Study of the Bria-IMT regimen and CPI vs physicians' choice in advanced metastatic breast cancer (BRIA-ABC).
Bibliographic record
Abstract
TPS1137 Background: BriaCell (BC) human immortalized cell lines have been engineered to trigger robust immune responses and deliver efficacy through diverse mechanisms, including adaptive (involving T-cells) and innate responses (dendritic and NK cells). BC can match patients’ HLA antigens for optimal effectiveness. BC works by several mechanisms, including direct antigen presentation and activation of CD4+ T-cells. When combined with an immune checkpoint inhibitor, the BC regimen has demonstrated clinical benefit in 54 heavily treated MBCs. Most pts whose disease has progressed after checkpoint inhibitor (CPI) therapy showed similar or improved PFS compared to the patient's last treatment regimen. Disease control after prior antibody-drug conjugates (ADCs) has been observed in 40% of patients, and clinical benefit has been seen in 5/7 patients with untreated intracranial metastases. CD8+ Immuno PET shows an increase in CD8+ tumor infiltrating lymphocytes suggesting systemic activation and infiltration into lymphoid organs and metastatic sites. Sequencing of CPI with BC and the latest phase 3 formulation are associated with improved clinical outcomes, including OS (median 13.4 months), PFS, and CBR, which are reflected in the design of this ongoing pivotal registration enabling Phase 3 study [doi:10.1158/1538-7445.sabcs22-p3-07-12]. Methods: Multicenter randomized, open label Bria-IMT regimen (with SV-BR-1-GM cells) plus CPI vs Treatment of Physicians' Choice (TPC) in MBCs with no approved curative therapies available. ECOG <2 allowed with no limit on prior therapies. Eligibility encompasses all MBC subtypes including pts with CNS metastases. Prior immune therapy is allowed if administered more than 21 days before the first cycle of Bria-IMT; treatments within 21 days preclude participation. Initial randomization will be 1:1:1 to the Bria-IMT regimen + CPI (combination), TPC, and the Bria-IMT regimen alone (monotherapy). There will be 100 sites across the US, Canada, and ex-NA for 404 total evaluable pts. The Bria-IMT regimen includes: Day -2 Cyclophosphamide 300mg/m2, Day 0 20 million irradiated SV-BR-1-GM cells intradermally, and 0.1mcg peg α interferon intra-dermally (Day 2 or 3) into each Bria-IMT inoculation site. After the first 150 pts have enrolled, the monotherapy arm will be discontinued. Bria regimen + CPI arms treatment cycles occur q3w. CPI infusion is given every cycle between Day –3 to Day 3 TPC cycle details will be according to the site's SOC. Imaging assessment will be q6w x2 then q8w. The primary endpoint is overall survival with an interim analysis at 144 events targeting a hazard ratio of 0.6. Key secondary endpoints will include PFS, ORR, CBR, CNS event free survival, and TWiST (time without symptoms or toxicities). Safety analysis will be ongoing. Patient-reported outcomes will be incorporated to assess subjective treatment effects. Clinical trial information: NCT06072612 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.005 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".