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A data safety monitoring board recommended the continuation of a study of Bria-IMT plus immune checkpoint inhibition in metastatic breast cancer.
After a review of safety findings, an independent data safety monitoring board (DSMB) has issued a fourth positive recommendation for the phase 3 BRIA-ABC trial (NCT06072612) evaluating the targeted immunotherapy Bria-IMT (SV-BR-1-GM) in combination with immune checkpoint inhibition for patients with metastatic breast cancer.1
In the review of the data, no new safety signals were reported, and the DSMB recommended the trial continue without modifications.
“Repeated consecutive DSMB positive recommendations further strengthen our confidence in the excellent safety and tolerability profile of the [Bria-IMT] regimen,” William V. Williams, MD, FACP, president and chief executive officer of BriaCell, stated in a news release. “We strongly believe in Bria-IMT’s potential to transform cancer care and remain determined to make it a reality for patients with metastatic breast cancer who face urgent medical needs.”
Why is Bria-IMT being evaluated in metastatic breast cancer?
Prior data from a phase 2 trial (NCT03328026) showed that Bria-IMT plus an immune checkpoint inhibitor generated a 1-year overall survival (OS) rate of 52% in patients with heavily pretreated metastatic breast cancer who were treated with the phase 3 formulation of the agent (n = 25).2
This study population had received a median of 6 prior lines of therapy, and it included patients with hormone receptor (HR)–positive breast cancer (61%), HER2-positive breast cancer (6%), and triple-negative breast cancer (TNBC; 33%).
How is the phase 3 study of Bria-IMT designed?
The ongoing, multicenter, randomized, open-label BRIA-ABC trial is enrolling patients at least 18 years of age with locally recurrent unresectable and/or metastatic breast cancer who have persistent disease and local recurrence not amenable to local treatment.3 Investigators are enrolling patients with various histologies, if they meet the following criteria:
Patients also need to have an expected survival of at least 4 months and an ECOG performance status of 0 to 2.
Enrolled patients are being randomly assigned to 1 of 3 treatment arms: Bria-IMT plus immune checkpoint inhibition; Bria-IMT alone; or physician’s choice of therapy.
In the experimental combination arm, patients are receiving cyclophosphamide at 300 mg/m2 on days –3 and –2 prior to Bria-IMT given intradermally as 4 inoculations on day 0, following by retifanlimab-dlwr (Zynyz) on days 1 to 3. Interferon is also being given within each inoculation site alongside Bria-IMT. In the monotherapy arm, patients are receiving the same regimen without retifanlimab. Treatment options in the control arm comprise eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine, or taxanes, per standard of care.
OS is the trial’s primary end point. Secondary end points include progression-free survival, clinical benefit rate, overall response rate, quality of life, and central nervous system event-free survival.
The study is being conducted at 70 sites and has an estimated target enrollment of 404 patients.
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