REO 010 was an open-label Phase I trial of REOLYSIN® in combination with docetaxel in patients with advanced or metastatic solid tumours that were refractory to standard therapy or for which no curative therapy existed. Patients received docetaxel on day 1 of each twenty-one day cycle, as well as escalating doses of REOLYSIN® on days 1 through 5. Approximately 25 patients were enrolled in the study. The primary objectives of the trial were to determine maximum tolerated dose, dose-limiting toxicity, recommended dose and dosing schedule, and safety profile of the treatment combination. Secondary objectives included the evaluation of immune response to the drug combination and evidence of anti-tumour activity.
Final results from the study were published in the journal Clinical Cancer Research in November 2010. Of the 25 patients enrolled, 24 were exposed to treatment, 23 completed at least one cycle of therapy, and 16 were evaluable for response. The paper reported that the combination was safe and well tolerated, and that a maximum tolerated dose was not reached. Anti-tumour activity was seen, with one complete response (in the liver of a breast cancer patient with no evidence of disease recurrence at the end of the study, following eight cycles of treatment) and three partial responses. A disease control rate (combined complete response, partial response and stable disease) of 88% was observed. The authors concluded that the combination of reovirus and docetaxel was safe, with evidence of objective disease response, and warranted further evaluation.