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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.
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.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET) and the tag owner-request.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET) and the tag owner-request.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET) and the tag owner-request.
Shares Doxorubicin and the tag owner-request.
Shares Doxorubicin and the tag owner-request.
Shares Tazemetostat, Ipsen, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares EZH2, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares EZH2, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).