Disease control and survival data is presented from the clinical trials of Bria-IMT™ alone or in combination with immune checkpoint inhibitors in advanced breast cancer:
- M aximum tumor re duction and clinical benefit was observed in heavily pre-treated advanced breast cancer patients , particularly with moderately-well differentiated tumors .
- Patients with moderately-well differentiated tumors had a higher rate of disease control and prolonged survival .
- Median o verall survival of 12.5 months in all patients with moderately-well differentiated tumors in spite of having failed an average of 7 prior therapy attempts (versus 7.2-9.8 months without BriaCell's treatment ) .
BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V: BCT ) (OTCQB:BCTXF) a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce the presentation results of the clinical studies with its lead product candidate, Bria-IMT™, summarized in a poster session held on December 9 11 during the 2020 San Antonio Breast Cancer Symposium ® (SABCS).
The poster summarizes the clinical and pathological data of the Bria-IMT™ monotherapy (i.e. the Bria-IMT™ regimen alone) study and Phase I/IIa clinical study of Bria-IMT™ in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA ® ; manufactured by Merck & Co., Inc.), and more recently, Incyte's INCMGA00012 (by Incyte Corporation), in advanced breast cancer.
Details and results on the poster presentation are summarized below:
Abstract Number: 1313
Presentation Title: Response to a modified whole tumor cell targeted immunotherapy in patients with advanced breast cancer correlates with tumor grade
Session Date: December 9-11, 2020
Program Number: PS17-20
Session Title: Poster Session 17
Summarized Data: 30 patients were treated with the Bria-IMT™ regimen (19 with the Bria-IMT™ regimen alone, 4 who began on the Bria-IMT™ regimen and transitioned to combination with a combination with Incyte's INCMGA00012, and 7 with combination therapy with of Bria-IMT™ with KEYTRUDA ® ).
11 of those patients had moderately-well differentiated tumors:
- 70% of these patients who were able to develop an immune response showed disease control suggesting that the Bria-IMT™, with a molecular signature most closely related to moderately-well differentiated tumors, may result in disease control especially in patients with moderately-well differentiated tumors. These patients were very heavily pre-treated with a median of 7 prior systemic therapy regimens (including chemotherapy, biological and "targeted" therapy). The median Progression-free survival (PFS) of this cohort was 5.7 months in the monotherapy study, and 6.9 months in combination therapy. Of the group, there were 9 patients with evaluable lesions including 6 with stable disease and 2 with partial responses according to RECIST criteria. One patient with stable disease had a marked reduction in numerous non-target lesions. The data suggests clinical and survival benefit for patients with moderately-well differentiated tumors who were treated with the Bria-IMT™ regimen with or without check point inhibitors. Notably, the survival benefit was higher in the group that received the Bria-IMT™ regimen with check point inhibitors suggesting an additive or synergistic effect.
- The median overall survival (OS) for the combined monotherapy and combination therapy was 12.5 months (data on 6 patients with moderately-well differentiated tumors). An OS of 7.2-9.8 months in similar patients with metastatic breast cancer in the third line setting has recently been published (Kazmi S, et al. "Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin, gemcitabine, or capecitabine." Breast Cancer Res Treat. 2020). This suggests a potentially significant survival benefit for the patients treated with the Bria-IMT™ regimen alone or in combination with check point inhibitors.
In summary, BriaCell observed tumor reduction and clinical benefit in heavily pre-treated advanced breast cancer patients, especially in those with moderately-well differentiated tumors, treated with the Bria-IMT™ regimen with or without immune checkpoint inhibitors. The addition of immune checkpoint inhibitors to the Bria-IMT™ regimen appeared to provide an additional clinical benefit suggesting an additive or synergistic effect.
A copy of the poster will be posted at the following: https://briacell.com/novel-technology/scientific-publications/ .
BriaCell is an immuno-oncology focused biotechnology company developing targeted and effective approaches for the management of cancer.
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For further information, please contact:
BriaCell Therapeutics Corp.:
William V. Williams, MD
President & CEO