AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)

The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of "brake" to keep the body's immune responses under control.
The study is seeking for participants who:
* Are confirmed to have NSCLC (Stage 3 or 4).
* Have PD-L1 levels in more than 50% of the cancer cells.
All participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab.
Participants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee how each participant is doing with the study treatment during regular visits at the clinic.

开始日期2025-05-04

申办/合作机构

Pfizer Inc.

NCT06549816

/ Active, not recruiting临床1期

An Open-label, Phase 1 Study to Investigate the Safety and Pharmacokinetics of SGN-B6A in Chinese Subjects With Advanced Solid Tumors

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) to find out whether it is safe for Chinese participants who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how do Chinese participants' body interact with sigvotatug vedotin.

开始日期2024-08-21

申办/合作机构

Seagen, Inc.

NCT06012435

/ Active, not recruiting临床3期

A Randomized, Phase 3, Open-label Study to Evaluate Sigvotatug Vedotin Compared With Docetaxel in Adult Participants With Previously Treated Non-small Cell Lung Cancer (Be6A Lung-01)

This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy.
This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle.
This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

开始日期2024-02-21

申办/合作机构

Seagen, Inc.

100 项与 Sigvotatug vedotin 相关的临床结果

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100 项与 Sigvotatug vedotin 相关的转化医学

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100 项与 Sigvotatug vedotin 相关的专利（医药）

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项与 Sigvotatug vedotin 相关的文献（医药）

2025-12-31·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

作者: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Barzaghi-Rinaudo, Patrizia ; Korn, Joshua ; Sagar, Vivek ; Hainzl, Dominik ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; Synan, Alyssa ; D’Alessio, Joseph A.

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

2025-06-12·ACS Medicinal Chemistry Letters

Site-Selective Anti-PD-L1 Antibody–MMAE Conjugate for Enhanced NSCLC Therapy

Article

作者: Kwon, Se Jeong ; Son, Jinyoung ; Chung, Sang J.

Nonsmall cell lung cancer (NSCLC) presents significant therapeutic challenges, causing advancements in targeted therapies. We have developed a site-selective antibody-drug conjugate (ADC), durvalumab-monomethyl auristatin E (MMAE), with a drug-antibody ratio (DAR) of 4, specifically targeting programmed death-ligand 1 (PD-L1), aimed at enhancing NSCLC therapy. Utilizing the innovative AbClick Pro linker, this ADC ensures stable, site-specific conjugation of MMAE to durvalumab, preserving antibody functionality and integrity. In vivo studies demonstrate that durvalumab-MMAE achieves substantial tumor growth inhibition in NSCLC xenograft models, with an impressive tumor growth inhibition rate of over 60% at lower dosages without significant toxicity. These results, combined with a favorable pharmacokinetic profile featuring extended half-life and low clearance, highlight the potential of durvalumab-MMAE (DAR4) as a potent next-generation ADC for treating PD-L1-expressing cancers, offering a promising avenue for improved NSCLC patient outcomes.

2025-06-02·MOLECULAR PHARMACEUTICS

Cleavable PEGylation Enhances the Antitumor Efficacy of Small-Sized Antibody–Drug Conjugates

Article

作者: Ding, Yu ; Zhang, Hongru ; Yang, Liu ; Yin, Dongming ; Hong, Zhangyong ; Han, Jiani ; Wang, Jian ; Wang, Xi ; Xu, Keyuan

Antibody-drug conjugates (ADCs) have emerged as a promising class of cancer therapeutics. However, traditional ADCs are often limited by poor tumor penetration due to their large molecular size. While the use of small-sized antibody fragments or analogues can improve tumor permeability, this approach typically results in an extremely shortened blood circulation half-life, which diminishes the therapeutic benefits and brings other metabolic challenges. In addition, the expression of target antigens on normal tissues often leads to unnecessary on-target/off-tumor toxicity. To address these issues, we developed a novel tumor site-specific cleavable PEGylation strategy for small-sized ADC design. The small ADC molecule Z_HER2-MMAE was site-specifically PEGylated at its N-terminus with a 20 kDa polyethylene glycol (PEG) chain and a uPA (LSGRSDNH) cleavage sequence was inserted between them (PEG_20k-U-Z_HER2-MMAE). Our results showed that PEG_20k-U-Z_HER2-MMAE achieves a similar half-life extension (6.4 and 6.0 h) compared to the conventional PEG_20k-Z_HER2-MMAE, both representing about a 26-fold improvement compared to Z_HER2-MMAE. Importantly, PEG_20k-U-Z_HER2-MMAE exhibited significantly higher drug accumulation at the tumor site, leading to the complete eradication of NCI-N87 and SK-OV-3 tumors at a dose of 5.5 mg/kg. Additionally, it demonstrated a maximum tolerated dose (MTD) exceeding 35 mg/kg, while the noncleavable PEG_20k-Z_HER2-MMAE could only slow tumor growth. In addition, compared to Z_HER2-MMAE, the in vitro cytotoxic activity of PEG_20k-Z_HER2-MMAE or PEG_20k-U-Z_HER2-MMAE was reduced by about 50 times, with the latter expected to reduce the on-target/off-tumor side effects due to the specific activation by uPA at tumor sites. These data fully demonstrate the effectiveness and high safety of our tumor-specific cleavable PEGylation strategy, supporting the potential in the development of next-generation ADCs for cancer therapy.

项与 Sigvotatug vedotin 相关的新闻（医药）

2025-07-28

·抗体密码

辉瑞披露PD-1 x VEGF双抗SSGJ-707详细数据

近日，辉瑞召开主题讲座，详细介绍了PD-1 x VEGF双抗SSGJ-707 （707）详细临床数据并对其临床前功能进行了解析，并且也披露了其后续如何将707融入辉瑞的产品管线。下文为会议详细内容及PPT。主持人大家下午好，欢迎参加辉瑞Pflash活动，本期主题为“聚焦PD-1 x VEGF双特异性抗体”。今天的电话会议将被录音。现在，我将电话转交给辉瑞首席投资者关系官兼高级副总裁Francesca DeMartino女士。请开始您的发言。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢，大家早上好。我是Francesca DeMartino，辉瑞的首席投资者关系官。我代表辉瑞团队，感谢大家参加第六期辉瑞Pflash网络直播。今天的电话会议将被录音，并可在辉瑞投资者关系网站pfizer.com上回放。需要提醒的是，辉瑞Pflash系列旨在深入探讨我们的研发管线、产品和团队。每次会议将聚焦某一特定产品、治疗领域或增长计划，并为大家提供与业务领导者互动交流的机会。今天的会议将以简短讨论开始，随后是现场问答环节。请注意，本次会议仅面向投资界人士，包括卖方分析师和机构投资者。如果您无法全程参与，可以在我们的投资者关系网站上找到回放。另外，今天的会议中我们将涉及前瞻性声明。请参阅演示文稿中的第2页以及我们提交给美国证券交易委员会（SEC）的文件中的披露内容，这些均可在辉瑞投资者关系网站pfizer.com上获取。电话会议中的前瞻性声明存在重大风险和不确定性，仅代表会议当日的观点，我们无义务更新或修订任何声明。接下来，让我们正式开始。Jeff Legos - 辉瑞公司 - 首席肿瘤官谢谢，Francesca。很高兴今天与大家交流。我是Jeff Legos，辉瑞的首席肿瘤官，负责领导从临床前到后期临床开发的癌症治疗全流程研发工作，包括医学事务。在加入辉瑞之前，我曾担任Vardis的执行副总裁兼全球肿瘤与血液学开发负责人，更早之前曾在葛兰素史克担任副总裁兼全球肿瘤医学开发负责人。现在请Johanna介绍自己。Johanna Bendell - 辉瑞公司 - 肿瘤首席开发官谢谢，Jeff。我是Johanna Bendell，辉瑞肿瘤首席开发官，负责辉瑞肿瘤后期临床开发的战略与执行。我最近加入辉瑞，此前在罗氏担任全球肿瘤负责人，领导发现和早期临床开发工作。接下来请Arati。Arati Rao - 辉瑞公司 - 胸部肿瘤开发负责人谢谢，Johanna。我是Arati Rao，胸部肿瘤开发负责人，负责肺癌和头颈癌领域所有小分子、抗体偶联药物（ADC）及免疫肿瘤资产的临床开发策略。我通过辉瑞收购Seagen加入公司，此前担任Seagen早期开发副总裁，负责多个ADC和免疫治疗项目的临床开发策略。现在我将话筒交还给Francesca。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢大家的自我介绍。Jeff，首先能否请您介绍一下707是什么，以及它如何融入辉瑞更广泛的肿瘤研发管线？Jeff Legos - 辉瑞公司 - 首席肿瘤官当然。707是一种靶向PD-1和VEGF的双特异性抗体。PD-1是免疫细胞上的受体，通常用于阻止它们攻击癌细胞；而VEGF在肿瘤血管生成中起关键作用。从辉瑞肿瘤战略的角度来看，707的定位非常契合。首先，它是一种生物制剂，这是我们三大核心治疗模式之一，我们在多特异性抗体领域拥有深厚的经验和行业领先的能力。其次，我们在许多癌症类型中拥有强大的专注度和特许经营权，例如胸部肿瘤、泌尿生殖系统肿瘤和胃肠道肿瘤，这些领域正是PD-1 x VEGF双特异性抗体可能产生重大影响的领域。最后，我们有机会探索707与我们领先的ADC产品组合（尤其是vedotin类ADC）的联合治疗方案，临床数据已显示其与抗PD-1药物可能存在协同效应。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢，Jeff。除了战略契合，能否请您概述一下选择投资707的具体原因以及协议的条款？Jeff Legos - 辉瑞公司 - 首席肿瘤官当然。首先，我们对707的作用机制充满信心。抗PD-1和PD-L1检查点抑制剂是历史上最广泛应用的肿瘤药物类别之一。最近的3期临床数据显示，通过将PD-1和VEGF抑制结合到单一分子中（如707），可能实现比单独PD-1抑制更优的疗效。如果这一结果能在临床试验中得到验证，并且安全性可接受，我们认为这将为患者带来革命性的改变。具体到707，我们相信它有可能在PD-1 x VEGF双特异性抗体类别中脱颖而出。其结构与其他药物不同，临床前数据显示其具有同类最佳的抗血管生成活性以及对PD-1的高亲和力。重要的是，这些临床前活性已在临床中转化为令人鼓舞的1期和2期数据，证明了707在非小细胞肺癌和转移性结直肠癌等多种癌症类型中作为单药或与化疗联用的抗癌活性。基于这些早期结果，我们认为707有潜力成为多种适应症的免疫肿瘤基础疗法。关于协议条款，辉瑞获得了全球（不包括中国）的独家权利，以开发、生产和商业化707。此外，辉瑞还拥有将许可扩展至中国市场的选择权。作为对价，3SBio获得了12.5亿美元的预付款、1亿美元的股权投资，并有资格获得高达48亿美元的里程碑付款以及分层销售提成。我们相信这些条款充分体现了707的价值，同时使辉瑞能够利用全球能力为患者和公司创造持续价值。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁您提到辉瑞的全球肿瘤能力是创造价值的关键。能否简要谈谈这些能力？Jeff Legos - 辉瑞公司 - 首席肿瘤官当然。如幻灯片6所示，辉瑞肿瘤拥有多项能力，支撑我们在新癌症疗法开发中的卓越表现和全球专长。其中最重要的是我们的全球规模和深厚专业知识，这些使我们能够设计创新的临床试验、制定灵活的监管策略，并加速为癌症患者开发潜在的新治疗方案。我们的核心优势在于团队。特别是在临床开发和医学组织中，我们拥有50多名肿瘤医学专家，他们带来了无与伦比的临床肿瘤学经验，致力于从根本上改变全球癌症患者的诊断轨迹。此外，我们的全球临床运营规模也非常关键。我们在45个国家的4000个临床研究基地开展临床试验，并在三大洲拥有10个生产和临床试验供应基地。所有这些使我们能够以惊人的速度执行临床开发。例如，在一项评估sigvotatug vedotin用于二线非小细胞肺癌的关键研究中，我们在不到15个月的时间内完成了近700名患者的入组目标。此外，我们拥有强大的新型治疗药物管线，目前有50多个项目，涵盖小分子、ADC和生物制剂（包括多特异性抗体）三大治疗模式。我们的管线和已获批药物在模式和机制上的多样性，为探索707的潜在联合治疗方案提供了广阔空间。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢，Jeff。谈到多特异性抗体的开发，能否简要定义什么是多特异性抗体，并分享一些辉瑞在该领域的经验？Jeff Legos - 辉瑞公司 - 首席肿瘤官好的，Francesca。请翻到幻灯片7。典型的抗体（如单克隆治疗性抗体）是由体内B细胞产生的，选择性识别并结合单一靶点。相比之下，多特异性抗体是经过设计的生物制剂，可选择性结合两个或多个靶点。这一切得益于蛋白质工程技术的发展，使我们能够设计具有新颖形式和功能的生物制剂。辉瑞在蛋白质工程和抗体设计方面拥有深厚的技术专长，这对于我们评估707在PD-1 x VEGF双特异性抗体领域中的潜力至关重要。幻灯片上展示了辉瑞多特异性抗体的几个例子。ELREXFIO是一种双特异性抗体，通过BCMA和CD3分别识别并结合B细胞和T细胞，目前已获批用于三重暴露的多发性骨髓瘤。在我们的免疫与炎症（I&I）产品组合中，有两种潜在“首创”的三特异性抗体，目前正处于治疗特应性皮炎的2期开发阶段。开发这些多特异性药物的经验，增强了我们对707在多种实体瘤适应症中成功开发的信心。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁我们知道目前有多种PD-1 x VEGF双特异性抗体处于不同开发阶段。707如何实现差异化？Jeff Legos - 辉瑞公司 - 首席肿瘤官这是一个很好的问题。请翻到幻灯片8，我将带大家了解707的一些关键特性。从结构设计上看，707在多个方面与其他PD-1 x VEGF双特异性抗体不同，包括PD-1和VEGF结合区域的位置和几何形状，以及Fc区域。707是一种四价抗体，这意味着它有四个结合域，其中两个用于PD-1，两个用于VEGF。抗体的每条臂可以结合肿瘤环境中的一个VEGF和免疫细胞表面的一个PD-1。这些结合区域的相对位置不仅独特，还提供了强大的协同结合效应，即结合一个靶点会增强对第二个靶点的结合。例如，当707在肿瘤微环境中结合VEGF后，其与PD-1的结合强度增加了约100倍。这种协同性增强了靶点结合，可能有助于驱动协同抗肿瘤活性。这一特性还可能使活性更集中于肿瘤（由于VEGF在肿瘤中高表达），从而潜在地提高安全性和耐受性。此外，由于VEGF以二聚体形式存在，它可以结合两分子707，我们认为这种“菊花链”效应可能通过PD-1增强T细胞的结合。关于707的Fc区域，它也与众不同，因为它源自IgG4，这是一种天生免疫激活能力较低的免疫球蛋白类别，可能限制不良的炎症性免疫反应。而许多其他PD-1 x VEGF双特异性抗体使用的Fc区域需要经过工程改造，以减少其他免疫球蛋白类别的强促炎效应功能。从现有临床前数据的整体来看，我们相信707具有潜在同类最佳的抗血管生成活性，同时对PD-1具有高亲和力，这些都增强了我们对临床开发前景的乐观态度。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢，Jeff。能否进一步谈谈PD-1 x VEGF的作用机制为何如此引人注目？Jeff Legos - 辉瑞公司 - 首席肿瘤官当然。请翻到幻灯片9。抗PD-1和抗VEGF单克隆抗体作为独立疗法的临床益处早已被充分理解，这也促使人们研究它们的联合治疗方案。然而，联合使用这些药物会产生副作用，限制了其广泛应用。有趣的是，通过单一药物同时靶向PD-1和VEGF，不仅可以减轻抗VEGF和抗PD-1联合疗法的一些副作用，还可能提供新的生物学特性，从而增强抗肿瘤活性。PD-1和VEGF双特异性抗体通过将这两种强大且经过验证的机制结合到一种新型治疗药物中，提供了一种潜在的革命性作用机制。抗VEGF活性抑制血管生成（即肿瘤血管的生长）。肿瘤对能量的需求非常高，它们会分泌化学物质，促使身体扩张血管以输送支持癌细胞快速生长的营养物质。如果切断这些血管的供应，癌细胞通常会死亡，肿瘤也会缩小。抗PD-1活性（有时称为免疫检查点抑制）则阻断了PD-1与PD-L1之间的蛋白质相互作用。肿瘤细胞通常表达PD-L1蛋白，它可以与免疫细胞上的PD-1结合，指示免疫细胞忽略癌细胞。然而，当这种相互作用被阻断时（例如通过抗PD-1抗体），免疫细胞可以识别肿瘤细胞并触发抗肿瘤免疫反应。抗PD-1活性对辉瑞尤为重要，因为它可能与我们领先的vedotin类ADC产品组合产生临床协同效应。新颖的作用机制固然令人兴奋，但支持数据才是创造价值的关键。目前，该领域已为PD-1 x VEGF机制提供了概念验证数据，特别是在非小细胞肺癌的3期研究中，与抗PD-1单药治疗相比，其无进展生存期（PFS）具有统计学显著改善。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁非常棒。现在能否请您介绍一下707的临床经验以及最近在ASCO上公布的数据？Jeff Legos - 辉瑞公司 - 首席肿瘤官很高兴分享。请翻到幻灯片10。ASCO上公布的数据来自一项在中国进行的2期研究，其中707作为一线治疗用于PD-L1阳性晚期非小细胞肺癌患者。研究设计相对简单，入组患者为无已知驱动基因突变、ECOG评分为0或1、PD-L1肿瘤比例评分（TPS）≥1%的患者。研究包括两个队列，分别对应非小细胞肺癌的两种主要组织学类型：非鳞状和鳞状细胞癌患者。研究评估了每三周一次给药的多剂量递增方案，主要终点为安全性和客观缓解率（ORR）。10毫克/千克剂量组的数据显示出特别令人鼓舞的疗效，这也是我们今天讨论的重点。幻灯片11展示了10毫克/千克剂量组的疗效数据，提示其具有深度和持久的缓解。左侧的瀑布图显示了从基线开始的肿瘤缩小情况，向下的长条表示肿瘤缩小幅度更大。这些数据对应的确认客观缓解率为近65%（约三分之二的患者），其中一名患者在数据截止时尚未确认部分缓解。右侧的蜘蛛图显示了缓解的深度和持久性。与瀑布图一样，向下的线条表示更好的结果。此外，随着时间的推移，许多线条进一步下降并保持稳定，为缓解的持久性和深度提供了早期证据。10毫克/千克单药治疗的安全性（如幻灯片12所示）是可管理的。左侧显示了最常见的治疗相关不良事件，最高发生率约为30%，其中仅有三例为3级或更高。右侧显示了总体频率，包括约23.5%的患者发生3级及以上治疗相关不良事件，约20%的患者发生治疗相关严重不良事件。重要的是，导致停药的治疗相关不良事件非常低，且无治疗相关死亡。幻灯片13显示，在10毫克/千克剂量下，客观缓解率和疾病控制率（即病情稳定或更好的患者比例）在各亚组中基本一致，包括难治的鳞状和PD-L1低表达患者群体。左侧数据显示，鳞状和非鳞状组织学的缓解率相似：鳞状细胞癌患者的确认缓解率为75%，非鳞状细胞癌患者为近65%，两者的疾病控制率均非常高。这令人鼓舞，因为许多治疗药物可能仅对一种组织学有效，而707在两种类型中均表现良好。右侧数据显示，不同PD-L1表达水平（通过TPS评分衡量）的患者缓解率相似。这一结果尤其令人鼓舞，因为通常TPS评分较低的肿瘤患者缓解率较低，但在这里，他们的缓解率和疾病控制率与高TPS评分患者非常接近。幻灯片14通过两个患者案例总结了临床数据。上图显示了一名50岁男性鳞状转移性疾病患者（TPS评分<50%）的连续CT扫描结果。红色箭头指示基线时的靶病灶。治疗第6周时，患者达到部分缓解；第24周时，双侧靶病灶较治疗开始时缩小了76%。下图显示了一名62岁男性IV期疾病患者（PD-L1 TPS>50%）的图像。该患者的靶病灶肿瘤负荷（红色箭头指示基线）在治疗第24周时减少了54%。需要注意的是，在非小细胞肺癌等癌症中，缓解可能表现为空洞化。例如，在下图中，治疗第6周后，随着肿瘤大小和密度的减少，原先的肿瘤区域似乎形成了一个空泡。简单来说，当肺部肿瘤被治疗快速杀死时，可能会在CT扫描中留下一个看似空洞的黑洞。然而，这些残留的空洞性病灶仍需在扫描中测量并与基线肿瘤大小比较。这意味着仅关注缓解率可能低估了707对伴有空洞性病灶的非小细胞肺癌患者的真实临床益处。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢，Jeff。数据确实非常令人鼓舞。在结束之前，能否简要介绍一下707的当前状态以及近期优先事项？Jeff Legos - 辉瑞公司 - 首席肿瘤官当然。请翻到幻灯片15。我和今天参会的同事们以及整个开发团队对推进707充满热情，并已基于迄今为止在非小细胞肺癌和结直肠癌患者中观察到的1期和2期疗效与安全性数据（包括单药和与化疗联用），制定了数据驱动的全球临床开发计划。我们期待在未来几个月分享更多细节。我可以透露，我们的近期目标包括启动全球3期开发计划，重点是非小细胞肺癌和其他实体瘤。我们还将探索707在其他肿瘤类型中的应用，并已开始构建数据包，以评估未来关键研究在哪些适应症中能为患者和药物创造额外价值。当然，开发计划的一部分还包括探索内部产品组合的联合机会，尤其是与一些ADC药物的联用，我们已积累证据表明其与抗PD-1药物的联合可能带来改变临床实践的结果。我们有很多计划，并且迫不及待想要推进。请翻到下一页幻灯片16。为了更具体地说明这一点，我们在幻灯片16中高层面展示了707的潜在开发机会，并叠加了美国流行病学数据，以帮助大家了解潜在的可覆盖患者群体。这些机会直接映射到我们的关键特许经营领域，包括胸部肿瘤、泌尿生殖系统肿瘤和胃肠道肿瘤。然而，我们认为这些仅是冰山一角，707可能惠及更多癌症患者。我们期待不仅在上述癌症类型中评估707，还将探索其他领域。所有这些表明，我们相信存在大量新机会，有望巩固辉瑞作为癌症创新治疗开发领导者的地位。我们期待分享更新的开发计划、临床数据，以及在适当时候的商业化计划。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢，Jeff。总结今天的讨论，我想说707完美契合辉瑞的肿瘤产品组合和战略。辉瑞在多特异性抗体开发方面拥有良好的记录，一些药物正在开发中，而像ELREXFIO这样的药物已上市。此外，707的目标应用与辉瑞当前的肿瘤治疗领域一致。其次，这一许可协议展示了辉瑞业务发展目标的持续执行，旨在通过当前100亿至150亿美元的交易能力推动本十年末及以后的增长。第三，我们对最近在ASCO上公布的2期数据感到鼓舞。基于1期和2期数据的整体表现，我们相信707有潜力成为未来多种适应症的基础治疗选择，前提是临床试验和监管取得成功。最后，正如我们之前提到的，我们正在制定详细的开发计划，以释放707的价值，包括在多个适应症中开展关键3期研究。这些研究以及早期试验将评估707单药及与其他药物（包括辉瑞领先的ADC产品组合）的联合效果。我们将在今年晚些时候开始沟通这些细节。此外，辉瑞计划在北卡罗来纳州的桑福德生产707的原料药，在堪萨斯州的麦克弗森生产成品药。现在我们将进入问答环节，Jeff、Johanna和Arati将参与回答。需要提醒的是，辉瑞Pflash系列旨在深入探讨我们的研发管线项目，因此请参与者将问题集中在707及其数据和机会上，避免需要我们提供前瞻性财务预测的问题。虽然我们乐意澄清演示中分享的任何信息，但不会提供超出已沟通内容的预估。感谢大家的理解。Nishant Gandhi - Citi - 分析师大家好，早上好。我是Nishant，代表Geoff提问。感谢接受我们的问题以及非常有用的演示。我想问关于开发计划的问题。您是否认为即将公布的Summit Therapeutics的Harmony试验数据是决定您进一步开发该分子适应症范围的关键因素？其次，您提到计划将该分子与一些ADC联用。能否强调几种您认为具有强大协同潜力的药物？谢谢。Jeff Legos - 辉瑞公司 - 首席肿瘤官谢谢提问。也许我先回答，然后请Johanna补充。正如我在演讲中提到的，这两种作用机制已在多种癌症中得到了充分验证，并对患者产生了重大影响。具体到PD-1/PD-L1检查点抑制剂，仅单药就有近30个获批适应症，更不用说Summit已开展的联合治疗。这为我们提供了基于免疫肿瘤学原理和已验证生物学的广泛探索空间。关于联合治疗，我们已有将vedotin类ADC与Pembrolizumab联用治疗尿路上皮癌的经验，但这仅是冰山一角。Johanna，能否请您分享一下对这一领域的看法以及开发该分子的计划？Johanna Bendel - 辉瑞公司 - 肿瘤首席开发官完全同意Jeff的观点。我们会综合考虑所有数据，包括其他PD-1 x VEGF双特异性药物的数据，以及PD-1抑制剂和VEGF抑制剂在其他领域的活性，这些将帮助我们完善临床开发计划。我们在尿路上皮癌中与PADCEV（一种潜在联合ADC）的数据令人振奋，同时sigvotatug vedotin与PD-L1的数据也值得期待。正如Jeff提到的，我们还研究了这些药物与Pembrolizumab的联合效果，并期待探索它们与707的协同作用，尤其是在非小细胞肺癌领域。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢。操作员，请下一个问题。主持人BMO Capital Markets的Evan Seigerman。Malcolm Hoffman - BMO Capital Markets - 分析师大家好，我是Malcolm Hoffman，代表Evan提问。感谢接受我们的问题。您提到在VEGF存在的情况下，PD-1结合亲和力增加了100倍。能否说明其他PD-1 x VEGF药物是否也表现出这种亲和力增加，或者707的增加幅度是否更高？谢谢。Jeff Legos - 辉瑞公司 - 首席肿瘤官谢谢Malcolm的问题。我们今天重点介绍707的特性，对这种100倍的结合活性增强感到非常兴奋。关于其他竞争对手的情况，我们不便评论。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢Jeff。操作员，请下一个问题。主持人Bank of America的Tim Anderson。Tim Anderson - Bank of America - 分析师谢谢。我有两个问题。首先，您表示对该分子和方法充满信心，这是否意味着您也相信即将公布的ASCO和Summit数据将显示肺癌患者在生存期上的临床显著获益，而不仅仅是PFS的显著改善？我猜您的回答是肯定的。其次，关于中国以外首个适应症的预计上市时间，能否给出大致范围？谢谢。Jeff Legos - 辉瑞公司 - 首席肿瘤官谢谢Tim的两个问题。是的，我重申在演讲中的观点：基于我们看到的707及PD-1 x VEGF双特异性抗体类别的整体数据，我们对分子和方法充满信心。关于Summit的总生存期数据，您可以向他们直接提问。但我们的研究将设计为同时评估总生存期和无进展生存期。关于最早可能的批准和上市时间，我们将在今年晚些时候分享更多开发计划的细节时进一步说明。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢Tim。操作员，请下一个问题。主持人UBS的Trung Huynh。Trung Huynh - UBS AG - 分析师大家好，感谢举办这次会议。我有两个关于数据的问题。首先，ASCO数据中20毫克和30毫克剂量的疗效低于10毫克剂量。虽然您不打算推进这些高剂量，但您认为其表现较差的原因是什么？是否与剂量强度较低有关？另外，数据中提到的未确认缓解是否现已确认？其次，35Bio在其公司资料中分享了10毫克剂量与化疗联用治疗非鳞状非小细胞肺癌的ORR为58%，低于ASCO中单药治疗的65%。您认为这种差异的原因是什么？谢谢。Jeff Legos - 辉瑞公司 - 首席肿瘤官谢谢Trung的问题。关于剂量反应，我们观察到10毫克/千克剂量以下的活性也值得关注。Arati，能否请您具体谈谈剂量反应以及未确认缓解的更新情况？Arati Rao - 辉瑞公司 - 胸部肿瘤开发负责人是的，20毫克和30毫克剂量组的疗效略低于10毫克剂量组是正确的。我们正在分析PK数据和剂量强度，并与监管机构探讨10毫克/千克是否是最佳推进剂量。关于联用数据，非小细胞肺癌中与化疗联用的结果令人鼓舞，我们计划在未来会议上公布这些数据。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢。操作员，请下一个问题。主持人TD Securities的Steve Scala。Chris LoBianco - TD Securities - 分析师谢谢。我是Chris，代表Steve提问。我们有几个关于尽职调查过程的问题。辉瑞在决定选择707之前，对多少种PD-1 x VEGF资产进行了深入评估？仅基于中国生成的数据，辉瑞如何确保其可靠性？在707的尽职调查中，最重要的三个问题是什么？谢谢。Jeff Legos - 辉瑞公司 - 首席肿瘤官谢谢提问。我们无法具体评论整体BD&L（业务开发和许可）流程，但我们进行了深入的尽职调查，包括访问35Bio在中国的团队，以确保作用机制、临床前数据、已生成的临床数据以及生产工艺均符合辉瑞的标准。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢。操作员，请下一个问题。主持人Wells Fargo的Mohit Bansal。Mohit Bansal - Wells Fargo Securities LLC - 分析师非常感谢接受我的问题。我有两个问题。首先，竞争对手提到“菊花链”形成可能是其疗效和安全性更优的原因。考虑到707的结构，您认为这是否会成为一个问题？其次，此前PD-1与VEGF抑制剂的联用试验中，VEGF毒性是一个问题。707的VEGF活性更高，这是否可能产生不利影响？如何平衡高效力与安全性？谢谢。Jeff Legos - 辉瑞公司 - 首席肿瘤官谢谢Mohit。关于结构和“菊花链”的潜在益处，我们已在演讲中讨论。Arati，能否请您补充安全性数据？Arati Rao - 辉瑞公司 - 胸部肿瘤开发负责人是的，作用机制是我们选择该分子的关键。作为四价抗体，其与VEGF二聚体的结合及“菊花链”效应是其重要特征。临床前数据显示，其结合VEGF和PD-1的协同机制优于部分竞品。关于安全性，2期数据显示VEGF相关不良事件与该类别其他药物相当。研究中入组的患者更接近真实世界，例如使用抗凝剂或有大空洞病灶的患者。我们将与监管机构和KOL合作，优化未来试验的安全性标准。Johanna Bendell - 辉瑞公司 - 肿瘤首席开发官补充一点，我们对VEGF活性增强感到兴奋，因为PD-1 x VEGF双特异性抗体的结合主要发生在VEGF高浓度区域（即肿瘤附近）。这可能在增强抗血管生成活性的同时，改善毒性谱。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢。操作员，请下一个问题。主持人Morgan Stanley的Terence Flynn。Terence Flynn - Morgan Stanley - 分析师非常感谢。我的问题分为两部分。首先，如何评估中国人群的ORR和安全性数据对美国及欧洲人群的可转化性？在分析数据时，有哪些考虑因素？其次，随着BioNTech/百时美施贵宝可能成为该领域的第三家进入者，辉瑞如何设计试验以展示竞争优势？您期望的临床获益阈值是多少？谢谢。Jeff Legos - 辉瑞公司 - 首席肿瘤官谢谢Terence的问题。关于ORR，我们不仅看数值，还关注缓解深度和持久性（如瀑布图和蜘蛛图所示）。对于未来的时间-事件终点，病情稳定也是重要的临床相关指标。对于这类药物，早期数据已显示其在中国以外人群中的可转化性。我们的下一步开发计划将设计为全球多中心关键注册试验。关于竞争，我们相信辉瑞的规模和速度是差异化优势。例如，最近一项二线非小细胞肺癌试验在15个月内完成了700名患者入组。我们在40多个国家开展业务，拥有4000个临床基地和全球肿瘤专家网络，能够快速推进多国3期关键研究，缩短上市时间。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁谢谢。操作员，请最后一个问题。主持人HSBC的Rajesh Kumar。Rajesh Kumar - HSBC Securities (USA) Inc - 分析师大家好，能听到吗？Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁现在可以了，请继续。Rajesh Kumar - HSBC Securities (USA) Inc - 分析师谢谢。我的问题关于开发计划的优先级。首先，在多个适应症中推进开发时，首个项目的成功将如何影响其他项目的启动？其次，3期试验和批准的预计时间表是什么？最后，作为潜在第三家进入市场的公司，您如何设计试验以展示优于竞品的临床获益？谢谢。Jeff Legos - 辉瑞公司 - 首席肿瘤官谢谢Rajesh的多个问题。Johanna，能否请您谈谈优先级？Johanna Bendell - 辉瑞公司 - 肿瘤首席开发官我们在尽职调查中看到的单药和联用数据增强了我们的信心。非小细胞肺癌是明确的首选领域，同时我们将通过信号搜寻探索其他肿瘤类型，以指导未来关键研究的投入。Jeff Legos - 辉瑞公司 - 首席肿瘤官补充一点，辉瑞的规模和速度是关键优势。例如，最近的二线非小细胞肺癌试验在15个月内入组700名患者。我们在40多个国家的4000个临床基地和专家网络将助力快速推进全球3期计划。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁看起来UBS的Trung有一个后续问题。Trung，请提问。Trung Huynh - UBS AG - 分析师抱歉，快速补充一个问题。ASCO数据中20毫克剂量组有一例死亡（发生在20个月时），原因是什么？谢谢。Arati Rao - 辉瑞公司 - 胸部肿瘤开发负责人该患者近期接受过肺部放化疗，入组后出现咯血等并发症。这类患者通常因近期放疗史不符合我们的临床试验入组标准（需洗脱期）。这是导致出血和并发症的原因。Francesca DeMartino - 辉瑞公司 - 首席投资者关系官、高级副总裁感谢同事Jeff、Arati和Johanna的参与，也感谢大家的出席。请注意，我们将于8月5日周二举行下一季度财报电话会议，Pflash系列将在财报后恢复。祝大家夏日愉快，几周后再见！我们已经建立抗体密码读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！往期精彩回顾抗体密码文章合集双特异抗体平台靶点相关双特异抗体作用机制综述，行业概览抗体筛选技术相关公司技术汇总医药资讯因为你的分享、点赞、在看我足足的精气神儿！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！欢迎扫码交流/咨询/合作=

抗体药物偶联物并购引进/卖出免疫疗法

2025-04-23

·Business Wire

Pfizer Advances Bold Vision for Future of Cancer Care at the ASCO 2025 Annual Meeting

ASCO press program to feature overall survival and progression-free survival data for BRAFTOVI ® (encorafenib) combination regimen in first-line BRAF V600E -mutant metastatic colorectal cancer and progression-free survival data from VERITAC-2 study of vepdegestrant in metastatic breast cancer NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) will showcase data across its portfolio of potential breakthrough cancer medicines at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 30 to June 3 in Chicago. Data from more than 60 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 9 oral presentations and 6 rapid oral presentations, will be presented across Pfizer’s key tumor areas, including breast, genitourinary, hematologic, and thoracic cancers, as well as colorectal cancer. “This has already been a significant year for Pfizer’s Oncology pipeline, with multiple Phase 3 data readouts and regulatory approvals, and the initiation of pivotal registrational programs across our major tumor areas of focus,” said Chris Boshoff, MD, PhD, Chief Scientific Officer and President, Research & Development, Pfizer. “The depth and diversity of our data presentations at ASCO are building on that momentum to bring us closer to our goal of delivering eight breakthrough cancer medicines by 2030.” Pfizer will have two late-breaking oral presentations featured in ASCO’s embargoed pre-meeting press briefing on May 27. These include the primary analysis of the pivotal overall survival (OS) and progression-free survival (PFS) results from the Phase 3 BREAKWATER study investigating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 in patients with BRAF V600E-mutant metastatic colorectal cancer,* as well as the first presentation of the PFS results from the Phase 3 VERITAC-2 study of vepdegestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (a/mBC) in partnership with Arvinas.** Pfizer will share additional updates from key late-stage programs, including five-year survival data from the Phase 3 ARCHES study of XTANDI® (enzalutamide) in combination with androgen deprivation therapy in metastatic hormone-sensitive prostate cancer (mHPSC),*** and the first combination data for ELREXFIO® (elranatamab) + daratumumab + lenalidomide from the ongoing MagnetisMM-6 study in patients with transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM). Pfizer will also share new findings highlighting the company’s strategy to explore novel vedotin antibody-drug conjugates (ADCs) in combination with immune checkpoint inhibitors to potentially enhance anti-tumor activity. For the first time, Pfizer will present encouraging Phase 1 data on two novel investigational ADCs in combination with pembrolizumab in thoracic cancers: sigvotatug vedotin (SV), an integrin beta-6 (IB6)-directed ADC, in lung cancer and head and neck cancers, and PDL1V (PF-08046054), a PD-L1 directed ADC, in head and neck cancers. Additionally, new exploratory analyses will be presented from the pivotal EV-302 trial with PADCEV® (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).**** Several presentations will highlight updated results from ongoing Phase 1 studies that inform the dosing strategy in registrational programs for two molecules targeting epigenetic regulators: mevrometostat, an investigational EZH2 inhibitor being evaluated in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC); and PF-07248144, a potential first-in-class KAT6 inhibitor for ER+/HER2- metastatic breast cancer (mBC). “Our data at ASCO this year reflect how we are strategically progressing our deep pipeline of next generation cancer medicines while simultaneously extending the impact of our foundational therapies to reach more people living with cancer,” said Megan O’Meara, Head of Early-Stage Development and Interim Head of Late-Stage Development, Pfizer Oncology. “Important early-stage updates highlight our extensive pipeline and depth within our core cancer types, as we advance up to nine new pivotal Phase 3 trials this year.” Key ASCO Presentations Colorectal Cancers BRAFTOVI : A late-breaking session will detail PFS and OS results from the Phase 3 BREAKWATER study of BRAFTOVI in combination with cetuximab and mFOLFOX6 chemotherapy in BRAF V600E -mutant metastatic colorectal cancer, further establishing the benefit of the BRAFTOVI combination regimen following its FDA accelerated approval in late 2024. These pivotal study results follow the topline results announcement for PFS and OS and the objective response rate (ORR) results presented at ASCO GI . These new data will also be featured in the ASCO press program. Breast Cancer Vepdegestrant : In a late-breaking session, PFS data will be presented for the first time from the Phase 3 VERITAC-2 study of vepdegestrant, a PROTAC ER degrader, in ER+/HER2− a/mBC. These detailed data follow the topline results from VERITAC-2 announced earlier this year and will also be featured in the ASCO press program. PF-07248144 (KAT6 inhibitor) : A rapid oral presentation will highlight dose optimization data from an ongoing Phase 1 study for PF-07248144, a potential first-in-class KAT6 inhibitor, in patients with ER+/HER2− mBC. These results support the recommended dosing for PF-07248144 ahead of the Phase 3 trial initiation in second-line mBC planned for 2H 2025. IBRANCE ® (palbociclib) : Roche will present detailed results from the OS analysis of the Phase 3 INAVO120 study investigating ITOVEBI™ (inavolisib) in combination with IBRANCE and fulvestrant in patients with PIK3CA -mutated, HR+/HER2-, endocrine-resistant, locally a/mBC. This presentation will be featured in ASCO’s embargoed pre-meeting press briefing on May 21. Genitourinary Cancers XTANDI : Five-year follow-up overall survival data from the ARCHES study of XTANDI in combination with androgen deprivation therapy in patients with mHSPC will be featured in an oral presentation. In addition, updates from the Astellas-supported, investigator-sponsored ENZAMET Phase 3 research study, led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and sponsored by the University of Sydney, will also be presented, including 8 year-outcomes in men with mHSPC. These presentations further underscore the value of XTANDI across approved indications. Mevrometostat : A poster presentation will highlight pharmacokinetic and safety data from the ongoing Phase 1 study for mevrometostat, an investigational EZH2 inhibitor, in combination with XTANDI. These updated data further inform the dosing strategy for mevrometostat in a robust registrational program that includes two Phase 3 trials in mCRPC, and a third trial in metastatic castration-sensitive prostate cancer (mCSPC) that is planned to start in 1H 2025. PADCEV : Additional updates from the Phase 3 EV-302 study of PADCEV in combination with KEYTRUDA in previously untreated la/mUC will be presented, including an oral presentation with exploratory analysis of responders. Hematologic Cancers ELREXFIO : Initial safety and efficacy results from Part 1 of the ongoing MagnetisMM-6 study of ELREXFIO in combination with daratumumab and lenalidomide in patients with newly diagnosed MM that are not eligible for transplant will be presented as an oral presentation. Part 1 of the ongoing MagnetisMM-6 study evaluates the optimal dose of the ELREXFIO combination regimen in patients with RRMM or NDMM to determine the recommended phase 3 dose for part 2. Thoracic Cancers Sigvotatug vedotin (SV): Phase 1 results for SV, an IB6-directed vedotin ADC, in combination with pembrolizumab in non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) will be featured in a rapid oral presentation. This initial combination data for SV with pembrolizumab support a Phase 3 study in first line PD-L1-High NSCLC, initiated this year. The data also support the overall SV trial program that includes an ongoing Phase 3 monotherapy trial in second line+ NSCLC. PDL1V (PF-08046054) : Two poster presentations will highlight interim Phase 1 results for PDL1V, a PD-L1 directed vedotin ADC, as monotherapy in NSCLC and initial safety and efficacy data in combination with pembrolizumab in patients with first-line recurrent or metastatic (r/m) HNSCC. These data provide additional support for the initiation of the two pivotal Phase 3 trials planned for PDL1V in 2025 in second line+ NSCLC and first line r/mHNSCC. Additional information on key Pfizer-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting May 22, 2025. COLORECTAL CANCERS Oral Presentation (Abstract LBA3500) Friday, May 30, 2:45-5:45 PM CDT First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): progression-free survival and updated overall survival analyses Elez et al BREAST CANCER Rapid Oral Presentation (Abstract 1020) Friday, May 30, 2:45-4:15 PM CDT Dose optimization of PF-07248144, a first-in-class KAT6 inhibitor, in patients (pts) with ER+/HER2− metastatic breast cancer (mBC): Results from phase 1 study to support the recommended phase 3 dose (RP3D) LoRusso et al Oral Presentation (Abstract LBA1000) Saturday, May 31, 1:15-4:15 PM CDT Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: Results of the global, randomized, phase 3 VERITAC-2 study Hamilton et al GENITOURINARY CANCERS Oral Presentation (Abstract 4502) Sunday, June 1, 9:45 AM-12:45 PM CDT Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) Gupta et al Oral Presentation (Abstract 5005) Tuesday, June 3, 9:45 AM-12:45 PM CDT ARCHES 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) Armstrong et al Poster Presentation (Abstract 4571) Monday, June 2, 9:00 AM-12:00 PM CDT EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) Bedke et al Poster Presentation (Abstract 5046) Monday, June 2, 9:00 AM-12:00 PM CDT Safety and pharmacokinetics of mevrometostat (M) in combination with enzalutamide (E) in patients with metastatic castration-resistant prostate cancer (mCRPC) Matsubara et al HEMATOLOGIC CANCERS Oral Presentation (Abstract 7504) Tuesday, June 3, 9:45 AM-12:45 PM CDT Elranatamab in combination with daratumumab and lenalidomide (EDR) in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant: Initial results from MagnetisMM-6 part 1 Quach et al THORACIC CANCERS Rapid Oral Presentation (Abstract 3010) Monday, June 2, 8:00-9:30 AM CDT Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001) Sehgal et al Poster Presentation (Abstract 6033) Monday, June 2, 9:00 AM-12:00 PM CDT Initial safety and efficacy of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in combination with pembrolizumab in patients with recurrent or metastatic (R/M) HNSCC Gillison et al Poster Presentation (Abstract 8611) Saturday, May 31, 1:30-4:30 PM CDT Interim results of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in patients with NSCLC in a phase 1 trial Fontana et al *The BREAKWATER trial was conducted with support from ONO Pharmaceutical, Merck KGaA, Darmstadt, Germany and Eli Lilly and Company. **Pfizer and Arvinas have a global collaboration for the co-development and co-commercialization of vepdegestrant. ***XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States. ****Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV® and KEYTRUDA® in patients with previously untreated metastatic urothelial cancer. Prescribing Information for Pfizer Medicines Please see full Prescribing Information for BRAFTOVI®. Please see full Prescribing Information, including BOXED WARNING, for ELREXFIO™ (elranatamab-bcmm). Please see full Prescribing Information for IBRANCE® (palbociclib) tablets and IBRANCE® (palbociclib) capsules. Please see full Prescribing Information, including BOXED WARNING, for PADCEV® (enfortumab vedotin). Please see full Prescribing Information for XTANDI® (enzalutamide). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Disclosure Notice The information contained in this release is as of April 23, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and Pfizer’s oncology portfolio of marketed and investigational therapies, including their potential benefits; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data; the development or commercial potential of our product pipeline, in-line products, product candidates and additional indications or combinations, including expected clinical trial protocols, the potential and timing for the initiation and progress of clinical trials and data read-outs from trials; the timing and potential for the submission of applications for and receipt of regulatory approvals; the timing and potential for product launches and commercialization; expected breakthrough, best- or first-in-class or blockbuster status or expected market entry of our medicines; potential patients reached; the regulatory landscape; the competitive landscape; and other statements about our business, operations and financial results that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

临床3期ASCO会议临床1期临床结果免疫疗法

2025-03-06

·PRNewswire

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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100 项与 Sigvotatug vedotin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期非小细胞肺癌	临床3期	美国	Pfizer Inc.	2025-05-04
局部晚期非小细胞肺癌	临床3期	日本	Pfizer Inc.	2025-05-04
局部晚期非小细胞肺癌	临床3期	比利时	Pfizer Inc.	2025-05-04
局部晚期非小细胞肺癌	临床3期	保加利亚	Pfizer Inc.	2025-05-04
局部晚期非小细胞肺癌	临床3期	以色列	Pfizer Inc.	2025-05-04
局部晚期非小细胞肺癌	临床3期	荷兰	Pfizer Inc.	2025-05-04
局部晚期非小细胞肺癌	临床3期	波兰	Pfizer Inc.	2025-05-04
局部晚期非小细胞肺癌	临床3期	西班牙	Pfizer Inc.	2025-05-04
局部晚期非小细胞肺癌	临床3期	中国台湾	Pfizer Inc.	2025-05-04
转移性非小细胞肺癌	临床3期	美国	Pfizer Inc.	2025-05-04

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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


NCT04389632 (SGNB6A-001, ASCO2025)	临床1期	胰腺腺癌 \| 卵巢癌 \| 食管腺癌 ... PD-L1 TPS \| PD-L1 CPS 更多	31	Sigvotatug vedotin (SV) 1.8 mg/kg	壓鹹願夢繭齋積鹽窪簾(襯夢窪積鏇膚憲齋膚蓋) = 餘壓簾遞膚鬱糧艱獵鹽遞淵築糧夢膚餘製艱膚 (窪襯積憲餘壓遞構繭繭 ) 更多	积极	2025-05-30
NCT04389632 (SGNB6A-001, ASCO2024) 人工标引	临床1期	非小细胞肺癌 Integrin beta-6 (IB6)	113	Sigvotatug vedotin	鹽艱築膚積艱鏇壓蓋鹽(衊繭廠艱繭觸網選網鹹) = 鹽醖簾鑰範鹹鏇餘廠鹹夢繭窪鬱齋壓鏇膚鹽繭 (築觸糧簾廠膚築選糧窪, 12.6 ~ 28.0) 更多	积极	2024-05-24
				Sigvotatug vedotin (1.8 mg/kg AiBW)	鹽艱築膚積艱鏇壓蓋鹽(衊繭廠艱繭觸網選網鹹) = 範餘鬱選窪鬱製鹹壓齋夢繭窪鬱齋壓鏇膚鹽繭 (築觸糧簾廠膚築選糧窪, 8.6 ~ 42.3) 更多
NCT04389632 (SGNB6A-001, ASCO 12023 \| ASCO 22023) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	148	SGN B6A	餘鹹淵夢餘憲襯範壓齋(選構鏇膚窪獵醖糧餘餘) = 齋製遞醖鑰壓膚築夢醖淵範願願淵鬱鹹壓遞願 (築鹹餘鏇觸膚鏇簾窪繭 ) 更多	积极	2023-05-26
				SGN B6A (NSCLC)	廠夢範蓋衊製憲築積遞(簾願糧築積願窪艱鹽範) = 築製齋憲構選構膚襯窪餘餘觸憲簾築窪憲鹽範 (繭製膚膚糧窪鹹願窪醖 ) 更多
NCT04389632 (SGNB6A-001, SITC2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	48	SGN-B6A (Q1W)	構積繭餘網簾範鑰獵壓(鹹簾窪憲窪簾網網鏇鹹) = 襯壓窪壓糧鑰醖窪壓鹹憲鬱鏇觸構襯鑰醖簾餘 (觸衊糧廠鏇鹹淵構顧壓 )	积极	2022-11-01
				SGN-B6A (2Q3W)	構積繭餘網簾範鑰獵壓(鹹簾窪憲窪簾網網鏇鹹) = 築鹽願構餘齋築鏇醖繭憲鬱鏇觸構襯鑰醖簾餘 (觸衊糧廠鏇鹹淵構顧壓 )