Abstract
We previously showed the feasibility and immunologic effects of multivalent peri-lymphatic cytokine injection (IRX-2) in early-stage breast cancer. We now report outcomes of a pilot evaluation of IRX-2 + pembrolizumab induction preceding neoadjuvant chemo-immunotherapy in triple-negative breast cancer (TNBC). Single-cycle induction was associated with radiographic tumor regression, tumor necrosis, immune infiltration, and high pathologic complete response rate following platinum-sparing chemo-immunotherapy. Further investigation of peri-lymphatic cytokines in TNBC is warranted.
Data availability
Deidentified datasets generated and analyzed in this study may be available from the corresponding author upon reasonable request. However, these datasets are not publicly available to respect subject confidentiality and prevent the remote possibility of subject re-identification.
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Acknowledgements
We thank the patients who provided consent for study enrollment as well as provide tumor samples from the Providence Cancer Institute. This work was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and Brooklyn Immunotherapeutics.
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A.S. — analysis of data, interpretation of data, manuscript writing, acquisition of data, substantive revisions. E.C.H.—acquisition of data, substantive revisions. N.M.—acquisition of data, substantive revisions. S.M.—acquisition of data, substantive revisions. T.K.—acquisition of data, substantive revisions. A.C.—acquisition of data, substantive revisions. Z.T.—acquisition of data, substantive revisions. P.N.—acquisition of data, substantive revisions. N.F.—acquisition of data, substantive revisions. K.P.M.—acquisition of data, substantive revisions. Y.W.—acquisition of data, substantive revisions. W.R.—acquisition of data, substantive revisions. S.A.—acquisition of data, substantive revisions. Z.S.—acquisition of data, substantive revisions. J.I.—acquisition of data, substantive revisions. S.S.—conception and design of trial, patient enrollment, interpretation of data, substantive revisions. T.N.—acquisition of data, interpretation of data, substantive revisions. D.A.H.— analysis of data, interpretation of data, substantive revisions. M.J.C.— analysis of data, interpretation of data, substantive revisions. D.B.P.—conception and design of trial, patient enrollment, analysis of data, interpretation of data, manuscript writing, substantive revisions.
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A.C. serves in an advisory role for Seattle Genetics/Astellas, AstraZeneca, and Gilead Sciences. W.R. receives institutional research support from GlaxoSmithKline, Inhibrx, Shimadzu, and Galecto. They also hold a patent with Galectin Therapeutics. Lastly, they serve in an advisory role for Vesselon and Medicenna. S.S. receives institutional research support from IMV Inc. They also receive consulting fees from Margenza and Stanford Burnham Prebys. T.J.N. is currently employed with Oncocyte. D.B.P. receives institutional research support from Merck, Bristol-Myers Squibb, and Brooklyn Immunotherapeutics. They also receive consulting fees from AstraZeneca, D-S, Lilly, Genentech, Gilead, Merck, NGM Bio, Novartis, Pfizer, and Stemline. They also have a speaking honoraria with Novartis and Pfizer. The other authors declare no other Competing Financial or Non-Financial Interests.
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Su, A., Hong, E.C., Moxon, N. et al. Peri-lymphatic cytokines (IRX-2) as immunologic induction preceding neoadjuvant chemo-immunotherapy in triple-negative breast cancer. npj Breast Cancer (2026). https://doi.org/10.1038/s41523-026-00925-0
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DOI: https://doi.org/10.1038/s41523-026-00925-0
