Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ: ONCY) ("Oncolytics") today announced that interim data from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer (REO 017) indicated that the clinical study had successfully reached its primary endpoint, and that the drug combination is active.
To date, eight patients of 13 evaluable patients in the study had stable disease (SD) for 12 weeks or longer, for a clinical benefit rate (complete response (CR) + partial response (PR) + SD) of 62%. An additional patient had an unconfirmed PR of less than six weeks.
The study is using a one sample, two-stage design. In the first stage, 17 patients were to be enrolled, and best response noted. If less than three responses (defined as CR or PR or SD for 12 weeks or more) were observed, the study would have concluded that the combination was inactive and been terminated. If three or more responses were observed among the 17 patents, the study would enroll an additional 16 patients for a total of 33 evaluable patients. As previously disclosed, this initial endpoint was met after six evaluable patients were enrolled. If at least eight responses were observed out of 33 patients, the study would have reached its primary endpoint and conclude that the drug combination is active.
"These results far exceeded our initial expectations, having met the primary endpoint in a study designed to enroll 33 patients with just over a third of enrolment completed," said Dr. Matt Coffey, Chief Operating Officer of Oncolytics. "We will continue to enroll in this study to evaluate the progression free survival of the patient group, and will continue testing REOLYSIN with various chemotherapeutic agents including gemcitabine and carboplatin/paclitaxel across multiple trials to further understand its potential in the treatment of pancreatic cancer."