On October 22, 2024 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, reported new positive survival data, outperforming patients, and survival rates in its Phase 2 metastatic breast cancer (MBC) study (Press release, BriaCell Therapeutics, OCT 22, 2024, View Source [SID1234647332]).
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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 types
61% HR+
33% TNBC
6% HER2+ 6 13.4*
15.6** 55%
Cortes et al.1 All types
57% HR+
18-19% TNBC
18-20% HER2+ 4 9.1-9.3 ~38-40%
Kazmi et al.2 All types
51-52% HR+
25-29% TNBC
9-24% 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
Cortes J, et al. Annals of Oncology 2018
Kazmi S, et al. Breast Cancer Res Treat. 2020
Bardia A, et al. J Clin Oncol. 2024
Rugo HS, et al. The Lancet. 2023
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 receptor 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
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.