FDA grants fast track designation to IPI-549 for urothelial cancer
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The FDA granted fast track designation to IPI-549 in combination with nivolumab for the treatment of advanced urothelial cancer.
IPI-549 (Infinity Pharmaceuticals) is an oral selective inhibitor of PI3 kinase-gamma.
Results of the CheckMate-275 trial showed an association between high baseline levels of myeloid-derived suppressor cells and poor OS among patients with urothelial cancer.
Data from the MARIO-1 trial showed IPI-549, both as monotherapy and in combination with the anti-PD-1 therapy nivolumab (Opdivo, Bristol-Myers Squibb), appeared associated with reduced blood myeloid-derived suppressor cell levels.
Enrollment is underway for the randomized controlled phase 2 MARIO-275 trial, which will evaluate IPI-549 in combination with nivolumab for patients with platinum-refractory, immunotherapy-naive advanced urothelial cancer.
The study will enroll approximately 160 patients whose disease progressed or recurred after treatment with platinum-based chemotherapy.
Researchers will randomly assign patients 2:1 to IPI-549 plus nivolumab or placebo plus nivolumab.
Objective response rate will serve as the primary study objective. Secondary objectives will include time to response, duration of response and PFS.
“Receiving fast track designation is an important recognition of the significant unmet need in advanced urothelial cancer and reflects the potential for IPI-549, in combination with Opdivo, to improve outcomes for these patients,” Adelene Perkins, CEO and chair of Infinity Pharmaceuticals, said in a company-issued press release.