BriaCell Reports Positive Overall Survival (OS) in Metastatic Breast Cancer
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) has reported positive overall survival data from its Phase 2 clinical study of Bria-IMT™ in combination with an immune checkpoint inhibitor for late-stage metastatic breast cancer. The study showed a median overall survival of 15.6 months in patients treated since 2022, compared to 6.7-9.3 months reported in literature for similar patients. This represents a significant improvement over the previously reported 13.4 months median overall survival in December 2023.
The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients, with an average of 6 prior treatments. The Bria-IMT™ regimen showed no drug-related discontinuations to date. BriaCell is currently conducting a Phase 3 pivotal study using the same Bria-IMT™ formulation in metastatic breast cancer patients.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) ha riportato dati positivi di sopravvivenza complessiva dal suo studio clinico di Fase 2 riguardante Bria-IMT™ in combinazione con un inibitore del checkpoint immunitario per il cancro alla mammella metastatico in fase avanzata. Lo studio ha mostrato una sopravvivenza complessiva mediana di 15,6 mesi nei pazienti trattati a partire dal 2022, rispetto ai 6,7-9,3 mesi riportati nella letteratura per pazienti simili. Questa rappresenta un miglioramento significativo rispetto ai 13,4 mesi di sopravvivenza complessiva mediana precedentemente riportati nel dicembre 2023.
Lo studio di Fase 2 ha arruolato 54 pazienti con cancro alla mammella metastatico fortemente pretrattati, con una media di 6 trattamenti precedenti. Il regime di Bria-IMT™ non ha mostrato interruzioni correlate ai farmaci fino ad oggi. BriaCell sta attualmente conducendo uno studio di Fase 3 cruciale utilizzando la stessa formulazione di Bria-IMT™ in pazienti con cancro alla mammella metastatico.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) ha reportado datos positivos de supervivencia general de su estudio clínico de Fase 2 con Bria-IMT™ en combinación con un inhibidor de punto de control inmunitario para cáncer de mama metastásico en etapa avanzada. El estudio mostró una supervivencia general mediana de 15.6 meses en pacientes tratados desde 2022, en comparación con los 6.7-9.3 meses reportados en la literatura para pacientes similares. Esto representa una mejora significativa respecto a los 13.4 meses de supervivencia general mediana reportados anteriormente en diciembre de 2023.
El estudio de Fase 2 incluyó a 54 pacientes con cáncer de mama metastásico que habían sido tratados en múltiples ocasiones, con un promedio de 6 tratamientos previos. El régimen de Bria-IMT™ no ha mostrado discontinuaciones relacionadas con el medicamento hasta la fecha. BriaCell está actualmente llevando a cabo un estudio pivotal de Fase 3 utilizando la misma formulación de Bria-IMT™ en pacientes con cáncer de mama metastásico.
브리아셀 치료제 주식회사(나스닥: BCTX, TSX: BCT)는 진행성 전이성 유방암 환자를 위한 면역 체크포인트 억제제와 함께 사용되는 Bria-IMT™의 2상 임상 시험에서 긍정적인 전체 생존 데이터를 보고했습니다. 이 연구는 2022년 이후 치료받은 환자에서 중앙 전체 생존 기간이 15.6개월이라는 결과를 보여주었으며, 이는 유사한 환자에 대해 문헌에서 보고된 6.7-9.3개월보다 개선된 수치입니다. 이는 2023년 12월에 이전에 보고된 13.4개월의 중앙 전체 생존 기간에 비해 상당한 개선을 나타냅니다.
2상 연구에는 54명의 심각하게 사전 치료를 받은 전이성 유방암 환자가 등록되었으며, 평균 6개의 이전 치료를 받았습니다. Bria-IMT™ 요법은 현재까지 약물 관련 중단이 없었습니다. BriaCell은 현재 전이성 유방암 환자를 위해 동일한 Bria-IMT™ 제형을 사용한 3상 주요 연구를 진행 중입니다.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) a rapporté des données positives sur la survie globale de son étude clinique de Phase 2 utilisant Bria-IMT™ en combinaison avec un inhibiteur de point de contrôle immunitaire pour le cancer du sein métastatique à un stade avancé. L'étude a montré une survie globale médiane de 15,6 mois chez des patients traités depuis 2022, comparativement à 6,7-9,3 mois rapportés dans la littérature pour des patients similaires. Cela représente une amélioration significative par rapport aux 13,4 mois de survie globale médiane précédemment rapportés en décembre 2023.
L'étude de Phase 2 a inclus 54 patients atteints de cancer du sein métastatique ayant été fortement prétraités, avec une moyenne de 6 traitements antérieurs. Le régime Bria-IMT™ n'a jusqu'à présent montré aucune interruption liée aux médicaments. BriaCell réalise actuellement une étude pivot de Phase 3 utilisant la même formulation de Bria-IMT™ chez des patients atteints de cancer du sein métastatique.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) hat positive Überlebensdaten aus seiner Phase-2-Studie zu Bria-IMT™ in Kombination mit einem Immun-Checkpoint-Inhibitor für fortgeschrittenen metastasierenden Brustkrebs berichtet. Die Studie zeigte eine medianen Überlebenszeit von 15,6 Monaten bei Patienten, die seit 2022 behandelt wurden, verglichen mit 6,7-9,3 Monaten, die in der Literatur für ähnliche Patienten berichtet wurden. Dies stellt eine signifikante Verbesserung gegenüber den zuvor berichteten 13,4 Monaten medianer Überlebenszeit im Dezember 2023 dar.
Die Phase-2-Studie umfasste 54 stark vorbehandelte Patienten mit metastasierendem Brustkrebs, mit einer durchschnittlichen Anzahl von 6 vorangegangenen Behandlungen. Das Bria-IMT™-Regime zeigte bis heute keine medikamentenbedingten Abbrüche. BriaCell führt derzeit eine phase-3 entscheidende Studie mit der gleichen Bria-IMT™-Formulierung bei Patienten mit metastasierendem Brustkrebs durch.
- Median overall survival increased to 15.6 months, nearly double the 6.7-9.3 months reported in literature for similar patients
- Improvement from previously reported 13.4 months median overall survival in December 2023
- No drug-related discontinuations reported to date
- Ongoing Phase 3 pivotal study using the same Bria-IMT™ formulation
- None.
Insights
The reported 15.6-month median overall survival for BriaCell's Bria-IMT™ in combination with immune checkpoint inhibitors is indeed promising. This represents a significant improvement over historical data, which shows survival rates of 6.7-9.3 months for similar patient populations. The absence of drug-related discontinuations suggests a favorable safety profile.
However, it's important to note that this is Phase 2 data with a relatively small sample size of 25 patients. While encouraging, these results need to be validated in the ongoing Phase 3 trial. The progression-free survival of 4.1 months, while improved, still indicates rapid disease progression in many patients. This underscores the aggressive nature of metastatic breast cancer and the ongoing need for more effective treatments.
If confirmed in Phase 3, this therapy could offer a meaningful extension of life for patients with options. The potential synergy between Bria-IMT™ and checkpoint inhibitors warrants further investigation, as it could open new avenues for combination immunotherapies in breast cancer treatment.
The data presented by BriaCell is intriguing, particularly the near doubling of overall survival compared to literature controls. However, we must interpret these results cautiously. The non-randomized nature of this Phase 2 study and potential differences in patient characteristics between BriaCell's cohort and historical controls could influence outcomes.
The improvement from 13.4 to 15.6 months median overall survival with additional follow-up is noteworthy, suggesting durability of response in some patients. The consistent benefit in progression-free survival (PFS) further supports the potential efficacy of this combination.
It's important to highlight that these patients were heavily pre-treated, with a median of 5.5 prior lines of therapy. This makes the survival benefit more impressive, as outcomes typically worsen with each subsequent line of treatment. The ongoing Phase 3 study will be important in confirming these results in a larger, randomized setting, which is necessary for regulatory approval and clinical adoption.
From an investment perspective, BriaCell's latest data presents a potentially significant opportunity. The substantial improvement in overall survival could position Bria-IMT™ as a valuable asset in the competitive oncology market. If these results are replicated in the Phase 3 trial, it could lead to FDA approval and substantial revenue potential.
However, investors should remain cautious. The small sample size and non-randomized nature of the Phase 2 study introduce uncertainty. The ongoing Phase 3 trial is critical and any setbacks could significantly impact BriaCell's stock price.
Financially, the company's focus on a large, underserved market like metastatic breast cancer is strategically sound. The potential for Bria-IMT™ to become a new standard of care could drive significant value. However, the path to commercialization is long and costly. Investors should closely monitor the company's cash position and burn rate as the Phase 3 trial progresses, as additional financing may be needed before potential revenue generation.
- Median overall survival of 15.6 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint inhibitor
- OS of 15.6 months compares favorably with 6.7-9.3 months reported for similar patients in the literature
- Ongoing Phase 3 study investigating Bria-IMT™ in similar metastatic breast cancer population
- No drug related discontinuations to date
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 11, 2024 (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, is pleased to announce positive overall survival data of its Phase 2 clinical study of Bria-IMT™ in combination with an immune check point inhibitor (CPI) in late stage metastatic breast cancer.
Median overall survival of 15.6 months is reported in BriaCell’s most recent patients (treated since 2022) vs. 6.7-9.3 months for similar patients reported in the literature (see table below). These patients are being treated with the same Bria-IMT™ formulation currently being used in BriaCell’s ongoing Phase 3 pivotal study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612) and represent patients enrolled post-COVID when full study activities resumed.
This represents a substantial improvement over BriaCell’s 13.4 months median overall survival previously reported in December 2023.
“Overall survival in patients with heavily pre-treated metastatic breast cancer is very poor,” stated Sara A. Hurvitz, MD, Professor of Medicine, Fred Hutch Cancer Center and University of Washington and BriaCell medical advisory board member. “The BriaCell early data is quite encouraging from both efficacy and tolerability standpoints.”
“We wanted to look at the Phase 2 data of those patients who most closely resemble the patients being treated in our ongoing phase 3 study and compare them to similar patients in the literature,” stated Dr. William V. Williams, BriaCell’s President and CEO. “The nearly two-fold overall survival benefit we are seeing with the Bria-IMT™ regimen, together with the similar previously reported approximate doubling of progression free survival, compared with literature controls, strongly support our belief that Bria-IMT™ could have a meaningful impact in the lives of heavily pre-treated metastatic breast cancer patients. We look forward to further clinical development of Bria-IMT™ with the goal of establishing it as a new standard of care for patients with metastatic breast cancer.”
“The Bria-IMT™ regimen is the only investigational drug we have seen to show these impressive survival numbers in heavily pre-treated metastatic breast cancer patients who have failed numerous prior treatments including immune check point inhibitors and antibody drug conjugates,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “These survival and clinical benefit data support BriaCell’s hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT™ and drive the ongoing pivotal study of our combination regimen in the treatment of metastatic breast cancer.”
The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6) who were treated with the Bria-IMT™ regimen and an immune checkpoint inhibitor. Of these 54 patients, 37 were treated with the Phase 3 formulation and 25 of these were treated post-COVID when full study activities resumed. This data represents an additional six months of follow-up of the survival data presented at the San Antonio Breast Cancer Symposium in December 2023.
| Table 1. Comparative Median Overall Survival (OS) and Progression-Free Survival (PFS) in Similar Patients (Interim Analysis Using Kaplan-Meier Estimate) | |||||
| Study | Prior Lines of Therapy (median, range) | Number of Patients | OS (months) | PFS (months) | |
| BriaCell’s Phase 2 study patients who received pivotal Phase 3 study formulation (since 2022) | 5.5 (2-13) | 25 | 15.6 | 4.1 | |
| BriaCell’s Phase 2 study patients who received pivotal Phase 3 study formulation (total) | 6 (2-13) | 37 | 13.4 | 3.9 | |
| Bardia, A. et. al. 1 (TNBC) | 4 (2-14) | 262 | 6.9 | 1.7 | |
| Tripathy D. et. al. 2 (Brain metastases) | ≥4 in | 178 | 7.5-7.8 | 1.9-2.8 | |
| O’Shaughnessy J. et. al. 3 non-TNBC at initial diagnosis | 5 (2-14) | 76 | 6.7 | 2.3 | |
| O’Shaughnessy J. et. al. 3 TNBC at initial diagnosis | 4 (2-10) | 157 | 6.9 | 1.6 | |
| Cortes et. al. 4 | 4 (0-13) | 594 | 9.1-9.3 | 1.9-2.5 | |
References
- Bardia A, et al. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29. PMID: 38422473.
- Tripathy D, et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022;8(7):1047-1052. doi:10.1001/jamaoncol.2022.0514.
- O’Shaughnessy J et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11. PMID: 35545724; PMCID: PMC9374646.
- Cortes J, Perez-Garcia J, Levy C, Gómez Pardo P, Bourgeois H, Spazzapan S, Martínez-Jañez N, Chao TC, Espié M, Nabholtz JM, Gonzàlez Farré X, Beliakouski V, Román García J, Holgado E, Campone M. Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051. PMID: 29481630.
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: the impact of Bria-IMT™ on patients with metastatic breast cancer; BriaCell’s further clinical development of Bria-IMT™; and the efficacy of immune check point inhibitors, 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
Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
FAQ
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