Multicenter phase 1b study of linperlisib for relapsed and/or refractory peripheral T-cell lymphoma

Relapsed an/or refractory peripheral T-cell lymphoma (R/R PTCL) is an aggressive and heterogeneous hematologic malignancy. Previous studies showed activity but limited tolerability of PI3K inhibitors in patients with B- and T-cell lymphoma. Linperlisib is an oral next-generation PI3K-delta inhibitor. A multicenter phase 1 trial in China evaluated linperlisib 80 mg once daily for R/R PTCL. Treatment-related adverse events were manageable, with neutropenia (21% of patients), pneumonia (11.6%) and hypertriglyceridemia (7%) as most frequent grade 3 TRAEs. The objective response rate was 60.5% whereas the complete response rate was 35%, the median duration of response was 11.1 months, the median progression-free survival was 11.8 months, and the median overall survival was not reached after 38 months of follow-up. The authors conclude that linperslisib had acceptable toxicity and promising clinical actitivity in patients with R/R PTCL.