FDA orders a partial hold on Epizyme’s lead cancer drug tazemetostat following T-cell lymphoma case
Epizyme $EPZM is in some hot water this evening after the biotech revealed a partial clinical hold on its crucial program for tazemetostat.
The Cambridge, MA-based biotech was forced to slam the brakes on any enrollment for its clinical trials of the drug for now as investigators sort out a pediatric case of secondary T-cell lymphoma.
Investors didn’t like it. The biotech’s shares tanked 18% in after-market trading.
Doses explored in this study are higher than those in the company’s Phase 2 adult studies, an approach not uncommon to drug development in aggressive, difficult-to-treat pediatric cancers. At the time of the safety report, the patient had been on study for approximately 15 months and had achieved a confirmed partial response. This patient has now discontinued tazemetostat and is being treated for T-cell lymphoma.
The EZH2 inhibitor is being studied as a monotherapy in ongoing Phase I and II programs in molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; both follicular lymphoma and diffuse large B-cell lymphoma forms of NHL; mesothelioma; and combination studies in DLBCL and non-small cell lung cancer.
Last summer at ASCO, as the biotech was looking to blaze an accelerated pathway to an approval, investigators disappointed analysts with their latest set of responses in a Phase II for epithelioid sarcoma.
“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,” said Robert Bazemore, president and chief executive officer of Epizyme. “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.”