Phase 2 study update of Reolysin for pancreatic cancer

Oncolytics Biotech announced preliminary results from its Phase 2 trial using intravenous administration of Reolysin in combination with Gemzar (gemcitabine; Eli Lilly) in patients with advanced pancreatic cancer.

The trial is a single-arm, open-label study of Reolysin given intravenously with Gemzar every 3 weeks. The study’s primary objective is to determine the clinical benefit rate (complete response [CR] + partial response [PR] + stable disease [SD]) in patients with advanced or metastatic pancreatic adenocarcinoma with measurable disease who have not received any prior chemotherapy or biotherapy. The secondary objectives are to determine progression-free survival, and the safety and tolerability of Reolysin when administered in combination with Gemzar.

Seventeen evaluable patients with pancreatic cancer were expected to be treated in the first stage and if three or more patients received clinical benefit, the study would then proceed to the next stage. This endpoint was met after six evaluable patients were enrolled.  All patients treated reported symptomatic improvement. Three of six patients showed SD for 12 weeks or longer.

Reolysin is a formulation of the human reovirus designed to replicate specifically in tumor cells bearing an activated Ras pathway. Activating mutations of Ras and upstream elements of Ras may play a role in greater than two thirds of all human cancers.

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