Oncolytics Biotech ONCY today announced initial
positive top line data from the first endpoint in its double-blinded
randomized Phase III clinical study examining REOLYSIN in combination
with carboplatin and paclitaxel in second-line patients with
platinum-refractory, taxane-naïve head and neck cancers (REO 018).
The endpoint examines initial percentage tumour changes between the
pre-treatment and first post-treatment scans (typically performed at
six weeks post-first treatment) of all patients enrolled in the study.
The analysis was designed to assess early differences in response
between loco-regional tumours and metastatic tumours, as classified and
observed by the investigators. This is the first, and to this point
only, endpoint to be un-blinded for this study.
The first analysis compared the relative percentages of patients in the
test and control arms with tumours that had either stabilized or
exhibited shrinkage. For the purposes of this endpoint, the definition
of tumour stabilization was restricted to zero percent growth only. Of
the 105 total patients with evaluable metastatic tumours, 86 percent
(n=50) of those in the test arm of the study exhibited tumour
stabilization or shrinkage, compared with 67 percent of patients (n=55)
in the control arm.
See full press release
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