Oncolytics Biotech® Partner Adlai Nortye Advances Chinese Bridging Trial of Pelareorep-Paclitaxel Combination Treatment in Breast Cancer to Final Dosing Cohort
First two cohorts indicate pelareorep in combination with paclitaxel was well-tolerated with no new safety signals observed to date
Trial is designed to satisfy regulatory requirements and accelerate pelareorep’s development in large and rapidly growing pharmaceutical markets, including China, Hong Kong, Macau, Taiwan, Singapore, and South Korea
Final cohort’s dosing regimen is equivalent to Oncolytics’ North American phase 2 trial in metastatic breast cancer (BRACELET-1)
Excerpt from the Press Release:
SAN DIEGO, Calif. and CALGARY, AB, March 24, 2022 /PRNewswire/ — Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that its partner Adlai Nortye has advanced to the third and final dose escalation cohort of the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. The trial’s first two cohorts have completed their dose escalation evaluation periods and indicated pelareorep in combination with paclitaxel was well-tolerated with no new safety signals observed to date.
The dosing regimens for the bridging trial’s second and third cohorts are equivalent to those administered in Oncolytics’ randomized North American breast cancer trials, IND-213 and BRACELET-1, respectively. In IND-213, HR+/HER2- breast cancer patients treated with pelareorep and paclitaxel showed a statistically significant, near doubling of overall survival compared to those treated with paclitaxel alone. BRACELET-1, an ongoing phase 2 study evaluating pelareorep-paclitaxel combination therapy with and without a checkpoint inhibitor, is on track for a top-line data readout in Q4 2022 that will inform the design of a registrational study in the United States. Final results from the Chinese bridging trial are expected to accelerate pelareorep’s development in territories such as China, Hong Kong, and Macau, by allowing Adlai Nortye to include data from IND-213 and BRACELET-1 in future submissions to regulators in these jurisdictions.
Click the button below to read the entire Press Release:
Discover What Sets TrialStat Apart From Ordinary EDC Platforms
Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.
Request Your Demo Today!
From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?