Dr Fox on the Design of the TERZO Trial of Duvelisib in R/R Nodal T-Cell Lymphoma

“If the TERZO trial is positive and we see a statistically significant superiority of duvelisib in terms of PFS for patients with relapsed/refractory angioblastic or TFH subtype [nodal T-cell lymphoma], I think this would be a practice-changing study.”

Christopher P. Fox, PhD, MBChB(Hons), FRCP FRCPath, clinical professor, hematology, Faculty of Medicine & Health Sciences, University of Nottingham (Centre for Cancer Sciences, Academic Unit of Translational Medical Sciences, School of Medicine), discusses the design and potential future implications of the phase 3 TERZO trial (NCT06522737; EU CT: 2024-516605-23-00) evaluating duvelisib (Copiktra) in patients with relapsed/refractory nodal T-cell lymphoma with T follicular helper (TFH) phenotype.

The open-label, randomized, controlled study is comparing duvelisib with investigator’s choice of gemcitabine or bendamustine, which are currently standard-of-care options for patients with relapsed/refractory nodal T-cell lymphoma, Fox begins. This trial is designed to enroll patients with the TFH subtype of nodal T-cell lymphoma, a biologically distinct subset that comprises a large proportion of peripheral T-cell lymphoma (PTCL) cases, he says. TERZO incorporates a screening process that uses established immunohistochemical markers to confirm patient eligibility, he notes.

The primary end point of TERZO is progression-free survival (PFS). Given the rarity of PTCL, conducting this trial in a randomized, multicenter, international setting is essential for gathering robust and generalizable data, Fox emphasizes.

If the trial demonstrates a statistically significant PFS improvement with duvelisib and confirms the agent’s acceptable safety profile, TERZO may serve as a practice-changing advancement for patients with relapsed/refractory, angioblastic and TFH nodal T-cell lymphoma subtypes, Fox reports.

TERZO is designed with regulatory intent with the goal of using data to help secure approval for duvelisib in this population, he states. Fox explains that it is crucial for oncologists who treat patients with PTCL to recognize TFH as a unique biological entity. If the TERZO trial demonstrates superior PFS outcomes with duvelisib vs standard chemotherapy, it could lead to the approval of a biologically targeted intervention for patients with TFH nodal T-cell lymphoma, he concludes.