Role of tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer treated with KEYNOTE-522 in real-world setting

Tumor-infiltrating lymphocytes (TILs) are established prognostic and predictive biomarkers in early-stage triple-negative breast cancer (eTNBC), yet their role in patients treated with the KEYNOTE-522 (KN522) regimen remains underexplored. The Neo-Real/GBECAM-0123 study is a real-world cohort of patients with early-stage TNBC treated with pembrolizumab plus neoadjuvant chemotherapy across Brazil and Argentina since 2020; we evaluated baseline stromal TILs (<30%, 30–49%, or ≥50%) as predictors of pathologic complete response (pCR, primary endpoint) and event-free survival (EFS, secondary endpoint). Among 248 patients, TILs were <30% in 72.6%, 30–49% in 12.9%, and ≥50% in 14.5%. pCR rose with increasing TILs: 59%, 65.6%, and 91.4% ( P = 0.001). In multivariable analysis, TILs ≥50% (OR 6.96, 95% CI 1.89–25.65, P = 0.004) and Ki-67 ≥ 50% (OR 4.89, 95% CI 2.31–10.33, P < 0.001) independently predicted pCR; virtually all patients with both TILs ≥50% and Ki-67 ≥ 50% achieved pCR ( n = 26/27, 96.3%). Among patients with pCR, 2-year EFS was uniformly high across TIL groups (97.0%, 95.2%, 93.2%; P = 0.828); among those with residual disease, EFS trended higher with increasing TILs (73.3%, 90.0%, 100%; P = 0.350), non-significant. Baseline TILs, especially with Ki-67, emerged as a strong predictor of pCR in this real-world eTNBC cohort treated with KN522, supporting their systematic assessment in future studies.

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Journal
npj Breast Cancer
Published
2026-08-14
DOI
https://doi.org/10.1038/s41523-026-01031-x
Primary Topic
Retinoids in leukemia and cellular processes
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article
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article

Role of tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer treated with KEYNOTE-522 in real-world setting

Mariana Carvalho Gouveia, Zenaide Silva de Souza, Carlos Henrique dos Anjos, Maria gimena Ferreira et al.
npj Breast Cancer
Retinoids in leukemia and cellular processes
article

Role of tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer treated with KEYNOTE-522 in real-world setting

Mariana Carvalho Gouveia, Zenaide Silva de Souza, Carlos Henrique dos Anjos, Maria gimena Ferreira, Isadora Martins de Sousa, Natália Cristina Cardoso Nunes, Constanza Pérez de la Puente, Daniela Dornelles Rosa, S.M. Sanches, Débora De Melo Gagliato, Rafael Dal Ponte Ferreira, Daniele Assad-Suzuki, Fernanda Madasi, Flávia Cavalcanti Balint, Maria Marcela Fernandes Monteiro, Renata Colombo Bonadio, Matheus de Oliveira Andrade, C. L. Santos, A. U. Gomes, A. C. Ferrari, Mariana Ribeiro Monteiro, Maira Tavares, Noele de Jesus Barros Gomes, Gilmara Resende, Federico Waisberg, Monique Celeste Tavares, Bruna M. Zucchetti, Paulo M. Hoff, Laura Testa, Mayana Lopes de Brito, Romualdo Barroso-Sousa, Jose Bines, Vanesa Lopez, Maria del Pilar Estevez-Diz
article en

Abstract

Tumor-infiltrating lymphocytes (TILs) are established prognostic and predictive biomarkers in early-stage triple-negative breast cancer (eTNBC), yet their role in patients treated with the KEYNOTE-522 (KN522) regimen remains underexplored. The Neo-Real/GBECAM-0123 study is a real-world cohort of patients with early-stage TNBC treated with pembrolizumab plus neoadjuvant chemotherapy across Brazil and Argentina since 2020; we evaluated baseline stromal TILs (<30%, 30–49%, or ≥50%) as predictors of pathologic complete response (pCR, primary endpoint) and event-free survival (EFS, secondary endpoint). Among 248 patients, TILs were <30% in 72.6%, 30–49% in 12.9%, and ≥50% in 14.5%. pCR rose with increasing TILs: 59%, 65.6%, and 91.4% ( P = 0.001). In multivariable analysis, TILs ≥50% (OR 6.96, 95% CI 1.89–25.65, P = 0.004) and Ki-67 ≥ 50% (OR 4.89, 95% CI 2.31–10.33, P < 0.001) independently predicted pCR; virtually all patients with both TILs ≥50% and Ki-67 ≥ 50% achieved pCR ( n = 26/27, 96.3%). Among patients with pCR, 2-year EFS was uniformly high across TIL groups (97.0%, 95.2%, 93.2%; P = 0.828); among those with residual disease, EFS trended higher with increasing TILs (73.3%, 90.0%, 100%; P = 0.350), non-significant. Baseline TILs, especially with Ki-67, emerged as a strong predictor of pCR in this real-world eTNBC cohort treated with KN522, supporting their systematic assessment in future studies.

npj Breast Cancer
Universidade de São Paulo (BR), Instituto Nacional de Pesquisas da Amazônia (BR), AC Camargo Hospital (BR), Hospital Moinhos de Vento (BR), Instituto do Câncer do Estado de São Paulo (BR), Instituto Argentino de Diagnóstico y Tratamiento (AR), Hospital Samaritano de São Paulo (BR), Hospital Santa Paula (BR), D’Or Institute for Research and Education (BR), Grupo Ibmec Educacional (BR), Beneficência Portuguesa de São Paulo (BR), Hospital Haroldo Juaçaba (BR), Grupo Hospitalar Conceição (BR), Hospital Universitário de Brasília (BR), Hospital Ana Nery (BR), Hospital Sírio-Libanês (BR), Hospital São Domingos (BR)
Good health and well-being
Openalex Percentile: Top 16%
Retinoids in leukemia and cellular processes
DOIOpen Access PDFOpenAlex
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