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Positive Phase II Results Reported for Human Reovirus (Reolysin) in Lung Cancer
Treatment controls disease in 92% of patients (September 9)
Final tumor-response data have been reported from a phase II single-arm clinical trial in patients with squamous-cell carcinoma of the lung (SCCLC) receiving intravenous Reolysin (human reovirus, Oncolytics Biotech, Inc.) in combination with carboplatin and paclitaxel.
The study examined best overall tumor responses between pretreatment and up to six treatment cycles. Of 25 evaluable patients who had more than one cycle of therapy, 23 (92%) showed overall tumor shrinkage (mean shrinkage, 32.7%). Of the 25 evaluable patients, ten (40%) achieved a partial response (PR), while 13 (52%) had stable disease (SD) and two (8%) had progressive disease, for a disease control rate (complete response [CR] + PR + SD) of 92%.
The study enrolled patients with metastatic stage IIIB or IV, or recurrent, SCCLC who were chemotherapy-naïve for their metastatic or recurrent cancer. The trial’s primary objective was to evaluate the patients’ tumor response. The secondary objectives were 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 6 months; and to assess the safety and tolerability of the treatment regimen in the study population.
Final progression-free survival and safety data from the study will be reported later this year.
Source: Oncolytics Biotech, Inc.; September 9, 2013.