迪扎尔将在2025年ASCO会议上展示其在血液恶性肿瘤和肺癌领域的最新进展-动脉网

Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025

CISION 等信源发布 2025-05-26 18:06



可切换为仅中文







DZD8586

demonstrated significant anti-tumor efficacy in heavily pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with ORR of 84.2%

在经过多轮治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者中展现出显著的抗肿瘤效力，客观缓解率（ORR）达到84.2%。

DZD6008

, a BBB-penetrant 4

，一种BBB渗透剂4

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

第一代EGFR TKI在经过多线治疗的EGFR突变型非小细胞肺癌（NSCLC）患者中，作为单药治疗显示出令人鼓舞且持久的抗肿瘤活性，同时具有良好的安全性和耐受性。

SHANGHAI

上海

，

May 26, 2025

2025年5月26日

/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

/PRNewswire/ -- 迪哲（上海证券交易所代码：688192），一家致力于开发治疗癌症和免疫疾病新药的生物制药公司，今日宣布将公布其在研药物的最新临床研究结果。

DZD8586

and

和

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.

在2025年美国临床肿瘤学会（ASCO）年会上，这些研究聚焦于B细胞非霍奇金淋巴瘤（B-NHLs）和非小细胞肺癌（NSCLC），这两个疾病领域是迪哲拥有已获批药物和强大临床管线的方向。

DZD8586

: A Potential Novel Therapeutic Option for Patients with B-NHL

：一种潜在的新型治疗B-NHL患者的选择

A pooled analysis of two phase I/II studies of

两项 I/II 期研究的汇总分析

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:

在使用共价或非共价BTK抑制剂和BTK降解剂治疗后的CLL/SLL患者（摘要#7010）被选为口头报告：

An objective response rate (ORR) of 84.2% was achieved

达到了84.2%的客观缓解率（ORR）

. 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.

之前接受过BTK抑制剂和BCL-2抑制剂治疗的患者中观察到肿瘤反应，反应率分别为82.4%和83.3%。

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.

无论之前是否接受过共价/非共价BTK抑制剂、BTK降解剂或BCL-2抑制剂治疗，也无论患者是否存在经典的BTK耐药突变（C481X）以及其他BTK突变（包括激酶失活突变），均观察到肿瘤反应。

Response was durable, with an estimated 9-month duration of response (DOR) rate of 83.3%.

反应持久，估计9个月的反应持续时间（DOR）率为83.3%。

Prof. Jianyong Li, MD, PhD at Jiangsu Province Hospital, and the leading principal investigator of the study, said,

江苏省人民医院医学博士、哲学博士、主任医师李建勇教授，同时也是该研究的首席主要研究者，表示：

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.'.

在复发/难治性CLL/SLL患者中显示出良好的抗肿瘤活性。通过靶向BTK依赖性和非依赖性信号通路，它可以克服由靶点耗竭或旁路激活引起的耐药性，解决当前BTK抑制剂的重大局限性。我们期待正在进行的临床研究的持续数据读出。

In addition, a Phase II study of

此外，二期研究

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.

作为单药治疗复发或难治性弥漫性大B细胞淋巴瘤（r/r DLBCL）（摘要编号：e19050）也将在会议上展示。试验中招募的患者曾接受过1至4线先前治疗，所有患者均接受过基于蒽环类药物和CD20抗体的化学免疫治疗。

At the doses of 50 mg and 75 mg QD, .

在每日50毫克和75毫克的剂量下，。

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.

展示了有希望的抗肿瘤活性和可控的安全性。在生发中心B细胞样（GCB）和非GCB亚型中均观察到肿瘤反应。本研究的更新结果将在2025年欧洲血液学协会（EHA）年会上公布。

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,

中国医学科学院血液病医院（血液学研究所）的邱录贵教授，医学博士，哲学博士，作为该研究的首席主要研究者，表示，

'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.'.

“复发/难治性DLBCL的治疗抵抗仍然是一个主要的临床挑战。DZD8586是一种非共价双重LYN/BTK抑制剂，在GCB和非GCB亚型中均显示出活性，这是一个重要特性。凭借完全的血脑屏障穿透能力和良好的安全性，它在伴有中枢神经系统受累的患者中也展现出潜力，而这些患者通常面临较差的预后。”

DZD6008

: A 4

：A 4

generation EGFR TKI Poised to Address Unmet Needs in NSCLC

第三代EGFR TKI有望满足NSCLC未竟之需

The presentation at ASCO 2025 will feature promising pre-clinical and early clinical data from an ongoing Phase I/II TIAN-SHAN2 study of

ASCO 2025年会上将展示来自正在进行的TIAN-SHAN2一期/二期研究的有前景的临床前和早期临床数据。

DZD6008

in patients with EGFRm NSCLC (Abstract #8616). Preclinical studies showed that

在EGFRm NSCLC患者中（摘要#8616）。临床前研究表明，

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.

对EGFR突变具有强效作用，包括单突变（L858R/19del）、双突变（T790M和L858R/19del）以及三重突变（C797X、T790M和19del），并对野生型EGFR具有良好的选择性（> 50倍）。

As of

截至

March 31, 2025

2025年3月31日

, 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).

，共有 12 名 EGFRm NSCLC 患者在剂量递增阶段被纳入研究。既往治疗的中位线数为 4.5（范围 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

单药治疗在这一经过多轮治疗的患者群体中展现出令人鼓舞且持久的抗肿瘤活性，并具有良好的耐受性。十名患者（83.3%）显示出目标病灶缩小。

DZD6008

treatment. Partial response (PR) was observed at ≥20 mg. In line with preclinical findings,

治疗。在≥20 mg时观察到部分反应（PR）。与临床前研究结果一致，

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.

表现出优异的血脑屏障穿透能力，以及在脑转移患者中的持续疗效。脑脊液与血浆中测得的游离药物浓度比值超过1.0。

Prof. Mengzhao Wang, MD, PhD at Peking Union Medical College Hospital, the leading principal investigator of the study said,

北京协和医院的王孟昭教授，医学博士，该研究的首席主要研究者表示，

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

是一种新型、高选择性、全血脑屏障渗透的EGFR酪氨酸激酶抑制剂，对不同的EGFR突变具有广谱活性。在2025年ASCO会议上公布的临床数据显示

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.'

在对EGFR TKIs耐药的EGFRm NSCLC患者中具有良好的抗肿瘤活性和耐受性，特别是对脑转移病灶的持久缓解效果。正在进行的TIAN-SHAN2研究旨在更广泛的患者群体中进一步验证这些发现。

'The clinical data on

“临床数据

DZD8586

and

和

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 .

“在今年的ASCO上展示的进一步突显了我们在应对难以治疗的血液恶性肿瘤和肺癌方面的强大研发能力和竞争优势。显著的有效数据和令人鼓舞的安全性让我们有信心推动其临床开发项目的加速进展，”该人士表示。

Xiaolin Zhang

肖林张

, PhD, CEO of Dizal.

博士，Dizal公司首席执行官。

About

关于

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).

是一流的、非共价的LYN/BTK双重抑制剂，具有完全的血脑屏障（BBB）渗透能力，被设计为B细胞非霍奇金淋巴瘤（B-NHL）的潜在治疗选择。

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.

虽然布鲁顿酪氨酸激酶（BTK）抑制剂已被批准用于治疗B-NHL，但耐药性可能通过两种主要机制产生：BTK C481X突变和不依赖BTK的BCR信号通路激活。目前尚无针对性疗法能够解决这两种耐药机制，这构成了一个紧迫的临床挑战。

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..

尽管BTK降解剂在早期临床研究中显示出令人鼓舞的疗效，但已有关于突变相关耐药性的报道，且降解剂相关的毒性可能影响长期临床应用。

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

对其他TEC家族激酶（TEC、ITK、TXK和BMX）具有高选择性。通过靶向BTK和LYN，它阻断了依赖于BTK和不依赖于BTK的BCR信号通路，有效抑制了B-NHLs在细胞系和动物模型中的肿瘤生长。一期临床试验表明，

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.

表现出良好的药代动力学特性、良好的中枢神经系统（CNS）渗透性、完全阻断BCR信号传导，并在B-NHL患者中显示出令人鼓舞的抗肿瘤疗效，同时具有良好的安全性和耐受性。

About

关于

DZD6008

is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

是一种新型、高选择性、全血脑屏障（BBB）渗透的EGFR酪氨酸激酶抑制剂（TKI），被设计为用于治疗晚期EGFR突变阳性（EGFRm）非小细胞肺癌（NSCLC）的潜在治疗选择。

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.

非小细胞肺癌是全球癌症死亡的主要原因。表皮生长因子受体（EGFR）基因是非小细胞肺癌最常见的驱动基因之一。多种药物可用于治疗对EGFR酪氨酸激酶抑制剂（TKIs）产生耐药性的EGFR突变型非小细胞肺癌患者，但临床效果并不令人满意。

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..

脑转移 (BM) 是非小细胞肺癌 (NSCLC) 患者死亡和疾病进展的主要原因之一。大约 23%-30% 的 NSCLC 患者在初次诊断时即伴随脑转移。以往的研究表明，在 EGFR 突变的患者中，脑转移的 3 年累计发生率介于 29.4% 至 60.3% 之间。

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and

目前，现有治疗对第三代EGFR TKI耐药的非小细胞肺癌的临床效益有限，并且

DZD6008

is expected to fill the unmet medical needs.

预计将会满足未被满足的医疗需求。

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

有效抑制EGFR突变的肿瘤在细胞系和动物模型中的生长。先前的临床研究已经验证了该分子的设计理念，并表明

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.

在第三代EGFR TKI治疗失败或接受过多线预处理的脑转移NSCLC患者中展现出良好的安全性和有效性。

About Dizal

关于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.

迪哲是一家生物医药公司，致力于发现、开发和商业化用于治疗癌症和免疫疾病的差异化疗法。该公司旨在开发首创和突破性的新药，进一步满足全球未被满足的医疗需求。

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 .

深深扎根于转化科学和分子设计，它已经建立了具有国际竞争力的产品组合，在全球关键研究中拥有两个领先的资产，这两个资产已经在中推出。

China

中国

。

To learn more about Dizal, please visit

要了解有关Dizal的更多信息，请访问

www.dizalpharma.com

, or follow us on

，或者关注我们

领英

或

。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿可能包含某些前瞻性陈述，这些陈述因其性质而受到重大风险和不确定性的影响。与迪哲（Dizal）相关的“预期”、“相信”、“估计”、“预计”和“意图”等词语及类似表达旨在识别某些前瞻性陈述。

Dizal does not intend to update these forward-looking statements regularly..

Dizal 并不打算定期更新这些前瞻性声明。

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.

这些前瞻性陈述是基于Dizal管理层在作出这些陈述时对未来事件的现有信念、假设、期望、估计、预测和理解。这些陈述并非对未来发展的保证，并且受风险、不确定性和其他因素的影响，其中一些因素超出Dizal的控制范围并且难以预测。

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..

因此，由于我们业务、迪哲竞争环境以及政治、经济、法律和社会状况的未来变化或发展，实际结果可能与前瞻性陈述中包含的信息存在重大差异。

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.

Dizal、董事及Dizal的员工（a）不承担更正或更新本网站所含前瞻性声明的义务；且（b）对任何前瞻性声明未能实现或被证明不正确的情况不承担责任。

Contacts

联系人

Investor Relations:

投资者关系：

ir@dizalpharma.com

Business Development:

业务发展：

bd@dizalpharma.com

Media Contact:

媒体联系人：

pr@dizalpharma.com