ARMO BioSciences, Inc., a clinical-stage biotechnology company, announced that the Journal of Clinical Oncology (JCO) has published clinical safety and efficacy data on the Company’s lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) in patients with advanced solid tumors. The peer-review article titled “Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients with Advanced Solid Tumors” was first published today in the online version of the JCO (http://jco.ascopubs.org/).
“The results of this study show exciting early signs of efficacy, with objective and durable responses achieved in advanced cancer patients who were treated with this single agent,” said Aung Naing, M.D., Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of TexasMD Anderson Cancer Center and lead author of the JCO publication. “Importantly, this appears to be a well-tolerated immunotherapy, which opens the door to combinations with additional immuno-oncology drugs as well as with other cancer chemotherapies as advanced cancer patients urgently need new treatment options.”
“This first peer-reviewed publication of clinical data for AM0010 further validates our understanding of the biological activity of AM0010, which specifically engages the immune system to induce comprehensive T-cellactivation and objective tumor responses in cancer patients with advanced malignancies,” said PeterVan Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. “As our Phase 1 trial continues to progress, we look forward to sharing additional data at upcoming scientific and medical meetings for AM0010 when used in combination with other immuno-oncology and cancer chemotherapies. To further the development of AM0010 for patients with advanced solid malignancies, we are moving forward with our plans to discuss the first registration-enabling Phase 3 trial with the FDA for this novel immunotherapy.”
About the Study Published in JCO
In the JCO publication of this Phase 1 study, 51 patients with advanced solid tumors were treated with AM0010 monotherapy, first in a dose escalation study and subsequently in a dose expansion cohort in patients with renal cell cancer (RCC). AM0010 was administrated daily at doses of 1-40µg/kg. The primary endpoint was safety and secondary endpoints included objective tumor responses (ORR), progression free survival (PFS) and immune activation.
33 patients were treated in the dose escalation cohort and 18 were treated in the expansion cohort. AM0010 led to systemic immune activation with elevated immune stimulatory cytokines and a reduction in the immune suppressive cytokine TGF-β in the serum. AM0010 was well tolerated in this heavily pretreated patient population who had failed a median of four prior therapies for metastatic resistant or refractory disease. The most common treatment-related adverse events were anemia and thrombocytopenia. Partial responses were observed in one patient with uveal melanoma and in four of 15 (27% objective response rate) evaluable RCC patients treated at 20µg/kg.