Bria-IMT Cell Immunotherapy Shows 71% Intracranial ORR in Breast Cancer With CNS Metastases


BriaCell also shared specific positive data from one patient with proptosis and ocular pain.

Carmen Calfa, MD

Carmen Calfa, MD

Bria-IMT (SV-BR-1-GM; BriaCell) treatment, in combination with retifanlimab, yielded a 71% intracranial objective response rate (iORR) in patients with advanced breast cancer and central nervous system (CNS) metastases.1

“The CNS tumor reductions demonstrated in five of seven advanced breast cancer patients are particularly compelling given the history of unsuccessful treatment of CNS metastases in this patient population,” Giuseppe Del Priore, MD, MPH, Chief Medical Officer, BriaCell, said in a statement.1

These data are from 7 patients enrolled in a phase 2 trial (NCT03328026) which recently completed enrollment. Five patients saw improvements in CNS lesions. These participants have heavily pretreated metastatic breast cancer that has failed multiple prior treatments, including 1 patient whose disease had failed 2 antibody-drug conjugates. Responses were seen across all breast cancer subtypes.

“We have accumulated positive clinical responses in five patients with intracranial metastases, which generally are extremely difficult to treat, and have a very poor prognosis. This antitumor activity furthers our excitement in our ongoing Phase 3 pivotal trial studying the Bria-IMT™ regimen in advanced breast cancer,” William V. Williams, MD, FACP, President and CEO, BriaCell, added.1

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BriaCell recently initiated the BRIA-ABC phase 3 trial (NCT06072612) and the company is adding a pre-planned subgroup analysis of patients with CNS metastases to the trial for potential market approval. Bria-IMT is a genetically engineered human breast cancer cell line targeted cellular immunotherapy.

BriaCell has also showcased imaging of one responder in the phase 2 trial with extensive metastatic breast cancer and an eye-bulging tumor behind the eye.2 This patient had significant improvements in proptosis and significant reductions in ocular pain after receiving Bria-IMT treatment.3

“Responses like this are not often seen in heavily pretreated patients and are especially rare in metastatic disease to the eye,” principal clinical investigator Carmen Calfa, MD, Clinical Research Lead, breast site disease group, University of Miami Miller School of Medicine, and codirector, Cancer Survivorship Program, Sylvester Comprehensive Cancer Center, said in an earlier statement.3 “We were excited to offer her the latest treatments and thrilled to share in her success and joy.”

The patient was heavily pretreated and had 7 prior regimens of treatment including antibody-drug conjugate therapy. After treatment, the eye regained its normal position in the skull and tumor reductions were observed.

“We are extremely excited to report significant tumor reduction in this very difficult to treat patient who had failed 7 prior regimens including treatment with Enhertu®, an antibody-drug conjugate, highlighting the robust anti-tumor activity of the Bria-IMT™ regimen in difficult to reach tumors such as those in the eye orbit. We observed significant tumor reduction along with significant eye pain reduction after only 3 cycles of treatment with the Bria-IMT™ combination regimen. The Bria-IMT™ regimen has been very well tolerated and the patient remains on treatment,” Williams said.2

“Women with metastatic breast cancer continue to have poor survival despite recently approved therapies and further development of novel treatments remains an area of high unmet medical need,” Del Priore added.2

1. BriaCell Reports 71% Central Nervous System Response Rate in Advanced Breast Cancer Patients. News release. BriaCell. December 28, 2023.
2.BriaCell Images Confirm Robust Anti-Tumor Activity in Patient with “Eye-Bulging” Metastatic Breast Cancer. News release. BriaCell. January 24, 2024.
3. BriaCell Records New Responder with Remarkable Improvement of "Eye-Bulging" Metastatic Tumor. News release. BriaCell. November 30, 2023.
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