Tumor infiltrating lymphocytes as a predictor of adjuvant avelumab efficacy in patients with high-risk triple negative breast cancer.

Authors

Maria Vittoria Dieci, Elisa Gasparini, Lorenzo Nicolè, Peter Schmid, Alberto Zambelli, Adolfo Favaretto, Federico Piacentini, Giulia Valeria Bianchi, Marta Mion, Antonella Ferro, Grazia Arpino, Alessandra Emiliani, Saverio Cinieri, Claudio Zamagni, Alessandra Gennari, Simon Spazzapan, Donata Sartori, Fable Zustovich, Stefano Tamberi, Lucia Del Mastro, Michelino De Laurentiis, Antonino Musolino, Katia Cagossi, Daniele Generali, Tommaso Giarratano, Filippo Giovanardi, Gian Luca De Salvo, Pierfranco Conte, Valentina Guarneri

Published in

Clinical cancer research : an official journal of the American Association for Cancer Research. Jul 17, 2026. Epub Jul 17, 2026.

Abstract

We aimed to investigate the prognostic and predictive value of tumor infiltrating lymphocytes (TILs) for adjuvant immunotherapy in high-risk early TNBC.
The phase III A-BRAVE trial randomized 466 patients with high-risk early TNBC to adjuvant avelumab or observation after standard therapy. Inclusion criteria allowed two strata: Stratum A (primary surgery followed by adjuvant chemotherapy, defined at high risk based on pathological stage) and Stratum B (neoadjuvant chemotherapy followed by surgery without pathological complete response). TILs were centrally assessed on treatment-naive tumor samples (BSL-TILs) and on residual disease after neoadjuvant chemotherapy (RD-TILs, Stratum B). Residual cancer burden (RCB) was assessed in Stratum B. Survival endpoints were: disease-free survival (DFS), distant disease-free survival (DDFS), and overall survival (OS).
BSL-TILs were available for 387 patients, RD-TILs for 330 patients (290 with both BSL-TILs and RD-TILs). Higher BSL-TILs were independently associated with improved outcomes across all endpoints. In Stratum B, higher RD-TILs showed a significant independent association with improved outcomes, outperforming BSL-TILs. RCB was also independently prognostic. Avelumab improved outcomes only for patients with BSL-TILs ≥30%, particularly in Stratum B (3-yr DDFS rates 92.0% vs 58.7%, HR 0.20 in high BSL-TILs and 70.4% vs 70.1%, HR 0.92 in low BSL-TILs, interaction p=0.019). Similar results for DFS and OS. RCB was not predictive for avelumab benefit.
TILs may predict benefit from adjuvant immunotherapy in early TNBC. These findings warrant validation and support TILs-guided immunotherapy strategies in future trials.
NCT02926196.

PMID:
42467210
Bibliographic data and abstract were imported from PubMed on 17 Jul 2026.

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