Duvelisib Induces Deep Responses in PTCL: Final Results of the Phase 2 PRIMO Trial of Duvelisib in Relapsed/Refractory Peripheral T-Cell Lymphoma.
2/5 보강
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
120 patients (97.
I · Intervention 중재 / 시술
≥2 cycles of 1 standard regimen for PTCL
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
[CONCLUSIONS] The PRIMO study demonstrates significant activity and tolerability of duvelisib in patients with R/R PTCL, most notably in the AITL subgroup. This provides strong rationale for further development in PTCL, and more specifically in the subgroup of nodal T-follicular helper cell lymphoma.
OpenAlex 토픽 ·
Lymphoma Diagnosis and Treatment
Chronic Lymphocytic Leukemia Research
T-cell and Retrovirus Studies
[BACKGROUND] Peripheral T-cell lymphomas (PTCLs) are rare, heterogeneous, aggressive lymphomas.
- 표본수 (n) 123
APA
N Mehta-Shah, Pier Luigi Zinzani, et al. (2026). Duvelisib Induces Deep Responses in PTCL: Final Results of the Phase 2 PRIMO Trial of Duvelisib in Relapsed/Refractory Peripheral T-Cell Lymphoma.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 101200JCO2503120. https://doi.org/10.1200/JCO-25-03120
MLA
N Mehta-Shah, et al.. "Duvelisib Induces Deep Responses in PTCL: Final Results of the Phase 2 PRIMO Trial of Duvelisib in Relapsed/Refractory Peripheral T-Cell Lymphoma.." Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2026, pp. 101200JCO2503120.
PMID
42018969 ↗
Abstract 한글 요약
[BACKGROUND] Peripheral T-cell lymphomas (PTCLs) are rare, heterogeneous, aggressive lymphomas. Five-year overall survival (OS) remains ∼30-40%, and most patients will develop relapsed or refractory (R/R) disease. Duvelisib is an oral dual inhibitor of phosphatidylinositol 3-kinase (PI3K)-δ and PI3K-γ isoforms. Here, we report on the final analysis of the phase 2 PRIMO trial (NCT03372057; Secura Bio, Inc.) evaluating duvelisib monotherapy in R/R PTCL.
[METHODS] PRIMO was conducted in 2 phases (Dose Optimization and Dose Expansion [PRIMO-EP]) at 45 centers globally. Eligible patients were ≥18 years of age, had histologically confirmed diagnosis of PTCL, and had received ≥2 cycles of 1 standard regimen for PTCL. Based on Dose Optimization results, the selected regimen for PRIMO-EP was 75 mg BID for 2 cycles (to maximize disease control) followed by 25 mg BID (to reduce late toxicities), continued until progressive disease or unacceptable toxicity.
[RESULTS] PRIMO-EP (N=123) outcomes included Independent Review Committee-assessed objective response rate (ORR): 48.0%, complete response rate (CRR): 33.3%, median progression-free survival (mPFS): 3.4 months, mOS: 12.4 months, median duration of response (mDOR): 7.9 months. In the AITL subgroup, outcomes were ORR: 62.2%, CRR: 51.4%, mPFS: 8.3 months, mOS: 18.1 months, mDOR: 11.3 months. Treatment-emergent adverse events (TEAEs) (any grade) occurred in 120 patients (97.6%), TEAEs grade ≥3 occurred in 91 patients (74.0%). TEAEs resulting in dose hold or dose reduction occurred in 44.7% and 9.8% of patients.
[CONCLUSIONS] The PRIMO study demonstrates significant activity and tolerability of duvelisib in patients with R/R PTCL, most notably in the AITL subgroup. This provides strong rationale for further development in PTCL, and more specifically in the subgroup of nodal T-follicular helper cell lymphoma.
[METHODS] PRIMO was conducted in 2 phases (Dose Optimization and Dose Expansion [PRIMO-EP]) at 45 centers globally. Eligible patients were ≥18 years of age, had histologically confirmed diagnosis of PTCL, and had received ≥2 cycles of 1 standard regimen for PTCL. Based on Dose Optimization results, the selected regimen for PRIMO-EP was 75 mg BID for 2 cycles (to maximize disease control) followed by 25 mg BID (to reduce late toxicities), continued until progressive disease or unacceptable toxicity.
[RESULTS] PRIMO-EP (N=123) outcomes included Independent Review Committee-assessed objective response rate (ORR): 48.0%, complete response rate (CRR): 33.3%, median progression-free survival (mPFS): 3.4 months, mOS: 12.4 months, median duration of response (mDOR): 7.9 months. In the AITL subgroup, outcomes were ORR: 62.2%, CRR: 51.4%, mPFS: 8.3 months, mOS: 18.1 months, mDOR: 11.3 months. Treatment-emergent adverse events (TEAEs) (any grade) occurred in 120 patients (97.6%), TEAEs grade ≥3 occurred in 91 patients (74.0%). TEAEs resulting in dose hold or dose reduction occurred in 44.7% and 9.8% of patients.
[CONCLUSIONS] The PRIMO study demonstrates significant activity and tolerability of duvelisib in patients with R/R PTCL, most notably in the AITL subgroup. This provides strong rationale for further development in PTCL, and more specifically in the subgroup of nodal T-follicular helper cell lymphoma.