Oncolytics Biotech has reported early positive top line data for the first endpoint in its randomised Phase III Reolysin study in head and neck cancers.
The double-blind randomised study is designed to assess Reolysin as combination therapy with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers.
Oncolytics president and CEO Dr. Brad Thompson said this was the first double-blinded randomised data from any study using an intravenously-administered oncolytic virus.
"We are delighted to have obtained statistically significant data for REOLYSIN in a randomised clinical setting," Thompson said.
"We continue to await the data for the other endpoints of this study, to which all parties still remain blinded at this point."
Initial percentage tumour changes between the pre-treatment and first post-treatment scans of all patients enrolled in the study are examined for the endpoint.
The study is designed to assess early differences in response between loco-regional tumours and metastatic tumours, as classified and observed by the investigators, which is the first endpoint to be un-blinded.
Initial analysis compared the relative percentages of patients in the test and control arms with tumours that had either stabilised or exhibited shrinkage, according to the company.
Under the initial analysis, 86% of 105 total patients with evaluable metastatic tumours in the test arm of the study exhibited tumour stabilisation or shrinkage compared with 67% patients in the control arm.
The magnitude of tumour response on an each patient-basis, using a comparison of percentage tumour shrinkage at six weeks in each patient with evaluable metastatic tumours, was examined as the second analysis.
According to second analysis, Reolysin in combination with carboplatin and paclitaxel was statistically significantly better than carboplatin and paclitaxel alone at stabilising or shrinking metastatic tumours.
A numeric trend favouring the test group in the direction of differing activity between the test and control groups in patients with loco-regional tumours was noted at the six week point.
Intragroup analysis of the test arm noted improvement in the percentage of patients’ metastatic tumours over loco-regional tumours and an improvement of magnitude of response in metastatic tumours over loco-regional tumours.
No statistical differences were noted between the responses of patients with evaluable metastatic tumours and patients with evaluable loco-regional tumours in the intragroup analysis of control arm.