ARMO BioSciences, Inc., a late-stage immuno-oncology company, announced clinical data on its lead investigational immuno-oncology drug AM0010 (pegilodecakin, PEGylated Interleukin-10) at the ESMO 19th World Congress on Gastrointestinal Cancer, taking place June 28 through July 1, 2017 in Barcelona, Spain. AM0010 is being evaluated in an ongoing Phase 1/1b clinical trial that has enrolled 352 advanced cancer patients and in a Phase 3 clinical trial that is enrolling patients with advanced pancreatic cancer.
About AM0010 Immunotherapy
AM0010 (pegilodecakin) is a long-acting form of recombinant human Interleukin-10 (IL-10), which has shown sustained anti-tumor effects and a good safety/tolerability profile in patients with multiple oncology indications. Due to its enhanced half-life, AM0010 has strong immune-stimulating effects that induce the activation, proliferation, and survival of intra-tumoral, tumor-reactive, cytotoxic CD8+ T cells in patients. CD8+ T cells mediate the cancer cytotoxic effect of this immuno-oncology agent.
The U.S. Food and Drug Administration (FDA) and the European Commission (EC) have granted AM0010 Orphan Drug designation for the treatment of pancreatic cancer. The FDA also granted Fast Track designation for AM0010 in combination with FOLFOX as second-line therapy in patients with pancreatic cancer.
“In an ongoing Phase 1/1b clinical trial, AM0010 in combination with FOLFOX (folinic acid, 5-fluorouracil and oxaliplatin) chemotherapy has demonstrated extremely promising efficacy and safety data to date in patients with advanced pancreatic cancer,” said J. Randolph Hecht, M.D., Professor of Clinical Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California and an investigator for the Phase 3 clinical trial. “The median follow-up on this study is 14.2 months (range 6.8-18.9 months) and 10 of 21 patients (47%) are still alive after more than one year.”
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Phase 1/1b Clinical Trial Results in Advanced Pancreatic Cancer
In this ongoing Phase 1/1b clinical trial, 47 patients with advanced pancreatic ductal adenocarcinoma (PDAC) have been treated with either AM0010 alone or AM0010 in combination with FOLFOX chemotherapy. Twenty-two patients with PDAC were treated with AM0010 monotherapy and twenty-one patients with PDAC who had not received a prior platinum-containing regimen were treated with AM0010 in combination with FOLFOX. AM0010 treatment was well tolerated in PDAC patients either alone or in combination with FOLFOX.
AM0010 in combination with FOLFOX increased immune stimulatory cytokines in the serum of patients and an increase of new T cell clones not previously detected in the patients. The expansion of new T cell clones correlated with a longer overall survival of patients. For more information about the clinical trial, please visit www.clinicaltrials.gov and use identifier NCT02923921.
Reference: Hecht J, et al. Immunologic and Objective Tumor Responses to PEGylated Human IL-10 (AM0010) with 5- FU/LV and Oxaliplatin (FOLFOX) in Metastatic Pancreatic Adenocarcinoma (PDAC). Abstract O-003. Presented at the ESMO 19th World Congress on Gastrointestinal Cancer, Barcelona, Spain.
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