Hutchmed has concluded the enrolment of 42 patients in a bridging study of tazemetostat to treat relapsed/refractory follicular lymphoma (R/R FL) in China.
Dr Junning Cao of Shanghai Fudan University Cancer Centre will act as the lead principal investigator for the open-label, multicentre study.
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The study is designed to assess the pharmacokinetics, safety, and efficacy of the EZH2 methyltransferase inhibitor tazemetostat in R/R FL patients.
Based on the EZH2 mutations, patients aged 18 years and above were enrolled into two cohorts.
Both the cohorts will receive 800mg tazemetostat twice per day (BID). An interval of 12 hours is suggested between the two doses.
Assessing the objective response rate (ORR) of cohort one with R/R FL, whose diseases harbour EZH21 mutations, is the primary objective of the study.
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By GlobalDataSecondary objectives include the evaluation of the safety and pharmacokinetics of tazemetostat in cohort two patients with R/R FL, whose disease do or do not harbour EZH2 mutations.
Overall survival, duration of response (DoR), and progression-free survival are the other secondary objectives of the study.
In the US, tazemetostat is approved for the treatment of paediatric patients and adults aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection.
It is also used to treat R/R FL in adults who have no satisfactory alternative treatment options, whose tumours are positive for an EZH2 mutation, and who have received a minimum of two systemic therapies previously.
Based on ORR and DoR, these indications were approved under accelerated approval from the FDA.
A,long with Ipsen, HUTCHMED is developing tazemetostat to treat several haematological and solid tumours in Greater China.
It is also participating in Ipsen’s global, biomarker-enriched, three-stage, active-controlled, double-blind, randomised, multicentre, confirmatory Phase Ib/III SYMPHONY-1 (EZH-302) study in China.
