FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.
上海，2024年4月7日 /PRNewswire/ — Dizal（688192.SH）今天宣布，美国食品药品监督管理局（“FDA”）已授予其突破性疗法称号（BTD），作为局部晚期或转移性非小细胞肺癌（NSCLC）患者表皮生长因子受体（EGFR）外显子20插入物（Exon20ins）的一线治疗药物) 突变。
This Breakthrough Therapy Designation (BTD) approval was based on results from the global multi-center phase I/II study (WU-KONG1). At 2023 ESMO, Dizal reported main study results, showing sunvozertinib as a single agent with confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months.
这项突破性疗法称号（BTD）的批准基于全球多中心I/II期研究（WU-KONG1）的结果。在2023年ESMO上，Dizal报告了主要的研究结果，显示作为单一药物的sunvozertinib的确诊客观缓解率（CorR）为78.6％，无进展存活率（MPF）中位数为12.4个月。
Sunvozertinib was previously granted BTDs by both the US FDA and the China Center for Drug Evaluation (CDE) for relapsed or refractory patients It was subsequently approved in China in 2023 for the treatment of patients who failed 1st line treatment. NDA submissions for US and EU approvals in the same setting is anticipated later in 2024.
Sunvozertinib此前曾获得美国食品药品监督管理局和中国药物评估中心（CDE）的批准，用于治疗复发或难治性患者，随后于2023年在中国获准用于治疗失败的患者 1st 线路治疗。预计将于2024年晚些时候在同一环境下提交美国和欧盟批准的保密协议。
"We are delighted with the FDA's decision granting the Breakthrough Therapy Designation to sunvozertinib for first-line treatment, coming on the heels of earlier BTD approval in later lines of therapy — a clear indication of sunvozertinib's transformative potential in the treatment of patients with EGFR exon20ins NSCLC. Multiple clinical trials have consistently demonstrated sunvozertinib's significant clinical benefits to our patients. As a single, oral agent, it offers apparent advantages in both safety and patient compliance over chemotherapies and infusion." said Xiaolin Zhang, PhD, CEO of Dizal, "Now enrollment for the global pivotal study in relapsed and refractory setting (WU-KONG1 PART B) has been completed, and we are going to report the study results as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. A randomized global phase III study in the first line setting (WU-KONG28) is well underway. This new BTD will enable us work more closely with the FDA and accelerate its clinical development and regulatory submission."
“我们对美国食品药品管理局决定授予sunvozertinib用于一线治疗的突破性疗法称号感到高兴，这是继BTD早些时候在后期疗法中获得批准之后做出的，这清楚地表明了sunvozertinib在治疗表皮生长因子外显子20因子非小细胞肺癌患者方面的变革潜力。多项临床试验一致表明，sunvozertinib对我们的患者具有显著的临床益处。作为一种单一的口服药物，与化疗和输液相比，它在安全性和患者依从性方面具有明显的优势。” Dizal首席执行官张晓林博士说，“现在，复发和难治性全球关键研究（WU-KONG1 PART B）的注册已经完成，我们将在2024年美国临床肿瘤学会（ASCO）年会上以口头报告形式报告研究结果。第一线组的随机全球III期研究（WU-KONG28）正在顺利进行中。新的BTD将使我们能够与FDA更紧密地合作，加快其临床开发和监管申报。”
Affecting roughly 2%-4% of NSCLC patients, EGFR Exon20ins mutations have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. There has been a persistent lack of safe and effective targeted treatment options for this mutation, leading to limited survival benefits for patients.
影响大约 2%-4% 的非小细胞肺癌患者的表皮生长因子 exon20INS 突变由于其独特的空间构象、不同的突变亚型和高异质性而难以治疗。该突变一直缺乏安全有效的靶向治疗方案，导致患者的生存益处有限。
Sunvozertinib's innovative molecular structure enables it to overcome the inherent difficulties of targeting EGFR Exon20ins mutations, offering improved efficacy, safety, and ease of administration. Supported by findings yielded in the multicenter phase 2 pivotal study WU-KONG6, sunvozertinib was approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy, validating its potent and well-tolerated profile in previously treated NSCLC patients with EGFR Exon20ins mutations.
Sunvozertinib的创新分子结构使其能够克服靶向表皮生长因子外显子20ins突变的固有困难，从而提高疗效、安全性并易于给药。在多中心2期关键研究 WU-KONG6 得出的研究结果的支持下，sunvozertinib在中国获准用于治疗局部晚期或转移性非小细胞肺癌的成年患者，这些患者在铂类化疗期间或之后出现进展，这证实了其在先前接受过表皮生长因子外显子20ins突变治疗的非小细胞肺癌患者中的有效和良好的耐受性。
About Breakthrough Therapy Designation
关于突破性疗法称号
The FDA's Breakthrough Therapy Designation is intended to expedite the development and regulatory review of drugs for serious or life-threatening conditions. To qualify, new drugs must demonstrate promising preliminary clinical results indicating substantial improvement on clinically significant endpoints over existing treatments. Drugs designated as breakthrough therapies benefit from a suite of accelerated development policies, including close guidance by FDA experts throughout the clinical development process, significantly improving communication efficiency. Upon submission of a marketing application, such drugs may also be eligible for priority review if they meet relevant criteria.
美国食品药品管理局的突破性疗法认证旨在加快治疗严重或危及生命的疾病药物的开发和监管审查。要获得资格，新药必须表现出令人鼓舞的初步临床结果，表明与现有疗法相比，具有临床意义的终点有显著改善。被指定为突破性疗法的药物受益于一系列加速开发政策，包括FDA专家在整个临床开发过程中的密切指导，从而显著提高了沟通效率。提交上市申请后，如果此类药物符合相关标准，也可能有资格接受优先审查。
About sunvozertinib (DZD9008)
关于 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 for the treatment of advanced NSCLC with EGFR exon20ins mutations 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 mutations. The primary endpoint of the study, which was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) 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. 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.
Sunvozertinib是Dizal科学家发现的一种不可逆的表皮生长因子抑制剂，可靶向具有野生型表皮生长因子选择性的广泛表皮生长因子突变。2023年8月，sunvozertinib获得国家药监局批准，用于治疗铂类化疗后出现表皮生长因子外显子20ins突变的晚期非小细胞肺癌。该批准基于 WU-KONG6 研究的结果，该研究是sunvozertinib在基于铂的化疗中进行预处理的具有表皮生长因子外显子20因子突变的非小细胞肺癌的关键研究。该研究的主要终点是独立审查委员会（IRC）评估的确认总体回应率（CorR）达到60.8％。在各种表皮生长因子外显子20因子亚型以及经过预治疗且脑转移稳定的患者中均观察到抗肿瘤疗效。此外，在表皮生长因子致敏、T790M 和罕见突变（如 G719X、L861Q 等）以及HER2外显子20因子突变的非小细胞肺癌患者中，sunvozertinib还显示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在临床表现出良好的耐受性和可控的安全性。最常见的药物相关TEAE（治疗紧急不良事件）本质上为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.
两项全球关键研究正在进行中，分别针对表皮生长因子外显子20ins突变的非小细胞肺癌患者，分别针对二线（WU-KONG1 B部分）和一线环境（WU-KONG28）。
Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).
sunvozertinib的临床前和临床结果发表在同行评审期刊上 癌症发现 （IF: 39.397）和 《柳叶刀》呼吸医学 （如果：76.2）。
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. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies and one already launched.
Dizal是一家生物制药公司，致力于发现、开发和商业化治疗癌症和免疫疾病的差异化疗法。该公司的目标是开发一流的开创性新药，并进一步满足全球未满足的医疗需求。它根植于转化科学和分子设计，建立了具有国际竞争力的投资组合，在全球关键研究领域拥有两项领先资产，另一项已经推出。
To learn more about Dizal, please visit , or follow us at Linkedin or Twitter.
要了解有关 Dizal 的更多信息，请访问或通过 Linkedin 或 Twitter 关注我们。
Forward-Looking Statements
前瞻性陈述
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.
本新闻稿可能包含某些前瞻性陈述，这些陈述就其性质而言，存在重大风险和不确定性。“预期”、“相信”、“估计”、“期望” 和 “打算” 等词以及与Dizal相关的类似表述旨在识别某些前瞻性陈述。Dizal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. 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.
这些前瞻性陈述基于发表这些陈述时Dizal管理层对未来事件的现有信念、假设、预期、估计、预测和理解。这些陈述不能保证未来的发展，并受风险、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。因此，由于我们业务的未来变化或发展、Dizal的竞争环境以及政治、经济、法律和社会状况，实际业绩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、Dizal的董事和员工认为（a）没有义务更正或更新本网站上包含的前瞻性陈述；（b）如果任何前瞻性陈述未实现或事实证明不正确，则不承担任何责任。
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SOURCE Dizal Pharmaceutical
来源 Dizal Phark
译文内容由第三方软件翻译。