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Tazemetostat for Follicular Lymphoma Granted Accelerated Approval

Follicular lymphoma.

Tazemetostat (TAZVERIK™, Epizyme, Inc.) has been approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have tumors that are positive for an EZH2 mutation, have received at least 2 previous systemic therapies, and have no satisfactory alternative treatment options. In addition, the FDA approved the cobas® EZH2 Mutation Test (Roche Molecular Systems, Inc.) as a companion diagnostic for tazemetostat.

An EZH2 inhibitor, tazemetostat has previously been approved for metastatic or locally advanced epithelioid sarcoma.

Efficacy was shown in two open-label, single-arm cohorts of a multi-center trial (E7438-G000-101; NCT04224493). The two cohorts were Cohort 4, which enrolled patients with EZH2-mutated FL and Cohort 5, which contained patients with EZH2 wild-type FL. Patients with histologically confirmed FL who received two previous systemic therapies were enrolled in the study. The researchers used formalin-fixed, paraffin-embedded tumor samples to identify EZH2 mutations and tested them using the companion diagnostic cobas® EZH2 Mutation Test. Participants were administered 800 mg of tazemetostat orally twice daily until confirmed disease progression or unacceptable toxicity. Primary end points included overall response rate (ORR) and duration of response (DOR).

In 42 patients with EZH2-mutated FL, ORR was 69%, including 12% complete responses. The median DOR was found to be 10.9 months. In 53 patients with EZH2 wild-type FL, ORR was 34%, with 4% complete responses, and the median DOR was 13 months.

Common adverse reactions, occurring in greater than 20% of patients with FL that take tazemetostat, include fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain. In 30% of these patients, serious side effects occurred, most commonly from infection. Treatment discontinuation occurred in 2% of patients due to second primary malignancy.

Tazemetostat is recommended to be taken orally twice daily at a dose of 800 mg with or without food.

For More Information

Clinicaltrials.gov (2020). Study in subjects with relapsed/refractory follicular lymphoma. NLM Identifier: NCT04224493.

TAZVERIK™ (tazemetostat) prescribing information (2020). Epizyme. Available at: https://www.tazverik.com/ 

Image Courtesy of Nephron. Licensed under CC BY-SA 3.0

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