Oncolytics Biotech Announces First Clinical Trial Examining Effects of REOLYSIN with Checkpoint Inhibitor

Strategic Insights -

Oncolytics Biotech Inc. ("Oncolytics") has announced the initiation of the first clinical trial examining the effects of REOLYSIN in combination with a checkpoint inhibitor in human patients. The Phase Ib study will investigate the safety and efficacy of REOLYSIN, a proprietary formulation of the human reovirus, in combination with pembrolizumab (KEYTRUDA) and chemotherapy in patients with advanced pancreatic adenocarcinoma. This trial builds on previous clinical work in pancreatic cancer and preclinical studies indicating that REOLYSIN can upregulate PD-1 and PD-L1.

Key Takeaways:

  • The study, titled "A Phase Ib study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma," aims to enroll patients 18 years or older with histologically confirmed advanced or metastatic pancreatic adenocarcinoma who have failed, or did not tolerate, first-line treatment.
  • The primary objectives of the trial include determining the safety and dose-limiting toxicities of the combination regimen, as well as evaluating the overall response rate and progression-free survival by immune-related response criteria.
  • Secondary endpoints include overall survival, and effects of REOLYSIN and pembrolizumab on pre- and post-treatment biopsies and blood-based immune markers.
  • The trial has received Investigational New Drug Application from the US FDA and will be conducted in the United States.
  • Oncolytics has previously conducted clinical studies in pancreatic cancer, including a Phase 2 single-arm clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine.
  • The Company has received Orphan Drug Designation from the US FDA and the European Medicines Agency for the use of REOLYSIN in the treatment of pancreatic cancer.

Statistics:

  • The American Cancer Society estimates that 48,960 Americans will be diagnosed with pancreatic cancer and an estimated 40,560 Americans will die from the disease in 2015.
  • The prognosis for patients diagnosed with pancreatic cancer is generally poor, with a relative five-year survival rate for all stages combined of approximately seven percent.
  • Approximately 44,539 patients are affected with pancreatic cancer at any time in the United States.
  • Oncolytics' clinical program includes various later-stage, randomized human trials in various indications using REOLYSIN.

Sources:

  • Oncolytics Biotech Inc., Press Release, October 20, 2015.
  • "A Phase Ib study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma," Investigational New Drug Application.
  • American Cancer Society, Cancer Facts & Figures 2015.
  • Oncolytics Biotech Inc., Press Release, July 2015.