LYT-200 Wins FDA Fast Track for High-Risk MDS
核心洞察
The FDA granted fast track designation to LYT-200 plus a hypomethylating agent for relapsed or refractory high-risk myelodysplastic syndromes (搜索), developer PureTech Health reported.
The designation followed an end-of-phase 1 meeting supporting a planned randomized phase 2 STRIDE-MDS trial of about 125 patients.
Phase 1b data in 11 efficacy-evaluable patients at 12 mg/kg plus an HMA showed a 45.5% overall response rate and no dose-limiting toxicities.
The FDA has granted fast track designation to LYT-200 in combination with a hypomethylating agent (HMA) for relapsed or refractory high-risk myelodysplastic syndromes (搜索) (HR-MDS), according to developer PureTech Health. The designation followed an end-of-phase 1 meeting with the FDA that supports advancing the first-in-class anti-galectin-9 (搜索) monoclonal antibody into the planned phase 2 STRIDE-MDS trial.
The end-of-phase 1 meeting was supported by topline data from the completed phase 1b trial (NCT05829226), which tested LYT-200 with azacitidine or decitabine in heavily pretreated HR-MDS patients who had relapsed or become refractory to prior HMA therapy. Among 11 efficacy-evaluable patients treated at 12 mg/kg plus an HMA, the combination produced a complete response rate of 27.3%, a partial response rate of 9.1%, a marrow complete response rate of 9.1% and an overall response rate of 45.5%, with an 18% conversion-to-transplant rate. No dose-limiting toxicities or myeloid suppression were reported. Patients had received a median of 3 prior lines of therapy and all had high-risk cytogenetics; median overall survival was 6.4 months and was not considered fully mature. Across the full phase 1b trial (n = 101) at 9 US sites, LYT-200 showed no dose-limiting toxicities, infusion-related reactions, or treatment-related serious adverse events, discontinuations or deaths.
STRIDE-MDS will be a randomized, double-blind, placebo-controlled phase 2 trial enrolling approximately 125 patients with relapsed or refractory HR-MDS, randomized 2:2:1 to LYT-200 at 12 mg/kg plus an HMA, LYT-200 at 7.5 mg/kg plus an HMA, or placebo plus an HMA. The trial will assess complete and partial response rates to support dose selection, with two doses included to meet FDA Project Optimus dose-selection requirements. LYT-200 targets galectin-9 (搜索), an oncogenic driver and immunosuppressor whose elevated expression in HR-MDS is associated with shorter survival, and has also received fast track designation in acute myeloid leukemia (搜索).
Source: CancerNetwork