Golidocitinib Yields Acceptable Safety, Promising Efficacy Among Patients With Heavily Pretreated R/R Peripheral T-Cell Lymphomas

Results from a Phase 1/2 Multinational Trial 

Janus kinase 1 (JAK1) selective inhibitor golidocitinib demonstrated acceptable safety and encouraging antitumor efficacy among patients with heavily pretreated relapsed/refractory (R/R) peripheral T-cell lymphomas (PTCLs), according to findings from a phase 1/2 multinational study published in Annals of Oncology. 

According to Dr Y Song, Peking University Cancer Hospital and Institute, Beijing, China, and coauthors, “Constitutive activation of the Janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway is reported to be associated with PTCLs.” To expand on the research on effective therapies for PTCLs, the study authors aimed to evaluate the efficacy and safety of JAK1 inhibitor golidocitinib among this patient population as primary end points, as well as antitumor activity and pharmacokinetics as secondary end points. 

In this study, 51 patients with R/R PTCLs and a median of 2 prior lines of therapies were administered golidocitinib treatment at 150 or 250 mg per day. Results indicated that both doses of golidocitinib were tolerated, but patients who received 250 mg experienced a higher incidence of serious adverse events and dose modifications. Grade ≥3 drug-related treatment-emergent adverse events of particular interest included neutropenia (27.5%) and thrombocytopenia (11.8%). 

Patients had an objective response rate of 39.2% and a complete response rate of 21.6%. At a median follow-up of 14.7 and 15.9 months, the median duration of response was 8 months and the progression-free survival was 3.3 months. The study authors noted that the recommended phase 2 dose of golidocitinib was 150 mg once daily. Golidocitinib showed a favorable pharmacokinetics profile. Analysis of biomarkers demonstrated a potential correlation between JAK/signal transducer and activator of transcription (STAT) pathway aberrations and clinical activity of the drug. 

Dr Song et al concluded, “golidocitinib demonstrated an acceptable safety profile and encouraging antitumor efficacy in heavily pretreated patients with R/R PTCLs.”

“These results support the initiation of the multinational pivotal study in patients with R/R PTCLs,” they added. 

Source: 

Song Y, Yoon DH, Yang H, et al. Phase I dose escalation and expansion study of golidocitinib, a highly selective JAK1 inhibitor, in relapsed or refractory peripheral T-cell lymphomas. Ann Oncol. Published online: September 4, 2023. doi:10.1016/j.annonc.2023.08.013