The Phase 2 PRIMO trial found that duvelisib (Copiktra), an oral drug targeting PI3K-δ and PI3K-γ, can work as a single treatment for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
In the study of 123 heavily pretreated patients, nearly half responded to the drug. The overall response rate was 48%, with about one-third achieving complete remission. Responses lasted a median of 7.9 months. Median progression-free survival was 3.4 months, and overall survival reached 12.4 months.
Effectiveness differed by PTCL subtype. Patients with angioimmunoblastic T-cell lymphoma (AITL) had the best outcomes, with response rates over 60% and longer survival, while those with ALCL had much lower response rates and shorter survival.
Patients received a higher dose initially to boost response, followed by a lower maintenance dose. Based on these results, duvelisib is now included in NCCN guidelines as a treatment option for relapsed or refractory PTCL.
However, side effects were common. Serious adverse events occurred in 74% of patients, including liver enzyme elevations, low white blood cell counts, diarrhea, and fatigue.