Bria-IMT Improves Survival in Patients With Metastatic Breast Cancer

In an update of a phase 2 study, investigators reported that Bria-IMT combined with an immune checkpoint inhibitor showed improved overall survival in heavily pretreated patients with metastatic breast cancer, according to a news release from BriaCell.

“We are thrilled to see our Bria-IMT regimen outperform established benchmarks like Trodelvy in TNBC and HR+ MBC patients,” Dr. William V. Williams, BriaCell’s president and CEO, said in the news release. “BriaCell’s patients had failed a median of six 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 endpoint.”

For triple-negative breast cancer, the median overall survival was 13.9 months with BriaCell’s treatment, compared with 11.8 months for the antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) and 6.9 months for single-agent chemotherapy. BriaCell’s prior median survival, reported at the 2025 ASCO Annual Meeting in June 2025, was 11.4 months.

Among patients with hormone receptor-positive breast cancer, the median overall survival with BriaCell’s therapy was 17.3 months compared with 14.4 months for Trodelvy and 11.2 months for single-agent chemotherapy.

In patients with triple-negative breast cancer, treatment with Bria-IMT plus a checkpoint inhibitor using the phase 3 formulation resulted in a 78% survival rate at six months and 56% at 12 months. For comparison, six- and 12-month survival rates were 80% and 49% with Trodelvy, and 56% and 22% with single-agent chemotherapy.

Among patients with hormone receptor-positive breast cancer, the Bria-IMT combination showed six- and 12-month survival rates of 90% and 61%, respectively. Survival with Trodelvy was 83% at six months and 61% at 12 months, while single-agent chemotherapy resulted in 76% and 47% survival at the same time points.

The phase 2 Bria-IMT study enrolled 54 patients with heavily pretreated metastatic breast cancer, who had received a median of 6 prior therapies, to evaluate the Bria-IMT regimen combined with a checkpoint inhibitor. Among them, 37 patients were treated with the same formulation now being used in BriaCell’s ongoing pivotal phase 3 trial in metastatic breast cancer. As of the most recent update, no patients have discontinued due to side effects related to Bria-IMT.

Sustained Complete Resolution of Temporal Lobe Brain Metastasis

Furthermore, a patient with breast cancer who is enrolled on BriaCell’s phase 2 study of Bria-IMT plus checkpoint inhibitor has sustained a complete resolution of a brain metastasis and continued tumor shrinkage behind the eye for more than 18 months, according to an additional news release from BriaCell.

The metastatic tumor had initially caused proptosis, or eye bulging. This patient, who had previously received multiple treatments for metastatic breast cancer, showed these responses as early as 8 and 11 months into treatment. Now, more than 18 months later, there is still no sign of the brain tumor returning, and the orbital lesion continues to shrink.

“These encouraging results continue to suggest that our novel Bria-IMT regimen may provide durable immunotherapeutic benefit in late-stage breast cancer patients with brain metastases who have exhausted other options,” Williams said in the news release. “The long-term response observed in this patient reinforces the potential of Bria-IMT to improve outcomes while maintaining a favorable tolerability profile.”

The patient had failed eight prior treatment regimens, including an antibody-drug conjugate, before starting Bria-IMT plus checkpoint inhibition. She has now completed 29 treatment cycles and remained on the study for more than 21 months. Imaging at 8, 11 and now 20 months confirmed no detectable disease in the right temporal lobe and continued response in the orbital lesion. Her tumor markers have also stayed markedly lower than baseline, supporting the sustained radiologic response.

References

1. “BriaCell’s Bria-IMT™ Demonstrates Survival Advantage over Trodelvy® and Control Group in Metastatic Breast Cancer,” BriaCell Therapeutics Corp.
2. “BriaCell Reports Complete and Sustained Resolution of Brain Metastasis and Sustained Regression of Orbital Metastasis in ‘Eye-Bulging’ Breast Cancer Patient,” BriaCell Therapeutics Corp.

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