- Oncolytics Biotech (TSX:ONC) revealed results from its Phase 2 study evaluating its pelareorep-based therapy in patients with advanced or metastatic breast cancer
- Final results were collected and analyzed two years after the last patient was enrolled in the study
- Median overall survival was not reached in the pelareorep + paclitaxel arm as more than half the patients in this cohort were alive by the end of the study
- Shares of Oncolytics Biotech are up 0.78 per cent to C$1.29 as of 10:51 am ET
Oncolytics Biotech (TSX:ONC) revealed results from its Phase 2 study evaluating its pelareorep-based therapy in patients with advanced or metastatic breast cancer.
The company stated in a news release that final results were collected and analyzed two years after the last patient was enrolled in the study.
Notably, median overall survival (OS) was not reached in the pelareorep + paclitaxel arm as more than half the patients in this cohort were alive by the end of the BRACELET-1 study.
Meanwhile, median OS for the paclitaxel monotherapy arm was 18.2 months, and the hazard ratio was 0.48 for pelareorep + paclitaxel vs. the paclitaxel monotherapy.
“The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us,” Wayne Pisano, interim of Oncolytics Biotech, said in a statement. “It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients.”
If the follow-up study had gone on for more than two years and patients survived only until the next planned visit, the median OS for patients in the pelareorep + paclitaxel arm would be 32.1 months.
As such, the two-year survival rate for patients in the pelareorep + paclitaxel arm was 64 per cent compared with 33 per cent for paclitaxel monotherapy patients.
Thomas Heineman, chief medical officer at Oncolytics, explained that recent discussions with the U.S. Food and Drug Administration (FDA) related to the company’s design elements for its next breast cancer study – and survival rate from the BRACELET-1 and IND-213 studies – the company anticipates conducting a registration-enabling study to assess the pelareorep-based combination therapy in patients with advanced or metastatic breast cancer.
Oncolytics Biotech is developing pelareorep, an intravenously delivered immunotherapeutic agent, that has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer.
Shares of Oncolytics Biotech are up 0.78 per cent to C$1.29 as of 10:51 am ET.
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