (EPNEC) who have previously received platinum-based first-line chemotherapy. Participants will receive tarlatamab on Cycle 1 Day 1 (C1D1), Day 8 (C1D8), and Day 15 (C1D15), followed by administration every two weeks thereafter. No placebo control is included in this study. 1. study rationale Extrapulmonary neuroendocrine carcinomas (EPNECs) are rare, aggressive malignancies with poor prognosis, lacking established second-line treatments. First-line therapy, adapted from small cell lung cancer (SCLC
                            15
                            2024PROSPERO
                            Efficacy and Safety of tarlatamab in recurrent small-Cell Lung Cancer: A systematic review and meta-anlaysis PROSPEROInternational prospective register of systematic reviews Print | PDFEfficacy and Safety of tarlatamab in recurrent small-Cell Lung Cancer: A systematic review and meta-anlaysisWasfi Alghwyeen, Toujan Alghwyeen, Rahaf khatibTo enable PROSPERO to focus on COVID-19 submissions . Efficacy and Safety of tarlatamab in recurrent small-Cell Lung Cancer: A systematic review and meta-anlaysis. PROSPERO 2024 CRD42024500170 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024500170Review questionOur review sets out to examine the efficacy and safety of tarlatamab in treating patients with recurrent small-sell lung cancer. Our patients are those
                            16
                            2024Clinical Trials
                            Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
                            17
                            2024Clinical Trials
                            Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308) The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
                            18
                            2024Clinical Trials
                            Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS). undefined
                            19
                            2023Clinical Trials
                            Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS). undefined
                            20
                            2023Clinical Trials
                            Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen). undefined