BriaCell Reports Positive Overall Survival (OS) in Metastatic Breast Cancer
September 11 2024 - 6:50AM
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 91% |
178 |
7.5-7.8 |
1.9-2.8 |
|
O’Shaughnessy J. et. al. 3non-TNBC at initial
diagnosis |
5 (2-14) |
76 |
6.7 |
2.3 |
|
O’Shaughnessy J. et. al. 3TNBC 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
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“seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,”
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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
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in this announcement are made as of this date, and BriaCell
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except as required under applicable law.
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Contact Information
Company Contact:William V.
Williams, MDPresident &
CEO1-888-485-6340info@briacell.com
Media Relations:Jules AbrahamCORE
IRjulesa@coreir.com
Investor Relations Contact:CORE
IRinvestors@briacell.com
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