29 September 2020 - Infinity Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer, in the first-line setting.
Infinity is currently enrolling patients in MARIO-3, the Company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq and Abraxane in triple negative breast cancer.
Earlier this year Infinity also received fast track designation for eganelisib in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer which the company is studying in MARIO-275, the company’s global, randomised, controlled Phase 2 study in patients with advanced urothelial cancer.