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

IF 3.2 Q2 ONCOLOGY

Oncology and Therapy Pub Date : 2025-09-04 DOI:10.1007/s40487-025-00372-0

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

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引用次数: 0

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.

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Tarlatamab治疗小细胞肺癌的2期delphi -301研究的亚洲亚组分析

Tarlatamab是一种双特异性T细胞接合剂（BiTE®）免疫疗法，它结合小细胞肺癌（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delphi301研究（NCT05060016）的初步分析中，tarlatamab在既往治疗过的SCLC患者中显示出良好的获益风险比，具有持久的客观反应和有希望的生存结果。这里给出了亚洲地区子组的第二阶段数据。方法：先前接受过治疗的晚期SCLC患者每2周接受10mg塔拉他单抗治疗。主要终点是盲法独立中心评价（RECIST version 1.1）的客观缓解率（ORR）。关键次要终点包括反应持续时间（DOR）、无进展生存期（PFS）、总生存期（OS）和安全性。本分析包括在亚洲地区登记的患者。结果：共有43名患者在亚洲地区入组。ORR为46.3%(95%可信区间[CI]， 30.7-62.6)，中位DOR为7.2个月（95% CI 3.9至不可估计）。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至不可估计）。最常见的治疗不良事件（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。没有因治疗相关不良事件而中断治疗。结论：在对亚洲既往治疗过的SCLC患者的事后分析中，Tarlatamab显示出持久的反应和有希望的生存结果，具有可管理的安全性。试验注册：ClinicalTrials.gov, NCT05060016。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncology and Therapy ONCOLOGY-

CiteScore

3.40

自引率

0.00%

发文量

审稿时长

6 weeks

期刊介绍： Now indexed in PubMed Aims and Scope Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of clinical therapies. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts. Digital features and plain language summaries Oncology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. 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All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). 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