Golidocitinib Yields Favorable Benefit-Risk Profile Among Heavily Pretreated Patients With R/R PTCL

Findings from the Single-Arm Multicenter Phase 2 JACKPOT8 Part B Trial 

Golidocitinib, a Janus kinase 1 (JAK1) inhibitor, yielded a favorable benefit-risk profile among heavily pre-treated patients with relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL), according to results from the single-arm, multicenter, phase 2 JACKPOT8 trial published in The Lancet Oncology. 

Yuqin Song, MD, Peking University Cancer Hospital, Beijing, China, and coauthors explained that golidocitinib “has shown encouraging anti-tumour activity in heavily pre-treated patients with relapsed or refractory peripheral T-cell lymphoma in a phase 1 study (JACKPOT8 Part A).” 

In phase 2 of this trial, the study authors aimed to examine the anti-tumor activity of golidocitinib among this patient population. The primary end point was the computed tomography (CT)-based objective response rate, identified by the Lugano 2014 criteria. 

A total of 104 patients with R/R PTCL who had received 1 or more previous lines of systemic therapy and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 were enrolled in this trial. Patients received golidocitinib orally at 150 mg once daily until disease progression or other reasons for discontinuation occurred. 

At a median follow-up of 13.3 months, the objective response rate was 44.3% per independent review committee assessment. Among these patients, 24% (n = 21) achieved a complete response and 20% (n = 18) had a partial response. 

Regarding safety, 59% of patients (n = 61) experienced grade 3 to 4 drug-related treatment-emergent adverse events, the most common being decreases in neutrophil count (n = 30), white blood cell count ( n = 27), lymphocyte count (n = 22), and platelet count (n = 21). The study authors noted that these events were clinically manageable and reversible. A total of 25 patients experienced treatment-related serious adverse events. Mortality occurred in 3 patients due to treatment-related adverse; 2 due to pneumonia and 1 due to a confusional state. 

Song and coauthors concluded, “In this phase 2 study, golidocitinib showed a favourable benefit–risk profile in treating relapsed or refractory peripheral T-cell lymphoma.”

“The results of this study warrant further randomised clinical studies to confirm activity and assess efficacy in this population,” they added. 

Source: 

Song Y, Malpico 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. Published online: December 9, 2023. doi: 10.1016/S1470-2045(23)00589-2