Epizyme shuts down failing lymphoma trial as FDA imposes clinical hold

pharmafile | August 3, 2018 | News story | Medical Communications, Research and Development Epizyme, FDA, lymphoma, pharma, tazemetostat 

Epizyme’s Q2 financial results have been derailed by the company’s decision to terminate further Phase 2 development of its lead drug tazemetostat in the treatment of relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL), after an interim data assessment revealed it was not effective enough to continue pursuing.

The news tore a chunk out of the company’s shares, which plunged 24%.

The firm said in a press release detailing its latest financials: “Epizyme has conducted an interim assessment of data from this trial and concluded that the clinical activity seen in these cohorts is not sufficient to warrant further development of tazemetostat in DLBCL as a monotherapy or in combination with prednisolone.”

However, the release noted that Epizyme still intends to pursue the drug in two other combination indications through ongoing trials, and plans “to evaluate other potential combinations in this aggressive and difficult-to-treat cancer longer term”.

In addition, the company conceded that a partial clinical hold had been placed on trials of tazemetostat by the FDA, pausing the enrolment of new participants in the US, France and Germany after a paediatric patient administered with the drug developed secondary T-cell lymphoblastic lymphoma.

The company said in its release: “First and foremost, we are working diligently to resolve the partial clinical hold and resume enrollment in tazemetostat clinical studies. In addition, we are progressing tazemetostat toward a first NDA for the treatment of epithelioid sarcoma, continuing to advance its development in follicular lymphoma based on the strength of our clinical data, and advancing our novel inhibitor of G9a, EZM8266, toward the clinic. We believe the actions we have taken will allow us to capitalise on our near-term tazemetostat opportunities while also extending our cash runway.”

Matt Fellows

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