BriaCell Presents Phase 3 Clinical Biomarker Data at ESMO 2025
BriaCell (Nasdaq: BCTX) presented biomarker data from its ongoing pivotal Phase 3 trial of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer at ESMO 2025 (poster #3928).
Pooled, blinded data from 113 patients (median 6 prior lines) show biomarker trends consistent with Phase 2: neutrophil-to-lymphocyte ratio (NLR) remains a potential predictor of clinical benefit (Phase 2 PFS 4.5 vs 2.5 months; HR 0.5, 95% CI 0.3–0.8, p=0.005). No new safety or tolerability signals were identified and there were no treatment-related discontinuations.
Interim OS analysis is planned at 144 events. Bria-IMT combination has FDA Fast Track designation.
BriaCell (Nasdaq: BCTX) ha presentato dati biomarker dal suo attuale trial pivotale di fase 3 di Bria-IMT in aggiunta a un inibitore di checkpoint immunitario nel cancro al seno metastatico all'ESMO 2025 (poster #3928).
Dati combinati e ciechi da 113 pazienti (mediana 6 linee precedenti) mostrano tendenze biomarker coerenti con la fase 2: rapporto neutrofili-lymphociti (NLR) resta potenziale predittore di beneficio clinico (PFS fase 2 4.5 vs 2.5 mesi; HR 0.5, 95% CI 0.3–0.8, p=0.005). Nessuna nuova segnalazione di sicurezza o tollerabilità è stata identificata e non ci sono state interruzioni legate al trattamento.
L'analisi interima dell'OS è pianificata a 144 eventi. La combinazione Bria-IMT ha la designazione FDA Fast Track.
BriaCell (Nasdaq: BCTX) presentó datos biomarcadores de su ensayo pivotal de fase 3 en curso de Bria-IMT más un inhibidor de punto de control inmunitario en cáncer de mama metastásico en ESMO 2025 (póster #3928).
Datos combinados y cegados de 113 pacientes (mediana de 6 líneas previas) muestran tendencias de biomarcadores consistentes con la fase 2: relación neutrófilo-linfocito (NLR) continúa siendo un posible predictor de beneficio clínico (PFS de la fase 2 4.5 vs 2.5 meses; HR 0.5, IC del 95% 0.3–0.8, p=0.005). No se identificaron nuevas señales de seguridad o tolerabilidad y no hubo descontinuciones relacionadas con el tratamiento.
El análisis interino de OS está planificado a 144 eventos. La combinación Bria-IMT tiene designación FDA Fast Track.
브리아셀(나스닥: BCTX)은 진행 중인 3상 임상시험에서 브리아-IMT와 면역 체크포인트 억제제를 병용한 전이성 유방암 치료에 대한 biomarker 데이터를 ESMO 2025에서 발표했습니다(포스터 #3928).
113명의 데이터(중위값 6회 이전 치료 선)에서 2상과 일치하는 생체표지자 경향이 확인되었으며, 호중구-림프구 비율(NLR)은 임상적 이익의 잠재적 예측 인자로 남아 있습니다(2상 PFS 4.5대 2.5개월; HR 0.5, 95% CI 0.3–0.8, p=0.005). 새로운 안전성 또는 내약성 신호는 확인되지 않았고 치료 관련 중단도 없었습니다.
중간 OS 분석은 144건의 사건에서 계획되어 있습니다. Bria-IMT 조합은 FDA Fast Track 지정을 받았습니다.
BriaCell (Nasdaq : BCTX) a présenté des données biomarqueurs de son essai pivot de phase 3 en cours associant Bria-IMT à un inhibiteur du point de contrôle immunitaire dans le cancer du sein métastatique à l'ESMO 2025 (Poster n°3928).
Des données regroupées et en aveugle de 113 patients (médiane de 6 lignes de traitement antérieures) montrent des tendances de biomarqueurs conformes à la phase 2 : le taux neutrophile-lymphocyte (NLR) demeure un prédicateur potentiel de bénéfice clinique (PFS de la phase 2 4,5 vs 2,5 mois ; HR 0,5, CI à 95% 0,3–0,8, p=0,005). Aucune nouvelle signalisation de sécurité ou de tolérance n'a été identifiée et il n'y a pas eu d'arrêts liés au traitement.
L'analyse intermédiaire de l'OS est prévue à 144 événements. La combinaison Bria-IMT bénéficie d'une désignation FDA Fast Track.
BriaCell (Nasdaq: BCTX) stellte Biomarker-Daten aus ihrer laufenden pivotalen Phase-3-Studie von Bria-IMT in Kombination mit einem Immun-Checkpoint-Inhibitor bei metastasiertem Brustkrebs auf der ESMO 2025 vor (Poster #3928).
Gekoppelte, verblindete Daten von 113 Patienten (Median 6 vorherige Behandlungen) zeigen Biomarker-Trends, die mit Phase 2 übereinstimmen: Der Neutrophil-Lymphozyten-Verhältnis (NLR) bleibt ein potenzieller Prädiktor für klinischen Nutzen (PFS Phase 2 4,5 vs 2,5 Monate; HR 0,5, 95% KI 0,3–0,8, p=0,005). Es wurden keine neuen Sicherheits- oder Verträglichkeits-Signale identifiziert und es gab keine behandlungsbedingten Abbrüche.
Eine Zwischen-OS-Analyse ist bei 144 Ereignissen geplant. Die Bria-IMT-Kombination hat die FDA Fast-Track-Bewertung.
BriaCell (ناسداك: BCTX) قد قدمت بيانات بيوماركر من تجربتها المحورية من المرحلة 3 الجارية لــ Bria-IMT مع مثبِّط نقطة تفتيش مناعي في سرطان الثدي النقيلي في ESMO 2025 (بوستر #3928).
بيانات مجمّعة ومُعمَّاة من 113 مريضاً (الوسيط 6 أسطر علاج سابقة) تُظهر اتجاهات البيوماركر متوافقة مع المرحلة 2: نسبة العدلات إلى الخلايا اللمفاوية (NLR) ما تزال مُتَنبِئاً محتملاً بفائدة سريرية (PFS للمرحلة 2 4.5 مقابل 2.5 أشهر؛ HR 0.5، 95% CI 0.3–0.8، p=0.005). لم تُسجَّل أي إشارات أمان جديدة أو تحمل، ولم تُسجَل أي توقفات مرتبطة بالعلاج.
من المخطط إجراء تحليل OS في منتصف الفترة عند 144 حدثاً. تركيبة Bria-IMT حصلت علىDesignation FDA Fast Track.
BriaCell (纳斯达克：BCTX) 在正在进行的 Bria-IMT 联合免疫检查点抑制剂治疗转移性乳腺癌的关键性III期试验中，在ESMO 2025（海报 #3928）上公布了生物标志物数据。
来自113 名患者（中位线前6条治疗线）的盲法合并数据显示生物标志物趋势与阶段 2 相符：中性粒细胞-淋巴细胞比值（NLR）仍然是临床获益的潜在预测因子（阶段 2 的进展无生存 PFS 4.5 vs 2.5 个月；HR 0.5，95% 置信区间 0.3–0.8，p=0.005）。未发现新的安全性或耐受性信号，且未有治疗相关的中止情况。
计划在144 次事件时进行中期总生存分析。Bria-IMT 联合被 FDA Fast Track 授予。
- Pooled data available for 113 patients (median 6 prior lines)
- NLR biomarker aligns with Phase 2 predictive trends (Phase 2 HR 0.5, p=0.005)
- No new safety signals and no treatment-related discontinuations reported
- FDA Fast Track designation for the Bria-IMT combination regimen
- Interim OS plan triggered at 144 patient events
- Phase 3 efficacy comparison remains blinded; PFS vs physician’s choice not yet disclosed
- Pooled dataset is limited to 113 patients, below interim OS event threshold
- Patient population is heavily pretreated with median 6 prior lines, which may affect outcomes
- Reported predictive NLR effect is based on prior Phase 2 subgroup data, not mature Phase 3 OS
Insights
Phase 3 pooled biomarker signals mirror Phase 2 and show a clear NLR association with longer PFS; safety remains manageable.
BriaCell reports pooled, blinded data from
The pooled dataset covers 113 patients with heavy prior therapy (median six prior lines) and reports no treatment‑related discontinuations and mostly mild adverse events such as fatigue, anemia, and nausea. These safety observations support tolerability but do not prove clinical benefit; the primary efficacy readout remains overall survival at the planned interim after 144 events.
Monitor the unblinded PFS/OS comparisons after the planned
- Biomarkers identified in BriaCell’s Phase 2 study are showing similar and encouraging trends in the ongoing pivotal Phase 3 study of Bria-IMT™ in metastatic breast cancer (MBC)
- No new safety or tolerability issues identified in pooled analysis of ongoing pivotal Phase 3 study
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 20, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces encouraging clinical biomarker data in its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer. The findings are being presented in BriaCell’s poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 Annual Meeting taking place October 17 – 21, 2025 in Berlin, Germany. The Phase 3 data shown is for all patients evaluated regardless of treatment assignment (i.e. is blinded).
“We are encouraged by the early constructive clinical biomarker data which could allow us to predict clinical and survival outcomes in our patients and would help guide treatment decisions for metastatic breast cancer patients with limited options,” stated Dr. William V. Williams, BriaCell’s President and CEO.
Poster #3928: Feasibility and Biomarker Validation of an International Randomized Phase 3 Trial of Bria-IMT Cell Therapy in Late Stage MBC (BRIA-ABC)
In BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer, patients are randomized 1:1:1 to Bria-IMT + CPI, Treatment of Physician’s Choice, or Bria-IMT monotherapy. As of the time of the poster submission, pooled data was available in 113 patients, with a median of 6 prior lines of treatment (2–13). Evaluable only pertains to imaging. All 113 are evaluated for safety, PFS, etc.
As reported in the Phase 2 study, Neutrophil to Lymphocyte Ratio (NLR) continues to be a potential biomarker of clinical benefit as progression free survival (PFS) was significantly higher in patients with NLR of 0.7 – 2.3 (4.5 months) vs those with NLR < 0.7 or > 2.3 (2.5 months) {(HR) of 0.5 (
In the Phase 3 study, PFS data comparing BriaCell’s Bria-IMT combination regimen versus those treated with physician’s choice remains blinded at this time. Bria-IMT has been well tolerated in the Phase 3 study with no treatment-related discontinuations due to adverse events (AEs). The most common AEs are minor, including fatigue, anemia, and nausea.
About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients
BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.
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 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell reported positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen. The Bria-IMT combination regimen has received FDA Fast Track designation.
For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.
A copy of the poster presentation is 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: BriaCell's plans to present clinical data presentations at the ESMO Congress 2025, and the contents of all such presentations; BriaCell's statements regarding early constructive clinical biomarker data allowing the Company to predict clinical and survival outcomes and guide treatment decisions for metastatic breast cancer patients; and the Company's anticipated timing of analysis of interim data 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 biomarker did BriaCell report at ESMO 2025 for BCTX Bria-IMT?
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