在tarlatamab用于既往治疗过的小细胞肺癌的2期DeLLphi-301研究中对患者进行的亚洲亚组分析。

Asian Subgroup Analysis of Patients in the Phase 2 DeLLphi-301 Study of Tarlatamab for Previously Treated Small Cell Lung Cancer.

作者信息

Ahn Myung-Ju, Cho Byoung Chul, Ohashi Kadoaki, Izumi Hiroki, Lee Jong-Seok, Han Ji-Youn, Chiang Chi-Lu, Huang Shuang, Hamidi Ali, Mukherjee Sujoy, Xu Krista Lin, Akamatsu Hiraoki

机构信息

Hematology-Oncology Department, Samsung Medical Center (SMC), Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Medical Oncology Department-501, ABMRC, Yonsei University, Seoul, Republic of Korea.

出版信息

Oncol Ther. 2025 Sep 4. doi: 10.1007/s40487-025-00372-0.

DOI:10.1007/s40487-025-00372-0

PMID:40908346

Abstract

INTRODUCTION

Tarlatamab is a bispecific T-cell engager (BiTE) immunotherapy that binds delta-like ligand 3 on the surface of small cell lung cancer (SCLC) cells and CD3 on T cells, facilitating T cell-mediated cancer cell lysis. In the primary analysis of the phase 2 DeLLphi-301 study (NCT05060016), tarlatamab showed a favourable benefit-to-risk profile with durable objective responses and promising survival outcomes in patients with previously treated SCLC. Here, phase 2 data for the Asia region subgroup are presented.

METHODS

Patients with previously treated, advanced SCLC received 10 mg tarlatamab every 2 weeks. The primary endpoint was objective response rate (ORR) by blinded independent central review (RECIST version 1.1). Key secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety. The present analysis includes patients enrolled at sites in Asia.

RESULTS

A total of 43 patients were enrolled at sites in Asia. ORR was 46.3% (95% confidence interval [CI], 30.7-62.6) and median DOR was 7.2 months (95% CI 3.9 to not estimable). The median follow-up was 16.6 months for PFS and 21.2 months for OS. Median PFS was 5.4 months (95% CI 3.0-8.1) and median OS was 19.0 months (95% CI 11.4 to not estimable). The most common treatment-emergent adverse event (AE) was cytokine release syndrome (48.8%), and all such events were grade 1 or 2. There were no discontinuations due to treatment-related AEs.

CONCLUSIONS

Tarlatamab demonstrated durable responses and promising survival outcomes with a manageable safety profile in this post hoc analysis of patients from Asia with previously treated SCLC.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT05060016.

摘要

引言

塔勒妥单抗是一种双特异性T细胞衔接器（BiTE）免疫疗法，可结合小细胞肺癌（SCLC）细胞表面的δ样配体3和T细胞上的CD3，促进T细胞介导的癌细胞裂解。在2期DeLLphi-301研究（NCT05060016）的初步分析中，塔勒妥单抗显示出良好的风险效益比，在先前接受过治疗的SCLC患者中具有持久的客观缓解和有前景的生存结果。在此，我们展示亚洲地区亚组的2期数据。

方法

先前接受过治疗的晚期SCLC患者每2周接受10mg塔勒妥单抗治疗。主要终点是由盲法独立中央审查（RECIST 1.1版）评估的客观缓解率（ORR）。关键次要终点包括缓解持续时间（DOR）、无进展生存期（PFS）、总生存期（OS）和安全性。本分析纳入了在亚洲各研究点入组的患者。

结果

亚洲各研究点共纳入43例患者。ORR为46.3%（95%置信区间[CI]，30.7 - 62.6），中位DOR为7.2个月（95% CI 3.9至无法估计）。PFS的中位随访时间为16.6个月，OS为21.2个月。中位PFS为5.4个月（95% CI 3.0 - 8.1），中位OS为19.0个月（95% CI 11.4至无法估计）。最常见的治疗中出现的不良事件（AE）是细胞因子释放综合征（48.8%），所有此类事件均为1级或2级。没有因治疗相关AE而停药的情况。