For patients with metastatic breast cancer, the search for effective therapies often feels like a race against time. Many have endured multiple lines of treatment, each one offering diminishing hope as the disease advances. But new clinical results released on January 27, 2026, are sparking cautious optimism among oncologists and patients alike. According to recent press releases and clinical data covered by Cancer Network and Targeted Oncology, the investigational immunotherapy Bria-IMT is showing promising results in extending survival for those with heavily pretreated metastatic breast cancer.
Bria-IMT, an allogeneic whole-cell immunotherapy, has been evaluated in a phase 2 trial involving 54 patients who had exhausted a median of six prior therapies. In this population—where options are typically limited and outcomes grim—the median overall survival (OS) reached 15.6 months. For context, historical data for physician-selected treatments in this setting show 2-year survival rates ranging from just 7% to 25%. Yet, with Bria-IMT, the 2-year survival rate climbed to 32%, and the 1-year survival rate reached 52% among those receiving the therapy in combination with an immune checkpoint inhibitor.
These numbers are more than just statistics—they represent real patients whose lives have been extended in the face of a relentless disease. The trial's cohort included a diverse mix of breast cancer subtypes: 61% hormone receptor–positive, 33% triple-negative, and 6% HER2-positive. Notably, the regimen appeared effective across these subtypes, suggesting broad potential benefit.
Several case studies from the trial put a human face on the data. Take Patient 01-009, for example: a 74-year-old with estrogen receptor–positive (ER+)/progesterone receptor–positive (PR+)/HER2-low disease, who had already undergone five prior lines of therapy. Remarkably, this patient has survived 47 months since entering the study, receiving 14 cycles of Bria-IMT. Another, Patient 11-018, a 66-year-old with ER+/PR+/HER2+ disease, faced metastases behind the right eye, in the temporal lobe of the brain, and in multiple bones. After 35 cycles of Bria-IMT, this patient experienced complete resolution of the brain metastasis, improvement in the orbital lesion, and stable bone disease—remaining alive 27 months after enrollment.
Other long-term survivors include a 55-year-old with ER+/PR+/HER2-low disease who has survived 30 months post-treatment, a 62-year-old with ER+/PR-/HER2- disease who has reached the same milestone, and a 64-year-old with ER+/PR-/HER2- disease who, after eight prior therapies including sacituzumab govitecan, achieved 25 months of survival. These stories are powerful reminders of the potential for new therapies to change the trajectory of even the most advanced cancers.
Importantly, Bria-IMT appears to be well-tolerated. As Targeted Oncology reports, "no patients have discontinued treatment due to adverse events related to Bria-IMT." The regimen includes low-dose cyclophosphamide and local interferon-alpha-2b, and so far, the safety profile has been encouraging. This is especially significant for patients who have already endured the toxicities of multiple prior treatments.
How does Bria-IMT work? The therapy is a genetically modified, irradiated allogeneic breast cancer cell line engineered to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF). This modification is designed to stimulate the patient’s immune system, prompting it to recognize and attack tumor-associated antigens. By expressing HLA class I and II molecules, the cell line can directly activate both CD4- and CD8-positive T cells, potentially bypassing the need for traditional dendritic cell antigen processing. In other words, Bria-IMT aims to jumpstart the immune system’s ability to target and destroy cancer cells, even after other treatments have failed.
Comparisons to existing therapies are instructive. In the Bria-IMT plus checkpoint inhibitor cohort, the median OS of 15.6 months exceeded the 14.4 months reported for sacituzumab govitecan (Trodelvy) in hormone receptor-positive, HER2-negative metastatic breast cancer. Furthermore, the survival benefit was particularly notable in patients who had failed prior therapies with sacituzumab govitecan or trastuzumab deruxtecan (Enhertu), two of the most advanced treatments currently available for this patient population.
William V. Williams, MD, FACP, president and CEO of BriaCell, emphasized the significance of these findings in a statement: "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." He added, "We look forward to confirming these findings in BriaCell’s ongoing pivotal phase 3 study with overall survival as its primary end point."
This ongoing phase 3 trial, known as BRIA-ABC (NCT06072612), is a multicenter, randomized, open-label study. Patients are being assigned in a 1:1:1 ratio to receive either Bria-IMT plus an immune checkpoint inhibitor, Bria-IMT monotherapy, or chemotherapy (the latter according to each site’s standard of care). Imaging assessments are scheduled every six weeks for the first two rounds, then every eight weeks thereafter. The primary endpoint is overall survival, with secondary endpoints including progression-free survival and clinical benefit rate. Notably, the trial is evaluating Bria-IMT in combination with the PD-1 inhibitor retifanlimab (Zynyz), further exploring the potential synergy between immunotherapies in this setting.
The momentum behind Bria-IMT is further underscored by the U.S. Food and Drug Administration’s decision to grant fast track approval for the therapy in April 2022. This designation is reserved for treatments that address unmet medical needs and have the potential to offer significant advances over existing options—a recognition of both the dire need in metastatic breast cancer and the early promise shown by Bria-IMT.
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, summed up the situation: "This 2-year overall survival data show the possible therapeutic potential of the 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."
Of course, experts caution that these results, while encouraging, are still early. Larger, randomized trials are needed to confirm the survival benefits and further clarify the safety profile. But for now, the stories of patients living longer—and living better—thanks to Bria-IMT offer a glimmer of hope in a field where such hope is often in short supply.