A single-center retrospective study of golidocitinib for the treatment of peripheral T-cell lymphoma

Abstract Background Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous and aggressive type of non-Hodgkin lymphoma. More than 70% of patients relapse after first-line treatment, and the median overall survival (OS) for the relapsed or refractory (R/R) PTCL patients is suboptimal. The JACKPOT8 Part B study has demonstrated the superior efficacy of golidocitinib monotherapy for R/R PTCL. As the world's first selective JAK1 inhibitor targeting PTCL, golidocitinib significantly improved the PTCL patients survival. Aim This study aimed to evaluate the real-world efficacy and safety of golidocitinib-based treatment for PTCL patients. Methods This single-center retrospective study included 19 PTCL patients (age ≥18 years old) treated with golidocitinib monotherapy or combination regimens at Qilu Hospital of Shandong University from July 2024 to August 2025. Among them, 17 patients were available for efficacy and safety evaluation. Results A total of 19 patients were included in this analysis, 7 (37%) patients were diagnosed with angioimmunoblastic T-cell lymphoma (AITL), 6 patients (32%) with monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) and 3 patients(16%) with PTCL not otherwise specified (PTCL-NOS). 12 (63%) patients were ≥60 (median 64, range 51-94) years old, 12 (63%) patients were male, 14 (74%) patiens had stage III-IV disease, 11 (58%) patients had an IPI score of 4-5, 13 (69%) patients had received at least one prior line of therapy. 14 (74%) patients received golidocitinib combination therapy, while the remainder received golidocitinib monotherapy. All patients completed at least 1 cycle of golidocitinib-based treatment, with a median of 3 (range 1-5) treatment cycles. At the end of the 2 cycle, the objective response rate (ORR) and complete response rate (CRR) were 86% (12/14) and 21% (3/14), respectively. In newly diagnosed and relapsed/refractory patients, the ORR for golidocitinib combination therapy were 80% (4/5) and 86% (6/7). Among the R/R PTCL patients, 6 (46%) patients used golidocitinib-based treatment as third-line or fourth-line therapy, with an ORR of 100% after 2 cycles. In patients ≥60 years old, unable to tolerate intensive chemotherapy, golidocitinib monotherapy and golidocitinib combined chemofree therapy also demonstrated favorable efficacy with an ORR of 86% (6/7). Treatment-related adverse events (TRAEs) were observed in 16 (84%) patients. Among 5 patients receiving golidocitinib monotherapy, 2 patients developed grade ≥3 hematologic toxicity, 1 patient developed grade ≥3 pulmonary infection and 2 patients developed grade 2 herpes zoster. Among patients receiving golidocitinib combination therapy, grade ≥3 TRAEs occurred universally, with the incidence of grade ≥3 neutropenia and thrombocytopenia being 43% (6/14) and 21% (3/14), respectively. One patient received golidocitinib combined chemotherapy died due to infection. No unexpected TRAE occurred during follow-up. Conclusions The application of golidocitinib combination therapy in the real world can further improve outcomes for PTCL patients. In elderly unfit patients(age ≥60 years old), golidocitinib monotherapy and combined chemofree therapy represent viable therapeutic options.