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ARTICLE | Clinical News

Reolysin: Phase III delayed

September 17, 2012 7:00 AM UTC

Oncolytics amended the double-blind, international Phase III REO 018 trial after blinded data for the combined Reolysin and chemotherapy control arms showed higher than expected median PFS and best response rate. Oncolytics said it expected a combined partial response rate of about 20%, but instead saw a >=30% rate. Oncolytics also said median evolving PFS for the combined arms was significantly higher in patients with distal metastatic disease compared to patients with a local head and neck tumor with or without metastatic disease (120 days vs. not disclosed, p=0.008). At the time of the blinded analysis, 23 of the 80 patients included had not yet progressed.

As a result of the blinded analysis, Oncolytics expanded enrollment in REO 018 to 160 patients from 80 and plans to introduce an additional prospective segregation to differentiate between subgroups of patients with local recurrent disease with or without metastases and patients with distal metastases. The company believes that a 160-patient enrollment will allow for a "meaningful analysis" of the 2 subgroups. Furthermore, the company will now conduct the second stage of REO 018 as a separate Phase III trial. The second stage of the trial was designed to use an adaptive design to allow for frequent data evaluation to determine the probability of reaching significance. ...