FDA Grants Fast Track Status to Bria-IMT for Metastatic Breast Cancer


FDA fast track designation has been granted to cell-based immunotherapy Bria-IMT for the treatment of patients with metastatic breast cancer.

The FDA has granted fast track designation to cell-based immunotherapy Bria-IMT for the treatment of metastatic breast cancer, according to BriaCell Therapeutics.1

“We are grateful for the opportunity to accelerate the development of our novel immunotherapy in advanced breast cancer. We continue to move forward with the clinical evaluation of Bria-IMT™ towards a potential registration study to bring hope to patients living with this deadly disease,” said Del Priore, MD, chief medical officer of BriaCell, in the press release.

A single arm study of the SV-BR-1-GM regimen in combination with other checkpoint inhibitors, including retifanlimab (MGA012) and epacadostat (INCB24360), in patients with metastatic or locally recurrent breast cancer who have failed at least 2 lines of therapy is currently being explored within a phase 1/2a, ongoing, single arm study (NCT03328026).2,3

The study enrolled 35 patients, 27 who were given the SV-BR-1-GM regimen alone and 12 who received the combination therapy. The SV-BR-1-GM regimen as monotherapy occurred in cycles of every 2 weeks, then 3 times monthly while the combination study uses the SV-BR-1-GM regimen with PD-1 inhibitors with cycles every 3 weeks.

Enrollment is open to patients aged 18 and older with histologically confirmed breast cancer with recurrent and/or metastatic lesions who were not amenable to local treatment. Other requirements include having a survival of at least 4 months and an ECOG performance status of 0-1.

Primary end points of the trial include evaluating adverse events (AEs) and safety regarding proportion of patients with abnormalities, changes in the electrocardiogram QT interval, and changes in patients’ weight. Secondary end points include objective response rate, complete response or partial response, and durability of response. 

All patients enrolled in the study had a median of 5 prior systemic regimens and most patients were estrogen receptor and/or progesterone receptor positive (58%). A total of 18% were Her2/neu positive and 33% were triple negative.

Findings which were first presented at the San Antonio Breast Cancer Symposium in December 2021 showed the treatment to be generally safe and well tolerated with the disease control rate for the SV-BR-1-GM regimen alone at 30% and 33% for the combination with a PD-1 inhibitor. Patients who received the SV-BR-1-GM regimen alone, median progression-free survival was 2.8 months compared to 4.2 months for those who received combination therapy. Additionally, median overall survival (OS) was 7.0 months for those who received monotherapy (data available on 9 patients) vs 12.0 months for those in the combination therapy group (data available on 7 patients).

Overall, findings revealed the median OS to favorably compare with previous data published regarding survival in third-line trials. Further, OS seen in some subjects suggests that patients are more likely to derive clinical benefit depending on their patient subpopulations.

Both the SV-BR-1-GM regimen alone or in combination with a PD-1 inhibitor may have elicited effective immune responses in some patients when administered in this patient population, however, the PFS and OS of combination therapy with a PD-1 inhibitor was shown to be superior to the monotherapy regimen. PFS and OS also appeared to be better in patients with HLA matching with SV-BR-1-GM and those with grade 1 or 2 tumors.

The study remains ongoing and will focus primarily on patients who are most likely to benefit including those with at least 1 HLA match and those with grade 1 or 2 tumors.

  1. BriaCell receives FDA fast track approval for targeted breast cancer immunotherapy. News release. BriaCell Therapeutics Corp. April 13, 2022. Accessed April 13, 2022. https://bit.ly/3rt17fj
  2. Williams WV, Dakhil SR, Calfa C et al. Overall Survival following treatment with a modified whole tumor cell targeted immunotherapy in patients with advanced breast cancer. Presented at: San Antonio Breast Cancer Symposium 2022.
  3. Combination study of SV-BR-1 GM in combination with INCMGA00012 and epacadostat. Clinicaltrials.gov. Accessed April 13, 2022. https://clinicaltrials.gov/ct2/show/NCT03328026
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