JAK1 TKI Golidocitinib Shows Promise in Relapsed/Refractory PTCL

In this single-arm study, 44.3% of patients achieved an objective response, including 24% of patients with a complete response, and 19% of patients achieved stable disease.

Golidocitinib demonstrated promising antitumor activity among patients with relapsed/refractory peripheral T-cell lymphoma (PTCL), with nearly one-quarter of patients achieving a complete response (CR), according to the results of a phase 2 study published in the Lancet Oncology.

This single-arm study (ClinicalTrials.gov Identifier: NCT04105010) treated 101 patients with relapsed/refractory PTCL with golidocitinib. The primary endpoint was objective response rate (ORR) and secondary endpoints included duration of response, CR rate, progression-free survival, and safety.

At baseline, the median age was 58, 65% of patients were male, and the majority of patients were Asian. There were 57% of patients with PTCL not otherwise specified, 18% with angioimmunoblastic T-cell lymphoma, 11% with anaplastic large cell lymphoma, and the remaining patients had natural killer cell lymphoma, T-cell polymorphic leukemia, or PTCL of uncertain subtype. 

There were 73% of patients with 2 or more prior lines of therapy, with 100% having previously received chemotherapy, 50% a histone deacetylase inhibitor, 10% a CD30-targeted agent, and 1% an ALK inhibitor. 

Targeting JAK1 could provide a unique option to achieve a deep and durable response in patients with PTCL who have relapsed or been refractory to previous therapies.

There were 44.3% of patients who achieved an objective response, including 24% of patients with a CR. There were 19% of patients with stable disease. The median duration of response was 20.7 months. The median PFS was 5.6 months and the median overall survival was 19.4 months.

Grade 3-4 treatment-related adverse events (TRAEs) developed in 59% of patients, with the most common including decreases in white blood cell, neutrophil, lymphocyte, and platelet counts. Treatment discontinuation or interruption occurred in 9% and 38% of patients, respectively, due to TRAEs. There was 1 treatment-related death due to fungal pneumonia.

“Targeting JAK1 could provide a unique option to achieve a deep and durable response in patients with PTCL who have relapsed or been refractory to previous therapies,” the authors concluded in their report.

Disclosures: This study was supported by Dizal Pharmaceutical. Please see the original reference for a full list of disclosures.

This article originally appeared on Hematology Advisor

References:

Song Y, Malpica L, Cai Q, et al. Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study. Lancet Oncol. 2024;25:117-125. doi:10.1016/S1470-2045(23)00589-2