NEW YORK – BriaCell Therapeutics said on Thursday that it plans to begin a Phase II trial of its immunotherapy, Bria-IMT, in combination with a checkpoint inhibitor as a neoadjuvant treatment for early-stage, newly diagnosed, high-risk triple-negative breast cancer.
The investigator-initiated study will be led by Massimo Cristofanilli, director of breast medical oncology and associate director of precision medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine.
Researchers will evaluate the safety and efficacy of neoadjuvant Bria-IMT plus a checkpoint inhibitor for TNBC patients who did not achieve pathological complete remission. The primary endpoint of the trial will be event-free survival and will be compared to the event-free survival of 55 percent from the Keynote-522 trial of Merck's Keytruda (pembrolizumab) in early TNBC as a historical control.
BriaCell is conducting a separate Phase I/II clinical trial of Bria-IMT plus Incyte's PD-1 inhibitor Zynyz (retifanlimab-dlwr) in patients with recurrent or metastatic breast cancer. Last year, BriaCell partnered with Caris Life Sciences to support enrollment of patients in genetically defined breast cancer subgroups.
The combination of Bria-IMT plus checkpoint inhibitors was granted fast-track designation last year by the US Food and Drug Administration for the treatment of metastatic breast cancer.