Eisai Co., Ltd:...announced today that it has obtained manufacturing and marketing approval for the EZH2 inhibitor “Tazverik® Tablets 200 mg” (tazemetostat hydrobromide) in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma...

...To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of tazemetostat as a single agent administered orally twice daily (BID), continuously in 28-day cycles in subjects with advanced solid tumors or with relapsed and/or refractory B cell lymphomas`Maximum tolerated dose (MTD) (Phase 1 only)`To determine the objective response rate (ORR; complete response + partial response [CR + PR]) of tazemetostat in subjects with enhancer of zeste homolog 2 (EZH2) gene mutation positive or negative (wild-type) with histologically confirmed diffuse large B cell lymphoma (DLBCL) or follicular lymphoma (FL), with relapsed or refractory disease and the ORR of tazemetostat in combination with prednisolone in subjects with EZH2 wild-type DLBCL`Objective response rate (ORR; complete response + partial response [CR + PR]) (Phase 2)...

The ORR (CR + PR) was 40% in pts with DLBCL with EZH2 mutations (N  = 10), 18% in pts with DLBCL with wt EZH2 (N  = 85), 63% in FL pts with EZH2 mutations (N  = 8), and 28% in FL pts with wt EZH2 (N  = 46)….This phase 2 interim assessment shows preliminary clinical activity of tazemetostat with a favourable safety profile in pts with R/R DLBCL and FL, with preferential benefit in pts whose tumours bear activating EZH2 mutations.

...study is evaluating tazemetostat in pts with either mt or wt EZH2 R/R DLBCL...ORRs of 17% in both mt and wt arms and 9% in the prednisolone arm. Notably, DOR was substantially greater in the mt arm.