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NIZ985 is a recombinant heterodimer comprising physiologically active interleukin-15 (IL-15) and the IL-15 receptor alpha (IL-15Rα). It functions as an immunostimulatory cytokine therapy that promotes proliferation and activation of cytotoxic lymphocytes, including CD8+ T cells and natural killer cells. Spartalizumab is a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1), acting as an immune checkpoint inhibitor to enhance antitumor immune responses. The combination of NIZ985 with spartalizumab aims to synergistically enhance antitumor immunity by combining cytokine-driven lymphocyte activation with PD-1 blockade. This combination has been investigated in patients with advanced solid tumors, including melanoma, pancreatic cancer, and gastric cancer. Clinical studies have shown that the combination is generally well tolerated without dose-limiting toxicities at tested doses. The recommended dose for expansion was established at 1 µg/kg of NIZ985 administered subcutaneously thrice weekly plus 400 mg intravenous spartalizumab every four weeks. Preliminary antitumor activity includes partial responses in some patients resistant to prior immune checkpoint inhibitors.
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