Dizal to Present Promising Clinical Data on Golidocitinib and DZD8586 for the Treatment of Lymphoma at the Coming International Hematology Conferences

• The latest 2-year follow-up data on golidocitinib as a maintenance therapy for peripheral T-cell lymphoma (PTCL) patients who achieved tumor response after first-line systemic therapy will be presented orally at the 2025 ICML
• A pooled safety and efficacy analysis of two Phase I/II studies of DZD8586 in heavily pre-treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients has been selected for oral presentations at both 2025 ASCO and ICML

, /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the latest data from eight hematologic malignancy clinical trials will be presented at the 2025 European Hematology Association (EHA) Congress and the 18^th International Conference on Malignant Lymphoma (ICML). Notably, Dizal's two investigational drugs in lymphoma—golidocitinib and DZD8586—have collectively secured three oral presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, EHA Congress and ICML.

"Golidocitinib and DZD8586 are core assets in our hematologic malignancy pipeline. Accumulating clinical data continue to validate their clinical benefits to patients and attracted community's attention," said Xiaolin Zhang, PhD, CEO of Dizal. 

A high proportion of PTCL patients who achieved tumor response with first-line standard therapy will relapse. Approximately 40% of patients with complete response (CR) and 80% with partial response (PR) experience disease progression within 2 years after initial tumor response. The prognosis of these relapsed patients is very poor. Currently, there is no standard maintenance therapy available.

The latest 2-year follow-up data from JACKPOT26, a prospective, multicenter Phase II study of golidocitinib, will be presented at both the upcoming EHA Congress and ICML, where it has been selected for an oral presentation. This study explored golidocitinib as a maintenance therapy for peripheral T-cell lymphoma (PTCL) patients who achieved tumor response after first-line systemic therapy. The results showed that with more than 2 years follow-up, golidocitinib continued to demonstrate a promising effect on maintaining and enhancing tumor response in patients with PTCL post first-line therapies, with a manageable safety profile.

Initial positive results of Golidocitinib in combination with CHOP in 1^st line PTCL patients will be reported during these meetings. In addition, Dizal will present results for golidocitinib in rare T-cell lymphoma subtypes, including relapsed/refractory T-cell large granular lymphocyte leukemia (r/r T-LGLL), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL).                

Two studies of DZD8586 have been selected for presentation at ASCO, EHA, and ICML. The safety and efficacy analysis of Phase I/II studies of DZD8586 in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with prior treatment using covalent and/or non-covalent BTK inhibitors and BTK degraders has been accepted for oral presentation at both ASCO and ICML. The study results showed DZD8586 exhibited significant anti-tumor activities with well-tolerated safety profile in these heavily pre-treated CLL/SLL patients.

Results of a Phase II study of DZD8586 as monotherapy in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) will be reported for the first time at the 2025 EHA Congress. DZD8586 showed promising anti-tumor activity and a manageable safety profile.

Dizal presentation details during 2025 ICML、EHA：

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About golidocitinib (DZD4205)

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. 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. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 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 its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) was published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) was published in The Lancet Oncology (Impact Factor: 54.4).

About DZD8586

DZD8586 is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton's Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

DZD8586 has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. Phase I clinical trial suggests that DZD8586 exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

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. Deeply 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 China.

To learn more about Dizal, please visit www.dizalpharma.com, or follow us on Linkedin or X.

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