Bria-IMT Regimen Offers Strong Survival Benefits for Hard-to-Treat Breast Cancer
BriaCell Therapeutics has spotlighted new clinical data at the 2025 San Antonio Breast Cancer Symposium (SABCS), underscoring meaningful survival outcomes and significant biomarker findings from both their Phase 2 and ongoing Phase 3 trials. These advances may pave the way for more targeted, personalized therapies in metastatic breast cancer—a space marked by limited treatment options and frequent progression.
Key Clinical Findings Highlight Durable Survival and Safety
Data from a Phase 1/2 trial combining Bria-IMT with an anti-PD-1 checkpoint inhibitor revealed a notable survival advantage in metastatic breast cancer patients. Patients who tested positive for delayed-type hypersensitivity (DTH) had a median overall survival of 11.3 months compared to just 4.7 months in DTH-negative individuals, a difference that was statistically significant (P = 0.0001).
The clinical benefit was especially encouraging for patients with central nervous system (CNS) metastases. For example, 100% of HER2+ and hormone receptor positive (HR+) CNS metastatic patients experienced either stable disease or tumor shrinkage, supporting the broad applicability of the Bria-IMT regimen.
| Patient Subtype | Clinical Benefit Rate (CBR) |
|---|---|
| HER2+ | 100% |
| HR+ | 100% |
| Triple Negative (TNBC) | 50% |
| Overall CNS Metastasis | 75% |
Importantly, the Bria-IMT regimen was well tolerated, with no treatment-related discontinuations in the Phase 3 study. Adverse events such as fatigue, anemia, and nausea were mostly low grade.
Biomarker Analysis Supports Personalized Patient Selection
Interim analysis from the Phase 3 trial showed that certain patient subgroups, such as those with HR+/HER2- and HER2-Low disease, had the longest median progression-free survival (PFS) at 3.7 and 3.9 months, respectively. A key takeaway: the neutrophil-to-lymphocyte ratio (NLR) continued to emerge as a potential predictor of treatment benefit. Patients with an NLR between 0.7 and 2.3 enjoyed a longer median PFS (4.4 months) versus those outside this range (2.6 months).
| Patient Subtype | Median PFS (months) |
|---|---|
| HR+/HER2- | 3.70 |
| HER2-Low | 3.90 |
| NLR 0.7-2.3 | 4.40 |
| NLR <0.7 or >2.3 | 2.60 |
Further supporting personalized therapy, analysis of 35 cytokines/chemokines revealed that post-treatment elevation of certain Th1 immune signals (like IL-2, IL-15, IL-27, and TNF-a) corresponded to stable disease or partial response, and were associated with improved survival.
Cytokine Signature Points to Enhanced Immune Activation
The immunotherapy not only demonstrated a pro-inflammatory (Th1) immune profile—favorable for anti-tumor responses—but also did not stimulate signals linked with immune suppression. Markers like IL-1, IL-6, IL-8, and TNF-a post-treatment were positively associated with overall survival, suggesting that patients experiencing robust immune activation after Bria-IMT treatment might enjoy better outcomes.
Looking Ahead: Ongoing Trials Aim to Refine Patient Selection
These findings collectively reinforce BriaCell's approach: matching the right patient to immunotherapy using a suite of predictive biomarkers. As Phase 3 enrollment and data collection progress, ongoing analysis will likely shed more light on the potential to individualize treatment—potentially giving patients with advanced, hard-to-treat breast cancer a new hope.
Takeaway: BriaCell's Bria-IMT Brings Clinical Promise and New Avenues for Precision Medicine
While definitive conclusions await full Phase 3 readouts, the combination of improved survival, strong safety profile, and actionable biomarker data places Bria-IMT among the most compelling candidates for changing how metastatic breast cancer is managed. For investors and clinicians alike, monitoring BriaCell’s continued clinical development—and its focus on personalized, immune-based therapies—may provide important clues for the next generation of cancer treatment strategies.
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