Safety and efficacy of tiragolumab, atezolizumab and chemotherapy for early-stage or PD-L1-positive advanced triple-negative breast cancer: a phase Ib study
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 re...
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| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
December 2025
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| In: |
ESMO open
Year: 2025, Volume: 10, Issue: 12, Pages: 1-11 |
| ISSN: | 2059-7029 |
| DOI: | 10.1016/j.esmoop.2025.105869 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.esmoop.2025.105869 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S2059702925017387 
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| Author Notes: | S. Kuemmel, K.H. Jung, L. Andrade, D. Assad-Suzuki, L. de la Cruz Merino, R. Freitas-Junior, R. Hegg, C.-S. Huang, H. Martin, A. Schneeweiss, M. Dieterich, A. Nguyen Duc, Y. Feng, R. Meng, A. Swat, A. Seiller, B. Bermejo & E.P. Hamilton |
| Summary: | 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 B (n = 42), carboplatin was associated with more haematological effects but no increase in pathologic complete response rate [arm A: 46% (95% CI 24% to 68%); arm B: 55% (95% CI 32% to 77%)]. Adverse events led to treatment discontinuation in 23% and 20% of patients in arms A and B, respectively. - Conclusions - The activity of tiragolumab-containing regimens appeared similar to that of atezolizumab plus chemotherapy in randomised phase III trials in early-stage and advanced TNBC. The safety profile of all three regimens was consistent with previous experience of similar regimens in other tumour types and with symptoms of the underlying disease. - Clinical trial registration - ClinicalTrials.gov NCT04584112. |
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| Item Description: | Online verfügbar: 25. November 2025 Gesehen am 04.03.2026 |
| Physical Description: | Online Resource |
| ISSN: | 2059-7029 |
| DOI: | 10.1016/j.esmoop.2025.105869 |