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SHR Neuro Cancer Cardio Lipid Metab Microb

Chiang, AC; Olmedo, Garcia, ME; Carlisle, JW; Dowlati, A; Reguart, N; Felip, E; Jost, PJ; Steeghs, N; Stec, R; Gadgeel, SM; Loong, HH; Jiang, W; Hamidi, A; Parkes, A; Paz-Ares, L.
Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy.
ESMO Open. 2025; 10(4):104538 Doi: 10.1016/j.esmoop.2025.104538 [OPEN ACCESS]
Web of Science PubMed PUBMED Central FullText FullText_MUG

 

Co-authors Med Uni Graz
Jost Philipp
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Abstract:
BACKGROUND: Tarlatamab, a bispecific T-cell engager immunotherapy targeting delta-like ligand 3, has demonstrated promising survival outcomes in small-cell lung cancer (SCLC). Given the risk of cytokine release syndrome (CRS), initial clinical trials incorporated 48-72-h inpatient monitoring in cycle 1. METHODS: Patients with previously treated SCLC were enrolled into DeLLphi-300 part F, which evaluated the safety of tarlatamab 10 mg every 2 weeks (Q2W) with 6-8-h outpatient monitoring following cycle 1 doses. The primary endpoint, safety, was compared with patients from DeLLphi-300 part A receiving tarlatamab 10 mg Q2W with 48-h inpatient monitoring for cycle 1 doses. RESULTS: In cycle 1, the rates of treatment-related adverse events and hospitalizations, including emergency room visits, were similar between outpatient (n = 30) and inpatient (n = 58) groups (93% versus 100% and 27% versus 34%, respectively). The incidence of all grade and serious CRS during cycle 1 was similar between outpatient and inpatient groups (any grade: 60% versus 62%; serious: 17% versus 22%). The median time to CRS resolution was 3 days for both groups. CONCLUSIONS: 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.

Find related publications in this database (Keywords)
small-cell lung cancer
tarlatamab
patient monitoring
safety
adverse events
cytokine release syndrome
outpatient
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