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Nisevokitug (NIS793) is a fully human anti-TGF-β IgG2 monoclonal antibody developed by Novartis. It is designed to selectively inhibit the Transforming Growth Factor Beta (TGF-β) pathway, specifically targeting the TGF-β1 and TGF-β2 isoforms. TGF-β is a cytokine known to promote fibrosis and immune evasion within the tumor microenvironment, particularly in desmoplastic tumors like pancreatic cancer. By blocking this pathway, nisevokitug aims to reduce stromal fibrosis and restore the sensitivity of tumor cells to chemotherapy and immune-mediated destruction. The drug was primarily evaluated in Phase 3 clinical trials (e.g., daNIS-2) for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) in combination with gemcitabine and nab-paclitaxel. Despite receiving Orphan Drug Designation from the FDA, Novartis discontinued the development of nisevokitug for pancreatic cancer and other malignancies in 2023.
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