Ipsen Withdraws Tazverik Following Safety Concerns In SYMPHONY-1 Trial

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(RTTNews) - Ipsen (IPSEY, I7G.F) announced that it has voluntarily withdrawn Tazverik (tazemetostat) from all indications across its markets. The decision follows emerging data from the ongoing Phase Ib/III SYMPHONY-1 trial, which is evaluating tazemetostat in combination with lenalidomide plus rituximab (R2) versus R2 alone in follicular lymphoma.

The Independent Data Monitoring Committee (IDMC) advised that, due to adverse events involving secondary hematologic malignancies, the risks may outweigh potential benefits for patients receiving this regimen. As a result, Ipsen has immediately withdrawn Tazverik for both follicular lymphoma (FL) and epithelioid sarcoma (ES).

In addition, Ipsen has initiated steps to discontinue treatment with tazemetostat for all patients currently enrolled in SYMPHONY-1. Participants will continue with standard of care treatment using lenalidomide plus rituximab only. The study will remain open for long-term safety follow-up, but no new patients will be enrolled. Ipsen is also halting all active tazemetostat clinical trials and expanded access programs.

The company confirmed that this withdrawal is not expected to impact its financial guidance.

Ipsen said it is working with the United States (U.S.) Food and Drug Administration (FDA) on the next steps to execute the withdrawal of Tazverik and provide all necessary information to complete this process. Tazverik is marketed in the U.S. by Ipsen in FL and ES. Tazverik received accelerated approval from the U.S. FDA in 2020 for adults with relapsed or refractory FL whose tumors are positive for an EZH2 mutation and who have received at least two prior therapies as well as relapsed or refractory FL adult patients who have no satisfactory alternative treatment options.

Tazverik also received U.S. FDA accelerated approval in 2020 for the treatment of adults and adolescents aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

Ipsen S.A. on the Frankfurt Stock Exchange is currently trading at EUR 155.90, reflecting a decline of EUR 9.20 or 5.57%.