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Oncolytics Biotech® Reports Favorable Results for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study
Overall survival (OS) results from BRACELET-1 corroborate results of previous randomized IND-213 breast cancer studyTogether, these two studies support the
About this update from Oncolytics Biotech Inc.
[{"type":"text","content":"Overall survival (OS) results from BRACELET-1 corroborate results of previous randomized IND-213 breast cancer studyTogether, these two studies support the compelling potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancerOncolytics Biotech is moving forward to secure funding for a registration-enabling study of pelareorep-based therapy in advanced or metastatic breast cancerOver half of BRACELET-1 patients in the pelareorep + chemotherapy arm alive at study end Median OS in the pelareorep + chemotherapy arm not reached; median OS at least 32 months (estimated) vs 18 months for the control chemotherapy-only armSAN DIEGO and CALGARY, AB, Sept. 19, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced positive clinical results from BRACELET-1, its randomized Phase 2 study evaluating pelareorep in patients with HR+/HER2- advanced or metastatic breast cancer.\n\nFinal BRACELET-1 Results\nFinal BRACELET-1 efficacy data were collected and analyzed two years after the last patient was enrolled as specified by the protocol. Results of the final BRACELET-1 analysis show that the median OS was not reached in the pelareorep + paclitaxel arm, as more than half of the patients in that arm remained alive at study end. In contrast, 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. Had study follow-up continued beyond two years, and patients survived only until the next planned visit (in four months), the median OS for patients in the pelareorep + paclitaxel arm would be 32.1 months. In accordance with these results, the two-year survival rate for patients in the pelareorep + paclitaxel arm was 64% compared to 33% for paclitaxel monotherapy patients. Additionally, the final median progression-free survival (PFS) for BRACELET-1 was 12.1 months in the pelareorep + paclitaxel arm vs. 6.4 months in the paclitaxel monotherapy arm, representing a 5.7-month benefit with a hazard ratio of 0.39.\nConfirmed overall response rate (ORR) was 37.5% for pelareorep + paclitaxel and 13.3% for paclitaxel. As previously reported, ORRs at week 16 (the trial's primary endpoint) in the pelar...