Oncolytics Biotech Announces Updated Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial that Show Pelareorep Driving Robust Increases in Progression-Free Survival and Confirmed Overall Response Rate - Seite 3

32.8

(95% CI: 11.7, 92.4)

0

(95% CI: -, -)

1. Data from a March 3, 2023 cut-off date. Numbers presented may change as they are derived from an unlocked database.

2. Data include all patients enrolled in trial. Response data presented by Clark et al. at ASCO 2023 included the 45 randomized patients and excluded participants in the three-patient safety run-in in cohort 3. 

CI: Confidence interval; NR: Not reached.

 

Key biomarker and safety findings from BRACELET-1 include:

• Association between T cell expansion and efficacy measures: A statistically significant increase in T cell fraction, a measure of T cell expansion, was observed in cohort 2 (paclitaxel + pelareorep) but not cohort 3 (paclitaxel + pelareorep + avelumab)
• Generally favorable and manageable safety profile: Pelareorep displayed a manageable safety profile consistent with what has been observed in prior clinical trials that have collectively treated over 1,100 patients

Dr. Thomas Heineman, Chief Medical Officer, commented, "BRACELET-1's impressive initial results are maturing quite favorably. While five patients in the pelareorep-paclitaxel group had partial responses at week 16, six patients in total had confirmed responses. This includes two patients who improved from stable disease to partial responses at later times, consistent with pelareorep's immunologic mechanism of action. Moreover, the compelling ORR and PFS hazard ratio achieved align with translational results showcasing pelareorep's immune-mediated mechanism of action and complement additional data that support the combination therapy's generally favorable safety profile. Collectively, these results bolster an expansive clinical dataset supporting the potential of pelareorep-paclitaxel combination therapy in HR+/HER2- metastatic breast cancer and are expected to propel our program to a pivotal licensure-enabling study."