Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) announced positive results from its BRACELET-1 trial, indicating a substantial overall survival benefit for pelareorep in combination with paclitaxel in patients with HR+/HER2- metastatic breast cancer. The company is also advancing its gastrointestinal cancer program, with key data readouts expected in 2025.
BRACELET-1 Trial Results
The BRACELET-1 trial demonstrated a progression-free survival of 12.1 months for patients treated with pelareorep and paclitaxel, compared to 6.4 months for those treated with paclitaxel alone. Furthermore, 64% of patients in the pelareorep combination arm were alive after two years, versus 33% in the paclitaxel-only arm. While overall survival data is still maturing, preliminary estimates suggest a median overall survival of 32.1 months for the combination therapy, compared to 18.2 months for paclitaxel monotherapy.
Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO, stated, "With positive BRACELET-1 results, we have two randomized phase two studies confirming pelareorep's potential in HR+/HER2- metastatic breast cancer... a registration-enabling study that is designed to support an accelerated approval is the next logical step for the development of pelareorep."
Advancing Gastrointestinal Cancer Program
Oncolytics Biotech is also focusing on its gastrointestinal cancer program. Updated efficacy data from the anal cancer cohort of the GOBLET study and safety data from the modified FOLFIRINOX pancreatic cancer cohort are expected in the first half of 2025. These indications represent significant unmet medical needs, and early data suggests that pelareorep has the potential to improve patient outcomes.
Financial Position
As of September 30, 2024, Oncolytics Biotech reported $19.6 million in cash and cash equivalents. The company anticipates that its current cash reserves will be sufficient to fund operations through key milestones and into 2025. The net loss for the third quarter of 2024 was $9.5 million, compared to $9.9 million for the same period in 2023.
Upcoming Milestones
Key milestones anticipated by Oncolytics Biotech include:
- Finalizing the master protocol for an adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma (PDAC) in H1 2025.
- Presenting safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and modified FOLFIRNOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic cancer, also in H1 2025.
- Sharing updated efficacy data from cohort 4 of the GOBLET study, evaluating pelareorep and atezolizumab in second-line or later anal cancer, in H1 2025.
- Enrolling the first patient in a registration-enabling study assessing pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer by mid-2025.
- Reporting initial efficacy results from cohort 5 of the GOBLET study, examining pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer, in H2 2025.
