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Positive Phase III Results for Oncolytic Virus, Reolysin, in Head-and-Neck Cancers
Tumors stabilized in 86% of patients (Dec. 13)
Initial results have been announced from a phase III study of Reolysin (Oncolytics Biotech Inc.), a proprietary formulation of the human reovirus, in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head-and-neck cancers.The study’s primary efficacy endpoint was the initial tumor changes between the pretreatment and first post-treatment scans (typically performed at 6 weeks after the first treatment) in all patients enrolled in the study. This analysis was designed to assess early differences in responses between local/regional tumors and metastatic tumors, as classified by the investigators. So far, this is the only endpoint that has been unblinded in this study.
The investigators first compared the percentages of patients in the treatment and control arms with tumors that had either stabilized or shrunk. The definition of tumor stabilization was restricted to zero percent growth. A total of 105 patients had evaluable metastatic tumors (50 in the treatment arm and 55 in the control arm). Tumor stabilization was observed in 86% of treated patients versus 67% of control patients (P = 0.025).
A second analysis examined the magnitude of tumor response on a per-patient basis using a comparison of tumor shrinkage at 6 weeks in each patient with evaluable metastatic tumors. This analysis showed that Reolysin, in combination with carboplatin and paclitaxel, was significantly better (P = 0.03) than carboplatin and paclitaxel alone at stabilizing or shrinking metastatic tumors.
Source: Oncolytics Biotech Inc.; December 13, 2012.