Bria-IMT Shows Promising OS in Advanced Metastatic Breast Cancer

Updated phase 2 survival data for the investigational immunotherapy Bria-IMT indicate a meaningful overall survival (OS) advantage in patients with heavily pretreated metastatic breast cancer.¹ The data suggest Bria-IMT in combination with an immune checkpoint inhibitor (CPI) may offer a valuable therapeutic option for patients who have exhausted multiple prior lines of therapy, including those with triple-negative breast cancer (TNBC) and hormone receptor-positive (HR+) disease.

In patients with TNBC, the median OS observed with Bria-IMT plus a CPI was 13.9 months. This compares favorably with published data for sacituzumab govitecan-hziy (Trodelvy), which reported a median OS of 11.8 months, and single-agent chemotherapy data, showing 6.9 months. These Bria-IMT data in TNBC represent an improvement from the 11.4 months previously reported at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2025.

For patients with HR+ metastatic breast cancer patients, the median OS with Bria-IMT plus a CPI was 17.3 months, exceeding the 14.4 months reported for sacituzumab govitecan and 11.2 months for single-agent chemotherapy.

“We are thrilled to see our Bria-IMT regimen outperform established benchmarks like [sacituzumab govitecan] in [patients with] TNBC and HR+ [metastatic breast cancer]. BriaCell’s patients had failed a median of 6 prior therapies, underscoring the potential clinical impact of our novel immunotherapy. We look forward to validating these findings in our ongoing pivotal phase 3 study with overall survival as its primary end point,” said William V. Williams, MD, FACP, president and chief executive officer of BriaCell, in a press release.

In contrast, the comparative data for sacituzumab govitecan and single-agent chemotherapy typically involved patients with fewer prior lines of treatment, with a median of 3 to 4 prior chemotherapy-containing regimens.

The phase 2 study enrolled 54 patients with heavily pretreated metastatic breast cancer who received the Bria-IMT regimen plus a checkpoint inhibitor. No Bria-IMT–related discontinuations have been reported in the study to date, suggesting a tolerable safety profile in this fragile patient population.

An ongoing phase 3 study (NCT06072612) will be crucial in further defining the clinical utility and establishing the efficacy and safety profile of Bria-IMT in this patient population.

About Bria-IMT

Bria-IMT is an off-the-shelf, targeted, cell-based immunotherapy for the treatment of metastatic breast cancer.² The mechanism of action is currently being investigated, and researchers hypothesize that Bria-IMT indirectly and directly stimulates a patient’s cancer-fighting cells.

In April 2022, the FDA granted fast track status to Bria-IMT in metastatic breast cancer.³

REFERENCES:

1. BriaCell's Bria-IMT(TM) demonstrates survival advantage over Trodelvy® and control group in metastatic breast cancer. News release. BriaCell Therapeutics Corp. July 11, 2025. Accessed July 14, 2025. https://tinyurl.com/2s3as2rj

2. Bria-IMT cell therapy. BriaCell Therapeutics Corp. Accessed July 14, 2025. https://briacell.com/briaimt/

3. BriaCell receives FDA fast track approval for targeted breast cancer immunotherapy. News release. BriaCell Therapeutics Corp. April 13, 2022. Accessed July 14, 2024. https://bit.ly/3rt17fj