Latest news with #Dizal
Yahoo
12 hours ago
- Business
- Yahoo
Dizal Completes Enrollment for its Phase III Pivotal Study of Sunvozertinib vs. Platinum Doublet in Treatment Naïve NSCLC Patients with EGFR Exon20 Insertional Mutations
SHANGHAI, June 19, 2025 /PRNewswire/ -- Dizal announced the completion of patient enrollment for its WU-KONG28 clinical trial: a multinational, randomized phase III study evaluating the efficacy and safety of sunvozertinib versus platinum-based doublet chemotherapies as a first-line treatment for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). EGFR exon20ins have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options due to the limited efficacy of first- to third-generation EGFR tyrosine kinase inhibitors (TKIs). Sunvozertinib, the only oral treatment for NSCLC patients with EGFR exon20ins approved, has demonstrated significant efficacy and a favorable safety profile in this patient population. Both the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) have granted Breakthrough Therapy designation to sunvozertinib for the treatment of EGFR exon20ins NSCLC. WU-KONG28 is a phase III, multinational, randomized clinical trial investigating sunvozertinib compared to platinum-based doublet chemotherapies in treatment-naïve NSCLC patients with EGFR exon20ins. The study is being conducted across 16 countries and regions in Asia, Europe, North America, and South America. At the 2023 European Society for Medical Oncology (ESMO) Annual Meeting, Dizal reported that sunvozertinib, as a single oral agent, achieved 100% reduction of target lesions, a confirmed objective response rate (ORR) of 78.6%, and a median progression-free survival (mPFS) of 12.4 months, in treatment-naïve patients with advanced or metastatic NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated a well-tolerated safety profile compaired to other EGFR TKIs. Sunvozertinib is approved in China for the treatment of relapsed and refractory NSCLC with EGFR exon20ins. U.S. FDA granted priority review for its NDA for the same indication with a PDUFA date of July 7, 2025. About sunvozertinib (DZD9008) Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine. 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. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two approved drugs and multiple assets in global pivotal studies. To learn more about Dizal, please visit or follow us on Linkedin or Twitter. 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. ContactsInvestor Relations: ir@ Development: bd@ Contact: pr@ View original content to download multimedia: SOURCE Dizal Pharmaceutical
Yahoo
12-06-2025
- Business
- Yahoo
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 DZD8586DZD8586 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 DizalDizal 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 or follow us on Linkedin or X. Forward-Looking StatementsThis 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. ContactsInvestor Relations: ir@ Development: bd@ Contact: pr@ View original content to download multimedia: SOURCE Dizal Pharmaceutical Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-06-2025
- Business
- Yahoo
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 DZD8586DZD8586 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 DizalDizal 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 or follow us on Linkedin or X. Forward-Looking StatementsThis 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. ContactsInvestor Relations: ir@ Development: bd@ Contact: pr@ View original content to download multimedia: SOURCE Dizal Pharmaceutical Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-06-2025
- Business
- Yahoo
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 DZD8586DZD8586 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 DizalDizal 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 or follow us on Linkedin or X. Forward-Looking StatementsThis 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. ContactsInvestor Relations: ir@ Development: bd@ Contact: pr@ View original content to download multimedia: SOURCE Dizal Pharmaceutical Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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26-05-2025
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Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025
DZD8586 demonstrated significant anti-tumor efficacy in heavily pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with ORR of 84.2% DZD6008, a BBB-penetrant 4th generation EGFR TKI, showed encouraging and durable anti-tumor activity with favorable safety and tolerability as a monotherapy in heavily pre-treated non-small cell lung cancer (NSCLC) patients with EGFR-mutations SHANGHAI, May 26, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that it will present latest clinical study results of its investigational drugs DZD8586 and DZD6008 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The studies focus on B-cell non-Hodgkin lymphomas (B-NHLs) and non-small cell lung cancer (NSCLC) two disease areas Dizal has approved drugs and strong clinical pipeline. DZD8586: A Potential Novel Therapeutic Option for Patients with B-NHL A pooled analysis of two phase I/II studies of DZD8586 in CLL/SLL patients after treatment with covalent or non-covalent BTK inhibitors and BTK degraders (Abstract #7010) was selected for an oral presentation: An objective response rate (ORR) of 84.2% was achieved. Tumor response was observed in patients previously treated with BTK inhibitors and BCL-2 inhibitors, with response rates of 82.4% and 83.3%, respectively. Tumor response was observed irrespective of prior covalent/non-covalent BTK inhibitor, 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. Response was durable, with an estimated 9-month duration of response (DOR) rate of 83.3%. Prof. Jianyong Li, MD, PhD at Jiangsu Province Hospital, and the leading principal investigator of the study, said, "DZD8586 has shown promising antitumor activity in patients with relapsed/refractory CLL/SLL. By targeting both BTK-dependent and -independent signaling pathways, it could overcome resistance driven by target depletion or bypass activation, addressing significant limitations of current BTK inhibitors. We look forward to continued data readout from ongoing clinical studies." In addition, a Phase II study of DZD8586 as monotherapy in relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) (Abstract # e19050) will also be presented at the conference. Patients recruited in the trial had received 1-4 prior lines of therapy, and all were treated with anthracycline-and CD20-antibody based chemoimmunotherapy. At the doses of 50 mg and 75 mg QD, DZD8586 demonstrated promising antitumor activity and a manageable safety profile. Tumor responses were observed in both germinal center B-cell-like (GCB) and non-GCB subtypes. Updated results from this study will be disclosed at the 2025 European Hematology Association (EHA) Annual Congress. Prof. Lugui Qiu, MD, PhD at Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, the leading principal investigator of this study, said, "Treatment resistance in relapsed/refractory DLBCL remains a major clinical challenge. DZD8586, a non-covalent dual LYN/BTK inhibitor, has shown activity in both GCB and non-GCG subtypes, an important feature. With full BBB penetration and a favorable safety profile, it also shows promise in patients with CNS involvement, who typically confront a poor prognosis." DZD6008: A 4th generation EGFR TKI Poised to Address Unmet Needs in NSCLC The presentation at ASCO 2025 will feature promising pre-clinical and early clinical data from an ongoing Phase I/II TIAN-SHAN2 study of DZD6008 in patients with EGFRm NSCLC (Abstract #8616). Preclinical studies showed that DZD6008 was potent against EGFR mutations, including single (L858R/19del), double (T790M and L858R/19del), and triple mutations (C797X, T790M and 19del), with good selectivity (> 50-fold) over wild-type EGFR. As of March 31, 2025, a total of 12 EGFRm NSCLC patients were enrolled in the study during the dose escalation phase. The median number of prior lines of therapy was 4.5 (range 2-8). DZD6008 monotherapy demonstrated encouraging and durable antitumor activity with good tolerability in this heavily pre-treated population. Ten patients (83.3%) showed target lesion shrinkage with DZD6008 treatment. Partial response (PR) was observed at ≥20 mg. In line with preclinical findings, DZD6008 exhibited excellent BBB penetration, as well as sustained efficacy in patients with brain metastases. The ratio of measured free drug concentrations in CSF over plasma is over 1.0. Prof. Mengzhao Wang, MD, PhD at Peking Union Medical College Hospital, the leading principal investigator of the study said, "DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI with broad-spectrum of activity against different EGFR mutations. The clinical data revealed at ASCO 2025 suggested that DZD6008 has good antitumor activity and tolerability in EGFRm NSCLC patients who were resistant to EGFR TKIs, especially their durable remission effect on metastatic brain lesions. The ongoing TIAN-SHAN2 study aims to further validate these findings in a broader patient population." "The clinical data on DZD8586 and DZD6008 presented at this year's ASCO further highlight our strong R&D capabilities and competitive edge in tackling difficult-to-treat hematologic malignancies and lung cancer. The significant efficacy data and encouraging safety profile give us confidence to push forward to accelerate its clinical development programs," said Xiaolin Zhang, PhD, CEO of Dizal. About DZD8586DZD8586 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 DZD6008DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC. Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR. Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments. About DizalDizal 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 or follow us on Linkedin or X. Forward-Looking StatementsThis 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. ContactsInvestor Relations: ir@ Development: bd@ Contact: pr@ View original content to download multimedia: SOURCE Dizal Pharmaceutical
