Full Press Release Details
Reports Positive Survival Data in Advanced Metastatic Breast Cancer
| 9 of 11 women remain alive from 2021/2022 dosing, highlighting strong survival benefits. | |
| Remains well tolerated with no dose limiting toxicities. | |
| Primary endpoint in pending pivotal trial will be survival, as agreed by the FDA. | |
| 9 additional patients have been screened/enrolled in the study, incremental to the 12 patients announced in December 2022. |
PA and VANCOUVER, British Columbia, February 23, 2023- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell"
or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, today reports
updated survival data from its previously disclosed group of 12 patients (11 patients enrolled in 2021/2022) in the ongoing Phase
II clinical trial evaluating Bria-IMT in combination with Incyte's retifanlimab for the treatment of advanced metastatic
| 9 of 11 (82%) patients remain alive from 2021/2022 dosing, suggesting strong survival benefits. | |
| 7 of 11 (64%) patients showed either disease control or progression-free survival ("PFS") benefits compared with their most recent prior therapy regimen suggesting clinical benefit, including survival and delayed cancer progression in this very difficult to treat patient population. | |
| Median PFS of 3.5 months (with one subject ongoing) compares favorably with other recent studies of patients with advanced disease including other approved agents in earlier lines of therapy (Tripathy "ATTAIN" 2022, Perez 2015 "BEACON", Cortes 2018, O'Shaughnessy 2022 "ASCENT"). | |
| Regimen remains well tolerated with no dose limiting toxicities. |
is working, and it's working well. We had high hopes going into this clinical read-out, and the survival numbers have even
exceeded our expectations. With 9 of 11 women still alive, this has a material impact for the patients and their loved ones, especially
since some patients may have had only weeks or months to live prior to our treatment," stated Dr. William V. Williams, BriaCell's
President and CEO. "This survival update bodes well for our upcoming pivotal trial, since the FDA has agreed to survival benefits
as the primary endpoint."
clinical data from BriaCell's combination regimen highlights survival benefits in a cohort (3rd line or later) with
a life expectancy of merely months or weeks in some cases. Patients in this cohort had failed a
median of 5 other treatments prior to enrolling in BriaCell's study. Other reportable benefits such as less pain and better
quality of life were also observed in these patients.
of top-responding patients: 4 of 5 patients with Grade I/II cancer, and 6 of 8 hormone receptor positive (HR+) patients had either
disease control or improved PFS suggesting potentially better responding subgroup/s of patients. These subgroups
represent large segments of the advanced breast cancer patient population.
update: 9 additional patients have been screened/enrolled in the study, incremental to the
12 patients announced in December 2022. With patients continuing to enroll and remain on the treatment, more data including overall survival
data will be disclosed at regular intervals.
BriaCell Therapeutics Corp.
is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. More information
is available at https://briacell.com/.
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