Ipsen has announced a voluntary global withdrawal of its oncology therapy Tazverik (tazemetostat) after emerging clinical data indicated potential safety risks in patients.
The company's decision follows interim findings from the ongoing SYMPHONY‑1 trial, a Phase Ib/III study evaluating tazemetostat in combination with lenalidomide and rituximab for the treatment of follicular lymphoma.
According to a press release from Ipsen, the trial's Independent Data Monitoring Committee identified adverse events involving secondary haematologic malignancies in patients receiving the combination therapy.
Based on these findings, the committee advised that the risks associated with the regimen may outweigh its potential benefits.
As a result, Ipsen is withdrawing Tazverik from all markets where it is currently available, including the US, where it is marketed for both follicular lymphoma and epithelioid sarcoma.
The company has also begun discontinuing treatment with tazemetostat for participants enrolled in the SYMPHONY-1 trial.
Patients in the study will continue to receive standard-of-care treatment with lenalidomide plus rituximab, while the trial remains open for long-term safety follow-up without further enrolment.
In addition, Ipsen is terminating all active clinical trials and expanded access programmes involving the drug.
"While this is an extremely disappointing outcome, the safety of patients remains our priority," said Christelle Huguet, Executive Vice President and Head of R&D at Ipsen.
Emerging data from this confirmatory study have highlighted a safety profile that is unfavourable 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," she added.
Tazverik, an inhibitor of the epigenetic regulator EZH2, received accelerated approval from the US Food and Drug Administration in 2020 for adults with relapsed or refractory follicular lymphoma whose tumours carry an EZH2 mutation, as well as patients with limited treatment options.
It was also approved for adults and adolescents aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete surgical resection.
These accelerated approvals were based on the medicine's overall response rate and duration of response, with continued approval contingent upon confirmation of clinical benefit in further studies.
Next steps
Ipsen said it is working with the FDA to complete the withdrawal process and provide the necessary regulatory information.
Despite the decision, the company stated that the withdrawal is not expected to impact its financial guidance.