‘Off-the-Shelf’ Cell Therapy in Metastatic Breast Cancer: Bria-IMT™ (SABCS 2025)
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‘Off-the-Shelf’ Cell Therapy in Metastatic Breast Cancer: Bria-IMT™ (SABCS 2025)
For advanced breast cancer (HR+ and TNBC) in which standard treatments have been exhausted, hope is emerging for an ‘off-the-shelf’ immunotherapy that does not require personalized manufacturing. Data presented at SABCS 2025 showed that Bria-IMT™ cell therapy could extend survival by 40%, particularly when combined with immune checkpoint inhibitors (ICI).
1) What Is Bria-IMT™, and How Does It Work?
Bria-IMT is derived from a genetically modified human breast cancer cell line (SV-BR-1-GM). These cells secrete the immune-stimulating factor GM-CSF . When administered, the immune system recognizes these cells as ‘foreign’ and ‘cancerous’, becomes activated, and begins attacking the patient’s own tumor. Unlike CAR-T cell therapies, it does not need to be manufactured separately for each patient; it can be used off the shelf.
2) Study Design (Phase 2 and Phase 3)
The data presented at SABCS 2025 cover two studies:
- Phase 2 (n=22): Bria-IMT + Retifanlimab (ICI) combination in heavily pretreated patients.
- Phase 3 (Ongoing): A total of 264 patients are planned; the Bria-IMT combination is compared with standard chemotherapy.
Visceral metastases were present in 80% of patients, who had received an average of 4 lines of treatment.
3) Overall Survival (OS) Advantage
Phase 2 DataEfficacy Commentary
Whereas expected survival in this challenging, heavily pretreated patient group is generally around 6–7 months, Bria-IMT increased it to 11.3 months . The 40% reduction in mortality risk (HR 0.60) was statistically significant.
4) Summary Data Table
| Parameter | Value / Rate | Clinical Meaning |
|---|---|---|
| Clinical Benefit (CBR) | 59% | Disease control in more than half of patients |
| Overall Survival (OS) | 11.3 Months | HR 0.60 (Marked survival advantage) |
| ORR (Response) | 28% | Tumor shrinkage |
| Biomarkers | Increase in TILs | Indicates infiltration of the tumor by immune cells |
5) Biomarkers and ctDNA
In Phase 3 interim analyses, clearance of circulating tumor DNA (ctDNA) was observed in 40%. A 25% increase in tumor-infiltrating lymphocytes (TILs) was also detected. This demonstrates that the treatment ‘awakens’ the immune system.
Safety Profile
Cell therapies are generally safe. In this study, the DSMB also reported ‘excellent safety’.
Common Adverse Effects:
- Injection Site: 8% (Redness, pain — indicates that the vaccine is working).
- Fatigue: 5%.
- Immune Events: 4% Thyroiditis (Mild, manageable).
The rate of Grade 3+ serious adverse effects is only 15%, and treatment discontinuation is very low (3%).
Frequently Asked Questions
DROZDOGAN Academy Commentary
Bria-IMT may represent a ‘quiet revolution’ in breast cancer immunotherapy. Survival of 11.3 months is particularly valuable in heavily pretreated patients. The mild adverse-effect profile allows patients to continue treatment without compromising their quality of life. Phase 3 results are eagerly awaited.
References
- Redmond WA, et al. SABCS 2025, Poster Session 5 (PS5-03-01). "Bria-IMT™ + retifanlimab in metastatic breast cancer: Phase 2 survival data".
- BriaCell Therapeutics. J Clin Oncol. 2025;43(suppl 17):PS5-03-02. (Phase 3 Biomarker Analysis).
- Schmid P, et al. N Engl J Med. 2019. (IMpassion130 Reference).
Note: This content is based on presentation data from the SABCS 2025 congress. It is not medical advice. *Historical control data were estimated from HR 0.60.
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