Accelerated approval has been granted by the FDA to the methyltransferase inhibitor tazemetostat (Tazverik) for the treatment of metastatic or locally advanced epithelioid sarcoma in adult and adolescent patients 16 years who are not eligible for complete resection.
Overall response rate (ORR) and duration of response data from cohort 5 of a multicenter, open-label, single-arm, 2-stage phase II trial of patients with INI1-negative tumors or relapsed/refractory synovial sarcoma treated with twice-daily tazemetostat served as the basis of the approval.
There is still an ongoing trial for synovial sarcoma: A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma, with no results so far.
Stacchiotti S, Schoffski P, Jones R, et al. Safety and efficacy of tazemetostat, a first-in-class EZH2 inhibitor, in patients (pts) with epithelioid sarcoma (ES) (NCT02601950).J Clin Oncol. 2019;37(suppl 15;abstr 11003).
https://www.mskcc.org/cancer-care/clinical-trials/15-328