Oncolytics Announces Positive Final Tumour Response Data for U.S. Phase 2 Study of REOLYSIN®
News Sep 10, 2013
Oncolytics Biotech Inc. has announced final tumour response data from 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 (REO 021).
The analysis examined percent best overall tumour responses between pre-treatment and up to six treatment cycles.
Of 25 evaluable patients who had more than one cycle of therapy, 23 (92%) exhibited overall tumour shrinkage (mean shrinkage was 32.7%).
Of the 25 evaluable patients, 10 (40%) had partial responses (PRs), while a further 13 (52%) showed stable disease (SD) and two (8%), had progressive disease (PD), for a disease control rate (complete response (CR) + PR + SD) of 92%.
A waterfall graph showing individual patient data will be available on the Company's website at http://www.oncolyticsbiotech.com/presentations.
"We are thrilled to have demonstrated 92% overall tumour shrinkage in this group of patients," said Dr. Brad Thompson, President and CEO of Oncolytics.
Dr. Thompson continued, "Squamous cell carcinoma of the lung is notoriously difficult to treat, and these results support further investigation of REOLYSIN in randomized clinical trials for this indication."
The study enrolled patients with metastatic stage IIIB or stage IV, or recurrent, squamous cell carcinoma of the lung, who were chemotherapy-naïve for their metastatic or recurrent cancer.
The primary objective of the trial is to evaluate the patients' tumour response. 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 were alive and free of disease progression at six months; and to assess the safety and tolerability of the treatment regimen in the study population.