Can Epizyme Survive This FDA Hold?

Epizyme Inc. (NASDAQ: EPZM) shares tumbled on Tuesday after the U.S. Food and Drug Administration (FDA) announced a temporary hold on one of the firm’s clinical trials. Specifically, the agency issued a partial clinical hold affecting new enrollment of patients with genetically defined solid tumors and hematologic malignancies for the firm’s tazemetostat trials.

There are patients in the study who have not experienced disease progression and may continue to receive tazemetostat.

The partial clinical hold was initiated following a safety report, submitted by Epizyme to the FDA and other regulatory authorities, regarding a patient with advanced poorly differentiated chordoma in the company’s Phase 1 pediatric study who developed a secondary T-cell lymphoma.

At the time of the safety report, the patient had been on study for roughly 15 months and had achieved a confirmed partial response. This patient has now discontinued tazemetostat and is being treated for T-cell lymphoma.

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T-cell lymphoma has been noted as a potential adverse event in tazemetostat study protocols and is included in the investigator’s brochure and the informed consent. More than 750 patients have been treated with tazemetostat to date, and this is the only case of secondary lymphoma that has been observed across the tazemetostat clinical program.

Robert Bazemore, president and CEO of Epizyme, commented:

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. 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.

Shares of Epizyme were last seen down 14% at $13.15, with a consensus analyst price target of $25.40 and a 52-week range of $9.30 to $21.40.

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