BriaCell Phase 2 Survival Achievement: 52% of Patients Surpass One-Year Milestone in Metastatic Breast Cancer
BriaCell Therapeutics (NASDAQ: BCTX) has reported impressive survival data from its Phase 2 clinical study of Bria-IMT in metastatic breast cancer patients. The study showed that 52% of the most recent 25-patient cohort survived beyond one year, surpassing current standard of care expectations. Notably, 11 patients remain alive, with two remarkable cases reaching 38.3 and 30.3 months of survival.
The study included heavily pre-treated patients who had previously failed multiple therapies, including checkpoint inhibitors and antibody-drug conjugates. The median number of prior treatments was 6, and importantly, no treatment discontinuations related to Bria-IMT have been reported, suggesting a well-tolerated profile.
BriaCell Therapeutics (NASDAQ: BCTX) ha riportato dati di sopravvivenza impressionanti dal suo studio clinico di Fase 2 su Bria-IMT in pazienti con carcinoma mammario metastatico. Lo studio ha mostrato che il 52% degli ultimi 25 pazienti del gruppo ha superato un anno di sopravvivenza, superando le aspettative degli standard di cura attuali. In particolare, 11 pazienti sono ancora vivi, con due casi eccezionali che hanno raggiunto rispettivamente 38,3 e 30,3 mesi di sopravvivenza.
Lo studio ha incluso pazienti fortemente pretrattati che avevano precedentemente fallito molteplici terapie, inclusi inibitori del checkpoint e coniugati anticorpo-farmaco. Il numero mediano di trattamenti precedenti era 6 e, cosa importante, non sono state segnalate interruzioni del trattamento correlate a Bria-IMT, suggerendo un profilo ben tollerato.
BriaCell Therapeutics (NASDAQ: BCTX) ha informado datos impresionantes de supervivencia en su estudio cl铆nico de Fase 2 con Bria-IMT en pacientes con c谩ncer de mama metast谩sico. El estudio mostr贸 que el 52% de la cohorte m谩s reciente de 25 pacientes sobrevivi贸 m谩s de un a帽o, superando las expectativas del est谩ndar actual de atenci贸n. Cabe destacar que 11 pacientes siguen vivos, con dos casos notables que alcanzaron 38,3 y 30,3 meses de supervivencia.
El estudio incluy贸 pacientes con tratamientos previos intensivos que hab铆an fallado m煤ltiples terapias, incluyendo inhibidores de puntos de control y conjugados anticuerpo-f谩rmaco. El n煤mero medio de tratamientos previos fue 6 y, lo que es importante, no se han reportado interrupciones del tratamiento relacionadas con Bria-IMT, lo que sugiere un perfil bien tolerado.
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BriaCell Therapeutics (NASDAQ : BCTX) a publi茅 des donn茅es impressionnantes sur la survie issues de son 茅tude clinique de phase 2 avec Bria-IMT chez des patientes atteintes d鈥檜n cancer du sein m茅tastatique. L鈥櫭﹖ude a montr茅 que 52 % de la cohorte la plus r茅cente de 25 patientes ont surv茅cu au-del脿 d鈥檜n an, d茅passant les attentes des standards actuels de soins. Notamment, 11 patientes sont toujours en vie, avec deux cas remarquables atteignant respectivement 38,3 et 30,3 mois de survie.
L鈥櫭﹖ude a inclus des patientes fortement pr茅trait茅es ayant 茅chou茅 脿 plusieurs th茅rapies, y compris des inhibiteurs de points de contr么le et des conjugu茅s anticorps-m茅dicaments. Le nombre m茅dian de traitements ant茅rieurs 茅tait de 6 et, fait important, aucune interruption de traitement li茅e 脿 Bria-IMT n鈥檃 茅t茅 rapport茅e, sugg茅rant un profil bien tol茅r茅.
BriaCell Therapeutics (NASDAQ: BCTX) hat beeindruckende 脺berlebensdaten aus seiner Phase-2-Studie mit Bria-IMT bei Patienten mit metastasiertem Brustkrebs ver枚ffentlicht. Die Studie zeigte, dass 52 % der j眉ngsten Kohorte von 25 Patienten l盲nger als ein Jahr 眉berlebten, was die Erwartungen der aktuellen Standardbehandlung 眉bertrifft. Bemerkenswert ist, dass 11 Patienten noch am Leben sind, wobei zwei au脽ergew枚hnliche F盲lle 脺berlebenszeiten von 38,3 und 30,3 Monaten erreichten.
Die Studie umfasste stark vorbehandelte Patienten, die zuvor mehrere Therapien, einschlie脽lich Checkpoint-Inhibitoren und Antik枚rper-Wirkstoff-Konjugate, nicht erfolgreich durchlaufen hatten. Die mediane Anzahl vorheriger Behandlungen lag bei 6, und wichtig ist, dass keine behandlungsbedingten Abbr眉che im Zusammenhang mit Bria-IMT gemeldet wurden, was auf ein gut vertr盲gliches Profil hinweist.
- 52% one-year survival rate exceeds standard of care expectations
- 11 patients still alive, with longest survival reaching 38.3 months
- No Bria-IMT-related treatment discontinuations reported
- Effective in heavily pre-treated patients who failed other advanced therapies
- Final median overall survival data still pending for some sub-populations
- Study conducted in a relatively small patient cohort (25 patients)
- Results from single-arm trial, not yet compared in randomized setting
Insights
BriaCell's Bria-IMT shows promising 52% one-year survival in heavily pre-treated metastatic breast cancer patients, outperforming standard care comparisons.
The Phase 2 data from BriaCell's Bria-IMT therapy represents a significant clinical development in the metastatic breast cancer space. The 52% one-year survival rate stands out particularly because these patients had already failed an average of 6 prior treatment regimens, including advanced therapies like checkpoint inhibitors and antibody-drug conjugates (TRODELVY庐 and ENHERTU庐).
Contextualizing these results against comparative one-year survival rates is crucial. The study population's 52% rate substantially outperforms benchmarks from similar patient populations: Cortes et al. (~38-40%), Kazmi et al. (30-38%), and especially the TNBC subpopulation in Bardia et al. (~23%). The durability of response in some patients is particularly noteworthy, with extended survival reaching 38.3 months and 30.3 months in two patients.
The treatment's safety profile appears favorable with no Bria-IMT-related discontinuations reported - a meaningful advantage in a heavily pre-treated population where treatment toxicity often limits therapeutic options. The ongoing pivotal Phase 3 study (NCT06072612) using the same formulation will be the definitive test of efficacy, as Phase 2 results, while promising, come from a single-arm study with inherent limitations in directly proving causality.
This survival signal in patients who have exhausted standard treatments, including modern immunotherapies and ADCs, suggests Bria-IMT may offer a mechanistically distinct approach to overcoming treatment resistance in advanced breast cancer.
52% of BriaCell鈥檚 most-recent 25-patient cohort* have surpassed the one-year survival milestone, exceeding current standard of care in similar patients- 11 patients remain alive as of recent contact, including one patient at 38.3 months and another at 30.3 months
- Survival benefit observed in heavily pre-treated patients, including those who failed treatment with checkpoint inhibitors (CPIs) and antibody-drug conjugates (ADCs)
PHILADELPHIA and VANCOUVER, British Columbia, July 08, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (鈥淏riaCell鈥� or the 鈥淐ompany鈥�), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, has reported updated survival data from its ongoing Phase 2 clinical study of Bria-IMT in patients with metastatic breast cancer (MBC).
- BriaCell鈥檚 most recent Phase 2 study cohort of 25 patients* achieved a
52% one-year survival rate (i.e.52% of patients remained alive at least one year after starting on the study). - 11 of these patients remain alive as of most recent contact, including one patient at 38.3 months and another at 30.3 months (see Table 1).
- Survival rate exceeds the survival expectations with the current standard of care therapies in similar patient populations (see Table 2).
- Notably, many patients had very advanced metastatic breast cancer, having already failed multiple prior lines of therapy including check point inhibitors (CPIs) and antibody-drug conjugates (ADCs) such as TRODELVY庐 - (sacituzumab govitecan-hziy) and ENHERTU庐 (fam-trastuzumab - deruxtecan-nxki).
- No treatment discontinuations attributed to Bria-IMT have been reported.
| Table 1: Select Long-Term Responders | ||||
| Patient | Months Survival | Age | Prior Regimens | Cycles of Bria-IMT |
| 01-009 | 38.3 | 74 | 5 | 13 |
| 07-001 | 30.3 | 55 | 7; including ENHERTU | 8 |
| 11-018 | 21.6 | 66 | 8 | 28 |
| 11-019 | 20.0 | 63 | 9; including TRODELVY | 6 |
| 16-003 | 19.4 | 80 | 5; including ENHERTU | 8 |
| 听 | 听 | 听 | 听 | 听 |
鈥淏riaCell鈥檚 Phase 2 data indicate a robust survival signal and a well-tolerated profile,鈥� stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women's Cancer Program. 鈥淭hese results reinforce BriaCell鈥檚 potential to improve survival and tolerability for late-stage patients.鈥�
鈥淢any patients with metastatic breast cancer unfortunately have disease progression despite treatment with CPIs and ADCs,鈥� added Aditya Bardia, MD, MPH, FASCO, a leading breast cancer expert. 鈥淏riaCell鈥檚 survival data in single arm Phase 2 trial highlights the potential activity of Bria-IMT in combination with CPIs and is subject to ongoing investigation in a Phase 3 randomized clinical trial in MBC.鈥�
| 听 | ||||
| Table 2: Comparable Analysis of One-Year Survival | ||||
| Reference | Breast Cancer Type | Median prior lines of therapy | Percent Survival at 1 year | |
| Bria-IMT plus CPI | All types: | 6 | ||
| Cortes et al.1 | All types: 18 18 | 4 | ~38 | |
| Kazmi et al.2 | All types: 51 25 9 | 2 | 30 | |
| Bardia et al. (TPC arm)3 | TNBC | 2-3 | ~ | |
| Rugo et al (TPC arm)4 | HR+ HER2- | 2 | ||
| 听 | 听 | 听 | 听 | |
* 25 patients treated with the Phase 3 formulation since 2022
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| 听 | 听 | 听 | 听 | |
Abbreviations:
HR+: hormone receptor-positive
TNBC: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor 2 (HER2))
HER2+: Human epidermal growth factor receptor 2 positive
HR+ HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negative
TPC: Treatment of Physicians Choice
BriaCell鈥檚 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鈥檚 ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as听). Final median overall survival calculation for the Phase 2 study is pending for some sub populations as many patients remain alive. 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 .
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Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
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FAQ
What are the key survival results from BriaCell's (BCTX) Phase 2 trial in metastatic breast cancer?
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