On November 26, 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 that it will be highlighting its positive overall survival and clinical benefit data in metastatic breast cancer (MBC) patients including those with CNS metastasis (not shown on the abstracts) who were treated with the Bria-IMT plus immune checkpoint inhibitor (CPI) combination in its "Spotlight" poster presentation session, at the 2024 San Antonio Breast Cancer Symposium (SABCS ) held at Henry B. Gonzalez Convention Center, San Antonio, TX (Press release, BriaCell Therapeutics, NOV 26, 2024, View Source [SID1234649125]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In the Phase 2 study, the Bria-IMT combination regimen significantly increased overall survival versus comparable published benchmarks. Additionally, objective response rate and clinical benefit rate data, support the potential benefit of Bria-IMT plus CPI in patients with this difficult-to-treat cancer," stated Saranya Chumsri, MD, Principal Investigator, and Professor of Oncology, Mayo Clinic. "We plan to confirm the impressive clinical data in the BriaCell pivotal Phase 3 study as we continue to explore the use of Bria-IMT regimen across all breast cancer subtypes."
"At BriaCell, we are committed to finding therapeutic options for difficult-to-treat metastatic breast cancer patients," stated Dr. William V. Williams, BriaCell’s President & CEO. "BriaCell’s clinical data demonstrating impressive overall survival in all patient subsets including very difficult to treat patient populations, such as those who have failed prior checkpoint inhibitor and/or antibody-drug conjugate therapy, reinforces our confidence in the potential use of the combination regimen in MBC patients. Additionally, clinical benefit was seen across metastatic breast cancer subtypes including HER2+, HR+/HER2-, and even in triple-negative breast cancer (TNBC) patients. Bria-IMT may provide a significant contribution to the lives of patients and their families fighting this incurable disease."
The details about the submitted abstracts are as follows:
Abstract Number: SESS-1071 (Selected as Spotlight Poster)
Title: Overall survival results of Bria-IMT allogenic whole cell-based cancer vaccine
Time: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST
Presentation ID: PS3-06
Abstract Summary:
54 patients were enrolled with 22 patients in phase 1 and 32 patients in phase 2.
11 patients were treated with pembrolizumab and 44 patients with retifanlimab (1 patient received pembrolizumab and later retifanlimab).
The Bria-IMT combination regimen was well tolerated.
The Bria-IMT regimen demonstrated promising results across all subtypes of breast cancer with favorable safety profiles.
Patients receiving the pivotal Phase 3 Bria-IMT combination regimen (n=37) showed significantly higher median overall survival (OS) (13.4), an objective response rate (ORR) of 9.5% and a clinical benefit rate (CBR) of 55%.
Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive.
mong 36 patients with post-dose cancer-associated circulating tumor cell (CTC) data, patients with post-dose CTC count < 5 had a significantly better OS compared with a CTC count > 5 (13.4 vs. 5.5 months, P 0.01).
Patients with positive delayed type hypersensitivity (DTH), an inflammatory marker to measure the response to Bria-IMT immunization, had significantly better OS.
"Our clinical findings support the use of the current Phase 3 formulation," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We plan to confirm the potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT plus CPI ongoing pivotal Phase 3 study ( NCT06072612 ) in metastatic breast cancer."
Abstract Number: SESS-1431
Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccines
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-06-02
Abstract Number: SESS-2217
Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysis
Time: Wednesday, December 11, 2024 12:00 – 2:00 PM CST
Presentation ID: P1-01-17
Abstract Number: SESS-1068
Abstract Title: ASTRO-VAC CNS: Bria-IMT in the management of tumor agnostic metastatic CNS lesions
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-10-24
Abstract Number: SESS-1069
Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn "Cold" tumor "Hot" in metastatic breast cancer
Time: Friday, December 13, 2024 12:00 PM – 2:00 PM CST
Presentation ID: P5-10-12
Following presentations, the posters can be viewed at the following: View Source