KEY TAKEAWAYS
- Golidocitinib is an oral JAK1 inhibitor being assessed in a multinational, pivotal study (JACKPOT8 Part B) for the cure of r/r PTCL and was well-tolerated, with diarrhea, fatigue, and nausea being the most frequent side effects.
- The efficacy and safety of golidocitinib in PTCL patients were evaluated using ORR, PFS, OS, and safety and tolerability as primary and secondary endpoints, respectively.
- The most common ≥ grade 3 TRAEs were hematological (decreased neutrophil count, white blood cell count, platelet count, and lymphocyte count). TRAEs led to dose interruption, reduction, and discontinuation.
PTCL is a rare and aggressive type of blood cancer that affects T cells, a white blood cell that helps fight infection. There is currently no standard trerapy for relapsed/refractory (r/r) PTCL, and the outlook for patients is poor. Golidocitinib, an oral JAK1 inhibitor, is under evaluation in a multinational study (JACKPOT8 Part B, NCT04105010) for enhancing outcomes in this cancer type. The study explored the efficacy and safety of golidocitinib in patients with r/r.
In this study, PTCL patients who had relapsed from or had been refractory/intolerant to ≥ 1 (but ≤ 3) prior systemic therapy(ies) were enrolled and received golidocitinib (150 mg) once daily until disease progression or pre-defined discontinuation criteria were met. The primary endpoint was the CT-based objective response rate (ORR), estimated by an independent review committee (IRC) according to the Lugano 2014 classification. The efficacy analysis set included patients with confirmed PTCL diagnoses from a central lab with at least one measurable lesion at baseline; the safety analysis set included all dosed patients.
A total of 104 patients with r/r PTCL were enrolled and dosed with golidocitinib (November 30, 2022). Baseline characteristics revealed a median age of 58 (64.4% male; 20.2% with baseline bone marrow involvement). Major subtypes included NOS (46.2%), AITL (15.4%), and ALCL (9.6%). The median prior lines of therapies were two, with all patients receiving chemotherapies and 48.1% treated with histone deacetylase inhibitors. By the data cut-off (DCO) date, 80 patients were involved in the efficacy analysis, with an overall response rate (ORR) of 43.8%, including 25.0% complete responses.
Tumor responses were observed across various subtypes (AITL 56.3%, NOS 45.7%, ALCL 11.1%, others 44.4%). Among patients who relapsed from HDAC inhibitor treatment, 54.8% achieved tumor response. With a median follow-up of 5.5 months for responders, the median duration of response (DoR) has yet to be reached. Golidocitinib was well-tolerated, with the longest treatment duration by the DCO date being 15.7 months (still responding). The most common ≥ grade 3 treatment-related adverse events (TRAEs) were hematological, including neutrophil count decreased (26.0%), white blood cell count decreased (25.0%), platelet count decreased (16.3%), and lymphocyte count decreased (16.3%). TRAEs leading to dose interruption, reduction, and discontinuation were 37.5%, 5.8%, and 7.7%, respectively, with the majority being reversible or clinically manageable.
Golidocitinib showed promise as a new targeted therapy for treating r/r PTCL, with updated data to be presented at the conference.
Source: https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.7503
Clinical Trial: https://www.clinicaltrials.gov/study/NCT04105010
Qingqing Cai, Jun Zhu, Yuqin Song, Weili Zhao, Keshu Zhou, Jianqiu Wu, Huilai Zhang, Luis Malpica, Kaiyang Ding, Yao Liu, Zengjun Li, Liling Zhang, Meifang Zheng, Jie Jin, Haiyan Yang, Yuerong Shuang, Dok Hyun Yoon, Sujun Gao, Wenlei Yu, Won Seog Kim. DOI 10.1200/JCO.2023.41.16_suppl.7503, J Clin Oncol 41, 2023 (suppl 16; abstr 7503)
