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SHANGHAI, Sept. 10, 2023 /PRNewswire/ -- Dizal today 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 golidocitinib to test the hypothesis. Golidocitinib is the first and currently the only Janus kinase 1 (JAK1) selective inhibitor for treating r/r PTCLs 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 irrespective 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.
About Annals of Oncology
Annals of Oncology (2022-2023 Impact Factor: 51.8), the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, provides rapid and efficient peer-review publications on innovative cancer treatments or translational work related to oncology and precision medicine.
About golidocitinib (DZD4205)
Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated robust and durable anti-tumor activity, with an ORR of 44.3% and a CRR of 23.9%. More than 50% of the patients with tumor remission achieved a complete response. The median relative dose intensity was 100%. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022.
About Dizal
Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs around the world. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies and one already launched.
To learn more about Dizal, please visit www.dizalpharma.com, or follow us at Linkedin or Twitter.
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