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FDA places partial clinical hold on tazemetostat trials
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The FDA placed a partial clinical hold on all clinical trials designed to evaluate tazemetostat, according to the drug’s manufacturer.
The hold places a temporary halt on U.S.-based enrollment of new patients into tazemetostat (Epizyme) trials. Patients on study who have not experienced disease progression may continue to receive treatment.
Tazemetostat is a first-in-class EZH2 inhibitor. Phase 1 and phase 2 trials are underway to evaluate the agent for patients with molecularly defined solid tumors and hematologic malignancies, including , follicular lymphoma, diffuse large B-cell lymphoma, mesothelioma and non-small cell lung cancer.
The FDA indicated the hold was due to a safety report of a pediatric patient enrolled in a tazemetostat trial who developed a secondary lymphoma.
The patient had advanced poorly differentiated chordoma and was being treated in a phase 1 pediatric study of tazemetostat.
At the time of the safety report, the patient had been on study for about 15 months and had achieved a confirmed partial response. The patient has discontinued tazemetostat and now is being treated for T-cell lymphoma.
To date, more than 750 patients have been treated with tazemetostat. This is the second case of secondary lymphoma observed during the tazemetostat clinical program, according to an Epizyme-issued press release.
“Patient safety is of the utmost importance to Epizyme. We are working expeditiously with clinical trial investigators and regulatory authorities to initiate the appropriate steps to resume enrollment,” Robert Bazemore, president and CEO of Epizyme, said in the release. “Epizyme, along with our global investigator community, has been very encouraged by the clinical responses and tolerability of tazemetostat observed in pediatric and adult patients with hematological malignancies and solid tumors enrolled in our trials. We remain encouraged by the potential of tazemetostat to address the unmet needs of many patients living with cancer.”