Oncolytics Biotech announced that Reolysin (pelareorep), an immune-oncology viral agent for the treatment of metastatic breast cancer, has been granted Fast Track designation by the Food and Drug Administration (FDA).
The designation is based on results from IND 213, a Phase 2 open-label, randomized trial. A total of 74 patients with metastatic breast cancer were enrolled and treated with either a combination of Reoslyin and paclitaxel, or paclitaxel only. Sixteen (22%) patients were excluded from the final analysis due to missing data. Results showed that the Reoslyin plus paclitaxel group had a median overall survival of 17.4 months vs. 10.4 months for the control group (HR 0.65, 80% CI: 0.46–0.91, P=0.10).
The only adverse event that was grade 3 or higher was fatigue with 16.3% incidence in the treatment group and 13.2% in the control group. The next most common adverse event was anorexia, occurring in 6.9% and 2.6%, in the treatment vs. control arms, respectively.
“Our goal is to conduct an End-of-Phase 2 meeting with the FDA as soon as is practical and obtain scientific guidance,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. “We are eager to leverage this designation and use the opportunity for more frequent dialogue with the FDA, as well as the potential for an expedited review process, to support the future development of Reoslyin.”
A further registration study is currently being planned by Oncolytics to examine Reolysin in breast cancer.
For more information visit Oncolyticsbiotech.com.