Update results from a Phase 2 clinical trial evaluating Oncolytics Biotech's (OTCQX:ONCYF) REOLYSIN (reovirus variant), in combination with chemo agents carboplatin and paclitaxel, in metastatic pancreatic cancer patients showed an encouraging long-term treatment benefit compared to carboplatin and paclitaxel alone as measured by overall survival (OS).
Participants in the open-label, randomized, two-arm study were treated every three weeks. Subjects in the REOLYSIN group received an intravenous dose on days one through five. The chemo agents were administered intravenously on day one only.
The test arm was REOLYSIN + chemo, the control arm was chemo only and the crossover arm was patients initially treated with chemo only who had REOLYSIN added to their regimen.
Median OS in the control arm was 6.57 months (n=20). 25% of patients (n=5) survived one year while 0% survived 2 - 3 years. In the test arm, median OS was 7.33 months (n=36) and the proportion surviving one year was 29.6% (27.8% if n=10 or 30.6% in n=11 so unclear on basis for 29.6%), neither statistically significant. Some patients survived longer, however. The proportions of those surviving two and three years were 17.7% (16.7% if n=6) and 8.87% (8.3% if n=3), respectively. At the time of the data cutoff on January 19, there were five total survivors in the test arm and one in the crossover arm.
In the crossover group, median OS was 10.97 months and the proportions of subjects surviving one, two and three years were 25.0%, 12.5% and 6.25%, respectively.
The differences between the test arm versus control, the crossover arm versus control and the test are plus the crossover arm versus control were all statistically significant for two-year OS.
Previously: Reolysin demonstrates modest results in pancreatic cancer trial (Sept. 17, 2014)