REO 020 was a single arm, open-label Phase II study of REOLYSIN® in combination with paclitaxel and carboplatin for patients with metastatic, malignant melanoma. Patients received paclitaxel and carboplatin on day 1 of each twenty-one day cycle, with REOLYSIN® administered on days 1 through 5. Up to 43 patients were to be enrolled in the study: up to 18 evaluable patients in the first stage of the study and, subject to meeting response endpoints, the remainder in the second stage. The primary objective was objective response rate (partial response (PR) and complete response (CR)). The secondary objectives were progression-free survival and overall survival, disease control rate (CR plus PR plus stable disease (SD)), duration of responses, and the safety and tolerability of the treatment combination.
In May 2013, the Company announced that it had met the primary endpoint for the first stage of the study. Up to 18 evaluable patients with metastatic melanoma were to be treated in the first stage. If three or more patients demonstrated a partial response or better, the study could then proceed to the second stage. This endpoint was met after 14 evaluable patients were enrolled. Three of 14 patients exhibited a PR, and an additional seven patients had SD for a disease control rate of 71.5%.
Final data from the study remains pending.