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Clinical Trial : IND 211

IND 211 is an open-label, randomized, non-blinded Phase II study of intravenously-administered REOLYSIN® in patients with advanced or metastatic non-small cell lung cancer. Patients with squamous cell histology were treated with either REOLYSIN® given in combination with docetaxel (test arm) or docetaxel alone (control arm). Patients with non-squamous cell histology were treated with either REOLYSIN® given in combination with pemetrexed (test arm) versus pemetrexed alone (control arm). After a patient safety run-in, a total of approximately one hundred and fifty response-evaluable patients were enrolled. The primary objective is progression-free survival. Secondary objectives include the tolerability and toxicity of the treatment combination, progression rates at three months, objective response rate, and overall survival. Other objectives include the measurement of molecular factors which may be prognostic or predictive of response.

In May 2016, the Company announced preliminary survival data from the study, correlating both genetic status and gender with the treatment outcomes of lung cancer patients who received REOLYSIN®:

  Median Progression Free Survival (months) Median Overall Survival (months)1
  Test Arms

(Arm A+C) (95% CI)

Control Arms
(Arm B+D) (95% CI)
Hazard Ratio
(95% CI)
Test Arms

(Arm A+C) (95% CI)

Control Arms
(Arm B+D) (95% CI)
Hazard Ratio

(95% CI)

EGFR2 5.16
(0.76-8.71)
(n=8)
4.63
(1.51-7.03) (n=5)
0.54
(0.13-2.22)
18.66
(1.38-26.84) (n=8)
7.49
(4.63-16.79) (n=5)
0.37
(0.08-1.71)
TP532 4.07
(2.63-6.21)
(n=24)
2.40
(1.28-2.99) (n=21)
0.58
(0.31-1.08)
8.74
(6.83-13.93) (n=23)
6.14
(3.02-8.18) (n=21)
0.55
(0.28-1.07)
Female Patients 3.98
(2.66-5.39)
(n=41)
2.84
(1.51-4.34) (n=34)
0.59
(0.36-0.98)
8.38
(5.36-10.38) (n=41)
7.59
(5.59-10.45) (n=34)
0.85
(0.49-1.46)
Male Patients 2.56
(1.45-3.94)
(n=36)
2.69
(2.46-4.24) (n=41)
1.34
(0.83-2.14)
7.66
(4.37-10.94) (n=36)
7.26
(4.86-10.78) (n=41)
1.0
(0.60-1.68)
Overall 2.96
(2.56-4.17)
(n=77)
2.83
(2.50-3.98) (n=75)
0.93
(0.66-1.31)
8.12
(5.85-9.40) (n=77)
7.39
(5.72-9.43) (n=75)
0.94
(0.64-1.37)

Source: Report of Statistical Analysis for NCIC CTG Protocol Number IND.211

1 This was an interim analysis, as 38 (25.0%) patients out of a total of 152 patients were alive at the time of data cut-off. Survival outcomes noted could change at final analysis.

2 Mutated

In an abstract presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in June 2016, the study investigators concluded that REOLYSIN® was reasonably well tolerated at the dose and schedule administered with pemetrexed or docetaxel and that no new safety signals were seen. They noted it was of interest that female patients in the REOLYSIN®-containing arms did better than in the standard treatment arms and that in a subgroup analysis that EGFR mutation and p53 mutation status was associated with a trend to improved progression free survival.

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.