IND 210 is an open-label, randomized, non-blinded, Phase II clinical study of REOLYSIN® given in combination with FOLFOX-6 and bevacizumab (Avastin®) versus the therapeutic combination of FOLFOX-6 and bevacizumab alone. Patients received FOLFOX-6 and bevacizumab every 14 days, with either REOLYSIN® (test arm) or placebo (control arm) administered on days 1 through 5 of cycles 1, 2, 4, 6, 8 and alternate cycles thereafter. Approximately fifty response-evaluable patients were enrolled in each arm, after a six- to nine- patient safety run-in. The primary objective is progression-free survival. Secondary objectives include changes in CEA levels, objective response rate, overall survival, quality of life, and the tolerability and toxicity of the treatment combination. Other objectives include the measurement of molecular factors which may be prognostic or predictive of response.
In May 2016, the Company announced preliminary response and survival data from the study, demonstrating an increase in objective response rates both in female patients and patients with liver metastases:
|Objective Response Rate
|Progression Free Survival (months)||Median Overall Survival (months)1|
|63.2 (n=19)||23.8 (n=21)||7.43 (n=19)||8.08 (n=21)||19.3 (n=19)||14.5 (n=21)|
|46.9 (n=32)||41.9 (n=31)||7.33 (n=32)||9.26 (n=31)||15.4 (n=32)||15.7 (n=31)|
|52.9 (n=51)||34.6 (n=52)||7.33 (n=51)||9.13 (n=52)||15.57 (n=51)||15.21(n=52)|
Source: Report of Statistical Analysis for NCIC CTG Protocol Number IND.210
1 This was an interim analysis, as 62 (60.2%) patients out of a total of 103 patients were alive at the time of data cut-off. All of the median survivals noted could change at final analysis.
In an abstract presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in June 2016, the study investigators reported that 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 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). 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).
The study is being sponsored and conducted by the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) at Queen’s University in Kingston, Ontario. Final results from the study remain pending.