Reolysin: Preliminary Phase II data

Preliminary data from 14 patients with metastatic melanoma in the first stage of the 2-stage, single-arm, open-label, U.S. Phase II REO 020 trial showed that IV Reolysin plus paclitaxel and carboplatin led to 3 partial responses and 7 cases of stable disease for a DCR of 71.5%. Oncolytics said the first stage of the trial therefore met its primary endpoint of achieving >=3 partial responses or better in up to 18 evaluable patients. However, Oncolytics said it will not proceed to the second stage of the trial due to "recent and potential additional near-term changes to the standard of care for the treatment of melanoma." The company said it is evaluating Reolysin in combination with other "emerging" treatments for a number of patient sub-populations and intends to conduct an additional trial in melanoma, but could not be reached for details. The trial enrolled patients with metastatic malignant melanoma who failed >=1 prior therapy or who were not considered a candidate for standard first-line therapy to receive IV Reolysin on days 1-5 plus paclitaxel and carboplatin on day 1 of a 21-day cycle. ...