Oncolytics Biotech Inc. has announced that, following submission to the U.S. Food and Drug Administration ("FDA") for review, the Investigational New Drug Application containing the protocol titled "Phase 2 study of REOLYSIN® (pelareorep) in combination with FOLFOX6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer metastatic to the liver" is now active.
"This study is intended to confirm the encouraging objective overall and liver metastases response rates in female patients that we saw in a sponsored randomized Phase II study conducted in Canada," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are adding a checkpoint inhibitor to the treatment regimen based on our evolving understanding of how REOLYSIN® up regulates immune responses and how the combination may make cancer cells more susceptible to attack by the immune system."
This is a multicenter, single arm safety and efficacy study of REOLYSIN® in combination with chemotherapy (FOLFOX6), bevacizumab (Avastin®) and pembrolizumab (KEYTRUDA®) in female patients with KRAS-mutant metastatic colorectal cancer (CRC) in the liver. The primary objective is to evaluate the overall response rate (ORR) according to Immune-related Response Evaluation Criteria in Solid Tumors ("irRECIST"). Secondary objectives include evaluating disease response in liver metastases and overall survival.
The Company also intends to examine the effect of study treatment on immune-related cells and biomarkers associated with immune response; and genetic biomarkers associated with positive response to study treatment. Study enrollment will be approximately 30 patients. Oncolytics recently announced data from a sponsored Phase 2 study of REOLYSIN®, in combination with FOLFOX6 and bevacizumab in patients with advanced or metastatic CRC (IND 210). In that study, the overall test arm had an objective response rate of 52.9% (n=51) versus 34.6% (n=52) in the control arm (p=0.06).
The Company conducted a pre-planned analysis of patient responses by gender, as specified in the study protocol. The female patients in the test arm had an objective response rate of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054), and in the test arm had a median overall survival of 19.3 months (n=19) versus 14.5 months (n=21) in the control arm.
The overall survival was an interim analysis, as 62 of 103 patients overall were alive at the time of data cut off. The male patients in the test arm had an objective response rate of 46.9% (n=32) versus 41.9% (n=31) in the control arm (p=0.6747). For patients (both male and female) who had metastases to the liver, those treated with REOLYSIN® had objective tumour response rates of 55% (n=40), versus 28.6% (n=42) for those who did not receive REOLYSIN® (p=0.0077).