REO 008 was an open-label, single-arm, Phase II trial of REOLYSIN® delivered via intratumoural injection to patients with advanced malignancies during low-dose radiotherapy cancer, and one each with gastric, pancreatic, ovarian, lung, sinus and thyroid cancers and cholangiocarcinoma. Patients received low-dose local tumour irradiation on five consecutive days, and intratumoural injections of REOLYSIN® on days 2 and 4. Sixteen patients were enrolled in the study: five with melanoma, four with colorectal. The primary objective of the trial was to assess the anti-tumour effects of the treatment combination. Thirteen had received prior chemotherapy, and five, prior radiotherapy. The secondary objectives were safety, tolerability, evaluation of immune response to REOLYSIN®, and evaluation of viral replication.
Oncolytics announced results from the study in June 2009. Of fourteen patients evaluable for response, thirteen had stable disease (SD) or better in the treated target lesions. Of these, partial response (PR) were observed in four patients (two with melanoma and one each with lung and gastric cancer). Minor responses were also observed in two patients (one each with thyroid and ovarian cancer), for a total disease control rate (complete response (CR) plus PR plus SD) of 93% in the treated lesions. The combination was well tolerated, with only mild (Grade 1 or 2) toxicities noted.