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Julie M. Vose, MD, MBA, discusses the investigation of tazemetostat vs placebo when given in combination with lenalidomide and rituximab in patients with relapsed/refractory follicular lymphoma in the phase 3 SYMPHONY-1 study.
Julie M. Vose, MD, MBA, division chief, Neumann M. and Mildred E. Harris Professor, physician, oncology and hematology, Division of Hematology and Oncology, University of Nebraska Medical Center, discusses the investigation of tazemetostat (Tazverik) vs placebo when given in combination with lenalidomide (Revlimid) and rituximab (Rituxan) in patients with relapsed/refractory follicular lymphoma (FL) in the phase 3 SYMPHONY-1 study (NCT04224493).
The double-blind, randomized, active-controlled, 3-stage trial’s eligibility criteria encompass patients who have relapsed/refractory FL regardless of EZH2 mutation status, Vose begins. Importantly, the presence or absence of this mutation does not affect a patient's ability to participate in the study, she states. Instead, this genetic factor will be assessed at a later stage by the investigative team. Patients entering the trial are randomly assigned to receive rituximab plus lenalidomide with or without the addition of tazemetostat, Vose explains. In the other arm of the trial, patients receive a placebo, Vose says, adding that the randomized design of this trial ensures patients remain unaware of the specific treatment they are receiving.
One aim of this trial was to maximize the duration of response (DOR) for patients with relapsed/refractory FL who receive tazemetostat plus lenalidomide and rituximab compared with standard lenalidomide plus rituximab, she expands. A key motivating factor for enrolling patients in this trial is to improve response rates in this patient population, Vose says. When administered as a single agent, tazemetostat elicits a modest response rate. Therefore, continuous efforts are underway to enhance both the objective response rate (ORR) and the DOR with this agent in patients with relapsed/refractory FL, she emphasizes.
In the current single-agent trials investigating this agent, the ORRs and DORs are considered moderate, she notes. However, by combining tazemetostat with established standard therapies, investigators hope to achieve results that exceed those that each agent could achieve on its own, Vose continues. This approach is driven by the goal of providing more effective and durable treatment options for patients with relapsed/refractory FL, she concludes.