The decision makes it "the world's first JAK1-only inhibitor" for PTCL patients, noted CEO Xiaolin Zhang, as well as the second approved drug from Dizal after the AstraZeneca spinout's lung cancer treatment sunvozertinib was waved through in China last year.
While a few drugs have been granted conditional regulatory approvals in the relapsed or refractory PTCL setting, Dizal noted that their single-agent activities have been "modest," with objective response rates (ORRs) below 30%.
However, Dizal says its drug has demonstrated "superior and durable" clinical benefits in the pivotal JACKPOT8B study, compared with these existing treatment options. Data from the trial presented last year showed an ORR of 44.3% with golidocitinib, including a 23.9% complete response rate.
Median duration of response was 20.7 months and 53.8% of patients were still responding. Moreover, tumour responses were observed across various PTCL subtypes. Results of the JACKPOT8 trial have been published in Annals of Oncology and The Lancet Oncology.
"With > 200 to 400-fold selectivity over other JAK family members and ideal pharmacokinetic properties, golidocitinib exerts potent antitumour efficacy with a favourable safety profile," the company said.
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