- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Reolysin Shows Promise in Treatment of Head-and-Neck Cancers
Drug extends progression-free survival in phase III trial (November 21)
Positive data have been reported for the endpoints in a randomized, double-blind phase III study of Reolysin (Oncolytics Biotech), a variant of the reovirus, in combination with carboplatin and paclitaxel in patients with second-line platinum-refractory, taxane-naïve head-and-neck cancers.
An analysis was performed on an intent-to-treat basis of 118 patients with loco-regional head-and-neck cancer, with or without metastases. Patients in the test arm were treated with carboplatin, paclitaxel, and Reolysin, whereas patients in the control arm were treated with carboplatin and paclitaxel.
The analysis showed median progression-free survival (PFS) of 94 days (13.4 weeks) in the test arm (n = 62) compared with 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.
A total of 88 patients with loco-regional disease did not receive additional therapy following discontinuation of study treatment. An analysis of these patients showed a median overall survival of 150 days (21.4 weeks) in the test arm (n = 50) compared with 115 days (16.4 weeks) in the control arm (n = 38).
As of the time of reporting, there have not been a sufficient number of events (i.e., patient deaths) to conduct a survival analysis of patients in the metastatic-only group (i.e., those patients with no loco-regional recurrence).
Source: Oncolytics Biotech; November 21, 2013.