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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

MorphoSys Receives U.S. FDA Fast Track Designation for Tulmimetostat in Endometrial Cancer

Published date:
09/12/2023
Excerpt:
MorphoSys AG...announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for tulmimetostat, the company’s investigational next-generation dual inhibitor of EZH2 and EZH1, for the treatment of patients with advanced, recurrent or metastatic endometrial cancer harboring AT-rich interacting domain containing protein 1A (ARID1A) mutations and who have progressed on at least one prior line of treatment.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

EZH2/EZH1 INHIBITOR TULMIMETOSTAT (CPI-0209): PRELIMINARY PHASE II RESULTS AND FIRST BIOMARKER FINDINGS IN PATIENTS WITH ARID1A-MUTANT OVARIAN CLEAR CELL OR ENDOMETRIAL CARCINOMAS (OCCC/EC)

Published date:
10/18/2023
Excerpt:
The Phase II study is evaluating tulmimetostat 350 mg once daily in 6 disease-based cohorts, including ARID1Amut OCCC/EC….Both cohorts are eligible for Stage 2 expansion, with 1 and 2 confirmed partial responses in patients with OCCC and EC, respectively (Table)....These preliminary findings in heavily pre-treated patients with ARID1Amut OCCC/EC support continued investigation of tulmimetostat monotherapy.
Trial ID: