Efficacy and safety of Golidocitinib-based first line regimen in peripheral T-cell lymphoma: A multicenter retrospective study

Abstract Background Peripheral T-cell lymphoma (PTCL) represents a heterogeneous and aggressive non-Hodgkin lymphoma associated with poor clinical outcomes. Although the selective JAK1 tyrosine kinase inhibitor golidocitinib has demonstrated promising efficacy in relapsed/refractory PTCL, its potential role as first-line therapy remains limited. This multicenter retrospective study reports the real-world experience with golidocitinib-based first-line treatment in PTCL. Aims To evaluate the efficacy and safety of golidocitinib-based regimen as first-line treatment for patients with PTCL. Methods Between April 2024 and July 2025, 17 adult patients >18 years old with newly diagnosed PTCL who received golidocitinib-based regimen as first-line treatment were collected at 4 medical centers: Shandong Provincial Hospital Affiliated to Shandong First Medical University, Cancer Hospital of Shandong First Medical University, Weihai Municipal Hospital, and Yantai Yuhuangding Hospital. Patient demographics, clinical characteristics, treatment modalities and therapeutic outcomes were summarized. Results Among the 17 enrolled patients who received at least one cycle of golidocitinib-based regimen, the median age was 71 years (range, 55-83), 10 patients (58.8%) were male, 8 (47.1%) had an ECOG PS of 0-1, 15 (88.2%) had stage III-IV disease, and 14 (82.3%) had an IPI score of 3-5. Seven (41.2%) patients were diagnosed with AITL, 7 patients (41.2%) were diagnosed with PTCL-NOS, 2 patients (11.8%) were with ALCL, and 1 patient (5.9%) was ENKTL. Baseline features included EBV infection (4, 23.5%), bone marrow involvement (4, 23.5%), extranodal involvement (70.6%; with 4 patients having ≥2 extranodal involvement), B symptoms (6, 35.3%), and elevated LDH (11, 64.7%). All patients received golidocitinib combined with chemotherapy, including CHOP-like regimens, chidamide plus thalidomide, or P-GEMOX. Fifteen patients (88.2%) received oral golidocitinib 150 mg QD. 2 patients (11.8%) received golidocitinib 150 mg QoD. Nine patients completed ≥3 treatment cycles and underwent interim assessment, achieving an overall response rate (ORR) of 66.6% (2 CR, 4 PR). Treatment-related adverse events (TRAEs) were observed in 7 patients (41.2%), with febrile neutropenia being the most common (4 patients, 23.5%), followed by rash, cytomegalovirus infection (CMV) reactivation, anemia and thrombocytopenia (1 patient each, 5.9%). All TRAEs were resolved with supportive therapy, and no treatment discontinuations due to toxicity were reported. One patient discontinued treatment due to progressive disease. One patient permanently withdrew from treatment to receive stem cell transplant. As of July 27, 2025, all patients remained alive. Summary/Conclusion This study specifically enrolled older patients (all ≥55 years) with predominantly advanced-stage PTCL. Despite the high-risk population, the golidocitinib-based first-line regimen demonstrated promising antitumor efficacy and clinical manageable safety. Further prospective study is warranted to validate the results. Keywords: Peripheral T-cell lymphoma, Janus Kinase inhibitor