ESMO World GI 2017: Pegilodecakin Plus FOLFOX in Advanced Pancreatic Cancer

Key Points

  • The pegilodecakin plus FOLFOX regimen produced a disease control rate of 79%, an objective response rate of 16%, and a complete response rate of 11%.
  • The median progression-free survival was 3.5 months and the median overall survival was 10.2 months on the combination regimen.
  • Pegilodecakin plus FOLFOX produced a 1-year survival rate of 47%. 

Clinical data on an investigational immuno-oncology drug pegilodecakin (PEGylated human interleukin-10, also known as AM0010) was presented by Hecht et al at the ESMO 19th World Congress on Gastrointestinal Cancer in Barcelona, Spain (Abstract O-004). Pegilodecakin is being evaluated in an ongoing phase I/Ib clinical trial that has enrolled 352 advanced cancer patients and in a phase III clinical trial that is enrolling patients with advanced pancreatic cancer.

“In an ongoing phase I/Ib clinical trial, pegilodecakin in combination with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) chemotherapy has demonstrated extremely promising efficacy and safety data to date in patients with advanced pancreatic cancer,” said J. Randolph Hecht, MD, Professor of Clinical Medicine, David Geffen School of Medicine at the University of California Los Angeles, and an investigator for the phase III 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 1 year.”

Phase I/Ib Clinical Trial Results

In the ongoing phase I/Ib clinical trial, 47 patients with advanced pancreatic ductal adenocarcinoma have been treated with either pegilodecakin alone or pegilodecakin in combination with FOLFOX chemotherapy. Twenty-two patients with pancreatic ductal adenocarcinoma were treated with pegilodecakin monotherapy and twenty-one patients with pancreatic ductal adenocarcinoma who had not received a prior platinum-containing regimen were treated with pegilodecakin in combination with FOLFOX.  

Pegilodecakin treatment was well-tolerated in pancreatic ductal adenocarcinoma patients either alone or in combination with FOLFOX. Grade 3/4 treatment-related adverse events associated with daily dosing of pegilodecakin included thrombocytopenia, anemia, and neutropenia, and were transient and reversible. Pegilodecakin plus FOLFOX with a modified pegilodecakin dose schedule (5 days on, 2 days off) was tested without grade 3/4 hematologic adverse events. This modified dose schedule is being used in the ongoing phase III clinical trial.

As of May 1, 2017, the pegilodecakin plus FOLFOX regimen produced a disease control rate of 79%, an objective response rate of 16%, and a complete response rate of 11%. Patients receiving pegilodecakin alone had a disease control rate of 53%, with objective and complete response rates of 0%. The median progression-free survival was 3.5 months and the median overall survival was 10.2 months on the combination regimen, with a 1-year overall survival rate of 47%.

Pegilodecakin 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.

About Pegilodecakin Immunotherapy

Pegilodecakin is a long-acting form of recombinant human interleukin-10 (IL-10), which has shown sustained antitumor effects and a good safety/tolerability profile in patients with multiple oncology indications. Due to its enhanced half-life, pegilodecakin has strong immune-stimulating effects that induce the activation, proliferation, and survival of intratumoral, tumor-reactive, cytotoxic CD8-positive T cells in patients. CD8-positive T cells mediate the cancer cytotoxic effect of this immuno-oncology agent.

The U.S. Food and Drug Administration (FDA) and the European Commission have granted pegilodecakin Orphan Drug designation for the treatment of pancreatic cancer. The FDA also granted Fast Track designation for pegilodecakin in combination with FOLFOX as second-line therapy in patients with pancreatic cancer.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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