In a phase II trial (JACKPOT8 Part B) reported in The Lancet Oncology, Song et al found that the selective JAK1 tyrosine kinase inhibitor golidocitinib showed activity in patients with relapsed or refractory peripheral T-cell lymphoma.
Study Details
In the trial, 104 patients from sites in Australia, China, South Korea, and the United States who had received at least one previous line of systemic therapy were enrolled between February 2021 and October 2022; a total of 94% of patients were Asian. Patients received oral golidocitinib at 150 mg once daily until disease progression or unacceptable toxicity. The primary endpoint was computed tomography–based objective response rate on independent review committee assessment (per Lugano 2014 classification).
Responses
Among 88 patients evaluable for response, objective response was observed in 39 (44.3%, 95% confidence interval [CI] = 33.7%–55.3%, P < .0001 vs null hypothesis of 15%), with complete response seen in 21 (24%). Median duration of response was 20.7 months (95% CI = 17.6 months to not estimable).
KEY POINTS
- Golidocitinib produced objective responses in 44% of patients.
- Median duration of response was 20.7 months.
With a median follow-up of 15.9 months (interquartile range [IQR] = 9.7–20.0 months), median progression-free survival was 3.4 months (95% CI = 1.7–5.6 months). With a median follow-up of 17.5 months (IQR = 13.8–20.8 months), estimated median overall survival was 19.4 months (95% CI = 13.1 months to not estimable).
Adverse Events
In the safety population of 104 patients, grade 3 or 4 treatment-related events occurred in 59%, most commonly decreased neutrophil count (in 29% of patients), decreased white blood cell count (26%), decreased lymphocyte count (21%), and decreased platelet count (20%). Treatment-related serious adverse events occurred in 24% of patients, most commonly pneumonia, herpes zoster, decreased platelet count, and pyrexia (3% each). Adverse events led to death in three patients (3%); two deaths were due to pneumonia (including one case with fungal infection considered treatment-related and one case with COVID-19 infection) and one was due to confused state.
The investigators concluded, “In this phase II study, golidocitinib showed a favorable benefit–risk profile in treating relapsed or refractory peripheral T-cell lymphoma. The results of this study warrant further randomized clinical studies to confirm activity and assess efficacy in this population.”
Jun Zhu, MD, of the Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by Dizal Pharmaceutical. For full disclosures of the study authors, visit thelancet.com.
