Golidocitinib combination therapy as first-line treatment in PTCL: Retrospective data from a single centre

Abstract Background: Peripheral T-cell lymphoma (PTCL), except for the anaplastic large cell lymphoma (ALCL) subtype, is characterized by a poor prognosis and low overall survival rate. Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, has shown encouraging anti-tumor activity in heavily pre-treated patients with relapsed or refractory PTCL in a phase 2 study (JACKPOT8 Part B). Here we present 16 cases of adult PTCL that were identified and treated with golidocitinib as first-line therapy at Guangdong Provincial People's Hospital since July 2024. Aims: To evaluate the efficacy and safety of golidocitinib combination with CHOP-like chemotherapy as first-line treatment for patients with PTCL. Methods: Between July 2024 and July 2025, 16 adult patients >18 years old with PTCL and received golidocitinib combined with CHOP-like chemotherapy regimen as first-line treatment were identified at Guangdong Provincial People's Hospital. Patient demographics, clinical characteristics and treatment modalities were summarized. Results: Among 16 patients enrolled into the study, the median age was 61.5 years (range, 40-74), 8 patients (50%) were male, 5 (31.3%) had an ECOG PS of 0-1, 14 (87.5%) had stage III-IV disease, and 14 (87.5%) had an IPI score of 3-5. Six patients (37.5%) had bone marrow involvement before treatment, and 12 (76%) had extranodal involvement (with 10 patients having ≥2 extranodal involvement). Two patient (12.5%) was diagnosed with EATL, 11 patients (68.8%) were diagnosed with AITL, 3 patients (18.8%) were diagnosed with PTCL-NOS. ALL patients received golidocitinib plus CHOP-like chemotherapy as first-line treatment. One patients (6.3%) received golidocitinib 150 mg QD，5 patients (31.3%) received golidocitinib 150 mg QD（2 week-on and 1 week-off schedule）,and 10 patients (62.5%) received golidocitinib 150 mg QOD（2 week-on and 1 week-off schedule）.Treatment-related adverse events (TRAEs) were observed in 7 patients (43.8%), with pulmonary infection and neutropenia being the most common (2 patients each, 12.5%), followed by infectious pneumonia, cytomegalovirus reactivation, leukopenia, febrile neutropenia, rash, abnormal liver function and thrombocytopenia (1 patient each, 6.3%). One patient permanently withdrew from treatment to receive stem cell transplant. 14 patients were evaluable for efficacy: 6 reached CR, 7 reached PR during mid-term evaluation,resulting in an overall response rate (ORR) of 92.9% and a CR rate of 42.9%. Conclusion: Golidocitinib demonstrated encouraging antitumor efficacy and clinical manageable safety profile in combination with CHOP-like chemotherapy in newly-diagnosed PTCL patients. Further prospective study is warranted to validate the results. Disclosures: No relevant conflicts of interest to declare.