Lori A. Leslie, MD, discusses the approval of tazemetostat in the follicular lymphoma setting and the data that that led to its FDA approval.
Lori A. Leslie, MD, lymphoma attending, John Theurer Cancer Center, discusses the approval of tazemetostat in the follicular lymphoma setting and the data that that led to its FDA approval.
Leslie says that tazemetostat is an oral EZH2 inhibitor. The first designation for this agent was in epithelioid sarcoma in January 2020. On June 18, 2020, tazemetostat was approved for use in patients with relapsed or refractory follicular lymphoma (FL).
Although there is activity with this agent in both EZH2 mutant and EZH2 wild-type FL, the label is for patients with relapsed/refractory disease with an EZH2 mutation or who have no other appropriate options. Because of this indication, there's some room in terms of the label based on the data that led to the approval, according to Leslie.
The results used for the approval were from a multicenter phase 2 trial that looked at the use of this agent in 99 patients. Leslie explains that one cohort enrolled patients with EZH2-mutant relapsed/refractory FL, and the other was made up of patients with EZH2 wild-type disease. The dosing for tazemetostat was 800 mg twice a day until patients experienced disease progression or unacceptable toxicity.
In terms of the primary end point of the trial, the objective response rate in patients with EZH2-mutant disease was higher, at 69%, according to Leslie. Twelve percent of patients achieved complete remission. There was also activity with this drug in those with EZH2 wild-type disease; for this cohort, the objective response rate was 34%, with a complete remission rate of 4%.