Ipsen removes Tazverik from market and cancels all trials with the blood cancer drug

Ipsen has withdrawn the cancer drug Tazverik (tazemetostat) from all markets because of a risk for secondary hematological malignancies. In a news release, company officials said this is based on emerging data from the ongoing phase 1b/3 SYMPHONY-1 trial, which is evaluating Tazverik in combination with lenalidomide plus rituximab compared with lenalidomide plus rituximab to treat patients with follicular lymphoma.

Additionally, all patients currently enrolled in the ongoing SYMPHONY-1 trial will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrollment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active Tazverik clinical trials and expanded access programs.

“Emerging data from this confirmatory study have highlighted a safety profile that is unfavorable compared to that previously observed in clinical evaluation. We will now work closely with investigators and clinical teams to support patients through the respective next steps and transition plans,” Christelle Huguet, Ph.D., executive VP and head of R&D at Ipsen, said in a news release.

An independent data monitoring committee advised that the risks may outweigh potential benefits for patients within this treatment regimen. In the trial, patients experienced secondary hematologic malignancies.

Tazverik is indicated to treat patients 16 years of age or older with metastatic or locally advanced epithelioid sarcoma, a rare and aggressive soft tissue sarcoma. Tazverik is indicated to treat patients with a positive test for an EZH2 mutation who have relapsed or refractory follicular lymphoma, a slow-growing form of non-Hodgkin lymphoma that arises from B-lymphocytes.

Tazverik is an oral therapy and an EZH2 inhibitor. EZH2 overexpression and mutation play a critical role in the development, progression, and metastasis of many cancers. In follicular lymphoma, about 25% of cases have an EZH2 mutation.

Both indications were approved in the United States under the FDA’s accelerated approval regulatory pathways based on overall response rate and duration of response in 2020. It was developed by Epizyme, which Ipsen acquired in August 2022.

SYMPHONY-1 trial was the confirmatory trial for Tazverik and was expected to enroll 612 patients 18 years of age or older with relapsed or refractory follicular lymphoma. The first stage of this trial was to establish safety and the recommended dose. The second and third stages would have evaluated patients both with and without an EZH2 mutation with follow-up of up to five years.

Ipsen is now working with FDA on the next steps to execute the withdrawal of Tazverik.