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OK-432 + interleukin-2 is a combination immunotherapy regimen consisting of OK-432 (picibanil), a lyophilized preparation of an attenuated strain of Streptococcus pyogenes with biological response-modifying activity, and interleukin-2 (IL-2), a recombinant cytokine that stimulates immune cell proliferation and activation. This combination is used as an adjunct to chemotherapy or as part of immunochemotherapy protocols for various cancers including advanced ovarian cancer and hepatocellular carcinoma. The mechanism involves the induction and enhancement of anti-tumor immune responses through the recruitment and activation of neutrophils, macrophages, lymphocytes (including helper/inducer T cells and natural killer cells), as well as the upregulation of multiple cytokines such as IL‑1, IL‑6, IFN‑γ, TNF‑α, G-CSF/GM-CSF. Clinical studies have shown that this combination can reduce recurrence rates in advanced ovarian cancer when added to standard chemotherapy regimens[1][4]. In hepatocellular carcinoma models it has been shown to induce tumor-infiltrating lymphocytes with cytotoxic potential[2]. The regimen is not widely approved outside Japan but has been used in clinical practice for decades.
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