BriaCell 2024 SABCS® Spotlight Poster to Showcase Positive Overall Survival Data Across All Patient Subtypes in Metastatic Breast Cancer
BriaCell Therapeutics (Nasdaq: BCTX) will present positive survival data for its Bria-IMT™ plus immune checkpoint inhibitor combination therapy in metastatic breast cancer at SABCS® 2024. The Phase 2 study showed a median overall survival of 13.4 months, exceeding historical controls, with final calculations pending as many patients remain alive. The therapy demonstrated promising results across all breast cancer subtypes, with a 9.5% objective response rate and 55% clinical benefit rate. The study included 54 patients total, with positive outcomes observed in patients with low circulating tumor cell counts and positive delayed type hypersensitivity responses.
BriaCell Therapeutics (Nasdaq: BCTX) presenterà dati positivi sulla sopravvivenza per la sua terapia combinata Bria-IMT™ più inibitore del checkpoint immunitario nel cancro al seno metastatico al SABCS® 2024. Lo studio di Fase 2 ha mostrato una sopravvivenza globale mediana di 13,4 mesi, superando i controlli storici, con calcoli finali in sospeso poiché molti pazienti sono ancora in vita. La terapia ha dimostrato risultati promettenti in tutti i sottotipi di cancro al seno, con un 9,5% di tasso di risposta obiettiva e un 55% di tasso di beneficio clinico. Lo studio ha coinvolto un totale di 54 pazienti, con risultati positivi osservati nei pazienti con basse concentrazioni di cellule tumorali circolanti e risposte positive di ipersensibilità di tipo ritardato.
BriaCell Therapeutics (Nasdaq: BCTX) presentará datos positivos sobre la supervivencia de su terapia combinada Bria-IMT™ más inhibidor de punto de control inmunitario en cáncer de mama metastásico en SABCS® 2024. El estudio de Fase 2 mostró una supervivencia global mediana de 13.4 meses, superando los controles históricos, con cálculos finales pendientes ya que muchos pacientes siguen vivos. La terapia mostró resultados prometedores en todos los subtipos de cáncer de mama, con un 9.5% de tasa de respuesta objetiva y un 55% de tasa de beneficio clínico. El estudio incluyó un total de 54 pacientes, con resultados positivos observados en pacientes con bajos recuentos de célula tumoral circulante y respuestas positivas de hipersensibilidad de tipo retardado.
BriaCell Therapeutics (Nasdaq: BCTX)는 SABCS® 2024에서 전이성 유방암에 대한 Bria-IMT™ 및 면역 체크포인트 억제제 병용 요법의 긍정적인 생존 데이터를 발표할 예정입니다. 2상 연구에서 중간 전체 생존 기간이 13.4개월로 나타났으며, 이는 역사적 대조군을 초과하며, 많은 환자가 여전히 생존해 있으므로 최종 계산은 보류 중입니다. 이 요법은 모든 유방암 아형에서 유망한 결과를 나타내었으며, 9.5%의 객관적 반응률과 55%의 임상 이점률을 보였습니다. 연구에는 총 54명의 환자가 포함되었으며, 순환 종양 세포 수치가 낮고 지연형 과민 반응이 긍정적인 환자에서 긍정적인 결과가 관찰되었습니다.
BriaCell Therapeutics (Nasdaq: BCTX) présentera des données de survie positives pour sa thérapie combinée Bria-IMT™ et inhibiteur de point de contrôle immunitaire dans le cancer du sein métastatique au SABCS® 2024. L'étude de Phase 2 a montré une durée médiane de survie globale de 13,4 mois, dépassant les contrôles historiques, les calculs finaux étant en attente car de nombreux patients restent en vie. La thérapie a montré des résultats prometteurs dans tous les sous-types de cancer du sein, avec un taux de réponse objective de 9,5% et un taux de bénéfice clinique de 55%. L'étude a inclus au total 54 patients, avec des résultats positifs observés chez les patients ayant de faibles comptes de cellules tumorales circulantes et des réponses positives d'hypersensibilité de type retardé.
BriaCell Therapeutics (Nasdaq: BCTX) wird auf dem SABCS® 2024 positive Überlebensdaten für seine Kombinationstherapie Bria-IMT™ plus Immun-Checkpoint-Inhibitor bei metastasiertem Brustkrebs präsentieren. Die Phase-2-Studie zeigte eine mediane Gesamtüberlebenszeit von 13,4 Monaten, die die historischen Kontrollen übertrifft, wobei die endgültigen Berechnungen ausstehen, da viele Patienten noch leben. Die Therapie zeigte vielversprechende Ergebnisse in allen Subtypen von Brustkrebs, mit einer 9,5% objektiven Ansprechraten und einer 55% klinischen Nutzenrate. In der Studie waren insgesamt 54 Patienten eingeschlossen, wobei positive Ergebnisse bei Patienten mit niedrigen zirkulierenden Tumorzellzahlen und positiven verzögerten Überempfindlichkeitsreaktionen beobachtet wurden.
- Median overall survival of 13.4 months exceeds historical controls
- Clinical benefit rate of 55% across all breast cancer subtypes
- 9.5% objective response rate in Phase 2 trial
- Therapy shows efficacy across all breast cancer subtypes including difficult-to-treat populations
- Favorable safety profile reported for the combination therapy
- Final median overall survival data still pending
- Lower survival rate (5.5 months) in patients with high circulating tumor cell count
Insights
The Phase 2 clinical trial data for Bria-IMT™ combination therapy shows significant promise with a median overall survival of 13.4 months in metastatic breast cancer patients. The 55% clinical benefit rate and 9.5% objective response rate across all breast cancer subtypes, including difficult-to-treat populations, are particularly noteworthy. The identification of potential biomarkers (CTC counts and DTH response) for predicting treatment outcomes adds valuable stratification tools for patient selection.
The positive survival data in patients who failed prior checkpoint inhibitor and antibody-drug conjugate therapy suggests this could fill an important treatment gap. The increased presence of CD8+ T cells in tumors indicates successful immune system activation, while efficacy against CNS metastases addresses a critical unmet need in breast cancer treatment.
The survival benefit demonstrated across all breast cancer subtypes - HER2+, HR+/HER2- and triple-negative - represents a significant advancement. Most current therapies are subtype-specific, making this broad efficacy particularly valuable. The correlation between CTC counts <5 and improved survival (13.4 vs 5.5 months) provides a clear prognostic marker for monitoring treatment efficacy.
The safety profile appears favorable, which is important for combination therapy approaches. The pending final median overall survival data from Phase 2, with many patients still alive, suggests the possibility of even better long-term outcomes. The planned Phase 3 trial will be critical in validating these promising results.
- SABCS® “Spotlight” poster to be presented on Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST highlights positive BriaCell survival and clinical benefit data across all metastatic breast cancer patient subtypes
- Median overall survival of 13.4 months exceeds historical controls. Phase 2 final median overall survival calculation is pending, as many patients remain alive
- Potential identification of biomarkers to predict response
- Five poster presentations to feature increased presence of cancer fighting CD8+ “killer” T cell in metastatic breast cancer tumors, response in central nervous system (CNS) metastases and additional Bria-IMT™ clinical data from the Phase 2 trial of Bria-IMT™ + immune check point inhibitor in metastatic breast cancer
- Collaboration with the Medical College of Wisconsin will investigate use of Bria-IMT™ + CPI in any cancer patient with central nervous system (CNS) metastases
PHILADELPHIA and VANCOUVER, British Columbia, Nov. 26, 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, will be highlighting its positive overall survival and clinical benefit data in metastatic breast cancer (MBC) patients including those with CNS metastasis (not shown on the abstracts) who were treated with the Bria-IMT™ plus immune checkpoint inhibitor (CPI) combination in its “Spotlight” poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX.
“In the Phase 2 study, the Bria-IMT™ combination regimen significantly increased overall survival versus comparable published benchmarks. Additionally, objective response rate and clinical benefit rate data, support the potential benefit of Bria-IMT™ plus CPI in patients with this difficult-to-treat cancer,” stated Saranya Chumsri, MD, Principal Investigator, and Professor of Oncology, Mayo Clinic. “We plan to confirm the impressive clinical data in the BriaCell pivotal Phase 3 study as we continue to explore the use of Bria-IMT™ regimen across all breast cancer subtypes.”
“At BriaCell, we are committed to finding therapeutic options for difficult-to-treat metastatic breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO. “BriaCell’s clinical data demonstrating impressive overall survival in all patient subsets including very difficult to treat patient populations, such as those who have failed prior checkpoint inhibitor and/or antibody-drug conjugate therapy, reinforces our confidence in the potential use of the combination regimen in MBC patients. Additionally, clinical benefit was seen across metastatic breast cancer subtypes including HER2+, HR+/HER2-, and even in triple-negative breast cancer (TNBC) patients. Bria-IMT™ may provide a significant contribution to the lives of patients and their families fighting this incurable disease.”
The details about the submitted abstracts are as follows:
Abstract Number: SESS-1071 (Selected as Spotlight Poster)
Title: Overall survival results of Bria-IMT allogenic whole cell-based cancer vaccine
Time: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST
Presentation ID: PS3-06
Abstract Summary:
- 54 patients were enrolled with 22 patients in phase 1 and 32 patients in phase 2.
- 11 patients were treated with pembrolizumab and 44 patients with retifanlimab (1 patient received pembrolizumab and later retifanlimab).
- The Bria-IMT™ combination regimen was well tolerated.
- The Bria-IMT™ regimen demonstrated promising results across all subtypes of breast cancer with favorable safety profiles.
- Patients receiving the pivotal Phase 3 Bria-IMT™ combination regimen (n=37) showed significantly higher median overall survival (OS) (13.4), an objective response rate (ORR) of
9.5% and a clinical benefit rate (CBR) of55% . - Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive.
- Among 36 patients with post-dose cancer-associated circulating tumor cell (CTC) data, patients with post-dose CTC count < 5 had a significantly better OS compared with a CTC count > 5 (13.4 vs. 5.5 months, P 0.01).
- Patients with positive delayed type hypersensitivity (DTH), an inflammatory marker to measure the response to Bria-IMT™ immunization, had significantly better OS.
“Our clinical findings support the use of the current Phase 3 formulation,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We plan to confirm the potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study (NCT06072612) in metastatic breast cancer.”
Abstract Number: SESS-1431
Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccines
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-06-02
Abstract Number: SESS-2217
Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysis
Time: Wednesday, December 11, 2024 12:00 – 2:00 PM CST
Presentation ID: P1-01-17
Abstract Number: SESS-1068
Abstract Title: ASTRO-VAC CNS: Bria-IMT in the management of tumor agnostic metastatic CNS lesions
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-10-24
Abstract Number: SESS-1069
Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancer
Time: Friday, December 13, 2024 12:00 PM – 2:00 PM CST
Presentation ID: P5-10-12
Following presentations, the posters can be viewed at the following: 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 those about BriaCell’s potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study; BriaCell’s potential use of the combination regimen in MBC patients; BriaCell conducting a poster presentation at the 2024 San Antonio Breast Cancer Symposium®, and the contents of such presentation; the potential benefit of Bria-IMT™ plus CPI in cancer patients; BriaCell’s plans to confirm the clinical data in their pivotal Phase 3 study; BriaCell’s Phase 3 study exploring the use of the Bria-IMT™ regimen across all breast cancer subtypes; and the Bria-IMT™ regimen having the potential to provide a significant contribution to the lives of cancer patients 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, such as those 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
What is the median overall survival rate for BCTX's Bria-IMT therapy in Phase 2 trials?
What is the clinical benefit rate of BCTX's Bria-IMT therapy in metastatic breast cancer?
How many patients were enrolled in BCTX's Bria-IMT clinical trials?
What is the objective response rate for BCTX's Bria-IMT therapy?
