Oncolytics Biotech Inc. has announced that it has met the primary overall statistical endpoint in its U.S. Phase 2 single arm clinical trial 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 are chemotherapy naïve for their metastatic or recurrent cancer (REO 021).
The study is a two-stage design with a primary overall endpoint of objective tumor response rate.
The Company saw a sufficient number of responses 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 on study, nine of which exhibited PRs, while a further nine showed stable disease (SD) and three, progressive disease (PD), for a response rate of 42.8% and a disease control rate (complete response (CR) + PR + SD) of 85.7%.
"We are pleased to have met the response rate endpoint, which builds on the data we announced from the first stage of this study," said Dr. Brad Thompson, President and CEO of Oncolytics. "Based on the positive data seen to date, we intend to conduct further studies in this indication."
The secondary objectives of the trial, for which data has yet to be released, are to assess progression-free survival and overall survival for the treatment regimen in the study population; to determine the proportion of patients receiving the above treatment who are alive and free of disease progression at six months; and to assess the safety and tolerability of the treatment regimen in the study population.