China-based Dizal Pharmaceutical Co., Ltd, (SHA: 688192), a spin-off from AstraZeneca (AZ, NASDAQ: AZN) China established in 2017, has presented robust pivotal trial data for its pipeline candidate golidocitinib at the American Society of Hematology (ASH) Annual Meeting. The data was presented in an oral presentation, showcasing the full analysis from the multinational Phase II JACKPOT8 PART8 trial, which assessed the oral Janus kinase 1 (JAK1) inhibitor golidocitinib as a monotherapy treatment for relapsed/refractory peripheral T-cell lymphoma (r/r PTCL).
Golidocitinib demonstrated durable clinical benefits that significantly outperformed current market competitors. The trial involved 104 patients, with golidocitinib achieving a median duration of response (mDoR) of 20.7 months, a target lesion reduction in 70% of patients, an overall response rate (ORR) of 44.3%, and a complete response rate (CRR) of 23.9%. The mDoR indicated strongly durable responses, with a median progression-free survival (mPFS) of 5.6 months and a median overall survival (mOS) of 19.4 months, which is still ongoing. Treatment-related adverse events were found to be manageable.
Dizal CEO Zhang Xiaolin highlighted that current standard treatments typically only provide a 6-8 month survival benefit, as reported by Fiercebiotech.com. An NDA filing for golidocitinib was submitted to the NMPA in China in September this year and was granted priority review status. Dizal is now planning to discuss an NDA filing with the US FDA, seeking an accelerated approval pathway. The company is also exploring US partnerships for the future commercialization of the molecule, as stated by Zhang, according to Fiercebiotech.com.- Flcube.com
