Journal Article
. 2020 Jul; 11(1):3584.
doi: 10.1038/s41467-020-17414-y.

Exhausted T cell signature predicts immunotherapy response in ER-positive breast cancer

Manuela Terranova-Barberio 1 Nela Pawlowska 1 Mallika Dhawan 1 Mark Moasser 1 Amy J Chien 1 Michelle E Melisko 1 Hope Rugo 1 Roshun Rahimi 1 Travis Deal 1 Adil Daud 1 Michael D Rosenblum 2 Scott Thomas 1 Pamela N Munster 3 
  • PMID: 32681091
  •     50 References
  •     34 citations


Responses to immunotherapy are uncommon in estrogen receptor (ER)-positive breast cancer and to date, lack predictive markers. This randomized phase II study defines safety and response rate of epigenetic priming in ER-positive breast cancer patients treated with checkpoint inhibitors as primary endpoints. Secondary and exploratory endpoints included PD-L1 modulation and T-cell immune-signatures. 34 patients received vorinostat, tamoxifen and pembrolizumab with no excessive toxicity after progression on a median of five prior metastatic regimens. Objective response was 4% and clinical benefit rate (CR + PR + SD > 6 m) was 19%. T-cell exhaustion (CD8+ PD-1+/CTLA-4+) and treatment-induced depletion of regulatory T-cells (CD4+ Foxp3+/CTLA-4+) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder. Tumor lymphocyte infiltration was 0.17%. Only two non-responders had PD-L1 expression >1%. This data defines a novel immune signature in PD-L1-negative ER-positive breast cancer patients who are more likely to benefit from immune-checkpoint and histone deacetylase inhibition (NCT02395627).

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