Real-World Implementation of Tarlatamab-Dlle Therapy for Patients With Extensive-Stage Small Cell Lung Cancer and...

Tarlatamab-dlle, a bispecific T-cell engager targeting delta-like ligand 3 (DLL3) for relapsed small cell lung cancer (SCLC), requires hospitalization and observation for 24 hours after the first two doses because of the risk of cytokine release syndrome (CRS). Here, we describe the initial experience with an outpatient tarlatamab program at Winship Cancer Institute.

Patients received tarlatamab in the outpatient infusion center followed by observation in an outpatient oncology immediate care center (ICC) on-site to complete the 24-hour monitoring for CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). Patients were hospitalized if they developed ≥grade 2 CRS or ICANS based on American Society for Transplantation and Cellular Therapy consensus grading. Demographics, disease characteristics, treatment history, toxicities, and outcomes were abstracted from the electronic medical record. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method.

From June 2024 to September 2025, 49 patients with SCLC were treated on the outpatient protocol. Ten patients required admission from the ICC during the first two cycles because of CRS/ICANS (CRS: 3, ICANS: 4, both: 2, uncontrolled hypertension: 1). CRS/ICANS was observed in 25 patients, two (4.1%) experienced grade 3 CRS, and three (6.1%) experienced grade 3 ICANS. Of the 43 patients evaluable for efficacy, investigator-assessed radiographic partial response was observed in 17 patients, and stable disease in 10 patients. With a median follow-up of 6.94 months (95% CI, 5.03 to 11.34), the estimated median PFS was 3.7 months (95% CI, 2.7 to 5.2) and the median OS was 7.1 (95% CI, 4.9 to 9.3) months.

Outpatient administration of tarlatamab is safe and feasible with appropriate monitoring.