Enzalutamide

作者：戴珊珊 周昀茜美工：何国红 罗真真排版：马超01 引言值此三优生物医药十周年之际，我们见证了肿瘤精准医疗的飞速发展。从传统的细胞毒化疗药物到靶向治疗的兴起，从免疫检查点抑制剂的问世到ADC（抗体-药物偶联物）的创新应用，肿瘤治疗正在经历着革命性的变化。本文将聚焦于发病率和致死率相对较高的六大恶性肿瘤——肺癌，乳腺癌、结直肠癌，前列腺癌，胃癌，肝癌，介绍其治疗现状以及在研靶点，为行业专业人士提供全面的靶点开发参考。02 肺癌：精准治疗与免疫革新的前沿阵地肺癌长期位列全球发病率与致死率首位，2022年全球肺癌新发病例248万，死亡182万[1]  。肺癌治疗已进入精准医学时代。目前已形成EGFR/ALK靶向药物、PD-1/PD-L1免疫检查点抑制剂和抗体药物偶联物（ADC）三足鼎立的治疗格局。奥希替尼、帕博利珠单抗等药物显著改善患者生存，而T-DXd、DS-1062等新一代ADC为难治性患者带来新希望[2,3]。在研靶点与创新方向：1）免疫检查点：除PD-1/PD-L1外，CTLA-4、TIGIT、LAG-3等成为联合治疗新选择；2）ADC靶点：C-MET、DLL3、TROP2、CEACAM5、B7-H3等在NSCLC和SCLC中显示显著疗效；3）双特异性抗体：PD-1 × VEGF（ivonescimab）、DLL3 × CD3（tarlatamab）等代表免疫治疗新模式；4）新型靶向药物：KRAS G12C抑制剂等为更多患者提供治疗机会。▲ 图1 基于insight数据库统计肺癌靶点分布图03 乳腺癌：全球女性健康的重大挑战乳腺癌是女性最常见的恶性肿瘤，2022年全球肺癌新发病例229万，死亡67万，预计2040年将增至约300万例[4] 。乳腺癌治疗早期以手术为主，结合新辅助治疗；晚期采用分型指导的全身治疗策略[5] 。治疗模式从单药向精准联合、从晚期向早期辅助延伸。三大亚型展现不同的治疗特点和疗效进展：1）HER2阳性领域，曲妥珠单抗（trastuzumab）仍是核心基础治疗药物，DS-8201等新一代ADC进一步提升了治疗效果[6] ，国产RC48等也显示出良好的疗效[7] ；2）HR+/HER2-领域，CDK4/6抑制剂显著改善了患者生存获益[8] ；3）TNBC领域，TROP2-ADC联合免疫治疗为患者带来治疗突破[9] 。在研靶点与创新方向：1）新型ADC靶点：TROP2、HER3、NECTIN-4、B7-H3、LIV-1等；2）PI3K/AKT通路：alpelisib在PIK3CA突变患者中显效；3）新一代内分泌药物：口服SERD如camizestrant；4）免疫检查点：PD-1/PD-L1、CLTA-4在TNBC中显示潜力；5）表观遗传调节：KMT2C、FOXM1等新靶点。▲ 图2 基于insight数据库统计乳腺癌靶点分布图04 结直肠癌：从传统治疗到精准分子分型结直肠癌是全球第三大高发癌种，仅次于肺癌和乳腺癌。2022年全球新发超190万例，死亡约90万例[1] 。手术切除为早期CRC一线方案，辅助和新辅助化疗根据危险因素分层应用。转移性CRC标准治疗包括基于RAS/BRAF/MSI分型的化疗联合靶向药物（EGFR、VEGF单抗），HER2和BRAF突变亚群也可选择相应靶向。MSI-H/dMMR亚型对免疫检查点抑制剂（PD-1/PD-L1或CTLA-4）响应显著，但仅约5% mCRC患者属于该亚型，其余大多数MSS/pMMR患者对免疫单药疗效有限[10] 。在研靶点与创新方向：1）已上市靶点持续拓展，EGFR、VEGF：EGFR单抗（西妥昔单抗、帕尼单抗）及VEGF单抗（贝伐珠单抗）在RAS/BRAF分型亚组中优化组合，HER2/BRAF靶向药不断纳入新版指南；2）c-MET、CEACAM5、TROP2、CDH17等新兴抗体药物偶联物（ADC）赛道快速推进，部分已进入注册阶段；3）LAG3、TIGIT、CLDN18.2、DLL3、B7-H3等成为双特异性抗体和ADC创新热点，特别是在MSS/pMMR人群联合免疫方向取得进展；4）分层诊疗理念下，mCRC分子分型指导多靶点精准联合（如BRAF/EGFR、HER2/PI3K等新组合），推动生存获益持续提升。▲ 图3 基于insight数据库统计结直肠癌靶点分布图05 前列腺癌：雄激素依赖向个体化精准治疗演进前列腺癌是全球第四大高发癌症，男性第二大恶性肿瘤。2022年前列腺癌新发病例146万，死亡40万人[1,11] 。前列腺癌早期多通过根治性手术和/或放疗治疗。中晚期及转移性病例以内分泌去势（ADT）联合AR抑制剂（阿比特龙、恩扎卢胺等）为标准一线方案，药物耐受性高、副作用相对较轻。去势抵抗后常加用多西他赛等化疗，伴DNA修复缺陷者可用PARP抑制剂奥拉帕利。核素靶向药物、免疫检查点抑制剂、肿瘤疫苗等多线治疗也在逐步应用[12] 。在研靶点与创新方向：1）PSMA：前列腺特异性膜抗原，Lu-177-PSMA-617已获批，多个PSMA-ADC在研；2）AR：雄激素受体仍是核心靶点，新一代AR拮抗剂持续开发；3）GNRHR：促性腺激素释放激素受体，多个激动剂和拮抗剂在研；4）PD-1/PD-L1：免疫检查点，已批准抗体数量最多；5）PARP：聚腺苷二磷酸核糖聚合酶，在BRCA突变患者中显效；6）新兴靶点探索，包括DLL3、STEAP1、TROP2等。▲ 图4 基于insight数据库统计前列腺癌靶点分布图06 胃癌：精准亚型与新靶点带动创新胃癌是全球第五大癌症，2022年全球新发超96万例，死亡约66万例[13] 。胃癌精准治疗格局已基本确立。HER2阳性患者以曲妥珠单抗联合化疗为标准一线治疗[14] ，同时FDA/EMA已批准PD-L1阳性者加用帕博利珠单抗形成三联疗法。德曲妥珠单抗作为新一代HER2-ADC药物，已获批用于二线及后线治疗，显著改善生存获益。2024年12月新上市的佐妥昔单抗成为首个CLDN18.2靶向药物，针对HER2阴性、CLDN18.2阳性患者提供新的治疗选择。在研靶点与创新方向：1）CLDN18.2领域竞争激烈，除已获批的zolbetuximab外，超过100款相关药物在研，包括ADC、双特异性抗体和CAR-T疗法；2）TROP2-ADC领域，sacituzumab tirumotecan等药物展现良好前景；3）新免疫检查点方面，TIGIT抑制剂domvanalimab在EDGE-Gastric研究中显示抗肿瘤活性，STAR221 III期试验正在验证其疗效[13] ；4）新兴靶点探索，包括C-MET、TROP2、MSLN等；5）已上市靶点持续拓展，包括VEGFR2、FGFR2等。▲ 图5 基于insight数据库统计胃癌靶点分布图07 肝癌：免疫组合引领的治疗新格局肝癌是全球第六大癌症和第三大癌症死因，2022年新发病例约90万，死亡病例超过75万，其中中国占全球发病和死亡人数的一半以上，主要危险因素包括乙型肝炎病毒感染、丙型肝炎病毒感染、酒精性肝病和非酒精性脂肪性肝炎。肝细胞癌一线治疗现已步入多元化时代。索拉非尼和仑伐替尼（多靶点TKI）为晚期首选，阿替利珠单抗联合贝伐珠单抗免疫组合（IMbrave150方案）跃升为主要标准。二线包括瑞戈非尼、卡博替尼和拉姆西单抗等TKI，以及免疫检查点抑制剂纳武利尤单抗、帕博利珠单抗。创新药物如靶向VEGF/FGFR的多靶点抑制剂和联合免疫治疗也被广泛应用[15] 。在研靶点与创新方向：1）GPC3成为ADC与CAR-T疗法的重要靶点，已有突破性疗效报道；2）TGF-β通路相关抑制剂（如galunisertib）、TIGIT、LAG-3等新型免疫检查点在持续探索中；3）FGFR4、MET、AXL、PI3K/AKT/mTOR、Wnt/β-catenin等信号轴的新一代小分子抑制剂正在开发；4）肿瘤微环境调控、肠道菌群干预和溶瘤病毒疗法等新方向亦为创新热点[16] 。▲ 图6 基于insight数据库统计肝癌靶点分布图08 总结与展望：协同创新，引领未来肿瘤治疗进入了一个新时代。免疫检查点抑制剂、ADC药物和靶向治疗的快速发展，正在改写多种肿瘤的治疗指南。未来的突破将更多地来自于：◆ 创新靶点的发现：持续挖掘如DLL3、TROP2、B7-H3、GPC3、STEAP1、CDH17等新兴靶点的潜力；◆ 联合用药的智慧：“ADC+免疫”、“双抗+ADC”等联合策略将成为研发主流；◆ 三个体化精准医疗：基于生物标志物的深度分析，为每位患者匹配最优治疗方案。三优生物将继续秉持科学严谨、勇于创新的精神，与全球同道携手，共同推动抗体药物研发，为攻克癌症贡献我们的智慧与力量。注：本文内容基于最新发表的科学文献和临床研究数据，旨在为医药行业专业人士提供参考。具体治疗方案应遵循相关临床指南和专业医师建议。Sanyou 10th Anniversary | Six Major Malignant Tumor Targets Overview01 IntroductionOn the occasion of the 10th anniversary of Sanyou Biopharmaceuticals, we have witnessed the rapid evolution of precision oncology. From traditional cytotoxic chemotherapies to the rise of targeted therapies-and from the advent of immune checkpoint inhibitors to the innovative applications of antibody-drug conjugates (ADCs)-the landscape of cancer treatment is undergoing revolutionary change. This article focuses on high-incidence and high-mortality cancers-lung, breast, colorectal, prostate, and gastric-summarizing the current treatment patterns and landscape of investigational targets, providing industry professionals with a comprehensive reference for target development.02 Lung Cancer: Frontier of Precision Therapy and Immunological RevolutionLung cancer has long ranked first globally in incidence and mortality, with 2.48 million new cases and 1.82 million deaths in 2022[1] . Lung cancer therapy has entered the precision medicine era, now dominated by EGFR/ALK-targeting drugs, PD-1/PD-L1 immune checkpoint inhibitors, and ADCs. Osimertinib and pembrolizumab have significantly improved patient survival, while next-generation ADCs such as T-DXd and DS-1062 offer new hope for refractory cases[2,3] .Emerging Targets & Innovations:(1) Immune checkpoints: In addition to PD-1/PD-L1, new avenues include CTLA-4, TIGIT, LAG-3, enabling combination therapies;(2) ADC targets: C-MET, DLL3, TROP2, CEACAM5, B7-H3 have shown significant efficacy in NSCLC and SCLC;(3) Bispecific antibodies: PD-1×VEGF (ivonescimab), DLL3×CD3 (tarlatamab), representing new models of immunotherapy;(4) Novel targeted drugs: KRAS G12C inhibitors, MET antibodies, HER3-ADC provide more options to patients.▲ Fig.1 Mapping of lung cancer target distribution derived from Insight Database03 Breast Cancer: A Major Challenge to Women’s Health WorldwideBreast cancer is the most common cancer among women, with 2.29 million new cases and 666,103 deaths worldwide in 2022, projected to rise to 3 million cases by 2040[4] . Early-stage treatment emphasizes surgery with neoadjuvant therapy; advanced stages adopt subtype-guided systemic strategies[5] . Treatments have shifted from monotherapy to precise combinations and from late- to early-stage interventions.The three major subtypes demonstrate different treatment characteristics and therapeutic advances:(1) In the HER2-positive domain, trastuzumab remains the core foundational therapy, with next-generation ADCs such as DS-8201 further improving treatment outcomes[6] , while domestic drugs like RC48 also demonstrate good efficacy[7] ;(2) In the HR+/HER2- domain, CDK4/6 inhibitors significantly improve patient survival benefits[8] ;(3) In the TNBC domain, TROP2-ADC combined with immunotherapy brings therapeutic breakthroughs for patients[9] .Emerging Targets & Innovations:(1) Novel ADC targets: TROP2, HER3, NECTIN-4, B7-H3, LIV-1; (2) PI3K/AKT pathway: Alpelisib is effective in PIK3CA mutant patients; (3) Nextgen endocrine drugs: Oral SERD agents such as camizestrant;(4) Immune checkpoints: PD-1/PD-L1, CLTA-4 show promise in TNBC;(5) Epigenetics: KMT2C, FOXM1 and other new targets.▲ Fig.2  Mapping of Breast cancer target distribution derived from Insight Database04 Colorectal Cancer: From Traditional Therapy to Precision Molecular StratificationColorectal cancer is the third most common cancer worldwide, following lung and breast-with over 1.9 million new cases and 904,019 deaths in 2022[1] . Surgical resection remains the mainstay for early CRC, with adjuvant/neoadjuvant chemotherapy applied based on risk stratification. Metastatic CRC is treated with chemotherapy plus targeted drugs (EGFR, VEGF antibodies) guided by RAS/BRAF/MSI subtyping; HER2 and BRAF mutant subsets also have matching options. The MSI-H/dMMR subtype responds well to immune checkpoint inhibitors but accounts for only ~5% of metastatic CRC. Most MSS/pMMR patients show limited benefit from monotherapy[10] .Emerging Targets & Innovations: (1) Extension of existing targets: EGFR and VEGF monoclonal antibodies continue in combination regimens for RAS/BRAF subtypes, with HER2 and BRAF targeting steadily adopted in guidelines;(2) New ADC tracks such as c-MET, CEACAM5, TROP2, CDH17 are progressing rapidly, with some reaching registration phase;(3) Double-specific antibodies and ADCs focusing on LAG3, TIGIT, CLDN18.2, DLL3, B7-H3 are innovative hotspots, especially in combined immunotherapy for MSS/pMMR patients;(4) Under molecular stratification, multi-targeted precise combos (e.g., BRAF/EGFR, HER2/PI3K) continue to push survival benefit upward.▲ Fig.3 Mapping of colorectal cancer target distribution derived from Insight Database05 Prostate Cancer: From Androgen Dependence to Personalized Precision TherapyProstate cancer is the fourth most common cancer globally and the second leading cancer among men, with 1.46 million new cases and 397,430 deaths in 2022[1,11] . Early-stage prostate cancer is primarily treated with radical surgery and/or radiotherapy. Advanced/metastatic cases are treated with androgen deprivation therapy (ADT) plus AR inhibitors (abiraterone, enzalutamide), offering high tolerability and mild side effects. With castration resistance, docetaxel or other chemotherapy and PARP inhibitors (e.g., olaparib) are added where DNA repair defects are present. Radionuclide therapies, immune checkpoint inhibitors, and cancer vaccines are also gradually being adopted[12] .Emerging Targets & Innovations:(1) PSMA: Lu-177-PSMA-617 is approved; several PSMA-ADC drugs are in development;(2) AR: Androgen receptor remains core, with next-gen antagonists under active development;(3) GNRHR: Gonadotropin-releasing hormone receptor agonists/antagonists;(4) PD-1/PD-L1: The most widely approved checkpoint antibodies; (5) PARP: Highly effective in BRCA-mutant cohorts;(6) Exploring novel targets such as DLL3, STEAP1, TROP2.▲ Fig.4 Mapping of Prostate cancer target distribution derived from Insight Database06 Gastric Cancer: Precision Subtyping and Novel Targets Drive InnovationGastric cancer is the fifth most common globally, with over 968,784 new cases and 660,175 deaths in 2022[13] . The standard of care for HER2-positive patients is trastuzumab plus chemotherapy as first-line therapy[14] , with FDA/EMA now approving pembrolizumab for PD-L1-positive patients to form triple combinations. Next-generation HER2-ADC (trastuzumab deruxtecan) is approved for second- and later-line treatment. Zolbetuximab, approved in December 2024, is the first CLDN18.2-targeted therapy for HER2-negative/CLDN18.2-positive patients.Emerging Targets & Innovations:(1) Intense competition in CLDN18.2, with over 100 related agents under development (including ADCs, bispecifics, and CAR-T) besides approved zolbetuximab;(2) TROP2-ADC agents such as sacituzumab tirumotecan show promise;(3) Immune checkpoints: TIGIT inhibitor domvanalimab has shown anti-tumor activity in the EDGE-Gastric trial, with the Phase III STAR221 study ongoing[13] ;(4) New targets such as C-MET, TROP2, and MSLN are under active exploration;(5) Extension of existing targets: VEGFR2, FGFR2.▲ Fig.5 Mapping of Gastric cancer target distribution derived from Insight Database07 Liver Cancer: A New Treatment Paradigm Led by Immune CombinationLiver cancer is the sixth most common and third most deadly cancer worldwide-with about 968,784 new cases and over 758,725 deaths in 2022. Over half of these occur in China, with main risk factors including hepatitis B and C infection, alcoholic liver disease, and non-alcoholic steatohepatitis. First-line therapy for hepatocellular carcinoma is now diverse: sorafenib and lenvatinib (multi-targeted TKIs) as traditional standards for the advanced stage, while the combination of atezolizumab and bevacizumab (IMbrave150) has become a major new standard. Second-line options include regorafenib, cabozantinib, ramucirumab, and immune checkpoint inhibitors (nivolumab, pembrolizumab). Next-generation TKIs targeting VEGF/FGFR and combination immunotherapies are widely used[15] .Emerging Targets & Innovations:(1) GPC3 is a pivotal target for both ADC and CAR-T, with breakthrough efficacy reported;(2) TGF-β pathway inhibitors (like galunisertib), TIGIT, LAG-3 (novel checkpoint targets) are under active exploration;(3) Inhibitors targeting FGFR4, MET, AXL, PI3K/AKT/mTOR, and Wnt/β-catenin pathways are advancing;(4) Tumor microenvironment modulation, gut microbiome intervention, and oncolytic virus therapies are promising new directions[16] .▲ Fig.6 Mapping of Liver cancer target distribution derived from Insight Database08 Conclusion & Outlook: Synergistic Innovation Leading the WayCancer treatment has entered a new era. Immune checkpoint inhibitors, ADCs, and targeted treatments are rapidly rewriting clinical guidelines. Future breakthroughs will increasingly come from:◆ Discovery of innovative targets: Continued exploration of new targets such as Claudin 18.2, TROP2, B7-H3, and CDH17;◆ Combination wisdom: Strategies such as “ADC plus immunotherapy” and “bispecific plus ADC” will become R&D mainstream;◆ Personalized precision medicine: Deep biomarker analysis enables optimal treatment for each patient.SanyouBio will continue to uphold scientific rigor and innovative spirit, working in concert with global peers to advance antibody drug development and contribute our wisdom and strength to conquering cancer.Note: This content is based on the latest published scientific literature and clinical research data, and is intended as a reference for medical industry professionals only. Specific treatment decisions should follow current clinical guidelines and the recommendations of professional physicians.▍参考文献[1] BRAY F, LAVERSANNE M, SUNG H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J/OL]. CA: A Cancer Journal for Clinicians, 2024, 74(3): 229-263. DOI:10.3322/caac.21834.[2] ZHAO S, ZHAO H, YANG W, et al. The next generation of immunotherapies for lung cancers[J/OL]. Nature Reviews Clinical Oncology, 2025: 1-25. DOI:10.1038/s41571-025-01035-9.[3] ZHOU F, GUO H, XIA Y, et al. The changing treatment landscape of EGFR-mutant non-small-cell lung cancer[J/OL]. Nature Reviews Clinical Oncology, 2025, 22(2): 95-116. DOI:10.1038/s41571-024-00971-2.[4] ARNOLD M, MORGAN E, RUMGAY H, et al. Current and future burden of breast cancer: Global statistics for 2020 and 2040[J/OL]. The Breast, 2022, 66: 15-23. DOI:10.1016/j.breast.2022.08.010.[5] GRADISHAR W J, MORAN M S, ABRAHAM J, et al. Breast Cancer, Version 3.2024, NCCN Clinical Practice Guidelines in Oncology[J/OL]. Journal of the National Comprehensive Cancer Network, 2024, 22(5): 331-357. DOI:10.6004/jnccn.2024.0035.[6] LI R, HUA M, LI J, et al. The safety of trastuzumab deruxtecan (DS‐8201) with a focus on interstitial lung disease and/or pneumonitis: A systematic review and single‐arm meta‐analysis[J/OL]. Cancer, 2024, 130(17): 2968-2977. DOI:10.1002/cncr.35349.[7] HONG X, CHEN X, WANG H, et al. A HER2‐targeted Antibody‐Drug Conjugate, RC48‐ADC, Exerted Promising Antitumor Efficacy and Safety with Intravesical Instillation in Preclinical Models of Bladder Cancer[J/OL]. Advanced Science, 2023, 10(32): 2302377. DOI:10.1002/advs.202302377.[8] MORRISON L, LOIBL S, TURNER N C. The CDK4/6 inhibitor revolution-a game-changing era for breast cancer treatment[J/OL]. Nature Reviews Clinical Oncology, 2024, 21(2): 89-105. DOI:10.1038/s41571-023-00840-4.[9] BARDIA A, HURVITZ S A, TOLANEY S M, et al. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer[J/OL]. New England Journal of Medicine, 2021, 384(16): 1529-1541. 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