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Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers

S. Champiat, E. Garralda, V. Galvao, PA. Cassier, C. Gomez-Roca, I. Korakis, P. Grell, A. Naing, P. LoRusso, R. Mikyskova, N. Podzimkova, M. Reinis, K. Ouali, A. Schoenenberger, J. Kiemle-Kallee, S. Tillmanns, R. Sachse, U. Moebius, R. Spisek, D....

. 2025 ; 6 (2) : 101967. [pub] 20250210

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, klinické zkoušky, fáze I

Perzistentní odkaz   https://www.medvik.cz/link/bmc25009857

Grantová podpora
UL1 TR001863 NCATS NIH HHS - United States

Nanrilkefusp alfa (nanril; SOT101) is an interleukin (IL)-15 receptor βγ superagonist that stimulates natural killer (NK) and CD8+ T cells, thereby promoting an innate and adaptive anti-tumor inflammatory microenvironment in mouse tumor models either in monotherapy or combined with an anti-programmed cell death protein 1 (PD-1) antibody. In cynomolgus monkeys, a clinical schedule was identified, which translated into the design of a phase 1/1b clinical trial, AURELIO-03 (NCT04234113). In 51 patients with advanced/metastatic solid tumors, nanril increased the proportions of CD8+ T cells and NK cells in peripheral blood and tumors. It had a favorable safety profile when administered subcutaneously on days 1, 2, 8, and 9 of each 21-day cycle as monotherapy (0.25-15 μg/kg) or combined (1.5-12 μg/kg) with the anti-PD-1 pembrolizumab (200 mg). The most frequent treatment-emergent adverse events were pyrexia, injection site reactions, and chills. Furthermore, early clinical efficacy was observed, including in immune checkpoint blockade-resistant/refractory patients.

Citace poskytuje Crossref.org

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