SAFFRON-103: a phase Ib study of sitravatinib plus tislelizumab in anti-PD-(L)1 refractory/resistant advanced melanoma.

IF 2.7 4区医学 Q3 IMMUNOLOGY

Immunotherapy Pub Date : 2024-03-01 Epub Date: 2024-01-10 DOI:10.2217/imt-2023-0130

Xuan Wang, Hongming Pan, Jiuwei Cui, Xiao Chen, Won-Hee Yoon, Matteo S Carlino, Xin Li, Hui Li, Juan Zhang, Jingchao Sun, Jun Guo, Chuanliang Cui

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引用次数: 0

Abstract

Aim: Investigate TKI sitravatinib plus anti-PD-1 antibody tislelizumab in patients with unresectable/advanced/metastatic melanoma with disease progression on/after prior first-line anti-PD-(L)1 monotherapy. Methods: Open-label, multicenter, multicohort study (NCT03666143). Patients in the melanoma cohort (N = 25) received sitravatinib once daily plus tislelizumab every 3 weeks. The primary end point was safety and tolerability. Results: Treatment-emergent adverse events (TEAEs) occurred in all patients, with ≥grade 3 TEAEs in 52.0%. Most TEAEs were mild-or-moderate in severity, none were fatal, and few patients discontinued treatment owing to TEAEs (12.0%). Objective response rate was 36.0% (95% CI: 18.0-57.5). Median progression-free survival was 6.7 months (95% CI: 4.1-not estimable). Conclusion: Sitravatinib plus tislelizumab had manageable safety/tolerability in patients with anti-PD-(L)1 refractory/resistant unresectable/advanced/metastatic melanoma, with promising antitumor activity. Clinical Trial Registration: NCT03666143 (ClinicalTrials.gov).

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SAFFRON-103：西曲替尼联合替赛珠单抗治疗抗PD-(L)1难治/耐药晚期黑色素瘤的Ib期研究。

目的：研究TKI西曲替尼联合抗PD-1抗体tislelizumab用于既往接受过一线抗PD-(L)1单药治疗且疾病进展的不可切除/晚期/转移性黑色素瘤患者。研究方法开放标签、多中心、多队列研究（NCT03666143）。黑色素瘤队列中的患者（N = 25）每天接受一次西曲拉替尼治疗，每3周加用一次替赛珠单抗。主要终点是安全性和耐受性。研究结果所有患者都发生了治疗突发不良事件（TEAEs），52.0%的患者发生了≥3级的TEAEs。大多数 TEAE 的严重程度为轻度或中度，无死亡病例，因 TEAE 而中断治疗的患者很少（12.0%）。客观反应率为36.0%（95% CI：18.0-57.5）。中位无进展生存期为 6.7 个月（95% CI：4.1-无法估计）。结论在抗PD-(L)1难治/耐药的不可切除/晚期/转移性黑色素瘤患者中，西曲伐替尼联合替赛珠单抗具有可控的安全性/耐受性，并具有良好的抗肿瘤活性。临床试验注册：NCT03666143（ClinicalTrials.gov）。

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

Immunotherapy 医学-免疫学

CiteScore

5.00

自引率

3.60%

发文量

113

审稿时长

6-12 weeks

期刊介绍： Many aspects of the immune system and mechanisms of immunomodulatory therapies remain to be elucidated in order to exploit fully the emerging opportunities. Those involved in the research and clinical applications of immunotherapy are challenged by the huge and intricate volumes of knowledge arising from this fast-evolving field. The journal Immunotherapy offers the scientific community an interdisciplinary forum, providing them with information on the most recent advances of various aspects of immunotherapies, in a concise format to aid navigation of this complex field. Immunotherapy delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this vitally important area of research. Unsolicited article proposals are welcomed and authors are required to comply fully with the journal''s Disclosure & Conflict of Interest Policy as well as major publishing guidelines, including ICMJE and GPP3.