Immuno-Oncology Drug, AM0010, Is Effective in Treating Advanced Pancreatic Cancer

New clinical trial research presented at the European Society for Medical Oncology 19th World Congress on Gastrointestinal Cancer suggests that ARMO BioSciences’ immuno-oncology drug, AM0010, is effective in treating patients with advanced pancreatic cancer.

The phase 1/1b trial included 47 advanced pancreatic ductal adenocarcinoma (PDAC) patients. Of the total patients, 22 were treated with AM0010 alone, while 21 patients were given AM0010 in combination with FOLFOX chemotherapy. Both forms of treatment were observed to be effective; however, grade 3/4 treatment of daily doses of AM0010 correlated with thrombocytopenia, anemia, and neutropenia. When AM0010 was utilized with FOLFOX and on a modified dose schedule, no grade 3/4 adverse events were experienced.

“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,” J. Randolph Hecht, MD, professor of clinical medicine at the David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California and an investigator for the phase 3 clinical trial, said in a statement. “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.”

The phase 3 clinical trial will include the modified dose schedule, of 5 days on and 2 days off, of AM0010 and FOLFOX combination treatment in patients with advanced pancreatic cancer. The increased immune stimulatory cytokines and the increase of T cell clones resulting from AM0010 and FOLFOX combination treatment is associated with an overall increased survival of PDAC patients.

“We are very encouraged that we continue to see such promising data trends from the patients in this trial,” said Peter Van Vlasselaer, PhD, founder of ARMO. “These phase 1/1b data provide the rationale for our ongoing pivotal phase 3 clinical trial of AM0010 in combination with FOLFOX as second-line therapy for advanced metastatic pancreatic cancer.”