Esmo 2018 – Epizyme keeps the tazemetostat flame burning

Epizyme has not given up on its lead project, tazemetostat. Fresh from the lifting of a US clinical hold, the company presented data at Esmo today that it reckons will support accelerated approval in epithelioid sarcoma in the first half of next year. Epizyme no doubt hopes that a lack of approved therapies for this cancer will mean the FDA looks favourably on its data, which come from just 62 patients in an open-label phase II trial. The objective response rate of 13% is in line with previous results from 31 patients, but Epizyme pointed to new results on durability of response, an endpoint the company says the FDA is “very interested” in. At 41-48 weeks this is higher than the 16-24 weeks seen in historic controls, noted the group’s chief medical officer, Shefali Agarwal, on a conference call today. But investors did not seem convinced, sending Epizyme’s stock down 5% this morning. The epithelioid sarcoma market is small, but approval here could help assuage any lingering safety concerns following tazemetostat’s US clinical hold in April. The project is still on hold in Germany and France, and the company is working to resolve this.

Tazemetostat phase II epithelioid sarcoma trial results
Endpoint Treatment naive (n=24) Relapsed and/or refractory (n=38) Total (n=62)
ORR (CR + PR)* 5 (21%) 3 (8%) 8 (13%)
Durability of response 41 weeks 48 weeks Not given
Overall survival Not reached 47.7 weeks 82.4 weeks
*Primary endpoint. Source: company presentation.

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