On March 25, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IPI-549 in combination with nivolumab (Opdivo) for the treatment of advanced urothelial cancer (Press release, Infinity Pharmaceuticals, MAR 25, 2020, View Source [SID1234555814]). Infinity is currently enrolling patients in MARIO-275, the company’s ongoing global, randomized, controlled Phase 2 study in collaboration with Bristol Myers Squibb, to evaluate IPI-549 in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial cancer.
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"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," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "A retrospective analysis of Bristol Myers Squibb’s Checkmate-275 accelerated approval study of Opdivo monotherapy in patients with urothelial cancer revealed an important association between high baseline levels of myeloid derived suppressor cell (MDSC) and poor overall survival. These data, combined with our MARIO-1 data that showed IPI-549, both as a monotherapy and in combination with Opdivo treatment, is associated with a reduction in blood MDSC levels, inspired our MARIO-275 study with the goal of improving outcomes for urothelial cancer patients."
Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.1
MARIO-275 is a global, randomized, controlled Phase 2 study in collaboration with Bristol Myers Squibb trial to evaluate the efficacy and safety of IPI-549 administered in combination with Opdivo compared to Opdivo monotherapy. The study will enroll approximately 160 checkpoint-naïve, advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy. Patients will be randomized 2:1 to receive IPI-549 administered in combination with Opdivo compared to Opdivo monotherapy plus placebo. The primary objective of the study is objective response rate (ORR) as measured by RECIST v1.1. Secondary objectives include time to response (TTR), duration of response (DOR) and progression-free survival (PFS).