Oncolytics reports ~15‑month median response duration for pelareorep plus atezolizumab in anal cancer

Oncolytics Biotech announced updated results from Cohort 4 of its Phase 1/2 GOBLET trial, showing that the combination of pelareorep and atezolizumab produced a median duration of response of roughly 15 months in patients with second‑line or later squamous cell anal cancer. The company compared this to a historical median of 9.5 months for the FDA‑approved checkpoint inhibitor retifanlimab. All patients who achieved a response remained alive beyond 12 months, and the FDA has granted Fast Track designation for the regimen.

The company says the durability of responses could support an accelerated approval pathway and may lead to a full registration in anal cancer, which could increase ONCY’s market potential. The FDA Fast Track status may also accelerate further clinical development and partnership opportunities.

  • 1The median duration of response in Cohort 4 was approximately 15 months.
  • 2Historical median duration of response for FDA‑approved retifanlimab in a similar population is 9.5 months.
  • 3All patients who responded to the pelareorep‑atezolizumab regimen survived beyond 12 months.
  • 4The FDA has granted Fast Track designation for pelareorep in squamous cell anal cancer.
  • 5CEO Jared Kelly said the data provide a path to pursue registration in anal cancer and to expand into other HPV‑driven tumors.

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