BCTXW - BriaCell Doubles Progression-Free-Survival (PFS) and Reports Clinical Benefit Data at ASCO 2024 | Benzinga
- 83% intracranial objective response rate (iORR) with Bria-IMT™ in heavily pretreated advanced breast cancer patients with CNS metastases
- Median progression free survival (PFS) of 4.1 months in ADC resistant patients - double the PFS of patients in similar studies1,2,3
- Clinical benefit rate of 55% in evaluable patients includes HR+, HER2+ and TNBC disease - much higher than comparable studies1,2,3
PHILADELPHIA and VANCOUVER, British Columbia, May 24, 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, announces positive clinical data of its lead product candidate, Bria-IMT™, to be presented in one oral presentation session (by Principal Investigator and Professor of Oncology, Mayo Clinic, Saranya Chumsri, MD), two poster sessions, and one abstract on the updated clinical data of BriaCell's randomized Phase 2 study evaluating Bria-IMT™ in patients with advanced metastatic breast cancers at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place taking place May 31 - June 4, 2024 at McCormick Place, Chicago, IL. The abstracts for these presentations are now available at https://conferences.asco.org/am/abstracts.
"Patients with heavily pretreated metastatic breast cancer that have developed resistance to antibody drug conjugates (ADC) face a very poor prognosis. Novel, well tolerated and effective treatments remain a critical need," stated Sara A. Hurvitz, MD, Professor of Medicine, Fred Hutchinson Cancer Center and University of Washington and BriaCell medical advisory board member. "Early data from the BriaCell study are quite promising and if confirmed in the larger clinical trial could be a game changer for patients."
"Bria-IMT™ is a novel therapeutic which has the potential to address a major therapeutic challenge in the management of progressive metastatic breast cancer, and these early results with preliminary activity in a refractory patient setting are encouraging," stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and a member of BriaCell's medical advisory board.
"With 4 published abstracts and an oral presentation, we expect this year's ASCO Annual Meeting to be a very important event for BriaCell," stated Giuseppe Del Priore, MD, MPH, BriaCell's Chief Medical Officer. "We are thrilled to present promising updated data from our Phase 2 Bria-IMT™ regimen showing clinical efficacy across all patient groups, along with a preferred safety profile."
Oral presentation by Mayo Clinic Professor and Phase 2 Principal Investigator, Saranya Chumsri, MD, on Monday June 3; 11:30 AM-1:00 PM CDT
Abstract Number for Publication: 1022
Title: Outcomes of advanced/metastatic breast cancer (aMBC) treated with Bria-IMT™, an allogeneic whole cell immunotherapy.
Session Type and Title: Rapid Oral Abstract – Breast Cancer – Metastatic
Phase 2 clinical data of the Bria-IMT™ regimen in 54 advanced metastatic breast cancer patients who failed multiple prior treatments including ADCs and immune check point inhibitors (CPIs) (median of 6 prior treatments) are presented.
Clinical Efficacy
- Median progression free survival (PFS)# of 4.1 months in heavily pretreated ADC resistant patients
- PFS of 3.9 months in patients treated with planned pivotal Phase 3 formulation is double the PFS of patients in similar studies who received physician's treatment of choice (the comparator in the ongoing phase 3 study)
- Overall response rate (ORR)## of 9.5% and clinical benefit rate (CBR)### of 55% in evaluable patients compares favorably with the literature (Table 1)
- 5/6 (83%) of evaluable patients (one inevaluable) with intracranial lesions treated with Bria-IMT™ in all BriaCell studies had intracranial responses, including complete and partial responses
# PFS is defined as the length of time during which a patient's cancer does not get worse
## ORR defined as the percentage of patients who achieved either a complete response (complete disappearance of tumor) or partial response (tumor volume reduction of 30% or more)
### CBR defined as percentage of patients whose disease shrinks or remains stable over a certain time period
| Table 1: Bria-IMT™ and historical clinical data in aMBC patients who failed multiple prior treatments |