Secura Bio presented new data from its Phase 2 PRIMO trial of Copiktra® (duvelisib) in relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) at the 2024 American Society of Hematology (ASH) Annual Meeting. The results demonstrated promising activity, particularly in the angioimmunoblastic T-cell lymphoma (AITL) subgroup.
The PRIMO trial, an open-label, single-arm study, evaluated the safety and efficacy of duvelisib monotherapy in 123 R/R PTCL patients across the U.S., EU, UK, and Japan. The expansion arm results showed an overall response rate (ORR) of 48%, with a complete response (CR) rate of 33% and a median duration of response (DOR) of 7.89 months. Adverse events were consistent with previous duvelisib studies and were generally manageable with dose modifications.
Efficacy in AITL Subgroup
Notably, a subgroup of 37 patients with AITL exhibited a higher ORR of 62% and a CR of 51%. The median progression-free survival (PFS) was 8.34 months, and the median overall survival (OS) reached 18.07 months in this subgroup.
Dr. Neha Mehta-Shah from Washington University School of Medicine commented, "Patients with R/R PTCL usually relapse quickly and have limited treatment options. The PRIMO data show very promising activity, particularly in the AITL subgroup. Importantly, these observed responses support duvelisib as a promising potential agent for this disease."
Phase 3 Trial Plans
Based on these findings, Secura Bio is planning a randomized Phase 3 clinical trial to assess duvelisib in R/R nodal T-follicular helper cell lymphoma in the European Union and the United Kingdom (TERZO: NCT06522737; EU CT: 2024-516605-23-00). The trial design was presented in a separate poster, outlining a multicenter, open-label study comparing duvelisib to investigator's choice of gemcitabine or bendamustine. Enrollment is anticipated to begin in the first half of 2025.
The T-follicular helper (TFH) cell is the cell of origin in AITL. Lymphomas with a TFH cell of origin (including AITL) have similar genetic profiles and have been classified under the category of nodal TFH cell lymphomas. The outcomes of the AITL subgroup of PRIMO showed greater activity in patients who had R/R nodal T-cell lymphoma with TFH phenotype.
Management Perspective
Chip Romp, CEO of Secura Bio, stated, "We are encouraged by the robust results of the PRIMO trial in R/R PTCL, a devastating disease with a high unmet medical need, a poor prognosis, and limited effective treatment options. We are very enthusiastic about the data from the AITL subgroup, and we look forward to continuing development of this therapy and the initiation of the phase 3 TERZO trial in the coming weeks."
PRIMO Trial Details
The PRIMO trial enrolled patients with a median of 2 prior therapies. The patient population included 43.1% with PTCL-not otherwise specified (PTCL-NOS), 30.1% with AITL, and 16.3% with anaplastic large-cell lymphoma (ALCL). The median age of participants was 65 years.
Outcomes for the 123 patients included an ORR of 48% (59/123), with a CR rate of 33.3% (41/123). ORRs by baseline histology were 62.2% (AITL), 49.1% (PTCL-NOS), and 15.0% (ALCL). The median progression-free survival (PFS) by Independent Review Committee was 3.45 months with a median PFS by baseline histology of 8.34 months (AITL), 3.45 months (PTCL-NOS), and 1.64 months (ALCL). Median OS was 12.35 months. Nineteen (15%) patients went on to receive stem cell transplant (SCT) at the time of treatment discontinuation (11 of 12 had a planned SCT, and 8 additional patients received unplanned SCT).
Safety Profile
The safety profile in PRIMO aligned with previous duvelisib studies. Common grade ≥3 treatment-emergent adverse events (≥5% of patients) included alanine aminotransferase elevation (21.1%), decreased neutrophil count (17.9%), aspartate aminotransferase elevation (17.1%), and diarrhea (9.8%).
