Chiang A C, Olmedo Garcia M E, Carlisle J W, Dowlati A, Reguart N, Felip E, Jost P J, Steeghs N, Stec R, Gadgeel S M, Loong H H, Jiang W, Hamidi A, Parkes A, Paz-Ares L
Division of Thoracic Medical Oncology, Yale University School of Medicine, New Haven, USA.
Department of Medical Oncology, Ramón y Cajal University Hospital, Madrid, Spain.
ESMO Open. 2025 Apr;10(4):104538. doi: 10.1016/j.esmoop.2025.104538. Epub 2025 Apr 4.
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.
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.
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.
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.
Tarlatamab是一种靶向δ样配体3的双特异性T细胞衔接免疫疗法，在小细胞肺癌（SCLC）中已显示出有前景的生存结果。鉴于存在细胞因子释放综合征（CRS）风险，最初的临床试验在第1周期纳入了48 - 72小时的住院监测。
既往接受过治疗的SCLC患者被纳入DeLLphi - 300研究的F部分，该部分评估了每2周（Q2W）给予10 mg Tarlatamab并在第1周期剂量后进行6 - 8小时门诊监测的安全性。主要终点为安全性，与DeLLphi - 300研究A部分中接受每2周10 mg Tarlatamab并在第1周期剂量进行48小时住院监测的患者进行比较。
在第1周期，门诊组（n = 30）和住院组（n = 58）之间与治疗相关的不良事件和住院率（包括急诊就诊）相似（分别为93%对100%和27%对34%）。第1周期门诊组和住院组所有级别和严重CRS的发生率相似（任何级别：60%对62%；严重：17%对22%）。两组CRS缓解的中位时间均为3天。
在这项首次人体研究中，第1周期每2周给予10 mg Tarlatamab并进行6 - 8小时门诊监测与48小时住院监测相比，包括住院率在内的安全性结果相似。
