In the ten months since the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold it placed on U.S.-based clinical trials studying the drug tazemetostat, enrollment has reopened at sites across the country. In particular, clinical studies examining the EZH2 inhibitor tazemetostat in patients with INI1-negative tumors, including chordoma, are open and continuing to accrue patient-participants. Two of these trials are currently accepting chordoma patients – a Phase 2 trial for adults and a Phase 1 trial for pediatric patients.
The partial clinical hold followed the submission of a safety report by the tazemetostat manufacturer, Epizyme, to the FDA about a pediatric patient with poorly differentiated chordoma enrolled in the company’s Phase 1 pediatric study who developed secondary T-cell lymphoblastic lymphoma (T-LBL).
In the following months, Epizyme convened a panel of scientific and medical experts and conducted a comprehensive review to:
- Determine which secondary malignancies might be associated with tazemetostat treatment
- Assess the potential risk factors for patients involved in the tazemetostat trials
- Implement a risk mitigation and monitoring plan in an effort to prevent future incidents
Epizyme’s formal response to the FDA included a thorough assessment of clinical benefit and safety data across all of its trials in hematological malignancies and solid tumors – both adult and pediatric – including the two trials enrolling chordoma patients.
With the partial clinical hold lifted, Epizyme has reopened enrollment in all of its company-sponsored trials in the U.S. If you or a loved one is interested in learning more about this clinical trial, please speak with your healthcare team.
Questions? Contact a Chordoma Foundation Patient Navigator for more information.
Learn more about the tazemetostat trials: