Tazemetostat with doxorubicin as front-line therapy for advanced epithelioid sarcoma (EZH-301 run-in)
The attempt to move the EZH2 inhibitor tazemetostat into first-line epithelioid sarcoma alongside doxorubicin; the safety run-in enrolled 25 patients and the study was stopped, leaving the accelerated approval without its confirmatory trial.
Overview
After tazemetostat's single-arm approval in 2020, Epizyme opened this study to test the drug with doxorubicin as front-line treatment for advanced epithelioid sarcoma, with a phase 1b run-in leading into a randomised phase 3. ClinicalTrials.gov records 25 participants and a terminated status; the sponsor's business changes after its acquisition by Ipsen preceded the closure. Its fate matters because the epithelioid sarcoma approval rested on a 62-patient cohort with a 15 percent response rate.
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