'No Question' Patients with Follicular Lymphoma Can Benefit from FDA's Approval of Tazverik

July 13, 2020
Ryan McDonald

“Having new options is important, particularly when patients have already been through chemotherapy and some of the other therapies that are available,” said Dr. John P. Leonard.

The Food and Drug Administration’s recent approval of Tazverik (tazemetostat) for the treatment of adults with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation and have received treatment with at least two systemic therapies offers patients who don’t have many options available a viable treatment option, according to Dr. John P. Leonard.

“In follicular lymphoma, we've been focusing on developing new options for patients that are not (eligible for) chemotherapy or who want an alternative that has a more favorable safety profile,” Leonard, the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medical College and an attending physician at NewYork-Presbyterian Hospital, said in an interview with CURE®’s sister publication, OncLive®. “This agent can also be effective in patients who have already undergone chemotherapy or in patients who have limited therapy options. (Tazverik) is another option for this subset of follicular lymphoma and there’s no question that patients can benefit from this treatment.”

The FDA based its accelerated approval on data from a phase 2 clinical trial that showed that patients with EZH2-mutant disease who received Tazverik achieved an objective response rate (ORR) — the percentage of complete and partial responses to treatment – of 69% in patients with wild-type EZH2 follicular lymphoma achieved an ORR of 35%.

The approval is also indicated for adults with relapsed or refractory disease who have no other available treatment options.

Importance of New Options

Follicular lymphoma is generally incurable, which, according to Leonard, results in patients who are diagnosed with this cancer needing many treatments over the course of their lifetime.

“Having new options is important, particularly when patients have already been through chemotherapy and some of the other therapies that are available,” said Leonard. “In EZH2-mutant disease, the effectiveness of this drug is pretty substantial, with an overall response rate in these patients of about 70%, give or take. This is a very meaningful response rate for patients with EZH2-mutant follicular lymphoma. In the wild-type group of patients, the response rates are lower, at approximately 35%. However, that is still a meaningful response rate for a subset of patients who, in some cases, don't have other options.”

Companion Diagnostic Test Available

Approximately 20% of patients with follicular lymphoma present with EZH2 mutations and although the efficacy of Tazverik is lower in patients with wild-type disease, Leonard notes that it’s still potentially meaningful depending on what other options remain for patients.

Part of this approval, Leonard highlighted, is that a companion diagnostic test is available to identify EZH2 mutations.

“The cobas EZH2 Mutation Test was approved as a companion diagnostic (for Tazverik) and will be available for clinicians to order. People are also, in some cases, doing mutation panels on their patients with lymphoma. EZH2 mutations are a marker that is often available as part of those panels,” he said.

Looking Ahead

The approval of Tazverik, according to Leonard, is great for patients because they have the option to receive the therapy at home since it is administered by mouth and is taken twice a day.

Additionally, he noted that the safety profile was favorable compared to some other therapeutic options patients might otherwise receive, including chemotherapy. The most common side effects patients experienced, Leonard noted, including fatigue and nausea, as well as the occasional serious or severe side effects, such as an infection.

Leonard also highlighted that there is a confirmatory phase 3 trial underway that is adding Tazverik to Revlimid (lenalidomide) plus Rituxan (rituximab) in patients with follicular lymphoma.

“In this randomized trial, we'll see if the addition of (Tazverik) adds to the efficacy of lenalidomide plus rituximab (and we’ll also understand more about) the safety profile,” he concluded.

To read CURE®’s original coverage of the Tazverik approval, click here. And for lymphoma updates, research and education, click here.

A version of this story originally appeared on OncLive® as, “Leonard Shares Significance of the Tazemetostat Approval in Follicular Lymphoma.”

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