Oncolytics Biotech ONCY today announced positive top-line
data for the endpoints in its double blinded, randomized clinical study
examining REOLYSIN in combination with carboplatin and paclitaxel in
patients with second-line platinum-refractory, taxane-naïve head and
neck cancers (REO 018).
Summary of Trial Results
Efficacy
An analysis was performed on an intent-to-treat basis of the 118
patients with loco-regional head and neck cancer, with or without
metastases. Patients in the control arm were treated with carboplatin
and paclitaxel, while patients in the test arm were treated with
carboplatin, paclitaxel and REOLYSIN;
The analysis showed a median progression free survival (PFS) of 94 days
(13.4 weeks) in the test arm (n=62), versus 50 days (7.1 weeks) in the
control arm (n=56). The test arm maintained a PFS benefit over the
control arm through five cycles of therapy;
Eighty-eight loco-regional patients did not receive additional therapy
following discontinuation of study treatment. An analysis of these
patients showed a median overall survival (OS) of 150 days (21.4 weeks)
in the test arm (n=50), versus 115 days (16.4 weeks) in the control arm
(n=38), and;
As of the time
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