Oncolytics Biotech announced positive top line data in its double-blinded randomized Phase 3 clinical study examining Reolysin in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers. Reolysin is a proprietary formulation of the human reovirus.
A first analysis compared the relative percentages of patients in the test and control arms with tumors that had either stabilized or exhibited shrinkage. For the purposes of this endpoint, the definition of tumor stabilization was restricted to 0% growth only. Of the 105 total patients with evaluable metastatic tumors, 86% (n=50) of those in the test arm of the study exhibited tumor stabilization or shrinkage, compared with 67% of patients (n=55) in the control arm. This was statistically significant, with a p-value of 0.025.
A second analysis examined the magnitude of tumor response on a per patient basis using a comparison of percentage tumor shrinkage at six weeks in each patient with evaluable metastatic tumors. This analysis showed that Reolysin in combination with carboplatin and paclitaxel was statistically significantly better than carboplatin and paclitaxel alone at stabilizing or shrinking metastatic tumors, yielding a p-value of 0.03