BriaCell Phase 2 Survival Data Beats Leading Standard in HR+ Breast Cancer
BriaCell Therapeutics (Nasdaq: BCTX) has announced promising Phase 2 survival data for its Bria-IMT™ treatment in metastatic breast cancer patients. The study showed a median overall survival of 17.3 months in hormone receptor positive (HR+) patients, surpassing TRODELVY®'s 14.4 months in similar heavily pre-treated cases.
The Phase 2 trial included 54 patients with a median of 6 prior treatments. Of these, 37 received the current Phase 3 formulation, with 25 identified as HR+ breast cancer patients. In triple negative breast cancer (TNBC) patients, Bria-IMT showed comparable results to TRODELVY® with 11.4 months versus 11.8 months survival, both significantly higher than chemotherapy's 6.9 months.
Notably, no Bria-IMT related discontinuations have been reported in the ongoing pivotal Phase 3 study (NCT06072612), suggesting good tolerability.
BriaCell Therapeutics (Nasdaq: BCTX) ha annunciato dati promettenti di sopravvivenza di Fase 2 per il suo trattamento Bria-IMT™ nei pazienti con carcinoma mammario metastatico. Lo studio ha evidenziato una sopravvivenza mediana complessiva di 17,3 mesi nei pazienti con recettori ormonali positivi (HR+), superando i 14,4 mesi di TRODELVY® in casi simili fortemente pretrattati.
La sperimentazione di Fase 2 ha coinvolto 54 pazienti con una mediana di 6 trattamenti precedenti. Di questi, 37 hanno ricevuto la formulazione attuale di Fase 3, con 25 pazienti identificati come affetti da carcinoma mammario HR+. Nei pazienti con carcinoma mammario triplo negativo (TNBC), Bria-IMT ha mostrato risultati comparabili a TRODELVY®, con una sopravvivenza di 11,4 mesi contro 11,8 mesi, entrambe significativamente superiori ai 6,9 mesi della chemioterapia.
È importante sottolineare che nella fase 3 in corso (NCT06072612) non sono state riportate interruzioni dovute a Bria-IMT, suggerendo una buona tollerabilità.
BriaCell Therapeutics (Nasdaq: BCTX) ha anunciado datos prometedores de supervivencia en la Fase 2 para su tratamiento Bria-IMT™ en pacientes con cáncer de mama metastásico. El estudio mostró una supervivencia global mediana de 17,3 meses en pacientes con receptores hormonales positivos (HR+), superando los 14,4 meses de TRODELVY® en casos similares con múltiples tratamientos previos.
El ensayo de Fase 2 incluyó a 54 pacientes con una mediana de 6 tratamientos previos. De ellos, 37 recibieron la formulación actual de Fase 3, con 25 pacientes identificados como cáncer de mama HR+. En pacientes con cáncer de mama triple negativo (TNBC), Bria-IMT mostró resultados comparables a TRODELVY®, con una supervivencia de 11,4 meses frente a 11,8 meses, ambas significativamente superiores a los 6,9 meses de la quimioterapia.
Es importante destacar que en el estudio pivotal de Fase 3 en curso (NCT06072612) no se han reportado discontinuaciones relacionadas con Bria-IMT, lo que sugiere una buena tolerabilidad.
BriaCell Therapeutics (나스닥: BCTX)는 전이성 유방암 환자를 대상으로 한 Bria-IMT™ 치료제의 2상 생존 데이터가 유망하다고 발표했습니다. 연구 결과 호르몬 수용체 양성(HR+) 환자에서 중앙 생존 기간이 17.3개월로, 유사한 다중 치료를 받은 환자에서 TRODELVY®의 14.4개월을 능가했습니다.
2상 임상시험에는 이전 치료가 평균 6회인 54명의 환자가 참여했으며, 이 중 37명은 현재 3상 제형을 받았고, 25명은 HR+ 유방암 환자로 확인되었습니다. 삼중 음성 유방암(TNBC) 환자의 경우 Bria-IMT는 TRODELVY®와 유사한 결과를 보였으며, 생존 기간은 각각 11.4개월과 11.8개월로, 화학요법의 6.9개월보다 현저히 높았습니다.
특히, 진행 중인 3상 주요 임상시험(NCT06072612)에서는 Bria-IMT 관련 중단 사례가 보고되지 않아 내약성이 우수함을 시사합니다.
BriaCell Therapeutics (Nasdaq : BCTX) a annoncé des données prometteuses de survie en Phase 2 pour son traitement Bria-IMT™ chez des patients atteints de cancer du sein métastatique. L'étude a montré une survie globale médiane de 17,3 mois chez les patients positifs aux récepteurs hormonaux (HR+), dépassant les 14,4 mois de TRODELVY® dans des cas similaires lourdement prétraités.
L'essai de Phase 2 a inclus 54 patients ayant reçu en moyenne 6 traitements antérieurs. Parmi eux, 37 ont reçu la formulation actuelle de Phase 3, avec 25 patients identifiés comme atteints de cancer du sein HR+. Chez les patients atteints de cancer du sein triple négatif (TNBC), Bria-IMT a montré des résultats comparables à TRODELVY® avec une survie de 11,4 mois contre 11,8 mois, toutes deux significativement supérieures aux 6,9 mois de la chimiothérapie.
Il est à noter qu'aucune interruption liée à Bria-IMT n'a été rapportée dans l'étude pivot de Phase 3 en cours (NCT06072612), ce qui suggère une bonne tolérance.
BriaCell Therapeutics (Nasdaq: BCTX) hat vielversprechende Überlebensdaten aus der Phase-2-Studie für seine Behandlung Bria-IMT™ bei Patienten mit metastasiertem Brustkrebs bekanntgegeben. Die Studie zeigte ein medianes Gesamtüberleben von 17,3 Monaten bei hormonrezeptorpositiven (HR+) Patienten, womit die 14,4 Monate von TRODELVY® in ähnlich stark vorbehandelten Fällen übertroffen wurden.
Die Phase-2-Studie umfasste 54 Patienten mit einer Medianzahl von 6 vorherigen Behandlungen. Davon erhielten 37 die aktuelle Phase-3-Formulierung, wobei 25 als HR+ Brustkrebspatienten identifiziert wurden. Bei Patienten mit triple-negativem Brustkrebs (TNBC) zeigte Bria-IMT vergleichbare Ergebnisse zu TRODELVY® mit 11,4 Monaten gegenüber 11,8 Monaten Überlebenszeit, beide deutlich höher als die 6,9 Monate der Chemotherapie.
Bemerkenswert ist, dass in der laufenden entscheidenden Phase-3-Studie (NCT06072612) keine behandlungsbedingten Abbrüche durch Bria-IMT gemeldet wurden, was auf eine gute Verträglichkeit hinweist.
- Superior survival rate in HR+ breast cancer: 17.3 months vs TRODELVY's 14.4 months
- Comparable efficacy to TRODELVY in TNBC patients (11.4 vs 11.8 months)
- 70% higher survival rate compared to chemotherapy in TNBC patients
- Zero treatment-related discontinuations reported
- Heavily pre-treated patient population (median 6 prior treatments) may limit market potential
- TNBC results slightly lower than TRODELVY (11.4 vs 11.8 months)
Insights
BriaCell's Phase 2 data represents a potentially significant advancement in treating hormone receptor positive (HR+) metastatic breast cancer patients. The 17.3-month median overall survival surpasses TRODELVY®'s 14.4 months by approximately 20% in heavily pre-treated patients who had received a median of 6 prior therapies.
What's particularly compelling is the efficacy maintained despite the patient population being more heavily pre-treated than in TRODELVY®'s trials (6 vs 4 prior lines). This suggests Bria-IMT could be effective even in later treatment lines where options are typically and outcomes poor.
For triple-negative breast cancer (TNBC), while not showing superiority over TRODELVY®, Bria-IMT demonstrated comparable survival (11.4 vs 11.8 months) and substantially outperformed chemotherapy (11.4 vs 6.9 months). This dual efficacy across different breast cancer subtypes expands the potential patient population.
The clean safety profile with no treatment-related discontinuations is remarkable and critically important for late-stage cancer patients. This tolerability advantage could position Bria-IMT as a more patient-friendly alternative to antibody-drug conjugates like TRODELVY® that often carry significant toxicity profiles.
With their pivotal Phase 3 trial already underway using overall survival as the primary endpoint, these data significantly de-risk BriaCell's clinical program. The immunotherapy approach appears particularly promising for HR+ patients who typically have fewer targeted therapy options after hormone therapy resistance develops.
- Median overall survival of 17.3 months in Bria-IMT™ treated patients with hormone receptor positive (HR+) metastatic breast cancer markedly exceeds historical data of 14.4 months in TRODELVY® (sacituzumab govitecan-hziy) in similar heavily pre-treated patients
- Survival data in triple negative breast cancer patients treated with the BriaCell regimen was comparable to TRODELVY®
- No Bria-IMT related discontinuations reported to date
PHILADELPHIA and VANCOUVER, British Columbia, April 16, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients.
In BriaCell’s Phase 2 clinical study in late-stage MBC, 25 of 37 patients treated with the ongoing pivotal Phase 3 Bria-IMT formulation were identified as having HR+ breast cancer. As shown in Table 1, the survival data of these 25 patients (17.3 months) exceeds those of the current ADC standard of care TRODELVY® (14.4 months). The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2) receptors, was similar to TRODELVY® but still markedly higher (
“We are truly impressed with the survival benefit data of the regimen that exceeds or meets those of TRODELVY® in HR+ and TNBC metastatic breast cancer patients, respectively. Bria-IMT appears to be very well-tolerated,” stated Dr. William V. Williams, BriaCell’s President and CEO. “We look forward to further confirming this clinical data in our ongoing pivotal Phase 3 study with overall survival as its primary endpoint.”
“HR+ and TNBC metastatic breast cancer represent a significant proportion of the patient population and are the most difficult patient groups to treat. They have limited therapeutic options and overall survival of only a few months,” commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “Our clinical data supports our hypothesis that the Bria-IMT regimen + CPI has the potential to address the unmet medical needs of HR+ and TNBC MBC patients and provide an effective and well-tolerated therapeutic option.”
| Table 1: Comparable Analysis of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s Bria-IMT™ plus CPI versus other drugs in MBC patient subsets | |||
| Reference | Breast Cancer Type | Median # of prior lines of therapy | Median OS (months) |
| Bria-IMT plus CPI* | HR+ | 6 | 17.3 |
| TRODELVY®1 (sacituzumab govitecan-hziy) | HR+ | 4 | 14.4 |
| Single agent chemotherapy | 4 | 11.3 | |
| Bria-IMT plus CPI* | TNBC | 6 | 11.4 |
| TRODELVY®1 (sacituzumab govitecan-hziy) | TNBC | 3** | 11.8 |
| Single agent chemotherapy | 3** | 6.9 | |
| * Patients treated with the Phase 3 formulation ** Number of prior chemotherapy-containing regimens | |||
| 1. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf | |||
Abbreviations:
HR+: hormone receptor-positive
TNBC: Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth factor receptor 2 (HER2))
The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6) who received the Bria-IMT regimen plus checkpoint inhibitor. Of these 54 patients, 37 were treated with the formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612). No Bria-IMT related discontinuations have been reported to date.
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 statements about: BriaCell further confirming positive clinical data in its ongoing pivotal Phase 3 study; BriaCell’s further clinical development of Bria-IMT™; the Company’s beliefs regarding the results of BriaCell’s pivotal Phase 3 study; and the Company’s beliefs that the Bria-IMT™ regimen + CPI has the potential to address the unmet medical needs of HR+ and TNBC MBC patients and provide an effective and well-tolerated therapeutic option, 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
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