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Clinical Trial : REO 016

REO 016 was a single arm, two-stage, open-label Phase II study of REOLYSIN® in combination with paclitaxel and carboplatin in patients with metastatic or recurrent non-small cell lung cancer with KRAS- or EGFR-activated tumours. Patients received paclitaxel and carboplatin on day 1 of each twenty-one day cycle, with either REOLYSIN® administered on days 1 through 5.  Approximately 37 patients were enrolled. The primary objectives were objective response rate and progression-free survival and 6 months. The secondary objectives were median survival, duration of progression-free survival, and the safety and tolerability of the treatment regimen.

In October 2013, interim data from the study that correlated the presence of specific biomarkers with best response, progression-free survival and one-year survival was presented at the International Association for the Study of Lung Cancer (IASLC) Conference in Sydney, Australia. At that time, 20 of 36 evaluable patients (56%) had survived a year or more. There were 13 patients with only EGFR mutations or amplifications, of whom nine (69.2%) had survived a year or longer. Four of four (100%) patients with BRAF and EGFR amplification had survived a year or longer. The chart below summarizes key interim findings for the 36 evaluable patients:

Molecular 
Abnormality
Number of 
Patients
Best Response Number 
Progression-Free 
at Six Months
Number 
Surviving One 
Year
BRAF mutation,
EGFR
amplification
4 2 PR, 1 SD, 1 PD 2 4
EGFR
amplification
10 5 PR, 5 SD 4 7
EGFR mutation,
EGFR
amplification
3 1 PR, 1 SD, 1 PD 1 2
KRAS 12 3 PR, 8 SD 6 4
KRAS, EGFR
amplification
7 6 SD, 1 PD 1 3
Total 36 11 PR, 11 SD
(30% response rate)
14 (38%) 20 (56%)

 

Final results from the study were presented by Oncolytics collaborators at the International Association for the Study of Lung Cancer (IASLC) 16th World Conference on Lung Cancer in September 2015. Median progression-free survival for the study was four months, and median overall survival was 13.1 months. One- and two-year survival rates were 57% and 30%, respectively, with the investigators concluding that the survival of 11 patients for longer than 2 years was substantial. Seven patients remained alive after a median follow-up of 34.2 months (range: 26.9 to 71.5 months), with 2 patients showing now evidence of disease progression at the time of analysis (50 and 37 months). For comparison, the Company referred to historical control data as per Schiller et al., 2002, which reported a median PFS of 3.1 months, median OS of 8.1 months, one-year survival rates of 34%, and two-year survival rates of 11% for 290 patients treated with carboplatin and paclitaxel.

The September 2015 presentation also disclosed that, of the 35 patients evaluable for clinical response in the REO 016 study, 11 patients (5 KRAS mutant) had a partial response (PR), 20 had stable disease (SD) and four had progressive disease by RECIST for an objective response rate (ORR) of 31%. Four patients with SD had a >40% PET standardized uptake value reduction after two cycles, yielding an ORR considering PET of 43%.