Golidocitinib shows promise in relapsed or refractory peripheral T-cell lymphoma

The investigational selective JAK1 tyrosine-kinase inhibitor golidocitinib demonstrates a favourable benefit–risk profile in the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, according to the phase II JACKPOT8 Part B study.

JACKPOT8 Part B included 104 adult patients who had received at least one previous line of systemic therapy and an Eastern Cooperative Oncology Group performance status of 0–2. These patients received golidocitinib 150 mg orally once daily until disease progression or other discontinuation criteria were met. The activity analysis set included 88 patients (median age 58 years, 65 percent men, 94 percent Asian). The safety analysis set included all patients who received at least one dose of study drug.

Over a median follow-up of 13.3 months, the primary endpoint of computed tomography (CT)-based objective response rate (assessed by an independent review committee [IRC] per Lugano 2014 classification) was 44.3 percent (95 percent confidence interval [CI], 33.7–55.3; p<0.0001), with 24 percent having a complete response and 20 percent having a partial response.

In the safety analysis set, grade 3–4 drug-related treatment-emergent adverse events (TEAEs) occurred in 59 percent of patients. The most frequent grade 3–4 drug-related TEAEs were decreases in neutrophil count (29 percent), white blood cell count (26 percent), lymphocyte count (21 percent), and platelet count (20 percent), all of which were clinically manageable and reversible.

Treatment-related serious AEs were documented in 24 percent of patients. Of these, 3 percent died (2 percent due to pneumonia and 1 percent due to confusional state).