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Epizyme's lead product candidate shows treatment effect in mid-stage study in certain types of treatment-resistant blood cancer

Jun. 20, 2016 11:40 AM ETIpsen S.A. (IPSEY) StockIPSEYBy: Douglas W. House, SA News Editor
  • Preliminary results from a Phase 2 clinical trial assessing Epizyme's (EPZM -3.7%) lead product candidate, orally administered tazemetostat, in heavily pre-treated patients with certain types of diffuse large B-cell lymphoma (DLBCL) showed a disease control rate as high as 60%. In addition, all the lymphoma cohorts have passed futility analyses by the Independent Data Monitoring Committee. The data were presented at the American Society of Hematology Meeting on Lymphoma Biology.
  • There were 47 efficacy-evaluable patients in four cohorts: three DLBCL (n=44) and one follicular lymphoma (FL) with EZH2 mutations (n=3). The three DLBCL group were further divided into those with the subtype GCB (Germinal Center B-cell) and EZH2 mutations (n=5), those with GCB and wild-type EZH2 (n=19) and those with non-GCB subtype (n=20).
  • The disease control rates (DCRs) for the three DLBCL cohorts were 60% (n=3/5), 47% (n=9/19) and 55% (n=11/20), respectively. The DCR for the FL cohort was 100% (n=3/3), but the futility assessment has not been reached. Patient enrollment is continuing.
  • DCR includes complete responders, partial responders and those with stable (non-progressive) disease.
  • Tazemetostat inhibits an enzyme called EZH2 (enhancer of zeste homolog 2), which plays a key role in DNA methylation and transcriptional repression. Mutation or over-expression of EZH2 is associated with a range of cancers. It is being developed for the treatment of non-Hodgkin lymphoma, certain genetically defined solid tumors and synovial sarcoma.

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