Patients 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 were treated in the first stage of two stage design study.
Five of 15 patients showed partial response (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 endpoint was met after 15 evaluable patients were enroled and the company is proceeding with the second stage of the study.
Oncolytics president and CEO Dr. Brad Thompson said the preliminary results are encouraging and further supportive of the decision to conduct a randomised Phase II study examining REOLYSIN in non-small cell lung cancer (NSCLC) patients including those with SCCLC.
"Oncolytics Phase II program continues to grow and now includes randomized trials in six separate indications," Thompson added.
The primary objective of the Phase 2 trial is to evaluate the antitumor effect of the treatment regimen in the study population in terms of objective response rates.
The secondary objectives include the assessment of 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.