AM0010 (pegilodecakin) is a cancer therapy being developed by ARMO BioSciences. The potential treatment is currently being studied in people with several types of advanced disease, including pancreatic cancer, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC).
The U.S. Food and Drug Administration (FDA) and the European Commission (EC) have designated AM0010 an orphan drug for the treatment of pancreatic cancer. The FDA has also placed AM0010 — in combination with FOLFOX, a chemotherapy consisting of folinic acid, 5-fluorouracil, and oxaliplatin — on fast track development as a second-line therapy for advanced pancreatic cancer.
How AM0010 works
AM0010 consists of recombinant interleukin 10 (IL-10), a naturally occurring protein that regulates the activity of various immune cells, that is linked to a molecule called polyethylene glycol (PEG). High concentrations of IL-10 activate an immune response against cancer cells.
The attachment of PEG to IL-10 increases its size, working to prevent or delay its breakdown so at to prolong the time it circulates in the body.
Upon administration, AM0010 works by stimulating the survival, proliferation, and killing potential of immune cells known as CD8+ T-cells, or killer T-cells, because of their ability to recognize and destroy cancer cells. Increasing the number of CD8+ T-cells within a tumor is thought to benefit a cancer patient’s likely prognosis and survival.
AM0010 in clinical trials
A Phase 1/1b clinical trial (NCT02009449) is ongoing in 350 patients with various advanced solid tumors. The study has already shown that AM0010 treatment, alone or in combination with chemotherapeutic drugs or anti-PD1 checkpoint inhibitors, such as Opdivo (nivolumab) or Keytruda (pembrolizumab), increases the number of activated killer T-cells in the blood and tumors of patients, and achieve a reduction in tumor size.
Interim data from a subgroup of 47 patients with advanced pancreatic ductal adenocarcinoma (PDAC) showed that AM0010, in combination with FOLFOX chemotherapy, was safe and more effective than AM0010 alone, with a longer overall survival rate (median overall survival of 10.2 months and one-year survival of 47 percent).
Interim data from two subgroups of patients, those with advanced NSCLC and metastatic RCC, also showed that the combination of AM0010 with either Opdivo or Keytruda induced tumor shrinkage in a greater percentage of people (high response rates) and a long-lasting decrease in tumor size (objective responses).
Based on the positive results in pancreatic cancer patients in the Phase 1b trial, the company started an open-label, pivotal, randomized, multicenter Phase 3 study (NCT02923921). This trial, now recruiting, aims to evaluate the safety and efficacy of AM0010 in combination with FOLFOX, compared to FOLFOX alone, as second-line therapy in patients with PDAC that has progressed during or following a first-line treatment containing Gemzar (gemcitabine).
The study’s primary endpoint is to evaluate overall survival. It aims to enroll about 566 patients and is currently recruiting across the U.S., Canada, Australia, Europe, Korea, Taiwan, and the U.K.; more information is available by clicking on its trial identification number.
The study is expected to finish in 2020.
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