Secura Bio Reports Sustained Efficacy of Duvelisib in Heavily Pretreated Peripheral T-Cell Lymphoma Patients
核心洞察
Extended follow-up analyses from the Phase 2 PRIMO trial demonstrate duvelisib maintains clinical activity across all treatment-experienced PTCL (搜索) populations, including patients with ≥3 prior lines of therapy.
Safety profile remains manageable with longer treatment duration, showing no consistent pattern of increased adverse events over time.
Results support the ongoing Phase 3 TERZO trial in nodal T-follicular helper cell lymphoma (搜索), which is actively enrolling at over 40 European centers.
Secura Bio (搜索) presented extended follow-up analyses from its Phase 2 PRIMO trial at the 2025 American Society of Hematology Annual Meeting, demonstrating that duvelisib maintains meaningful clinical activity with a manageable safety profile in heavily pretreated peripheral T-cell lymphoma (搜索) (PTCL (搜索)) patients. The findings reinforce the drug's therapeutic potential across a broad PTCL population and strengthen the rationale for the ongoing Phase 3 TERZO study.
Consistent Efficacy Across Treatment Lines
The new analyses examined 123 patients from the dose expansion phase of the PRIMO trial who had received at least two cycles of one standard regimen. Professor Pier Luigi Zinzani, Head of Hematology at the University of Bologna, presented the poster titled "Duvelisib in patients with relapsed/refractory peripheral T-cell lymphoma (搜索): from the Phase 2 PRIMO trial – impact of prior therapy and expanded safety analysis."
The extended analyses revealed no consistent impact on efficacy outcomes related to the number of prior lines of treatment. In patients with 1, 2, and ≥3 prior lines of therapy, overall response rates (ORR) were 29%, 66%, and 49%, respectively. Complete response rates were 18%, 52%, and 32%, while median duration of response was 6.5, 11.7, and 7.9 months. Median progression-free survival was 1.9, 9.0, and 3.0 months, and median overall survival was 30.2, 22.7, and 7.3 months.
"PTCL (搜索) patients often cycle through multiple treatments with little improvement in outcomes," said Prof. Zinzani. "Seeing consistent efficacy even in those with ≥3 prior lines, and without emergent safety concerns at the recommended 75 mg lead-in dose, is highly encouraging. These results reinforce duvelisib's therapeutic potential across this difficult-to-treat population."
Treatment History and Safety Profile
The patient population had extensive prior treatment exposure, with 68% receiving prior CHOP-based therapy, 35% having salvage chemotherapy, 20% undergoing autologous stem cell transplant, 17% receiving HDAC inhibitors, and 38% having prior exposure to brentuximab vedotin.
Expanded safety analyses based on treatment duration showed no consistent pattern of higher rates of persisting or emerging adverse events with longer treatment. Among the 123 patients who received ≤2 cycles, 63 patients received >2 to 6 cycles, and 25 patients continued to receive >6 cycles. While rates of diarrhea showed a modest trend of increase, there was no increase in rates of colitis.
Adverse events occurring in ≥20% of patients included neutropenia, aminotransferase increase, diarrhea, thrombocytopenia, leukopenia, and fatigue. Grade ≥3 adverse events in ≥5% of patients included neutropenia, aminotransferase increase, maculopapular rash, thrombocytopenia, lymphopenia, diarrhea, hypokalemia, and hypoxia.
Previous Trial Results and Future Development
Previously reported final data from the PRIMO trial showed an ORR of 48% (59/123) with a complete response rate of 33.3% (41/123). The median duration of response was 7.9 months, median progression-free survival was 3.4 months, and median overall survival was 12.4 months.
Efficacy varied by histological subtype, with ORRs of 62.2% for angioimmunoblastic T-cell lymphoma (搜索) (AITL (搜索)), 49.1% for PTCL (搜索)-not otherwise specified (PTCL-NOS), and 15.0% for anaplastic large cell lymphoma (ALCL). The AITL subgroup showed particularly favorable outcomes with an ORR of 62%, complete response rate of 51%, median duration of response of 11.7 months, median progression-free survival of 8.3 months, and median overall survival of 18.1 months.
These strong findings in AITL (搜索) directly informed the design of the ongoing Phase 3 TERZO trial (NCT06522737) in relapsed/refractory nodal T-follicular helper cell lymphoma (搜索), which is now actively enrolling at over 40 centers in Europe.
Clinical Context and Drug Profile
PTCL (搜索) is a rare, aggressive type of non-Hodgkin lymphoma (搜索) that accounts for 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. There are currently no well-established standards of care for patients with relapsed or refractory disease.
COPIKTRA (duvelisib) is an oral inhibitor of phosphoinositide 3-kinase (搜索) (PI3K) and the first US-approved dual inhibitor of PI3K-delta (搜索) and PI3K-gamma (搜索). These enzymes help support the growth and survival of malignant cells, and PI3K signaling may lead to the proliferation of malignant cells and play a role in the formation and maintenance of a supportive tumor microenvironment.
Dr. Christiane Langer, SVP and Head of Clinical and Medical Affairs at Secura Bio (搜索), commented: "These new analyses capture important insights on the many different profiles and treatment experiences of PTCL (搜索) patients in our trial and demonstrate the efficacy and safety of duvelisib, regardless of baseline treatment characteristics and prior lines of treatment across the patient population."