Interleukin-10 (AM0010) demonstrates antitumor activity, with an acceptable toxicity profile, in patients with renal cell carcinoma (RCC), according to a study published in the Journal of Clinical Oncology.1

Researchers evaluated patients who were treated with AM0010 in a dose-escalation study, as well as a RCC dose-expansion cohort, with primary endpoints being safety and tolerability. Secondary endpoints were clinical activity and immune activation.

In total, 33 patients through the dose-escalation cohort and 18 patients through the dose-expansion cohort were examined. The treatment was tolerated in a heavily pretreated patient population.

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Common treatment-related adverse events included anemia, fatigue, thrombocytopenia, fever, and injection site reactions, with grade 3 to 4 anemia or thrombocytopenia observed in 5 patients. Grade 3 to 4 nonhematopoietic treatment-related adverse events included rash and transaminitis in 5 of the patients in the dose-escalation cohort. Most treatment-related adverse events were transient or reversible.

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AM0010 led to systemic immune activation with an elevation in immune-stimulatory cytokines, as well as a reduction in transforming growth factor beta in the serum.


  1. Naing A, Papadopoulous KP, Autio KA, et al. Safety, antitumor activity, and immune activation of pegylated recombinant human interleukin-10 (AM0010) in patients with advanced solid tumors. J Clin Oncol. 2016 Aug 15. doi: 10.1200/JCO.2016.68.1106 [Epub ahead of print]