Oncolytics Meets Primary Endpoint for First Stage of U.S. Phase 2 SCLC Clinical Trial
News Feb 01, 2013
Oncolytics Biotech Inc. has announced preliminary results from its U.S. Phase 2 clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN® in combination with carboplatin and paclitaxel (REO 021).
The Principal Investigator is Dr. Alain Mita of Cedars-Sinai Medical Centre in Los Angeles, CA.
Eligible patients include those with metastatic stage IIIB, or stage IV, or recurrent squamous cell carcinoma of the lung who are chemotherapy naïve for their metastatic or recurrent cancer.
The primary objective of the Phase 2 trial is to assess the antitumor effect of the treatment regimen in the study population in terms of objective response rates.
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. Up to 19 evaluable patients with SCCLC were to be treated in the first stage.
If four or more patients demonstrated a partial response (PR) 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. Five of 15 patients showed PR, four confirmed, one unconfirmed, and an additional eight patients had stable disease (SD), for a disease control rate (complete response (CR) + PR + SD)) of 87%. The Company is proceeding with the second stage of the study.
"These preliminary results are encouraging and further supportive of the decision to conduct a randomized Phase II study examining REOLYSIN in non-small cell lung cancer (NSCLC) patients including those with SCCLC," said Dr. Brad Thompson, President and CEO of Oncolytics.
Dr. Thompson continued, "Oncolytics Phase II program continues to grow and now includes randomized trials in six separate indications."