Sunvozertinib monotherapy demonstrated superior efficacy and excellent safety in patients in the 1st line setting for advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion (Exon20ins) mutations, achieving a confirmed objective response rate (cORR) of 78.6% .

Sunvozertinib单药治疗在表皮生长因子受体（EGFR）外显子20插入（Exon20ins）突变的晚期或转移性非小细胞肺癌（NSCLC）一线治疗中表现出优异的疗效和优异的安全性，达到了确诊的客观反应率（cORR）为78.6%。

Anti-tumor efficacy of sunvozertinib was durable, as indicated by a median progression-free survival (PFS) of 12.4 months at the recommended phase II dose (RP2D) of 300mg

sunvozertinib的抗肿瘤疗效持久，推荐的II期剂量（RP2D）300mg的中位无进展生存期（PFS）为12.4个月

Anti-tumor activity was observed across various subtypes of EGFR Exon20ins mutations.

在EGFR外显子20ins突变的各种亚型中观察到抗肿瘤活性。

SHANGHAI, Oct. 20, 2023 /PRNewswire/ -- Dizal today announced the latest research findings on the efficacy and safety of sunvozertinib in treatment-naïve patients with advanced or metastatic NSCLC with EGFR Exon20ins mutations at the 2023 European Society for Medical Oncology (ESMO) Congress.

2023年10月20日，上海/PRNewswire/-Dizal今天在2023年欧洲肿瘤内科学会（ESMO）宣布了关于sunvozertinib治疗初治晚期或转移性NSCLC伴EGFR Exon20ins突变的疗效和安全性的最新研究结果。）大会。

The pooled analysis is based on the treatment-naïve NSCLC patients with EGFR Exon20ins mutations from the global multi-center phase I/II study (WU-KONG1) and the phase II study initiated by Chinese investigators (WU-KONG15). As of September 15, 2023, 28 patients were included in the efficacy analysis and 57 patients were included in the safety analysis..

汇总分析基于全球多中心I/II期研究（WU-KONG1）和中国研究者发起的II期研究（WU-KONG15）的EGFR外显子20ins突变的初治NSCLC患者。截至2023年9月15日，28名患者被纳入疗效分析，57名患者被纳入安全性分析。。

The research findings revealed that among the 28 patients included in the efficacy analysis, 100% of them exhibited a reduction in target lesions. The confirmed objective response rate (cORR) by investigator assessment reached an impressive 78.6%. Notably, the 300mg cohort demonstrated a median progression-free survival (mPFS) of 12.4 months, surpassing previous research findings.

研究结果显示，在纳入疗效分析的28例患者中，100%的患者表现出靶病变减少。研究者评估确认的客观缓解率（cORR）达到了令人印象深刻的78.6%。值得注意的是，300mg队列的中位无进展生存期（mPFS）为12.4个月，超过了之前的研究结果。

Sunvozertinib showcased potent and durable anti-tumor efficacy, demonstrating favorable efficacy across various subtypes of EGFR Exon20ins mutations. These results highlight its potential as a leading treatment option for treatment-naïve NSCLC patients with EGFR Exon20ins mutations..

Sunvozertinib显示出有效和持久的抗肿瘤功效，证明了EGFR外显子20ins突变的各种亚型的有利功效。这些结果凸显了其作为具有EGFR外显子20ins突变的未经治疗的NSCLC患者的主要治疗选择的潜力。。

Additionally, sunvozertinib is well tolerated with overall safety profile consistent with previous reports in the later-line settings and similar to traditional EGFR-TKIs.

此外，sunvozertinib耐受性良好，整体安全性与之前在后期设置中的报告一致，与传统的EGFR-TKI类似。

'Currently, there is a lack of targeted therapeutic drugs for first-line treatment of EGFR Exon20ins-mutated NSCLC, resulting in limited survival benefits for patients. However, significant advances have been made in research in this field in recent years. At this year's ESMO Congress, the results from the PAPILLON study were presented, evaluating the potential of Amivantamab in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic NSCLC with EGFR Exon 20ins mutations,' said Xiaolin Zhang, PhD, Chairman and CEO of Dizal, 'Moreover,  the latest research results from the pooled analysis of sunvozertinib provide further evidence to this therapeutic area and showcase its significant tumor response and clinically meaningful outcomes as a potential 'best-in-class' treatment.

'目前，EGFR外显子20ins突变NSCLC一线治疗缺乏靶向治疗药物，导致患者生存获益有限。然而，近年来在这一领域的研究取得了重大进展。在今年的ESMO大会上，PAPILLON研究的结果被提出，评估了Amivantamab联合化疗一线治疗EGFR外显子20ins突变的晚期或转移性NSCLC患者的潜力，张晓林博士说，Dizal主席兼首席执行官，“此外，sunvozertinib汇总分析的最新研究结果为该治疗领域提供了进一步的证据，并展示了其作为潜在的“一流”治疗的显着肿瘤反应和临床意义的结果。

This is particularly exciting for us, and we eagerly anticipate the ongoing evaluation of efficacy and safety of sunvozertinib as a first-line treatment for NSCLC with EGFR Exon20ins mutations as compared to platinum-based doublet chemotherapy in the global multicenter, randomized phase III study (WU-KONG28).

这对我们来说尤其令人兴奋，我们迫切期待在全球多中心随机III期研究中，与基于铂类的双联化疗相比，sunvozertinib作为EGFR Exon20ins突变NSCLC一线治疗的疗效和安全性的持续评估。（吴KONG28）。

This study will offer new and effective treatment options in this realm.' .

这项研究将为这个领域提供新的有效的治疗选择。

About sunvozertinib (DZD9008)

关于舒伏泽替尼（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 for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapies.

Sunvozertinib是Dizal科学家发现的一种不可逆的EGFR抑制剂，靶向具有野生型EGFR选择性的广泛EGFR突变。2023年8月，sunvozertinib获得NMPA的批准，用于铂类化学疗法后EGFR外显子20ins突变治疗晚期NSCLC。

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 mutations. As assessed by the Independent Review Committee (IRC), the primary endpoint of cORR at RP2D of 300mg QD reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR Exon20ins subtypes, and in patients with pretreated and stable brain metastasis.

该批准基于WU-KONG6研究的结果，该研究是sunvozertinib在具有EGFR外显子20ins突变的铂类化疗预处理的NSCLC中的关键研究。根据独立审查委员会（IRC）的评估，cORR在300mg QD的RP2D的主要终点达到60.8%。在广泛的EGFR外显子20ins亚型以及经过预处理和稳定的脑转移患者中观察到抗肿瘤功效。

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 mutations..

此外，sunvozertinib在EGFR致敏，T790M和罕见突变（如G719X，L861Q等）以及HER2 Exon20ins突变的NSCLC患者中也表现出令人鼓舞的抗肿瘤活性。。

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.

Sunvozertinib在临床上表现出良好的耐受性和可控性。最常见的与药物有关的TEAE（治疗紧急不良事件）本质上是1/2级，临床上可控。

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 mutations.

在EGFR Exon20ins突变的NSCLC患者中，分别在≥二线（WU-KONG1 B部分）和一线环境（WU-KONG28）中进行了两项全球关键性研究。

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journal of Cancer Discovery (IF:39.397).

sunvozertinib的临床前和临床结果发表在同行评审的癌症发现杂志（IF:39.397）上。

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 around the world.

Dizal是一家生物制药公司，致力于发现，开发和商业化用于治疗癌症和免疫疾病的分化疗法。该公司旨在开发一流，开创性的新药，进一步解决世界各地未满足的医疗需求。

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. .

它扎根于转化科学和分子设计，建立了五个临床阶段资产的国际竞争组合，其中两个主要资产在全球关键研究中，一个已经启动。 .

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

要了解有关Dizal的更多信息，请访问www.dizalpharma.com，或在Linkedin或Twitter上关注我们。

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，这些陈述本质上受到重大风险和不确定性的影响。与Dizal相关的“预期”，“相信”，“估计”，“期望”和“意图”等词语以及类似的表达方式旨在确定某些前瞻性陈述。

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

迪扎尔不打算定期更新这些前瞻性陈述。。

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在作出这些陈述时对Dizal管理的现有信念，假设，期望，估计，预测和理解。这些陈述不能保证未来的发展，并受到风险，不确定性和其他因素的影响，其中一些因素超出了迪扎尔的控制范围，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，由于我们业务的未来变化或发展，迪扎尔的竞争环境以及政治，经济，法律和社会条件，实际结果可能与前瞻性声明中包含的信息大不相同。。

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，Dizal的董事和员工承担（a）没有义务更正或更新本网站上包含的前瞻性声明；（b）如果任何前瞻性陈述没有实现或投票不正确，则不承担任何责任。

Contacts

联络

Investor Relations: ir@dizalpharma.comBusiness Development: bd@dizalpharma.com

投资者关系：ir@dizalpharma.comBusiness发展：bd@dizalpharma.com

SOURCE Dizal Pharmaceutical

来源Dizal制药