BriaCell Abstracts Showcase Positive Survival and Clinical Benefit Data at ASCO 2025
- Significant improvement in overall survival (13.4 months) comparable to FDA-approved therapies ASCENT (11.8 months) and TROPiCS-02 (14.4 months)
- Superior Clinical Benefit Rate of 61% compared to ASCENT (40%) and TROPiCS-02 (34%)
- Strong safety profile with no treatment-related discontinuations
- Positive efficacy demonstrated in more heavily pre-treated patient population
- 22% of patients remain in active survival follow-up
- Lower Objective Response Rate (14%) compared to some FDA-approved therapies (ASCENT-SG: 31%, TROPiCS-02-SG: 21%)
- Relatively short progression-free survival of 3.6 months compared to ASCENT-SG (4.8 months) and TROPiCS-02-SG (5.5 months)
Insights
BriaCell's Phase 2 cancer immunotherapy shows promising survival rates in heavily pretreated breast cancer patients, supporting ongoing pivotal Phase 3 trial.
The data presented by BriaCell at ASCO 2025 represents a significant clinical milestone for their Bria-IMT cellular immunotherapy. Most notably, patients receiving the Phase 3 formulation demonstrated a median overall survival of 13.43 months and progression-free survival of 3.6 months, which favorably compares to FDA-approved therapies in similar patient populations.
What makes these results particularly compelling is the patient context. The study cohort had a median of 6 prior therapies (range 2-13), meaning these were heavily pretreated patients who typically have poor prognoses. For comparison, patients in the ASCENT and TROPiCS-02 trials had median prior therapy counts of 3-4, making BriaCell's comparable survival outcomes even more noteworthy.
The clinical benefit rate of 61
The safety profile appears excellent, with no treatment-related discontinuations reported—a significant advantage in a therapeutic area where toxicity often limits treatment. The absence of treatment-limiting toxicity combined with efficacy in heavily pretreated patients could position Bria-IMT as an important late-line option for metastatic breast cancer.
The preliminary success of Bria-OTS (their off-the-shelf formulation) with a confirmed resolution of lung metastasis in the first patient is also promising, though with only 3 patients treated, it's too early to draw conclusions.
The ongoing pivotal Phase 3 study will be critical—if it confirms these Phase 2 results, BriaCell's pathway to regulatory approval appears well-defined.
BriaCell's Phase 2 data shows competitive efficacy against approved therapies, bolstering potential commercial viability ahead of pivotal Phase 3 readout.
BriaCell's latest clinical data represents a significant value inflection point for the company's development pipeline. The Phase 2 results for Bria-IMT in metastatic breast cancer demonstrate competitive efficacy metrics when benchmarked against approved therapies like Trodelvy, particularly notable given Bria-IMT was tested in a more heavily pretreated population (median 6 prior therapies versus 3-4 in comparator trials).
The comparative survival data is particularly compelling from a commercial perspective. The Phase 3 formulation achieved median overall survival of 13.43 months, positioning it competitively against Trodelvy's 11.8 months in ASCENT and 14.4 months in TROPiCS-02. More impressively, the clinical benefit rate of 61
From a regulatory pathway perspective, this data strengthens BriaCell's case for potential Priority Review designation if the Phase 3 trial confirms these outcomes. The press release specifically mentions potential for Biologics License Application, Priority Review, and Full Approval—suggesting confidence in their regulatory strategy.
The company's concurrent development of Bria-OTS, an off-the-shelf formulation, represents a significant manufacturing and commercialization advantage if successful. Allogeneic (off-the-shelf) therapies typically offer more favorable cost structures and logistical advantages compared to autologous approaches.
The clean safety profile with no treatment-related discontinuations is a major differentiator in the heavily pretreated metastatic setting, where patients often discontinue therapy due to adverse events. This could translate to longer treatment duration and improved real-world outcomes.
With multiple poster presentations at ASCO and continued patient enrollment in the pivotal Phase 3 trial, BriaCell appears to be executing well on both clinical development and scientific communication fronts. The decisive efficacy advantage of their Phase 3 formulation (13.4 vs. 6.9 months OS; p=0.01) compared to their alternative formulation provides clear direction for their pipeline strategy.
- Phase 2 survival and clinical benefit data meet or exceed outcomes of FDA-approved therapies in comparable metastatic breast cancer patients, with no treatment-related discontinuations
- Successful completion of the pivotal Phase 3 study may support Biologics License Application, Priority Review, Full Approval, and Commercialization
PHILADELPHIA and VANCOUVER, British Columbia, May 23, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announces the presentation of positive survival and clinical benefit data in three clinical poster presentations and one publish-only abstract at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL.
“We are highly encouraged by the survival and clinical benefit data from our Phase 2 Bria-IMT™ study which meets and outperforms outcomes seen with FDA approved therapies - despite our patients being more heavily pre-treated,” stated Dr. William V. Williams, BriaCell’s President & CEO. “These results reinforce our belief in Bria-IMT’s potential to address the urgent, unmet needs of patients with metastatic breast cancer and we look forward to confirming results in our ongoing pivotal Phase 3 study.”
“These data provide additional validation of the mechanism of action and support the clinical efficacy of Bria-IMT,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “Importantly, the regimen has been well-tolerated and its favorable safety and efficacy profile positions it as a promising, less toxic therapeutic option for patients battling metastatic breast cancer.”
The details of the poster presentation sessions and publish-only abstract are listed below.
Abstract Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician’s choice in advanced metastatic breast cancer (BRIA-ABC)
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1138
Poster Board Number: 108a
Session Type and Title: Poster Session – Breast Cancer—Metastatic
Preliminary selected clinical and biomarker data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612).
Abstract Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: 1096
Poster Board Number: 75
Session Type and Title: Poster Session – Breast Cancer—Metastatic
Phase 2 study of Bria-IMT in combination immunotherapy with an immune checkpoint inhibitor (CPI) consisted of 54 patients; 11 received pembrolizumab, 44 retifanlimab (1crossover).
| Table 1: Median overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR) were evaluated against two pivotal Phase 3 studies of FDA approved drugs, ASCENT (Trodelvy® (SG) or Treatment of Physicians Choice (TPC) in triple-negative breast cancer (TNBC)) and TROPiCS-02 (SG or TPC in Hormone Receptor +/HER2- MBC) | ||||||
| Trial (Cohort) | Age (median, range) | Prior Therapies (median, range) | OS (months) | PFS (months) | ORR (%) | CBR (%) |
| Bria-IMT (Overall Cohort) | 61 (38-81) | 6 (2-13) | 9.9 (1.8-30.3) | 3.6 | ||
| Bria-IMT (Phase 3 regimen) | 62 (44-80) | 6 (2-13) | 13.43 (1.8-30.3) | 3.6 (1.8-16.5) | 14% | 61% |
| ASCENT (SG) | 54 (27-82) | 4 (2-17) | 11.8 | 4.8 | ||
| ASCENT (TPC) | 53 (27-81) | 4 (2-14) | 6.9 | 1.7 | ||
| TROPiCS-02 (SG) | 57 (49-65) | 3 | 14.4 | 5.5 | ||
| TROPiCS-02 (TPC) | 55 (48-63) | 3 | 11.2 | 4 | ||
Bria-IMT was well-tolerated with no treatment-related discontinuations.
This analysis does not stratify Bria-IMT patients by hormone receptor or HER2 status, and the dataset reflects the information available at the time of abstract submission. Updated data will be shared during the company’s presentation at ASCO 2025.
PFS (median) and OS (median): Patients treated with Bria-IMT’s selected Phase 3 formulation (without IFNγ; N = 37) demonstrated significantly improved progression-free survival (3.6 vs. 2.6 months; P = 0.01) and overall survival (13.4 vs. 6.9 months; P = 0.01) compared to those who received the alternate formulation not advanced to Phase 3.
The overall survival observed in the Phase 3 formulation cohort (13.4 months) was comparable to that reported in the ASCENT (11.8 months) and TROPiCS-02 (14.4 months) studies and exceeded survival outcomes in their respective treatment of physician’s choice (TPC) arms (6.9 and 11.2 months).
BriaCell’s Phase 2 study also achieved a Clinical Benefit Rate (CBR) of
Importantly, these outcomes were achieved in a more heavily pretreated patient population than those in the comparator trials—highlighting Bria-IMT’s strong anti-cancer activity. The favorable efficacy profile of the Phase 3 formulation supports its continued evaluation in BriaCell’s ongoing pivotal Phase 3 trial comparing Bria-IMT to treatment of physician’s choice (NCT06072612).
Abstract Title: Trial in progress: A study of Bria-OTS™ cellular immunotherapy in metastatic recurrent breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1136
Poster Board Number: 107a
Session Type and Title: Poster Session – Breast Cancer—Metastatic
Heavily pre-treated MBC patients were treated in a dose escalation Phase 1/2 study of Bria-OTS monotherapy (single agent). The Phase 1 part of the study has enrolled and treated 3 patients. The first patient treated with single agent therapy has confirmed resolution of a breast cancer metastasis in the lung and remains on study.
Publish-Only Abstract Title: Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT Plus Anti PD1 in Advanced Breast Cancer
Following the presentations, copies of the presentations will be posted on https://briacell.com/scientific-publications/.
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.
Safe Harbor
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about BriaCell’s successful completion of the pivotal Phase 3 study supporting biologics license application, priority review, full approval, and commercialization; Bria-IMT’s potential to address the urgent, unmet needs of patients with metastatic breast cancer; BriaCell confirming results in their ongoing pivotal Phase 3 study; Bria-IMT being positioned as a promising, less toxic therapeutic option for patients battling metastatic breast cancer; BriaCell presenting at the 2025 American Society of Clinical Oncology and the contents of such presentations are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company's most recent Management’s Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under “Risks and Uncertainties” in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Investor Relations Contact:
investors@briacell.com
FAQ
What are the key Phase 2 survival results for BCTX's Bria-IMT cancer treatment?
How does BCTX's Bria-IMT compare to existing FDA-approved breast cancer treatments?
What is the safety profile of BCTX's Bria-IMT treatment?
What are the next steps for BCTX's Bria-IMT cancer treatment?
When will BCTX present their clinical trial results?
