The Californer - Dizal's Golidocitinib Pivotal Trial Demonstrates Superior and Durable Clinical Benefits for Patients with r/r PTCL in Oral Presentation at 2023 ASH

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Full analysis of multinational pivotal study results of golidocitinib in relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) (JACKPOT8 PART B) simultaneously published in The Lancet Oncology and presented in oral session at the 65th American Society of Hematology Annual Meeting and Exposition (2023 ASH, San Diego).
Golidocitinib demonstrated superior and durable clinical benefits in the treatment of r/r PTCL, with a median duration of response (mDoR) of 20.7 months, significantly outperforming existing treatment options.

SHANGHAI, Dec. 10, 2023 /PRNewswire/ -- Dizal today presented the full analysis of the multinational pivotal study of golidocitinib for r/r PTCL (JACKPOT8 PART B) in an oral presentation at the 65th American Society of Hematology Annual Meeting and Exposition (2023 ASH, San Diego). The results were simultaneously published in the prestigious peer-reviewed journal The Lancet Oncology (Impact Factor: 54.4). This follows the publication of the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PART A) in Annals of Oncology (Impact Factor: 51.8) three months ago.

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. A total of 104 patients with r/r PTCL were enrolled in the JACKPOT8 PART B study to evaluate the efficacy and safety of golidocitinib as a monotherapy. At the cut-off date of August 31, 2023, per independent review committee (IRC) assessment, 70% of patients achieved target lesion size reduction, yielding an overall response rate (ORR) of 44.3%, and a complete response rate (CRR) of 23.9%. Tumor responses were observed across various PTCL subtypes. The responses were durable, with the median duration of response (mDoR) of 20.7 months. The median progression-free survival (mPFS) was 5.6 months, and the median overall survival (mOS) was 19.4 months and still ongoing. As a potent JAK1 inhibitor with > 200 to 400-fold selectivity over other JAK family members, golidocitinib demonstrated a favorable safety profile. The most common treatment-related adverse events (TRAEs) were reversible and clinically manageable. These findings highlight the potential of golidocitinib to offer robust and durable clinical benefits for patients with r/r PTCL.

"PTCL is a highly heterogeneous and aggressive non-Hodgkin lymphoma (NHL) with the characteristics of various subtypes, high recurrence rate and poor prognosis. Patients with r/r PTCL have limited treatment options and a poor prognosis with a low survival rate. The efficacy of current treatment modalities varies among different r/r PTCL subtypes." said Jun Zhu, MD, PhD at the Department of Lymphoma, Peking University Cancer Hospital and Institute, the correspondence author of the paper, "The JAK/STAT signaling pathway plays a pivotal role in the pathogenesis and progression of various hematologic malignancies, including T-cell malignancies. Consequently, targeting the JAK/STAT pathway emerges as an innovative and highly promising treatment option for PTCL. Golidocitinib is an oral, potent, JAK1 only inhibitor with superior selectivity and favorable pharmacokinetic properties, offers robust and sustained inhibition of the JAK/STAT pathway while maintaining optimal clinical safety."

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"In the JACKPOT8 PART B study, more than 100 patients with r/r PTCL were enrolled. The efficacy analysis of 88 patients revealed an ORR of 44.3%, with 23.9% achieving complete response. Notably, a consistently high ORR was observed across various PTCL subtypes. The median DoR for golidocitinib was 20.7 months, mPFS reached 5.6 months, and mOS was 19.4 months." said Yuqing Song, MD, PhD at the Department of Lympho-Oncology of Peking University Cancer Hospital, the lead author of the paper, "Golidocitinib demonstrates superior ORR and survival results as compared to the current available treatment options and offers hope for improving the poor prognosis of patients with r/r PTCL. These findings present innovative therapeutic possibilities and paves the way towards better patient outcomes."

"It is gratifying to see the increasing recognition of golidocitinib's potential as a new therapy for patients with PTCL." said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal, "Patients with r/r PTCL have long been facing limited treatment options and a poor prognosis. Golidocitinib stands as a major achievement resulting from Dizal's dedicated translational science efforts. Its superior efficacy and safety, as demonstrated through compelling global pivotal trials, bring hope for these underserved patients."

These findings, highlighting the superior efficacy and safety of golidocitinib, have been widely acknowledged at prestigious conferences including ASCO, EHA, ICML, and ASH, with six oral presentations over four consecutive years. In September 2023, the NDA for golidocitinib was accepted by the CDE with Priority Review status for the treatment of r/r PTCL. Dizal continues to expand the scope of clinical research on golidocitinib and explore its application in a broader patient population. At 2023 ASH, Dizal will also announce positive results of golidocitinib as maintenance therapy for patients with PTCL after first-line systemic therapy in a phase 2 study (JACKPOT26).

About golidocitinib (DZD4205)

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCLs. At the data cut-off date of August 31, 2023, Golidocitinib has demonstrated robust and durable anti-tumor activity, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, mDoR reached 20.7 months. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted the NDA and granted the Priority Review status for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PART A) was published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trials data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) was published in The Lancet Oncology (Impact Factor: 54.4).

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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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