Epizyme has reported positive interim data from an ongoing Phase II trial of tazemetostat as a monotherapy to treat patients with relapsed or refractory follicular lymphoma (FL).

The data shows that the company’s lead candidate tazemetostat demonstrated meaningful clinical activity and was generally well tolerated in patients with EZH2 activating mutations, as well as with wild-type EZH2.

Epizyme chief medical officer Dr Shefali Agarwal said: “FL is an indolent, incurable disease, for which patients are in need of new effective and tolerable treatment options.

“Preparations for our NDA submission for tazemetostat for FL are underway, and we remain on track for submission in the fourth quarter of this year.”

In the Phase II trial, FL patients who had already been treated with two or more systemic therapies were enrolled into two cohorts.

Last December, one cohort enrolled patients with EZH2 activating mutations and completed the target enrollment of 45 patients.

In this cohort, 40% of patients were refractory to their last treatment, 40% to a rituximab regimen, and 22% were double refractory.

A second cohort enrolled patients with wild-type EZH2 and completed enrollment of a total of 54 subjects in 2017. In this, 37% were refractory to their last treatment, 61% to a rituximab regimen, and 39% were double refractory.

All subjects received 800mg of tazemetostat orally twice a day.

The trial’s primary endpoint is objective response rate (ORR) as assessed by the investigator defined as a complete response (CR) or partial response (PR), while secondary endpoints include the duration of response, overall survival, and progression-free survival and safety.

Favourable safety and tolerability have been observed with tazemetostat in these Phase II trial cohorts.