Reolysin: Additional Phase III data

Data from the subgroup of 118 patients with loco-regional head and neck cancer with or without distal metastases in the double-blind, international Phase III REO 018 trial showed that IV Reolysin plus carboplatin and paclitaxel led to a median PFS, a secondary endpoint, of 94 days vs. 50 days for carboplatin and paclitaxel alone. Oncolytics said a greater number of patients in the control arm received additional treatment with other agents following discontinuation of the study than in the Reolysin arm, which created a "confounding" effect on the primary endpoint of OS. In 88 patients who did not receive additional therapy following study discontinuation, median OS was 150 days with Reolysin plus chemotherapy (n=50) vs. 115 days for chemotherapy alone (n=38). Of 86 patients with measurable disease at first post-treatment scan at about 6 weeks, Reolysin plus chemotherapy significantly increased tumor shrinkage vs. chemotherapy alone (p=0.049).

The trial enrolled head and neck cancer patients into 2 subgroups - patients with local recurrent disease with or without distal metastasis and patients with only distal metastasis. Oncolytics said there have not been a sufficient number of patient deaths to conduct a survival analysis of the metastases-only subgroup, which enrolled 49 patients. The company declined to provide a time frame for the metastases-only OS data. Oncolytics did not provide p-values, saying a statistical analysis could not be performed due to "non-proportional hazard ratios" between treatment groups. ...