Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events.

IF 8.4 2区医学 Q1 ONCOLOGY

NPJ Breast Cancer Pub Date : 2026-06-26 DOI:10.1038/s41523-026-00971-8

Hope S Rugo, David W Cescon, Peter Schmid, Zbigniew Nowecki, Seock-Ah Im, Mastura Md Yusof, Carlos Gallardo, Hiroji Iwata, Oleg Lipatov, Felipe Cruz, Carlos Henrique Barrios, Roberto Hegg, Sherene Loi, Maria Gion, Marco Torregroza Otero, Péter Árkosy, Rafal Tarnawski, Lili Yao, Jaime Mejia, Wilbur Pan, Javier Cortés

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引用次数: 0

Abstract

Pembrolizumab plus chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in the phase 3 randomized KEYNOTE-355 study in participants with previously untreated, advanced triple-negative breast cancer (TNBC) with PD-L1 combined positive score (CPS) ≥ 10. Among participants with clinical benefit from pembrolizumab plus chemotherapy, discontinuation of chemotherapy before pembrolizumab for any reason was associated with similar median PFS and OS to that in the overall population. Additionally, we further characterized immune-mediated adverse events (AEs) in KEYNOTE-355. Most immune-mediated AEs were manageable with treatment interruption and supportive care. In participants treated with pembrolizumab plus chemotherapy with immune-mediated AEs, there appeared to be numerical improvement in efficacy. This analysis provides additional information on the use of pembrolizumab plus chemotherapy as standard-of-care therapy in patients with previously untreated, advanced TNBC with PD-L1 CPS ≥ 10. This trial is registered at ClinicalTrials.gov (NCT02819518; registration date, June 28, 2016).

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KEYNOTE-355在派姆单抗停药前化疗停药后和免疫介导的不良事件的结局。

在3期随机KEYNOTE-355研究中，在PD-L1联合阳性评分(CPS)≥10的未治疗晚期三阴性乳腺癌（TNBC）患者中，派姆单抗加化疗显著改善了无进展生存期（PFS）和总生存期（OS）。在从派姆单抗加化疗中获得临床获益的参与者中，在派姆单抗前因任何原因停止化疗与总体人群的中位PFS和OS相似。此外，我们在KEYNOTE-355中进一步表征了免疫介导的不良事件（ae）。大多数免疫介导的不良事件通过治疗中断和支持性护理是可控的。在接受派姆单抗联合免疫介导ae化疗的参与者中，疗效似乎有数值上的改善。该分析为PD-L1 CPS≥10的未治疗晚期TNBC患者使用派姆单抗加化疗作为标准治疗提供了额外信息。该试验已在ClinicalTrials.gov注册（NCT02819518，注册日期为2016年6月28日）。

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

NPJ Breast Cancer Medicine-Pharmacology (medical)

CiteScore

10.10

自引率

1.70%

发文量

122

审稿时长

9 weeks

期刊介绍： npj Breast Cancer publishes original research articles, reviews, brief correspondence, meeting reports, editorial summaries and hypothesis generating observations which could be unexplained or preliminary findings from experiments, novel ideas, or the framing of new questions that need to be solved. Featured topics of the journal include imaging, immunotherapy, molecular classification of disease, mechanism-based therapies largely targeting signal transduction pathways, carcinogenesis including hereditary susceptibility and molecular epidemiology, survivorship issues including long-term toxicities of treatment and secondary neoplasm occurrence, the biophysics of cancer, mechanisms of metastasis and their perturbation, and studies of the tumor microenvironment.