Safety and efficacy of tiragolumab, atezolizumab and chemotherapy for early-stage or PD-L1-positive advanced triple-negative breast cancer: a phase Ib study

作者：Sherko Küemmel, Kyung Hae Jung, Laise Rodrigues de Andrade, Daniele Xavier Assad, Luis de la Cruz‐Merino, Ruffo Freitas‐Júnior, Roberto Hegg, C.-S. Huang, Hilary Martin, Andreas Schneeweiß, Max Dieterich, Anh Nguyen Duc, Yanqiu Feng, Ran Meng, Aneta Swat, Alexandre Seiller, Begoña Bermejo, Erika Hamilton · 发表于：ESMO Open · 年份：2025 · DOI：10.1016/j.esmoop.2025.105869 · 被引用次数：1 · 研究领域：HER2/EGFR in Cancer Research、Cancer Immunotherapy and Biomarkers、Immunotherapy and Immune Responses

BACKGROUND: Immune checkpoint inhibitors have transformed the management of triple-negative breast cancer (TNBC) but outcomes could be improved further. We explored combining the T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) inhibitor tiragolumab with atezolizumab-containing regimens for patients with early-stage or advanced TNBC. PATIENTS AND METHODS: This multinational open-label phase Ib study included two cohorts. In cohort A [programmed death-ligand 1 (PD-L1)-positive advanced TNBC], patients received first-line tiragolumab with atezolizumab and nab-paclitaxel. The primary endpoint was confirmed objective response rate. In cohort B (early-stage TNBC, irrespective of PD-L1 status), patients were randomised to receive tiragolumab, atezolizumab and sequential taxane- and anthracycline-based neoadjuvant therapy with (arm A) or without (arm B) carboplatin. The primary objective was to evaluate safety in arm A versus arm B. RESULTS: Between September 2020 and October 2021, 83 patients were enrolled from 24 sites in eight countries. In cohort A (n = 41), the confirmed objective response rate was 54% [95% confidence interval (CI) 37% to 69%], median duration of response in 22 responding patients was 7.2 months (95% CI 4.9-13.1 months), median progression-free survival was 6.5 months (95% CI 5.4-9.0 months) and median overall survival was 24.6 months (95% CI 14.7 months-not estimable). Five patients (12%) discontinued tiragolumab for adverse events. In cohort...