Bria-IMT Continues to Improve Survival in Metastatic Breast Cancer

Extended survival was noted in a small cohort of patients receiving Bria-IMT for metastatic breast cancer, according to results from a phase 2 trial.¹

Among 9 patient cases, survival was between 18 and 47 months. For those receiving Bria-IMT plus an immune checkpoint inhibitor, the 1-year survival rate was 52%, and at 2 years, it was 32%. The median overall survival (OS) was 15.6 months. Additionally, patients had a median of 6 prior lines of therapy. Patient characteristics by breast cancer subtype included 61% of patients having hormone receptor–positive status, 33% having triple-negative breast cancer, and 6% having HER2-positive disease.

The press release highlighted data on 9 patients, including their subtype, age, time since study start, number of prior regimens, and number of Bria-IMT cycles. In select patients, more detail was given regarding sites of metastases and survival status.

The ongoing long-term survivors:

• Patients 01-009 had estrogen receptor–positive (ER+)/progesterone receptor–positive (PR+)/HER2-low disease. It had been 47 months since the beginning of the study. They were 74 years old, with 5 prior lines of therapy and 14 cycles of Bria-IMT.
• Patient 07-001 had ER+/PR+/HER2-low disease. It had been 30 months since the start of treatment. They were 55 years old, had 7 lines of previous therapy, and had 8 cycles of Bria-IMT.
• Patient 15-001 had ER+/PR-negative (PR–)/HER2– disease. They had been on treatment for 30 months, were 62 years old, had 3 lines of prior therapy, and had 12 cycles of Bria-IMT.
• Patient 11-018 had ER+/PR+/HER2+ disease. It had been 27 months since the start of the study. They were 66 years old, they had 8 prior lines of therapy including fam-trastuzumab deruxtecan-nxki (Enhertu), and had 35 cycles of Bria-IMT. Metastases were presented behind the right eye, the right temporal lobe of the brain, and multiple skeletal sites. Resolution of the temporal mass occurred with improvement in the orbital lesion and stable bone disease.
• Patient 15-005 had ER+/PR+/HER2– disease. It had been 27 months since the study start. She was 44 years old, had 5 lines of previous therapy, and had 6 cycles of Bria-IMT. This patient had metastases of the spine and achieved stable disease after 6 cycles as her best response.
• Patient 15-006 had ER+/PR–/HER2– disease. It had been 27 months since the start of the study, the patient age was 64, the number of previous lines of therapy was 8 including sacituzumab govitecan-hziy (Trodelvy), and she received 4 cycles of Bria-IMT. Additionally, this patient had metastases to the liver.
• Patient 15-004 had ER+/PR+/HER2– disease. It had been 25 months since the start of the study; the patient was 50 years old. She had received 3 prior lines of therapy and 6 cycles of Bria-IMT.
• Patient 11-019 had ER+/PR+/HER2-low disease. They had been on the study for 23 months, their age was 63, they had 9 prior lines of therapy including sacituzumab govitecan, and had 6 cycles of Bria-IMT.
• Patient 07-014 had ER+/PR+/HER2-low disease. They had been on the study for more than 18 months, they were 62 years old, had received 9 prior lines of therapy including sacituzumab govitecan, and had 5 cycles of Bria-IMT.

The study enrolled 54 patients who were heavily pretreated and had metastatic breast cancer. Of these patients, 37 were evaluated using the same formulation noted in the phase 3 BRIA-ABC trial (NCT06072612). This included 25 patients treated after 2022 and 12 treated prior to 2022. Results prior to 2022 showed a median OS of 13.4 months, and after 2022, it was 15.6 months.

The press release noted that, to date, there were no Bria-IMT-related discontinuations reported.

“Our drive to generate long-term data reflects our belief that clinicians and patients with cancer deserve clear, meaningful evidence to guide their treatment decisions. The number of long-term survivors is quite remarkable, given how heavily pretreated these patients are, and supports our hypothesis that the Bria-IMT regimen prolongs survival in patients with metastatic breast cancer,” stated William V. Williams, MD, FACP, BriaCell’s president and chief executive officer.¹ “We look forward to confirming these findings in BriaCell’s ongoing pivotal phase 3 study with [OS] as its primary end point.”

In the phase 3 trial, patients will be randomly assigned 1:1:1 to receive either Bria-IMT plus an immune checkpoint inhibitor, chemotherapy, or Bria-IMT monotherapy.² In the Bria-IMT arms, treatment will occur every 3 weeks. Chemotherapy will be given based on the site’s standard of care. Imaging will take place every 6 weeks for 2 rounds, and then every 8 weeks thereafter.

“This 2-year [OS] data show the possible therapeutic potential of Bria-IMT regimen for late-stage [metastatic breast cancer], a very difficult-to-treat cancer. Heavily pretreated metastatic breast cancer remains an unmet medical need with few to no treatment options and limited lifespan for many patients,” Adam M. Brufsky, MD, PhD, FACP, professor of medicine at the University of Pittsburgh School of Medicine and medical director of the Magee-Women's Cancer Program, said in the press release.¹

In April 2022, the FDA granted fast track designation to Bria-IMT.³

References

1. BriaCell highlights extended >18-47 months survival in phase 2 metastatic breast cancer patients. News release. BriaCell Therapeutics. January 27, 2026. Accessed January 28, 2026. https://tinyurl.com/ms8d4nrj
2. Study of the Bria-IMT regimen and cpi vs physicians' choice in advanced metastatic breast cancer. (BRIA-ABC). Updated January 6, 2026. Accessed January 28, 2026. https://tinyurl.com/bdcmh8bu
3. BriaCell received FDA fast track approval for targeted breast cancer immunotherapy. News Release. BriaCell Therapeutics. April 13, 2022. Accessed January 28, 2026. https://tinyurl.com/6sywze4v