Oncolytics Biotech announced that its Phase 2 single arm study has met the primary overall statistical endpoint in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of Reolysin in combination with carboplatin and paclitaxel in patients with metastatic stage IIIB, or stage IV, or recurrent SCCLC who were chemotherapy naïve for their metastatic or recurrent cancer (REO 021).
Reolysin is a formulation of the human reovirus designed to replicate specifically in tumor cells bearing an activated Ras pathway. The study is a two-stage design with a primary overall endpoint of objective tumor response rate. A sufficient number of responses were observed in the first stage of the study to proceed with enrollment in the second stage. A total of up to 36 patients were to be studied in the second stage.
The primary endpoint was met if nine or more patients in both stages combined had a partial response (PR) or better, which yields a true response rate of 35% or more. This endpoint was met after 21 evaluable patients were treated, nine of which exhibited PRs, while a further nine showed stable disease (SD) and three, progressive disease (PD). A response rate of 42.8% and a disease control rate of 85.7% (complete response + PR + SD) was noted.
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