FDA Grants Fast Track Designation to Bria-IMT in Metastatic Breast Cancer

The FDA has granted fast track designation to Bria-IMT for the treatment of metastatic breast cancer, according to a press release by the drug’s developer, BriaCell Therapeutics.¹

The fast track designation comes after results of a phase 1/2a trial (NCT03328026) examining targeted immunotherapy agent Bria-IMT in combination with immune-checkpoint inhibitor, retifanlimab (previously, INCMGA 0012), and immunomodulator, epacadostat (previously, INCB24360).

“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,” Del Priore, MD, chief medical officer at BriaCell, said in the press release.

Results from the trial were previously presented at the 2021 San Antonio Breast Cancer Symposium.² Within the trial, the monotherapy study 1 assessed 3 patients with metastatic breast cancer who had progressed past 2 prior lines of therapy, as well as 1 patient with HER2-positive ovarian cancer. The monotherapy 2 study included 23 patients who had progressed past a median of 5 prior therapies. The combination study included 12 patients with metastatic breast cancer who had progressed past a median of 6 prior therapies.

Patients included in the monotherapy study 1, had median ages from 58 to 72, and and recieved median lines of thereapy ranged from 2 to 6. All patients were estrogen receptor (ER)–positive and progesterone receptor (PR)–positive, with s disease control rate of 25% in the overall population. In the overall population, patients had grade 1/2 tumors.

Patients in the monotherapy 2 study had a median age of 59 plus or minus 10, and recieved a median of 5 prior therapies. Additionally, 52% of patients had ER-positive and PR-positive disease, and 19% were HER2/neu positive. Thirty-eight percent of patients had triple-negative disease, a baseline disease control rate of 30%, and 67% had grade 1 and 2 tumors.

The combination therapy study arm had a median age of 61 plus or minus 10 and received a median of 6 prior therapies. Additionally, 75% of patients were ER positive or PR positive, and HER2/neu-positive disease was reported in 17%. Twenty-five percent of patients had triple-negative disease and a baseline disease control rate of 33%.

The median progression-free survival (PFS) was 4.78 months in the monotherapy study 1 arm, 2.80 months in the monotherapy study 2 arm, and 4.23 months in the combination therapy study arm. The median overall survival was 34.65 months for the monotherapy study 1 arm, 7.0 months for the monotherapy study 2 arm, and 12.7 months for the combination study arm.

In the no human leukocyte antigen (HLA) matching subgroup, the median PFS was 3.1 months, 2.4 months for 1 or more HLA matches, and 5.5 months for 2 or more HLA matches. The median OS was 5.9 months, 12.7 months, and 13.4 months for the 3 respective subgroups.

Lastly, when assessing outcomes by tumor grade, the median PFS was 2.4 months for grade 3 tumors and 5.7 months for grade 1/2 tumors. The median OS was 6.7 months for grade 3 tumors and 12.9 months for grade 1/2 tumors.

References

1. BriaCell received FDA fast track approval for targeted breast cancer immunotherapy. News Release. BriaCell Therapeutics. April 13, 2022. Accessed April 14, 2022. https://bit.ly/3M1kWlC
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. Cancer Res. 2022; 82(suppl_4): P2-14-02. doi.10.1158/1538-7445.SABCS21-P2-14-02