BriaCell Phase III data

BriaCell Therapeutics Corp. presented clinical data from the pivotal Phase III study of its lead product candidate, Bria-IMT, in metastatic breast cancer (BRIA-ABC; NCT06072612 ) supporting the use of specific biomarkers to predict patients’ clinical response to Bria-IMT treatments at the American Association for Cancer Research (AACR Annual Meeting). Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefits with BriaCell’s novel Bria-IMT regimen.

Title: Bria-ABC [1] vs physician choice in late-stage MBC; early biomarker correlates of the randomized registration trial
Session Title: Late-Breaking Research: Clinical Research 4
Session Date: 4/30/2025 
Abstract Presentation Number: LB408

About the Bria-ABC Study

The multicenter randomized open label study is evaluating overall survival with the Bria-IMT regimen in combination with checkpoint inhibitor, versus Treatment of Patients’/Physicians’ Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available. A total of 57 clinical sites in the US are actively enrolling patients and additional sites are in various stages of start-up.

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase III study could result in full approval and marketing authorization for Bria-IMT in MBC patients.

Kaplan Meier analysis of early clinical data (n=62) in this multicenter study showed median progression free survival across all arms of 3.67 months. Prespecified subset analyses of PFS based on biomarker status were reported as follows:

• Positive DTH was significantly related to better PFS (4.5 vs 2.5 months, p = 0.001)

• Neutrophil-to-lymphocyte ratio (NLR) < 0.7 and ≥ 2.3 following the 1st treatment administration had significantly lower (p = 0.02) median progression-free survival (PFS)

• Circulating tumor cells (CTCs) < 1 were significantly related to better PFS values (3.8 months vs 2.4 vs, p = 0.04)

• • Baseline Cancer-Associated Macrophage-Like Cells (CAML) count ≥ 5 trended toward a higher PFS value (3.7 vs 2.2 months, p = 0.10)

The Bria-IMT regimen remains well-tolerated, with generally manageable treatment-emergent adverse events (TEAEs). There have been no Bria-IMT related treatment discontinuations, underscoring Bria-IMT’s excellent tolerability and favorable safety profile.