BriaCell Reports Outperforming Metastatic Breast Cancer Patients and Standard-Beating Survival Data
October 22 2024 - 7:50AM
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, announces new positive survival data, outperforming patients,
and survival rates in its Phase 2 metastatic breast cancer (MBC)
study.
In BriaCell’s Phase 2 clinical study, patients
treated with the same Bria-IMT™ regimen formulation being used in
the ongoing Phase 3 pivotal trial experienced a one-year survival
rate of 55% (i.e. 55% of patients remain alive at least one year
after starting on the study). This rate exceeds the survival data
of the current standard of care for similar patients (see Table 1).
Notably, 4 of 13 patients recruited in 2022 remain in survival
follow-up as well, including:
- Patient 01-009:
Overall survival (OS) of 25 months has been reported in a patient
who had failed 6 prior treatments prior to the BriaCell regimen.
Stable disease and lymph node shrinkage has been recorded during 13
cycles of therapy.
- Patient 07-001: OS
of 24 months. She had stable disease and received 8 cycles of
BriaCell’s therapy.
- Patient 16-003: OS
of 15 months and received 8 cycles of therapy with stable disease.
Prior to the BriaCell regimen, she had 7 lines of therapy, which
included the progression of disease while on the antibody-drug
conjugate (ADC) Enhertu.
- Patient 11-018: OS
of 14 months. This previously-reported responder with 100%
resolution of her brain metastasis has recently completed her 19th
cycle of therapy.
“With over 40,000 deaths each year in the US
alone, late-stage MBC remains an important unmet medical need for
many patients and their families. Approved treatments are
restricted by poor survival and harsh side effects,” 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. “We are impressed with BriaCell’s
promising randomized Phase 2 survival data indicating robust
survival and a preferred tolerability profile for Bria-IMT™ and
look forward to seeing the data being replicated in BriaCell’s
pivotal Phase 3 study.”
“A number of patients with metastatic breast
cancer have disease progression on currently approved drugs,
including CPIs and ADCs, with limited overall survival,” remarked
Dr. Aditya Bardia, Program Director of Breast Medical Oncology at
UCLA, who was not involved with the BriaCell Phase 2 clinical
trial. “BriaCell’s clinical data is interesting and highlights the
role of the combination of Bria-IMT™ with CPIs in MBC.”
“Significant numbers of patients with metastatic
breast cancer do not respond to currently approved drugs, including
CPIs and ADCs, and have a very limited lifespan of weeks to a few
months,” said Dr. William V. Williams, BriaCell’s President and
CEO. “BriaCell’s clinical data supports our hypothesis that our
regimen has prolonged survival in patients with metastatic breast
cancer who otherwise have not responded to currently available
treatments. We look forward to further confirming these impressive
data in our ongoing pivotal Phase 3 study, with interim results
expected in the second half of 2025. Overall survival is the
primary endpoint in our pivotal Phase 3 study.”
Table 1: Comparable Analysis of 1
year survival for the BriaCell Phase 2 study |
Reference |
Breast Cancer Type |
Median prior lines of therapy |
Median OS (months) |
Percent Survival at 1 year |
Bria-IMT™ plus
CPI |
All types61% HR+33%
TNBC6% HER2+ |
6 |
13.4* 15.6** |
55% |
Cortes et al.1 |
All types 57% HR+ 18-19% TNBC18-20% HER2+ |
4 |
9.1-9.3 |
~38-40% |
Kazmi et al.2 |
All types 51-52% HR+ 25-29% TNBC9-24% HER2+ |
2 |
7.2-9.8 |
30-38% |
Bardia et al. (TPC arm)3 |
TNBC |
2-3 |
6.9 |
~23% |
Rugo et al (TPC arm)4 |
HR+ HER2- |
2 |
11.2 |
47% |
* Patients treated with the Phase 3
formulation |
** Patients treated with the Phase 3 formulation
since 2022 |
|
1. Cortes J, et al. Annals of Oncology 2018 |
2. Kazmi S, et al. Breast Cancer Res Treat.
2020 |
3. Bardia A, et al. J Clin Oncol. 2024 |
4. Rugo HS, et al. The Lancet. 2023 |
|
Abbreviations:
HR+: hormone
receptor-positiveTNBC: Triple-negative breast
cancer (lacks or has low levels of the estrogen receptor,
progesterone receptor, and human epidermal growth factor receptor 2
(HER2))HER2+: Human epidermal growth factor
receptor 2 positiveHR+ HER2-: hormone
receptor-positive and human epidermal growth factor receptor 2
negativeTPC: Treatment of Physicians Choice
The 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’s ongoing pivotal
Phase 3 study in metastatic breast cancer (listed on
ClinicalTrials.gov as NCT06072612). Final median overall
survival calculation for the Phase 2 study is pending, 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 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™; the Company’s beliefs regarding the
results of BriaCell’s pivotal Phase 3 study; 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,
MDPresident & 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
1 Patients treated with the Bria-IMT™ formulation being used in
the phase 3 study.
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