BriaCell’s Bria-IMT™ Demonstrates Survival Advantage over Trodelvy® and Control Group in Metastatic Breast Cancer
BriaCell Therapeutics (NASDAQ: BCTX) has reported promising Phase 2 survival data for its Bria-IMT™ immunotherapy in combination with checkpoint inhibitors for metastatic breast cancer treatment. The study showed significant survival advantages over Trodelvy® and control groups:
In triple negative breast cancer (TNBC), Bria-IMT achieved median overall survival of 13.9 months, surpassing Trodelvy (11.8 months) and doubling control group (6.9 months). For hormone receptor positive (HR+) patients, Bria-IMT reached 17.3 months median survival versus Trodelvy's 14.4 months and control's 11.2 months.
The Phase 2 study included 54 heavily pre-treated patients who had received a median of 6 prior therapies. Notably, no Bria-IMT related treatment discontinuations were reported, and the company is currently conducting a pivotal Phase 3 study.
BriaCell Therapeutics (NASDAQ: BCTX) ha riportato dati promettenti di sopravvivenza nella Fase 2 per la sua immunoterapia Bria-IMT™ in combinazione con inibitori del checkpoint per il trattamento del cancro al seno metastatico. Lo studio ha evidenziato vantaggi significativi nella sopravvivenza rispetto a Trodelvy® e ai gruppi di controllo:
Nel cancro al seno triplo negativo (TNBC), Bria-IMT ha raggiunto una sopravvivenza mediana complessiva di 13,9 mesi, superando Trodelvy (11,8 mesi) e raddoppiando il gruppo di controllo (6,9 mesi). Per i pazienti con recettori ormonali positivi (HR+), Bria-IMT ha ottenuto una sopravvivenza mediana di 17,3 mesi contro i 14,4 mesi di Trodelvy e gli 11,2 mesi del gruppo di controllo.
Lo studio di Fase 2 ha incluso 54 pazienti fortemente pretrattati che avevano ricevuto una mediana di 6 terapie precedenti. È importante sottolineare che non sono state riportate interruzioni del trattamento correlate a Bria-IMT, e l’azienda sta attualmente conducendo uno studio pivotale di Fase 3.
BriaCell Therapeutics (NASDAQ: BCTX) ha presentado datos prometedores de supervivencia en la Fase 2 para su inmunoterapia Bria-IMT™ en combinación con inhibidores de puntos de control para el tratamiento del cáncer de mama metastásico. El estudio mostró ventajas significativas en la supervivencia frente a Trodelvy® y los grupos de control:
En cáncer de mama triple negativo (TNBC), Bria-IMT alcanzó una supervivencia global mediana de 13,9 meses, superando a Trodelvy (11,8 meses) y duplicando al grupo de control (6,9 meses). Para pacientes con receptores hormonales positivos (HR+), Bria-IMT logró una supervivencia mediana de 17,3 meses frente a 14,4 meses de Trodelvy y 11,2 meses del grupo de control.
El estudio de Fase 2 incluyó a 54 pacientes con tratamientos previos intensivos que habían recibido una mediana de 6 terapias anteriores. Cabe destacar que no se reportaron discontinuaciones del tratamiento relacionadas con Bria-IMT, y la compañía está llevando a cabo un estudio pivotal de Fase 3.
BriaCell Therapeutics (NASDAQ: BCTX)는 전이성 유방암 치료를 위한 체크포인트 억제제와 병용한 Bria-IMT™ 면역치료제의 2상 생존 데이터에서 유망한 결과를 보고했습니다. 연구 결과는 Trodelvy® 및 대조군에 비해 유의미한 생존 이점을 보여주었습니다:
삼중음성 유방암(TNBC)에서 Bria-IMT는 중앙 전체 생존 기간이 13.9개월로 Trodelvy(11.8개월)를 능가하고 대조군(6.9개월)의 두 배에 달했습니다. 호르몬 수용체 양성(HR+) 환자에서는 Bria-IMT가 중앙 생존 기간 17.3개월을 기록해 Trodelvy의 14.4개월과 대조군의 11.2개월을 앞섰습니다.
2상 연구에는 중증으로 다중 치료를 받은 54명의 환자가 포함되었으며, 이들은 평균 6회의 이전 치료를 받은 바 있습니다. 특히 Bria-IMT 관련 치료 중단 사례는 보고되지 않았으며, 회사는 현재 중추적 3상 연구를 진행 중입니다.
BriaCell Therapeutics (NASDAQ : BCTX) a annoncé des données prometteuses de survie en phase 2 pour son immunothérapie Bria-IMT™ en combinaison avec des inhibiteurs de points de contrôle dans le traitement du cancer du sein métastatique. L'étude a montré des avantages significatifs de survie par rapport à Trodelvy® et aux groupes témoins :
Dans le cancer du sein triple négatif (TNBC), Bria-IMT a atteint une survie globale médiane de 13,9 mois, dépassant Trodelvy (11,8 mois) et doublant le groupe témoin (6,9 mois). Pour les patientes hormono-dépendantes (HR+), Bria-IMT a obtenu une survie médiane de 17,3 mois contre 14,4 mois pour Trodelvy et 11,2 mois pour le groupe témoin.
L'étude de phase 2 a inclus 54 patientes fortement prétraitées ayant reçu en moyenne 6 traitements antérieurs. Il est à noter qu'aucune interruption de traitement liée à Bria-IMT n'a été rapportée, et la société mène actuellement une étude pivot de phase 3.
BriaCell Therapeutics (NASDAQ: BCTX) hat vielversprechende Überlebensdaten aus Phase 2 für seine Bria-IMT™ Immuntherapie in Kombination mit Checkpoint-Inhibitoren zur Behandlung von metastasiertem Brustkrebs berichtet. Die Studie zeigte signifikante Überlebensvorteile gegenüber Trodelvy® und Kontrollgruppen:
Bei triple-negativem Brustkrebs (TNBC) erreichte Bria-IMT eine mediane Gesamtüberlebenszeit von 13,9 Monaten, was Trodelvy (11,8 Monate) übertraf und die Kontrollgruppe (6,9 Monate) verdoppelte. Für Patienten mit hormonrezeptorpositivem (HR+) Brustkrebs lag die mediane Überlebenszeit von Bria-IMT bei 17,3 Monaten gegenüber 14,4 Monaten bei Trodelvy und 11,2 Monaten in der Kontrollgruppe.
Die Phase-2-Studie umfasste 54 stark vorbehandelte Patienten, die im Median 6 vorherige Therapien erhalten hatten. Bemerkenswert ist, dass keine behandlungsbedingten Abbrüche im Zusammenhang mit Bria-IMT gemeldet wurden, und das Unternehmen führt derzeit eine entscheidende Phase-3-Studie durch.
- Bria-IMT showed superior survival rates compared to both Trodelvy and control groups in TNBC and HR+ patients
- No treatment-related discontinuations reported, indicating good safety profile
- Impressive results despite patients having failed median of 6 prior therapies
- Survival advantage demonstrated in multiple breast cancer subtypes
- Phase 3 pivotal trial already ongoing with same formulation
- Study involved relatively small patient population (54 patients)
- Patients required combination therapy with checkpoint inhibitors
- Phase 2 results still need validation in larger Phase 3 trial
Insights
BriaCell's Bria-IMT shows superior survival rates in heavily pretreated metastatic breast cancer patients versus current standards.
The Phase 2 data for BriaCell's Bria-IMT immunotherapy shows remarkably promising survival outcomes in metastatic breast cancer patients who have exhausted multiple treatment options. The 13.9-month median overall survival in triple-negative breast cancer (TNBC) patients outperforms Trodelvy's 11.8 months and more than doubles the 6.9 months seen with standard chemotherapy. For hormone receptor-positive (HR+) patients, Bria-IMT achieved 17.3 months median survival versus Trodelvy's 14.4 months and standard chemotherapy's 11.2 months.
What makes these results particularly compelling is the patient population's treatment history. These patients had received a median of 6 prior therapies, compared to only 3-4 prior treatments in the Trodelvy studies, indicating Bria-IMT's efficacy in more heavily pre-treated patients who typically have poorer outcomes. The absence of treatment-related discontinuations suggests an excellent safety profile, addressing a major concern with many cancer therapies that often cause intolerable side effects.
The data show consistent improvement in BriaCell's metrics, with TNBC survival improving from 11.4 months (reported at ASCO June 2025) to the current 13.9 months, suggesting the durability of response may be increasing with longer follow-up. The 6-month survival rates of 78% (TNBC) and 90% (HR+) further support the treatment's efficacy in extending survival in these difficult-to-treat populations.
The company's ongoing pivotal Phase 3 study (NCT06072612) using this same formulation will be critical in confirming these findings. If validated in the larger study, Bria-IMT could represent a significant advancement for patients with limited treatment options, particularly in TNBC where the survival advantage appears most pronounced relative to current standards of care.
- Median Overall Survival (OS) of 13.9 months in triple negative breast cancer (TNBC) exceeds Trodelvy (11.8 months) and doubles control (6.9 months)
- OS of 17.3 months in HR+ metastatic breast cancer surpasses Trodelvy (14.4 months) and control (11.2 months)
- No treatment related discontinuations reported
PHILADELPHIA and VANCOUVER, British Columbia, July 11, 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 announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune check point inhibitor (CPI).
The data show a meaningful survival advantage in heavily pretreated metastatic breast cancer (MBC) patient subtypes:
- Triple negative breast cancer (TNBC): median overall survival (OS) of 13.9 months vs. 11.8 months for antibody drug conjugate Trodelvy (sacituzumab govitecan-hziy) and 6.9 months single agent chemotherapy data. BriaCell’s median OS has improved from 11.4 months last reported at ASCO in June 2025.1
- Hormone receptor positive (HR+): median overall survival (OS) of 17.3 months vs. 14.4 months for Trodelvy and 11.2 months in single agent chemotherapy data.
“We are thrilled to see our Bria-IMT regimen outperform established benchmarks like Trodelvy in TNBC and HR+ MBC patients,” stated Dr. William V. Williams, BriaCell’s President and CEO. “BriaCell’s patients had failed a median of six prior therapies, underscoring the potential clinical impact of our novel immunotherapy. We look forward to validating these findings in our ongoing pivotal Phase 3 study with overall survival as its primary endpoint.”
| Table 1: Analysis of survival data for BriaCell’s Phase 2 study versus Trodelvy in MBC patient subsets | |||||
| Breast Cancer Type | Treatment | Median # of prior lines of therapy | Median Overall Survival (months) | Survival rate at 6 months (%) | Survival rate at 12 months (%) |
TNBC | Bria-IMT plus CPI* | 6 | 13.9 | 78 | 56 |
TNBC | Trodelvy1 (sacituzumab govitecan-hziy) | 3** | 11.8 | 80*** | 49*** |
| Single agent chemotherapy | 3** | 6.9 | 56*** | 22*** | |
HR+ | Bria-IMT plus CPI* | 6 | 17.3 | 90 | 61 |
HR+ | Trodelvy1 (sacituzumab govitecan-hziy) | 4 | 14.4 | 83*** | 61 |
| Single agent chemotherapy | 4 | 11.2 | 76*** | 47 | |
| * Patients treated with the Phase 3 formulation ** Prior chemotherapy-containing regimens *** Derived from published Kaplan-Meier curves see1 1. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf | |||||
Abbreviations:
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))
- As shown in table 1, median OS number with Bria-IMT is higher than that reported in the treatment arm of the ASCENT study (SG) for TNBC patients, and twice that reported in treatment of physician’s choice arm.
HR+: hormone receptor-positive
The Phase 2 Bria-IMT 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 received the same 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 validating positive findings in its ongoing pivotal Phase 3 study with overall survival as its primary endpoint, 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
1https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
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