Dizal Pharmaceutical announced the publication of the Phase I clinical data of golidocitinib for the treatment of relapsed or refractory (r/r) peripheral T cell lymphomas (PTCL) (JACKPOT8 PARTA) in Annals of Oncology (2022-2023 Impact Factor: 51.8). PTCL is an aggressive non-Hodgkin lymphoma (NHL) that represents approximately 7% to 10% of NHLs worldwide. Patients with r/r PTCL face a poor prognosis, with a 3-year survival rate ranging from 21% to 28%.

Currently, there is no established consensus on the standard approach for treating r/r PTCL. Therefore, there is an urgent medical need for novel and innovative treatment options to improve survival of this patient population. Dizal identified that JAK/STAT pathway may mediate the pathogenesis of PTCL and launched clinical studies of golidocitinab to test the hypothesis.

Golidocitinib is the first and currently the only Janus kinase 1 (JAK1) selective inhibitor for treating r/r P TCLs at the stage of pivotal clinical development. Consistent with earlier data, golidocitinib demonstrated potent and durable anti-tumor efficacy in the pivotal study (JACKPOT8 PARTB), with the clinical results selected as oral presentation at 2023 American Society of Clinical Oncology (ASCO) and 2023 International Conference on Malignant Lymphoma (ICML). The primary endpoint of the study, objective response rate (ORR) assessed by an independent review committee (IRC), reached 44.3%, with a complete response rate (CRR) of 23.9%.

More than 50% of the patients with tumor remission achieved a complete response. Anti-tumor efficacy was observed across different PTCL subtypes and respective of the patients' prior treatment history. The median duration of response (mDoR) has not been reached.

The longest DoR was 16.8 months, and the patient is still responding. As a potent JAK1 inhibitor with > 200 to 400-fold selectivity over other JAK family members, golidocitinIB demonstrated a favorable safety profile. The majority of treatment-related adverse events (TRAEs) could be monitored and well managed in the clinic.

The median relative dose intensity was 100%. (Data cut-off date: February 16, 2023) Golidocitinib was granted Fast Track Designation for the treatment of r/r PTCL by the U.S. FDA in February 2022. Furthermore, the clinical significance of golidocitinIB has been widely acknowledged at prestigious conferences such as ASCO, European Hematology Association (EHA), ICML, and American Society of Hematology (ASH) with five oral presentations for four consecutive years.