Intratumoral Administration of REOLYSIN® in Combination with Low-Dose Radiation for Patients with Advanced Malignancies
In April 2009, Oncolytics announced the results of its Phase II clinical trial investigating the antitumor effects of intratumoral administration of REOLYSIN® in combination with low-dose radiation in patients with advanced cancers.
A total of sixteen heavily pretreated patients with advanced cancer (five with melanoma, four with colorectal, and one each with gastric, pancreatic, ovarian, lung, cholangiocarcinoma, sinus and thyroid cancer) were enrolled in the trial. Most of the patients had received prior chemotherapy (thirteen patients) or radiation (five patients). Of the fourteen patients evaluable for response, thirteen had stable disease (SD) or better in the treated target lesions. Of these, partial responses (PR) were observed in four patients (two with melanoma and one each with lung and gastric cancer) and minor responses were observed in two patients (thyroid, ovarian), for a total disease control rate (stable disease + partial response + complete response) of 93% in the treated lesions. The combination was well tolerated, with only mild (Grade 1 or 2) toxicities noted.
The trial was an open-label, single-arm, multi-centre Phase II study of REOLYSIN® delivered via intratumoral injection to patients during treatment with low-dose radiotherapy. The primary objective of the trial was to assess the antitumor activity of the combination of REOLYSIN® and low dose radiotherapy in treated and untreated lesions. Secondary objectives included the evaluation of viral replication, immune response to the virus and to determine the safety and tolerability of intratumoral administration of REOLYSIN® in patients with advanced cancers who are receiving radiation treatment.