Imdelltra (tarlatamab-dlle) / Amgen, BeOne Medicines, Royalty - LARVOL DELTA

Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy. (PubMed, ESMO Open) - "Safety outcomes, including hospitalization rates, were similar in this first-in-human study following tarlatamab 10 mg Q2W administration with 6-8-h outpatient versus 48-h inpatient monitoring in cycle 1."

Journal • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. (PubMed, N Engl J Med) - 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.)."

Journal • Cough • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. (PubMed, Lancet Oncol) - P1, P3 | "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)."

Journal • P1 data • Hematological Disorders • Infectious Disease • Lung Cancer • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • DLL3

Safety evaluation of tarlatamab: A pharmacovigilance study based on the FAERS database. (PubMed, Lung Cancer) - "These findings offer critical insights for clinicians to identify and manage Tarlatamab-related AEs, highlighting underestimated risks and informing tailored practice."

Adverse events • Journal • Atrial Fibrillation • Cardiovascular • Hypertension • Hypotension • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304. (ASCO 2025) - P3 | "The DeLLphi-304 trial showed tarlatamab significantly improved OS, PFS, and PROs, with a favorable safety and tolerability profile compared to CTx in pts with SCLC that progressed on or after initial platinum-based CTx, defining a new standard of care for these patients. Clinical Trial Information: NCT05740566; Legal entity responsible: Amgen Inc.; Funding: Amgen Inc.; Editorial acknowledgement: Medical writing support for the development of this abstract was provided by Sukanya Raghuraman, PhD, of Cactus Life Sciences, part of Cactus Communications, and was funded by Amgen Inc. MD: mean difference; NE: not estimable; wks, weeks.*Topotecan (n=185), lurbinectedin (n=47), or amrubicin (n=23).†EORTC QLQ-C30 scale.‡EORTC QLQ-LC13 scale.§Non-significant."

Clinical • Late-breaking abstract • Anemia • Cough • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Tarlatamab as second-line (2L) treatment for small cell lung cancer (SCLC): Outcomes by chemotherapy-free interval (CFI) and prior PD-(L)1 inhibitor use in the phase III DeLLphi-304 trial (ESMO 2025) - P3 | "Methods Patients were randomised 1:1 to tarlatamab or CTx (topotecan, lurbinectedin, or amrubicin) Post hoc analysis was conducted for prespecified subgroups based on CFI (< 90 vs ≥ 90 days) and prior anti-PD-(L)1 use (yes vs no). Additionally, in contrast to CTx, the reduced risk of death and higher ORR with tarlatamab remained consistent even in platinum-resistant disease where prognosis has been especially poor, reinforcing tarlatamab as a standard of care for 2L SCLC. Table: LBA101 CFI Tarlatamab CTx Tarlatamab CTx < 90 days ≥ 90 days Efficacy n = 109 n = 114 n = 145 n = 141 Median OS, mos 10.9 6.4 17.1 10.6 HR (95% CI) 0.60 (0.43, 0.84) 0.65 (0.45, 0.93) Median PFS, mos 3.2 2.7 4.5 4.4 HR (95% CI) 0.71 (0.54, 0.94) 0.73 (0.56, 0.95) Safety n = 107 n = 109 n = 145 n = 135 Grade ≥ 3 TRAEs, % 30 58 24 66 TRAE leading to dose interruption or reduction, % 21 50 18 59 CRS, % 59 - 54 - Prior PD-(L)1 Yes No Efficacy n = 180 n = 180 n = 74 n = 75 Median OS, mos..."

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

309: Platform Research Presentations (HOPA 2026) - "Knowledge or Application Based: Knowledge UAN: 0465-0000-26-077-L01-P Learning Objectives: Identify common adverse reactions of bispecific T-cell engagers including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)Discuss the real-world rates of infusion-related reactions (IRR) in patients receiving pertuzumab or ado-trastuzumab emtansine for the treatment of breast cancerUpon completion, learners will be able to evaluate how communication gaps and support needs influence Black patients' and caregivers' understanding of biomarker testing, clinical trials, and navigation across the lung cancer care continuumDescribe incidence and risk factors for CMV reactivation in patients receiving bispecific antibodies for multiple myeloma Presenters: Alyssa Cendagorta, PharmD, BCOP; Jennifer Hutchinson, PharmD, BCOP; Shanada Monestime, PharmD, BCOP; : Jordan Snyder, PharmD, BCOP Hybrid Observation Model for Bispecific T-Cell..."

Breast Cancer • Hematological Malignancies • Infectious Disease • Lung Cancer • Multiple Myeloma • Solid Tumor

TARLANEC: Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs) (clinicaltrials.gov) - P3 | N=129 | Recruiting | Sponsor: Intergroupe Francophone de Cancerologie Thoracique | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2030 ➔ Aug 2030 | Initiation date: Sep 2025 ➔ Feb 2026 | Trial primary completion date: Sep 2028 ➔ Feb 2029

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Endocrine Cancer • Gastrointestinal Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

T-BRAIN: Tarlatamab for SCLC Brain Metastases (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: Maastricht University Medical Center

New P2 trial • Brain Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Safety and Survival Update of Tarlatamab with Anti-PD-L1 as 1L Maintenance After Chemo-IO for ES-SCLC: DeLLphi-303 Ph1b Trial (IASLC-WCLC 2025) - P1, P3 | "Methods : Patients with ES-SCLC were eligible if they had completed 4 to 6 cycles of 1L platinum-etoposide chemotherapy and anti-PD-L1 (unless unavailable) without disease progression. Within 8 weeks from the start of the last chemo-immunotherapy cycle, patients received tarlatamab (10 mg IV Q2W) with either atezolizumab (1680 mg IV Q4W) or durvalumab (1500 mg IV Q4W) as 1L maintenance until disease progression...The median OS was 25.3 months (95% CI, 20.3-not reached) and the median PFS was 5.6 months (95% CI, 3.5-9.0) (Figure). Conclusions Tarlatamab in combination with anti-PD-L1 demonstrated an acceptable safety profile, with long-term tolerability and unprecedented OS."

Clinical • Lung Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

Detailed safety analysis of DeLLphi-304: The first phase III study to evaluate tarlatamab versus chemotherapy for previously treated small cell lung cancer (ESMO 2025) - P3 | "Methods Pts were randomized to tarlatamab or chemotherapy (CTx: topotecan, lurbinectedin, or amrubicin). Conclusions In the DeLLphi-304 trial, tarlatamab demonstrated a predictable and manageable safety profile in 2L SCLC, with no new safety signals identified. Table: LBA100 Treatment-related adverse events TRAE Tarlatamab (n = 252) CTx (n = 244) All Grades Grade ≥3 All Grades Grade ≥3 Anemia 19.8% 2.0% 61.5% 27.9% Neutropenia 7.5% 4.4% 29.5% 22.1% Thrombocytopenia 3.2% 0.4% 23.8% 11.8% Infection 6.3% 1.2% 15.2% 8.6%"

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer • DLL3

Initial Experience with Tarlatamab in Patients with SCLC and at least two previous lines of therapy (DKK 2026) - No abstract available

Clinical • Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Safety and Efficacy of Tarlatamab for SCLC in a Liver Transplant Recipient (DKK 2026) - No abstract available

Clinical • Lung Cancer • Small Cell Lung Cancer • Solid Tumor • Transplantation

Amgen...announced financial results for the fourth quarter and full year of 2025 versus the comparable periods in 2024. (PRNewswire) - "Nplate (romiplostim) sales increased 14% year-over-year to $385 million in the fourth quarter...IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) generated $234 million of sales in the fourth quarter....MVASI (bevacizumab-awwb) sales increased 9% year-over-year to $188 million in the fourth quarter..."

Sales • Cervical Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Glioblastoma • Immune Thrombocytopenic Purpura • Non Small Cell Lung Cancer • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer

Outpatient Administration of Bispecific Therapies in a Community Oncology Setting (TCT-ASTCT-CIBMTR 2026) - "Most adverse events are managed at home with oral dexamethasone and Tylenol, with IV dexamethasone or tocilizumab availability at the clinic. 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."

Clinical • CNS Disorders • Endocrine Disorders • Hematological Malignancies • Metabolic Disorders • Solid Tumor

Real-World Time Toxicity of Tarlatamab in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (IASLC-TTLC 2026) - "Supportive measures managed most cases; however, tocilizumab and anakinra were needed in 3 and 1 RW patients, respectively. RW patients had a significantly shorter time on treatment and twice as many Healthcare Days compared to trial participants, reflecting the higher disease burden, comorbidities, and lower performance status typical of RW populations. 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."

Clinical • Real-world • Real-world evidence • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Tarlatamab (IASLC-TTLC 2026) - No abstract available

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Tarlatamab with first-line chemoimmunotherapy for extensive stage small cell lung cancer (ES-SCLC): DeLLphi-303 study (ESMO 2025) - P1 | "c Fatal TRAE of septic shock related to platinum-etoposide chemotherapy. Conclusions The combination of tarlatamab with chemo-IO for 1L treatment of ES-SCLC demonstrated manageable safety with encouraging initial survival outcomes, supporting further investigation of this combination in the phase III DeLLphi-312 study."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

MERLIN: Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients (clinicaltrials.gov) - P2 | N=37 | Recruiting | Sponsor: Fundación GECP | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

Flare Reaction following Tarlatamab Treatment in a Patient with Extensive-Stage Small Cell Lung Cancer: Case Report. (PubMed, Case Rep Oncol) - "Our findings suggest that flare reaction occurs within days of initiating tarlatamab, possibly attributable to acute immune activation, as reported in BiTE therapies. Awareness of this possibility may help avoid premature discontinuation of effective treatment."

Journal • Lung Cancer • Oncology • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • DLL3

Real-World Safety and Outcomes of Tarlatamab in Extensive-Stage Small Cell Lung Cancer (IASLC-TTLC 2026) - "Primary endpoints included the 15-day incidence of cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), tocilizumab use, and mortality...Nearly all patients received prior etoposide (99%), and many had prior immunotherapy exposure (atezolizumab 59%; durvalumab 24%); 26% received lurbinectedin...At 6 months, 117 patients had died (34.8%), and only 27 patients (8%) received subsequent systemic therapy, most commonly platinum agents, irinotecan, or topotecan... Tarlatamab demonstrated a safety profile and clinical outcomes comparable to those reported in the DeLLphi-304 trial. The limited use of subsequent therapies after progression underscores the critical need for improved post-tarlatamab treatment options in extensive-stage SCLC."

Clinical • Real-world • Real-world evidence • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Management of Pulmonary Large-Cell Neuroendocrine Carcinoma (LCNEC): An Updated Review. (PubMed, Clin Lung Cancer) - "For unresectable, locally advanced disease, concurrent chemoradiation with etoposide-cisplatin followed by consolidation durvalumab is recommended, although the optimal dose-fractionation and the duration of consolidation immunotherapy remain to be investigated. Among the most promising emerging treatment strategies are DLL3-targeting therapies, buoyed by the recent success of tarlatamab in SCLC. The evolving role of molecular profiling in prognostication and treatment decision-making is also examined."

Journal • Review • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

SCLC Outcomes and Real-World Insight with Tarlatamab, a Multi-Center Experience (IASLC-TTLC 2026) - "After tarlatamab, 9 patients received lurbinectedin, 2 topotecan, 2 irinotecan and 1 cisplatin/etoposide. 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."

Clinical • Real-world • Real-world evidence • Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Structural and functional insights into CD3 bispecific antibodies targeting DLL3 in cancer immunotherapy. (PubMed, Med Oncol) - "This study systematically characterized three clinical-stage CD3×DLL3 BsAbs, Tarlatamab (AMG757), BI764532 and HPN328, via structural modeling, T-cell activation assays, cytokine profiling, and tumor cytotoxicity tests. BI764532 demonstrated a balanceed efficacy (ORR 18% in SCLC), while Tarlatamab achieved an ORR range of 13-40% across clinical trials. IS distance and epitope binding are strongly correlated with efficacy and safety of DLL3-targeted BsAbs, providing a critical framework for optimizing T-cell engager design in cancer immunotherapy."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Patient-reported outcomes (PROs) from DeLLphi-304: The first phase III trial evaluating tarlatamab and chemotherapy (CTx) in patients (Pts) with previously treated small cell lung cancer (SCLC) (ESMO 2025) - P3 | "Methods Pts were randomized to receive tarlatamab or CTx (topotecan, lurbinectedin or amrubicin) until disease progression. Conclusions Tarlatamab treatment delayed deterioration in cancer-related symptoms with a favorable benefit-risk profile and clinically meaningful improvements in quality of life. These findings reinforce tarlatamab as the new standard of care."

Clinical • P3 data • Patient reported outcomes • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3