A Phase II, Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib Plus Anlotinib in EGFR-Sensitive Mutations Combined With Co-Mutations Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (WUKONG-32)

This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.
Condition or disease Intervention/treatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2

开始日期2024-04-30

申办/合作机构

湖南省肿瘤医院

NCT06355609 / Not yet recruiting临床2期IIT

A Perspective Observation Phase II, Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib Plus Anlotinib in EGFR-Sensitive Mutations Combined With Co-Mutations Locally Advanced or Metastatic NSCLC

开始日期2024-04-30

申办/合作机构

湖南省肿瘤医院

NCT06195189 / Recruiting临床1/2期IIT

Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I/II (WU-KONG36)

To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.

开始日期2024-02-29

申办/合作机构

四川大学

100 项与舒沃替尼相关的临床结果

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100 项与舒沃替尼相关的转化医学

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100 项与舒沃替尼相关的专利（医药）

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项与舒沃替尼相关的文献（医药）

2024-01-01·JTO clinical and research reports

The Impact of On-Target Resistance Mediated by EGFR-T790M or EGFR-C797S on EGFR Exon 20 Insertion Mutation Active Tyrosine Kinase Inhibitors.

Article

作者: Ikei S Kobayashi ; William Shaffer ; Hollis Viray ; Deepa Rangachari ; Paul A VanderLaan ; Susumu S Kobayashi ; Daniel B Costa

Introduction:

Mechanisms of resistance to EGFR exon 20 insertion mutation active inhibitors have not been extensively studied in either robust preclinical models or patient-derived rebiopsy specimens. We sought to characterize on-target resistance mutations identified in EGFR exon 20 insertion-mutated lung cancers treated with mobocertinib or poziotinib and evaluate whether these mutations would or would not have cross-resistance to next-generation inhibitors zipalertinib, furmonertinib, and sunvozertinib.

Methods:

We identified mechanisms of resistance to EGFR exon 20 insertion mutation active inhibitors and then used preclinical models of EGFR exon 20 insertion mutations (A767_V769dupASV, D770_N771insSVD, V773_C774insH) plus common EGFR mutants to probe inhibitors in the absence/presence of EGFR-T790M or EGFR-C797S.

Results:

Mobocertinib had a favorable therapeutic window in relation to EGFR wild type for EGFR exon 20 insertion mutants, but the addition of EGFR-T790M or EGFR-C797S negated the observed window. Zipalertinib had a favorable therapeutic window for cells driven by EGFR-A767_V769dupASV or EGFR-D770_N771insSVD in the presence or absence of EGFR-T790M. Furmonertinib and sunvozertinib had the most favorable therapeutic windows in the presence or absence of EGFR-T790M in all cells tested. EGFR-C797S in cis to all EGFR mutations evaluated generated dependent cells that were resistant to the covalent EGFR tyrosine kinase inhibitors mobocertinib, zipalertinib, furmonertinib, sunvozertinib, poziotinib, and osimertinib.

Conclusions:

This report highlights that poziotinib and mobocertinib are susceptible to on-target resistance mediated by EGFR-T790M or -C797S in the background of the most prevalent EGFR exon 20 insertion mutations. Furmonertinib, sunvozertinib, and to a less extent zipalertinib can overcome EGFR-T790M compound mutants, whereas EGFR-C797S leads to covalent inhibitor cross-resistance-robust data that support the limitations of mobocertinib and should further spawn the development of next-generation covalent and reversible EGFR exon 20 insertion mutation active inhibitors with favorable therapeutic windows that are less vulnerable to on-target resistance.

2023-11-14·Drugs

Sunvozertinib: First Approval.

Review

作者: Sohita Dhillon

Sunvozertinib (^®) is an oral, irreversible, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Dizal Pharmaceuticals (a joint venture company formed by AstraZeneca and the Chinese Future Industry Investment Fund) for the treatment of non-small cell lung cancer (NSCLC). Sunvozertinib has potent activity against EGFR mutations, including EGFR exon 20 insertion (exon20ins), and weak activity against wild-type EGFR. In August 2023, sunvozertinib received its first approval for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon20ins mutations whose disease has progressed on or after, or who are intolerable to, platinum-based chemotherapy. Sunvozertinib was granted conditional approval based on the overall response rates and duration of response in a single-arm phase 2 trial. Its full approval is contingent on results from ongoing confirmatory phase 3 randomized trials. Clinical studies of sunvozertinib are underway in several countries worldwide. This article summarizes the milestones in the development of sunvozertinib leading to this first approval for metastatic NSCLC with EGFR exon20ins.

2023-10-31·Zhonghua yi xue za zhi

[China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)].

Article

作者: Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care ; Chinese Association for Clinical Oncologists

The incidence and mortality of lung cancer rank first among malignant tumors in China. Among them, non-small cell lung cancer (NSCLC) is the most important pathological type, accounting for 80%-85% of lung cancer patients, including adenocarcinoma, squamous cell carcinoma and other pathological subtypes. In recent years, with the discovery of epidermal growth factor receptor (EGFR) gene and the successful development of tyrosine kinase inhibitors (TKIs), the treatment efficacy of stage Ⅳ NSCLC patients with EGFR gene sensitive mutation has been greatly improved. As of August 23, 2023, the first generation EGFR-TKIs, gefitinib, icotinib, and erlotinib; the second generation EGFR-TKIs, afatinib and dacomitinib; and the third generation EGFR-TKIs, osimertinib, almonertinib, furmonertinib and befotertinib were all approved for marketing by China National Medical Products Administration (NMPA). In addition, multiple domestic third-generation EGFR-TKIs are undergoing clinical trials, such as rezivertinib (BPI-7711), limertinib (ASK120067), and oritinib (SH-1028). Meanwhile, mobocertinib and sunvozertinib, which targets EGFR 20ins mutations, were also approved by NMPA. With the increasing variety of EGFR-TKIs approved for marketing subsequently, it brings confusion to clinicians when choosing specific medications, and there is an urgent need to develop relevant treatment guidelines. Hence, the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and the Chinese Association for Clinical Oncologists convened experts to integrate the research results of various EGFR-TKIs, and proposed the "China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)", to provide reference for better clinical practice.

177

项与舒沃替尼相关的新闻（医药）

2024-04-07

·药研发

【药研发0408】普方18亿美金被Genmab收购 | 诺华核药Ⅲ期临床积极...

「本文共：17条资讯，阅读时长约：3分钟」今日头条普方18亿美金被Genmab收购。Genmab公司与普方生物达成最终协议，将以18亿美元现金收购后者，获得该公司下一代ADC产品组合资产。2024年1月，普方生物开发的靶向FRα的ADC药物rinatabart sesutecan (Rina-S，PRO1184)已获FDA授予快速通道资格，用于治疗表达叶酸受体α（FRα）的高级别浆液性或子宫内膜样铂耐药的卵巢癌患者。该新药目前正处于治疗卵巢癌和其他FRα表达实体瘤I/II期临床阶段。国内药讯1.益普生「兰瑞肽」获批新适应症。益普生醋酸兰瑞肽缓释注射液（预充式）获国家药监局批准新适应症，用于治疗不可切除、高分化或中分化、局部晚期或转移性胃肠胰神经内分泌瘤（GEP-NETs）成人患者；以及用于类癌综合征成人患者。在临床研究中，该产品可显著延长患者的无进展生存期（PFS）达38.5个月，疾病复发风险降低53%。2.九源基因「司美格鲁肽」报产。九源基因的生物类似药司美格鲁肽注射液上市申请获CDE受理，用于成人2型糖尿病患者的血糖控制。司美格鲁肽是一款长效GLP-1（胰高血糖素样肽-1）受体激动剂，原研产品由诺和诺德开发，商品名为诺和泰®，已获批用于辅助饮食和运动以改善2型糖尿病（T2DM）患者的血糖控制。今年初，司美格鲁肽片（Rybelsus，诺和忻）也在华获批上市，用于治疗2型糖尿病。3.君实降脂新药新适应症报产。君实生物PCSK9抑制剂昂戈瑞西单抗的新适应症上市申请获CDE受理，推测申报的适应症为“单药治疗原发性高胆固醇血症和混合型高脂血症患者”。公布在AHA2023年会上的Ⅲ期数据显示，治疗24周时，昂戈瑞西单抗（150mg Q2W和300mg Q4W）两队列LDL-C较基线变化百分比与安慰剂组差异的最小二乘均值分别为-67.74%和-61.2%；且疗效维持长达52周。4.泰它西普获干燥综合征快速通道资格。荣昌生物BLyS/APRIL双靶点融合蛋白泰它西普获FDA授予快速通道资格，用于治疗干燥综合征。该新药通过同时抑制BLyS和APRIL两个细胞因子的过度表达，“双管齐下”阻止B细胞的异常分化和成熟，从而治疗自身免疫性疾病。此前，该新药已获批用于治疗系统性红斑狼疮；泰它西普类风湿性关节炎适应症的补充上市申请也已获得CDE受理。5.驯鹿CAR-T美国获批自免病IND。驯鹿生物自主研发的靶向BCMA的CAR-T产品伊基奥仑赛注射液（CT103A）获FDA批准IND申请，拟开发用于治疗难治性全身型重症肌无力（gMG）患者。在一项针对复发/难治性抗体介导的神经系统特发性炎症性疾病的探索性研究（NCT04561557）中，2例难治性重症肌无力（MG）患者接受单次CT103A回输3个月-18个月期间，患者MG-ADL评分、QMG评分、MG-QOL评分和改良Rankin评分（mRS）持续改善。6.恩华抑郁症新药获批IND。恩华药业1类化药NH103草酸盐片获国家药监局临床试验默示许可，拟开发用于治疗抑郁症。NH103对常用抗抑郁靶点5-羟色胺转运蛋白（SERT）和抗抑郁活性增效靶点5-HT2A/5-HT2C受体均有较强且均衡的抑制活性，可阻断SERT将5-羟色胺（5-HT）回收至突触前的过程，从而特异性地提升5-HT的浓度。目前暂无相同机制的抗抑郁药上市。国际药讯1.第一三共ADC获批不限癌种sBLA。FDA加速批准阿斯利康与第一三共开发的HER2靶向抗体偶联药物（ADC）Enhertu（trastuzumab deruxtecan）的补充上市申请，用于治疗不可切除或转移性HER2阳性（免疫组化[IHC] 3+）实体瘤成年患者。这是首款获批的不限癌种HER2 ADC疗法。在DESTINY-PanTumor02中，Enhertu确认客观缓解率（ORR）达到51.4%，中位缓解持续时间（DOR）为19.4个月。2.BMS骨髓瘤CAR-T获批扩展使用范围。百时美施贵宝与2seventy bio开发的BCMA CAR-T疗法Abecma（idecabtagene vicleucel）获FDA批准扩大适用范围，用于治疗接受包括免疫调节剂（IMiD）、蛋白酶体抑制剂（PI）和CD38单抗三类药物治疗后进展的复发或难治性多发性骨髓瘤（MM）患者。在III期KarMMa-3临床中，Abecma较标准治疗使疾病进展或死亡风险降低51%（mPFS：13.3个月vs4.4个月）。此前，Abecma已获批用于治疗已接受过四线及以上治疗的R/R MM患者。3.诺华核药Ⅲ期临床积极。诺华靶向放射性配体疗法Pluvicto（177Lu-PSMA-617）治疗去势抵抗性前列腺癌（mCRPC）患者的Ⅲ期PSMAfore临床达到主要终点和关键次要终点。与使用改变种类的雄激素受体通路抑制剂（ARPI）治疗相比，Pluvicto治疗改善患者无进展生存期（rPFS），使疾病进展或死亡风险降低59%（p<0.0001）；在未经调整的意向治疗（ITT）患者中，患者的OS风险比小于1.0。Pluvicto的安全性与之前研究一致。4.默沙东肺癌联合疗法启动III期临床。默沙东宣布启动口服KRAS G12C抑制剂MK-1084联合PD-1抑制剂Keytruda一线治疗KRAS G12C突变且肿瘤表达PD-L1（TPS≥50%）转移性非小细胞肺癌（NSCLC）的III期临床试验。I期临床初步结果显示，MK-1084单药治疗实体瘤患者时ORR达到22%；在与Keytruda联合治疗NSCLC患者时ORR达71%，而在PD-L1表达（TPS≥50%）患者中ORR达到75%。5.Candel公司胰腺癌疗法II期临床积极。Candel公司溶瘤病毒疗法CAN-2409联合伐昔洛韦和化疗用于交界性可切除胰腺癌的II期研究结果积极。与对照组相比，CAN-2409联合治疗显著延长患者中位总生存期（mOS：28.8个月vs12.5个月）；患者两年期生存率分别为71.4%和16.7%；36个月时，接受CAN-2409并在手术前进行放化疗的患者存活率预估为47.6%，而对照组为16.7%。此外，CAN-2409耐受性良好。6.Macrogenics公司ADC早期临床积极。Macrogenics公司靶向B7H3的抗体偶联药物vobramitamab duocarmazine（MGC-018）治疗去势抵抗前列腺癌的Ⅱ期临床TAMARACK结果积极。数据显示，患者接受MGC-018（2.0mg/kg和2.7mg/kg）治疗，患者前列腺特异性抗原（PSA）水平下降超过50%；因副作用停止治疗的比例分别为4.4%和2.3%，没有副作用致死案例出现。详细结果将在今年ASCO会议上报告。7.强生131亿美元收购Shockwave Medical。强生宣布与Shockwave Medical达成最终协议，将以131亿美元总交易金额收购后者，并获得该公司创新血管内碎石术（IVL）技术平台以及用于缓解难治性心绞痛症状的Reducer System，以扩大强生医疗技术部门（Johnson & Johnson MedTech）在心血管介入治疗的应用范围。该交易预计将于2024年年中完成。此前，强生医疗技术部门已成功收购了心血管医疗技术巨头Abiomed以及左心耳闭合装置公司Laminar。医药热点1.三部委发文支持建设三级养老服务网络。4月2日，国家发改委等三部门修订印发《“十四五”积极应对人口老龄化工程和托育建设实施方案》，中央预算内投资支持三级养老服务网络中的县级养老服务中心建设和县城公办托育服务能力建设项目，并提出，引导金融机构对普惠养老、普惠托育企业和机构提供金融支持。中央预算内投资原则上按照东、中、西、东北地区分别不超过平均总投资的40%、60%、80%、80%的比例进行支持。2.山东省首家罕见病专科病房成立。4月3日，山东省济宁市第一人民医院成立济宁市罕见病诊疗中心，并率先在全省设立成建制的罕见病专科病房。罕见病专科病房由济宁市第一人民医院神经内科主任闫中瑞牵头，专职医生负责常规运行，秉承罕见病多学科诊疗模式，除专职医师外，多个临床科室派出医师兼职管理病房，同时还有罕见病多学科专家(MDT)团队参与MDT查房，为罕见病和未诊断疾病患者提供优质的医疗服务。3.中国科大附一院离子医学中心开诊。4月3日上午，中国科大附一院离子医学中心（合肥离子医学中心）正式开诊，这是安徽省首家全面开诊的质子治疗中心，旨在为广大肿瘤患者提供高质量的医疗服务。中国科大附一院离子医学中心位于合肥市高新区长宁大道与燕子河路交叉口东南角，是安徽省、合肥市超前布局，与中国科学院合肥物质科学研究院合作共建的创新平台项目。评审动态 1. CDE新药受理情况（04月07日) 2. FDA新药获批情况（北美04月05日）股市资讯上个交易日 A 股医药板块 +0.17%涨幅前三跌幅前三江苏吴中+8.56% 景峰医药-8.44%奥泰生物+8.43% 大理药业-6.43%富士莱 +7.20% 华神科技-6.07%【迪哲医药]舒沃哲®一线治疗EGFR 20号外显子插入突变型晚期非小细胞肺癌获美国FDA突破性疗法认定。[信立泰]公司与Salubris Bio收到国家药监局核准签发的《药品临床试验批准通知书》，同意JK07注射液开展治疗成人慢性心力衰竭(RENEU-HF)的II期临床试验。[海创药业]HP501缓释片联合非布司他片进行原发性痛风伴高尿酸血症患者的临床试验获得药物临床试验批准通知书。HP501是公司自主研发的小分子化学创新药。[百奥泰]于近日收到国家药监局核准签发的关于托珠单抗注射液(商品名称:施瑞立®)的《药品注册证书》。该药品获批新规格:200mg/10mL。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

临床3期免疫疗法临床2期快速通道细胞疗法

2024-04-07

·PRNewswire

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. 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. 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. "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." 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. 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. About Breakthrough Therapy Designation 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. 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 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 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 mutations. 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). 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 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. To learn more about Dizal, please visit , or follow us at 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. Contacts Investor Relations: [email protected] Business Development: [email protected] SOURCE Dizal Pharmaceutical

临床结果突破性疗法上市批准临床2期ASCO会议

2024-04-07

·美通社

迪哲医药舒沃哲EGFR ex20ins突变晚期一线再获FDA突破性疗法认定，全球注册临床研究入选2024 ASCO口头报告

上海 2024年4月7日 /美通社/ -- 2024年4月7日，迪哲医药（股票代码：688192.SH）宣布美国食品药品监督管理局（FDA）授予其首款自主研发的新型肺癌靶向药舒沃哲 ® （通用名：舒沃替尼片）突破性疗法认定，用于一线治疗携带表皮生长因子受体（ EGFR ） 20 号外显子插入（ exon20ins ）突变的晚期非小细胞肺癌（ NSCLC ）患者。这是继针对经治EGFR exon20ins突变型晚期NSCLC，舒沃哲 ® 成为肺癌领域首个获中、美双"突破性疗法认定"国创新药后的又一重要里程碑。目前，舒沃哲 ® 是全球唯一全线获 FDA 突破性疗法认定治疗EGFR exon20ins突变型NSCLC的药物。 EGFR exon20ins突变是非小细胞肺癌罕见难治靶点，发生率约占NSCLC的2%-4%。因其空间构象特殊、突变亚型繁多、异质性强，导致传统EGFR TKI对该靶点基本无效，中位无进展生存期（mPFS）和中位总生存期（mOS）不及EGFR敏感突变型晚期NSCLC的一半。过去20余年里，针对EGFR exon20ins突变NSCLC的新药研发大多折戟沉沙，长期缺乏安全有效的靶向治疗。舒沃哲 ® 于2023年8月在中国通过优先审评首发上市，填补了该领域近 20 年来的临床治疗空白，是目前全球唯一获批针对EGFR exon20ins突变型晚期NSCLC的小分子TKI。凭借独特且灵活的创新分子设计，舒沃哲 ® 突破EGFR exon20ins突变靶点难成药的魔咒，全面提升该靶点治疗的疗效、安全性及便利性。中国注册临床研究"悟空6"（WU-KONG6）数据显示，舒沃哲 ® 针对经治EGFR exon20ins突变型晚期NSCLC高效低毒，疗效和安全性均为同类潜在最佳。针对该适应症的全球注册临床研究"悟空 1 B 部分"（ WU-KONG1 PARTB ），已顺利完成全部患者入组，最新积极研究数据将首次在 2024 年美国临床肿瘤学会（ ASCO ）年会上以口头报告形式公布。本次突破性疗法认定主要基于舒沃哲 ® 的一项I/II期、开放标签、国际多中心临床研究"悟空1"（WU-KONG1）。2023年ESMO大会上，迪哲医药公布了该研究和中国研究者发起的II期研究"悟空15"（WU-KONG15）的汇总分析数据：舒沃哲 ® 单药一线治疗EGFR exon20ins突变型晚期NSCLC的经确认客观缓解率（cORR）达 78.6% ，II期推荐剂量（RP2D）300mg组中位无进展生存期（mPFS）为 12.4 个月，再次展现"高效低毒，同类最佳"的治疗潜力。迪哲医药创始人、董事长兼首席执行官张小林博士表示："舒沃哲 ® 再获FDA突破性疗法认定，是对迪哲在EGFR exon20ins突变非小细胞肺癌领域研究成果的高度肯定。同时，‘悟空1'（WU-KONG1）研究最新数据积极，成功入选ASCO口头报告令我们倍感振奋。我们还在加速推进舒沃哲 ® 一线治疗EGFR exon20ins突变型晚期NSCLC的全球多中心III期临床研究"悟空28"（WU-KONG28），期待尽快为全球更多患者带来突破性治疗选择。" 美国FDA授予"突破性疗法认定"旨在加速治疗严重或危及生命的疾病的药物开发和监管审查。新药需要通过令人鼓舞的初步临床结果，证明其与现有治疗手段相比具有显著临床优势。被授予"突破性疗法认定"的新药将享有一系列加速药物开发的政策，包括FDA专家介入指导临床开发整个过程，从而大幅提高与FDA沟通的效率。在提交药品上市申请时，符合相关标准即可获得优先审评。 - End - 关于舒沃哲 ® （舒沃替尼）舒沃哲 ® 是一款口服、不可逆、针对多种EGFR突变亚型的高选择性EGFR酪氨酸激酶抑制剂（TKI），首个适应症于2023年8月获国家药监局通过优先审评在中国批准上市，用于既往经含铂化疗出现疾病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体（EGFR）20号外显子插入（exon20ins）突变的局部晚期或转移性非小细胞肺癌（NSCLC）患者。关于迪哲医药迪哲医药（股票代码：688192.SH）是一家创新型生物医药企业，专注于恶性肿瘤、免疫性疾病领域创新疗法的研究、开发和商业化。公司坚持源头创新的研发理念，以推出全球首创药物（First-in-class）和具有突破性潜力的治疗方法为目标，旨在填补全球未被满足的临床需求。基于行业领先的转化科学和新药分子设计与筛选技术平台，公司已建立了具备全球竞争力的产品管线，两大领先产品处于全球关键性临床试验阶段，其中一款已获批上市。欲了解更多信息，请关注微信公众号：迪哲Dizal，或访问www.dizalpharma.com。前瞻性声明本新闻所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用"预期"、"相信"、"预测"、"期望"、"打算"、"有望"及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员概不承担（a）更正或更新本网站所载前瞻性表述的任何义务；及（b）若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。更多信息，敬请联系投资者关系：ir@dizalpharma.com 商务合作：bd@dizalpharma.com

ASCO会议突破性疗法优先审批申请上市临床结果

100 项与舒沃替尼相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
EGFR 20号外显子插入突变非小细胞肺癌	批准上市	中国更多	迪哲（江苏）医药股份有限公司更多
HER2突变型非小细胞肺癌	临床2期	中国更多	迪哲（江苏）医药股份有限公司更多
EGFR突变的非小细胞肺癌	临床2期	韩国更多	迪哲（江苏）医药股份有限公司更多
非霍奇金淋巴瘤	终止	中国更多	迪哲（江苏）医药股份有限公司更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


CTR20211009 \| NCT03974022 \| CTR20192097 (WU-KONG1 \| WU-KONG2 \| WU-KONG6, PRNewswire) 人工标引	临床1/2期	EGFR 20号外显子插入突变非小细胞肺癌一线 \| 二线 EGFR Exon 20 Insertion Mutation	119	Sunvozertinib	(膚願製鑰糧衊衊蓋鏇壓) = 簾範鏇獵艱醖齋遞齋遞糧衊齋獵廠廠艱鏇鑰艱 (簾醖鏇糧簾觸廠窪製觸 )	积极	2022-08-05
				Sunvozertinib (baseline brain metastasis)	(膚願製鑰糧衊衊蓋鏇壓) = 窪願願簾憲醖醖築範鏇糧衊齋獵廠廠艱鏇鑰艱 (簾醖鏇糧簾觸廠窪製觸 )
NCT05559645 \| NCT03974022 (WU-KONG1 \| WU-KONG15, ESMO2023) 人工标引	临床1/2期	EGFR 20号外显子插入突变非小细胞肺癌一线 EGFR Exon20 Mutation	28	Sunvozertinib	(廠獵鑰積積糧獵觸膚觸) = 齋壓網鹽醖齋網膚蓋選窪醖齋壓鑰構衊鑰衊衊 (蓋壓遞積淵鹽憲鹽築鹹 )	积极	2023-10-23
				Sunvozertinib	(廠獵鑰積積糧獵觸膚觸) = 遞鹽壓繭鹽遞鏇齋願顧窪醖齋壓鑰構衊鑰衊衊 (蓋壓遞積淵鹽憲鹽築鹹 )
NCT05712902 \| CTR20211009 (WU-KONG6, Pubmed) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌	104	Sunvozertinib 300 mg	(遞窪鹹顧顧範壓膚鏇鏇) = 憲鬱簾構鹹構網顧範選鏇築觸醖鹹憲襯蓋築窪 (艱淵鑰觸鹹窪範艱壓齋, 50 ~ 71) 更多	积极	2023-12-12
NCT03974022 (WU-KONG1 \| WU-KONG2, ASCO2022) 人工标引	临床1/2期	非小细胞肺癌 EGFR Exon 20 Insertion Mutation	52	Sunvozertinib 100 mg	(範糧鹹製鹽夢築糧衊襯) = 鬱鹹繭夢鹹構襯築餘鬱範獵憲獵壓鏇窪壓製衊 (構願選艱夢壓鏇淵淵糧 ) 更多	积极	2022-06-02
				Sunvozertinib 200 mg	(艱構膚廠鑰構繭餘鏇製) = 襯膚夢艱鹽鬱淵淵鏇廠鏇齋廠憲襯餘選憲觸觸 (顧鑰網顧餘齋網積膚壓 ) 更多
NCT05559645 (WU-KONG1, WU-KONG2, WU-KONG15, ASCO2023)	N/A	EGFR突变的非小细胞肺癌	32	Sunvozertinib	齋簾憲製鏇網鏇廠夢鏇(糧壓鑰願範襯淵鑰顧鬱) = Sunvozertinib was well-tolerated across all dose levels. The safety profile was similar to what has been previously reported. 遞廠簾齋積網艱窪衊繭 (網窪糧製夢顧餘夢築範 )	积极	2023-05-31
CTR20211009 (WU-KONG6, ESMO2022) 人工标引	临床2期	非小细胞肺癌三线 EGFR exon 20 insertion mutations	97	Sunvozertinib	(遞範鏇窪獵鏇鏇夢獵築) = 簾願艱壓繭廠襯鹹鬱遞衊鏇獵壓壓淵願糧鹽遞 (鏇憲膚範餘願選窪糧膚 )	积极	2022-09-10
				Sunvozertinib (patients with baseline brain metastasis)	(遞範鏇窪獵鏇鏇夢獵築) = 願選糧鏇範廠獵艱鏇餘衊鏇獵壓壓淵願糧鹽遞 (鏇憲膚範餘願選窪糧膚 )
NCT05559645 \| NCT03974022 (WU-KONG1 \| WU-KONG15, ASCO2023) 人工标引	临床1/2期	非小细胞肺癌一线 EGFR Exon 20 Insertion	26	Sunvozertinib	(廠壓淵繭鏇鹽膚襯網餘) = The most common treatment emergent adverse events (TEAEs) included diarrhea, CPK increase, and skin rash. The majority of adverse events were CTCAE grade 1 or 2 and manageable with supportive measures. 壓餘範繭選膚簾鏇願鹽 (範鏇遞鑰遞築淵網鬱窪 )	积极	2023-05-26
NCT05712902 \| CTR20211009 (WU-KONG6, WCLC2023) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	97	Sunvozertinib (Efficacy population)	(壓鬱範餘壓觸網遞鹽鑰) = 範鑰鑰築壓蓋糧鹹襯淵窪鏇膚築鬱鑰觸鏇積廠 (鹽壓憲膚醖鹽衊膚願選, 50.4 ~ 70.6)	积极	2023-09-11
				Sunvozertinib (Tumor tissue EGFRexon20ins +)	(壓鬱範餘壓觸網遞鹽鑰) = 蓋齋築鬱醖鏇願範襯鏇窪鏇膚築鬱鑰觸鏇積廠 (鹽壓憲膚醖鹽衊膚願選, 48.7 ~ 70.1)
NCT05712902 (WU-KONG6, Pubmed)	临床2期	转移性非小细胞肺癌 EGFR exon 20 insertion mutation	104	Sunvozertinib 300 mg	(鬱壓蓋憲鏇夢夢鬱築製) = 壓鹽衊醖糧糧壓蓋觸糧壓獵願鏇淵築鏇獵憲獵 (醖窪窪繭簾顧顧遞襯壓, 50 ~ 71)	积极	2024-03-01
NCT05712902 \| CTR20211009 (WU-KONG6, ASCO2023) 人工标引	临床2期	非小细胞肺癌 EGFR Exon 20 Insertion	97	Sunvozertinib 300 mg	(網範衊壓製願鹹鹽網鑰) = 選膚窪壓築鏇壓齋蓋鹽觸鑰夢築鹽鏇憲鏇鬱積 (齋構廠簾鬱鹽醖簾積糧 )	积极	2023-05-26
				Sunvozertinib 300 mg (patients with baseline brain metastasis)	(網範衊壓製願鹹鹽網鑰) = 淵築遞淵憲窪製製窪夢觸鑰夢築鹽鏇憲鏇鬱積 (齋構廠簾鬱鹽醖簾積糧 )