Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, today announced that the
To date, golidocitinib is the first and only approved Janus kinase 1 (JAK1) selective inhibitor for r/r PTCL patients globally.
PTCL is a heterogeneous group of aggressive T-cell/natural killer (NK) cell non-Hodgkin lymphomas (NHL). Patients with PTCL face an extremely high risk of disease relapse even if they achieved tumor remission following first-line conventional therapy. The outcome for relapsed or refractory patients is extremely poor, with a 3-year survival rate of 23% and a median overall survival (mos.) of 5.8 months. Although couple of drugs have been granted conditional approval by regulatory agencies in the relapsed or refractory setting, their single agent activities have been modest, with objective response rates (ORRs) lower than 30%.
Golidocitinib was approved based on findings from JACKPOT8 Part B (JACKPOT8B) study, the multinational pivotal study to evaluate the efficacy and safety of golidocitinib in r/r PTCL as a monotherapy. The primary endpoint was the objective response rate (ORR), assessed by an independent review committee (IRC). Full analysis of the study was simultaneously published in The Lancet Oncology and presented in oral session at the 65th
In JACKPOT8B study, golidocitinib demonstrated superior and durable antitumor efficacy and a favorable safety profile in r/r PTCL patients, compared with existing treatment options. At the data cut-off date
'Golidocitinib features novel mechanism and unique molecular design, positioning it as the first oral JAK1 only inhibitor for the treatment of r/r PTCL. Multiple studies have clearly demonstrated its favorable pharmacokinetic properties and significant clinical benefit,' said
Dizal was the first to identify and validate targeting the JAK/STAT pathway as a promising therapeutic approach for PTCL, leading to the development of golidocitinib as the world's first JAK1 only inhibitor. With > 200 to 400-fold selectivity over other JAK family members and ideal pharmacokinetic properties, golidocitinib exerts potent antitumor efficacy with a favorable safety profile.
'We are thrilled to bring golidocitinib, the world's first JAK1 only inhibitor, to patients in
With superior efficacy and safety profile, golidocitinib has been widely acknowledged at prestigious international congresses including ASCO, EHA, ICML, and ASH, with six oral presentations over four consecutive years. The results of the multinational study JACKPOT8 were published in Annals of Oncology and The Lancet Oncology.
About golidocitinib (
Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In
At the data cut-off date of
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 worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies, both of which have already been launched in
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