Oncolytics Biotech Inc. (ONC.TO,ONCY) reported preliminary results from its U.S. Phase 2 trial in patients with squamous cell carcinoma of the lung or SCCLC using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel. The Principal Investigator is Alain Mita of Cedars-Sinai Medical Centre in Los Angeles, CA.
The study's primary objective is to assess the antitumor effect of the treatment regimen in the study population in terms of objective response rates, while the secondary objectives 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.
The study is a two stage design, wherein up to 19 evaluable patients with SCCLC were to be treated in the first stage. If four or more patients demonstrated a partial response or better, the study would then proceed to the second stage, with up to 55 patients being treated in the entire study. This endpoint was met after 15 evaluable patients were enrolled. According to the company, five of 15 patients showed partial response, four confirmed, one unconfirmed, and an additional eight patients had stable disease, for 87% disease control rate.
The company said it is proceeding with the second stage of the study.
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