Dizal Showcases Two First-in-Class Therapies in Hematologic Malignancies at EHA and ICML 2025

• Golidocitinib demonstrated promising efficacy in maintaining and enhancing tumor response in peripheral T-cell lymphoma (PTCL) post first-line therapy with a 24-month disease-free survival (DFS) rate of 74.2%
• DZD8586 exhibited significant antitumor activity in heavily pretreated chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) patients with an objective response rate (ORR) of 84.2%
• Both golidocitinib and DZD8586 will be featured in oral presentations at ICML 2025, with DZD8586 also presented in an oral session at ASCO 2025

SHANGHAI, June 12, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that it will present research findings on two of its first-in-class hematologic oncology assets—golidocitinib and DZD8586—at the 2025 European Hematology Association (EHA) Annual Congress and the 18th International Conference on Malignant Lymphoma (ICML). These include long-term follow-up data on golidocitinib as a maintenance therapy in peripheral T-cell lymphoma (PTCL) after first-line systemic therapy and pooled analysis results for DZD8586 in chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL), both selected for oral presentations at ICML.

Golidocitinib Shows Potential to Significantly Improve Patient Outcomes in PTCL

PTCL patients who achieved tumor response with first-line standard therapy will relapse. Approximately 40% of patients with complete response and 80% with partial response experienced disease progression within 2 years after initial tumor response, and the prognosis of these relapsed patients was very poor.

The 24-month follow-up results from JACKPOT26, a prospective, multicenter Phase 2 clinical study of golidocitinib will be unveiled at EHA and featured as an oral presentation at ICML. The data suggest that golidocitinib showed promising efficacy in maintaining and enhancing tumor response with an acceptable and manageable safety profile in patients with PTCLs post first-line therapies.

• In Cohort 1 (patients with complete response), the 24-month disease-free survival (DFS) rate reached 74.2%, with consistent efficacy observed across different subtypes.
• In Cohort 2 (patients with partial response), the complete response rate (CRR) was 50.0%, the median duration of response (DoR) was 23.9 months, and the median progression-free survival (PFS) was 17.4 months, with the longest PFS reaching 35.9 months and the patient was still responding.

"Golidocitinib, a next-generation oral and highly selective JAK1 inhibitor, addresses a critical unmet need for effective maintenance therapy following first-line treatment in PTCL," said Professor Jie Jin, lead principal investigator of the JACKPOT26 study at the First Affiliated Hospital of Zhejiang University School of Medicine. "Its unique mechanism of action not only delivers strong anti-tumor activity—allowing 50% of patients with partial remission (PR) to achieve complete remission (CR)—but also modulates the tumor immune microenvironment through its anti-inflammatory and immunomodulatory effects. These unique features help delay relapse and extend survival, positioning golidocitinib as a highly promising option for maintenance therapy in PTCL."

In addition, golidocitinib has shown encouraging antitumor activities and favorable safety profiles in combination with CHOP in 1st line PTCL patients, as well as in rare T-cell lymphoma subtypes, including relapsed/refractory T-cell large granular lymphocytic leukemia (r/r T-LGLL) and monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL). Further studies are warranted to validate the results.

DZD8586 Overcomes Multi-Drug Resistance in CLL and other B-NHL

A pooled analysis of two phase I/II studies of DZD8586 in CLL/SLL patients previously treated with covalent/non-covalent Bruton's Tyrosine Kinase (BTK) inhibitors and BTK degraders was presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and will be presented at EHA. Subgroup analyses will be presented as an oral presentation at ICML.

In heavily pretreated CLL/SLL, DZD8586 achieved an ORR of 84.2%. Tumor response with a manageable safety profile was observed irrespective of prior covalent/non-covalent BTKi, BTK degrader, or BCL-2 inhibitor treatment, and in patients with classic BTK resistance mutations (C481X) as well as other BTK mutations, including kinase-dead mutations. No drug-related bleeding, atrial fibrillation, or major cardiac events observed.

A Phase II study of DZD8586 monotherapy in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) will also be presented at EHA and ICML. Clinical activities from small molecule targeted drugs such as BTK inhibitors have been less than desired for the treatment of DLBCL. Compensatory or redundant pathway activation could be one of the main escape mechanisms. DZD8586, a novel LYN/BTK dual inhibitor, is designed to overcome these limitations by blocking both BTK and LYN signaling pathways, and thus potentially improve therapeutic outcomes.

At recommended phase 2 doses (RP2Ds) of 50 mg and 75 mg QD, DZD8586 monotherapy demonstrated promising anti-tumor activity in r/r DLBCL. The majority of patients showed target lesion shrinkage, with a CRR of 35.5%. Complete responders showed durable responses, with 81.8% of patients remaining in response and the median DoR was not reached. Notably, it showed efficacy in both GCB and non-GCB subtypes, supporting its broad therapeutic potential.

Dr. Xiaolin Zhang, CEO of Dizal, remarked, "We are excited that golidocitinib and DZD8586 have demonstrated promising potential in PTCL and B-cell non-Hodgkin lymphoma (B-NHL), two areas with substantial unmet clinical needs. The selection of multiple studies for oral presentations at global leading conferences represents a strong recognition of our capabilities in research and development and further affirms our commitment to bringing transformative therapies to patients worldwide."

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, the median duration of response (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) were 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) were 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.

Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions.

Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect.

Contacts
Investor Relations: [email protected]
Business Development: [email protected]
Media Contact: [email protected] 

SOURCE Dizal Pharmaceutical