This phase II PRIMO trial demonstrated that duvelisib monotherapy has significant clinical activity in heavily pretreated relapsed/refractory peripheral T-cell lymphoma, with an overall response rate of 48% and complete response rate of 33%. The drug showed a particularly high efficacy in the angioimmunoblastic T-cell lymphoma subgroup with an ORR of 62%, and it was generally tolerable with manageable toxicities and infections, supporting its use as a therapeutic option and further development in PTCL.
Study
|
Phase II, multicenter, open-label study [PRIMO, NCT03372057] |
| Rel/ref peripheral T-cell lymphoma (PTCL), ≥2 prior regimens |
| Duvelisib until progression or unacceptable toxicity (N=123)
|
Efficacy
|
ORR: 48% |
| CRR: 33% |
| mPFS: 3.4 mos |
| mOS: 12.4 mos |
| mDoR: 7.9 mos |
| In AITL subgroup: ORR 62.2%, CRR 51.4%, mPFS 8.3 mos, mOS 18.1 mos, mDoR 11.7 mos
|
Safety
|
Grade >=3 TEAEs: neutropenia (18%), elevated ALT (21%), diarrhea (10%), thrombocytopenia (9%), anemia (6%) |
| Other serious AEs: infections (13%), colitis (2.4%), pneumonitis (1.6%) |
| Treatment discontinuations due to TRAEs: 33%
|
J Clin Oncol 2026;00:1-10
http://doi.org/10.1200/JCO-25-03120
Reviewed by Ulas D. Bayraktar, MD on Jun 17, 2026
