Loxo Oncology, Inc.

LONDON, Sept. 21, 2023 /PRNewswire/ -- Oncology is a multifaceted category in the realm of medical research and care, encompassing the study, diagnosis, treatment, and prevention of a wide spectrum of cancers, each with its own unique characteristics and challenges. This field of medicine, guided by relentless scientific innovation and a commitment to improving patient outcomes, strives to unravel the complexities of cancer, develop cutting-edge therapies, and provide support to individuals and their families affected by this formidable disease burden. Cancer, in all its forms, remains one of the most formidable challenges in modern medicine. The journey from understanding its mechanisms to delivering effective treatments and support for those affected is a complex one as far as the oncology industry is considered. Disease Landscape Insights (DLI), a pioneering research and healthcare consulting services company, stands at the forefront of oncology research, providing invaluable assistance at every step of the process. DLI is sure to transform the field of oncology by aiding in the oncology epidemiology of cancer worldwide and research of cancer, from diagnosis to prevention, treatment, and beyond. DLI's comprehensive approach to oncology research covers below and many other cancer types. DLI is empowering research and care for each of these specific cancer categories. 1. Lung Cancer 2. Breast Cancer 3. Colorectal Cancer 4. Prostate Cancer 5. Skin Cancer 6. Leukemia 7. Lymphoma 8. Ovarian Cancer 9. Pancreatic Cancer 10. Liver Cancer 11. Kidney Cancer 12. Melanoma 13. Thyroid Cancer 14. Head and Neck Cancer and Others DiseaseLandscape Insights (DLI), a dedicated oncology consulting services company, plays an invaluable role in empowering both patients, healthcare professionals, and niche players with their oncology market growth. Cancer Symptoms Cancer symptoms can manifest in diverse and often subtle ways, encompassing a range of warning signs that demand attention. These may include persistent symptoms such as a chronic cough, unexplained weight loss, fatigue, or persistent chest pain, which could signify underlying issues. Additionally, other concerning signs like unexplained bleeding, skin changes, or a lump in the breast or elsewhere on the body warrant thorough evaluation. Individuals experiencing changes in bowel or bladder habits, unusual vaginal discharge, or persistent headaches should also seek medical assessment. It's crucial to recognize that cancer's symptoms can be variable and nonspecific, underlining the importance of prompt medical consultation when any such changes or discomforts arise, as early detection can significantly impact treatment outcomes in the oncology drug market and helps in treatment gaps identification. Symptom Recognition and Early Detection: DLI's comprehensive databases and analytical tools enable healthcare providers to stay updated on the latest research regarding cancer symptoms. By offering insights into the subtleties of symptom presentation, DLI assists in recognizing potential warning signs earlier, facilitating prompt evaluation and diagnosis. Cancer Diagnosis Biopsy: Accurate diagnosis is the first crucial step in cancer care. DLI offers comprehensive data and resources on various biopsy techniques, helping clinicians make informed decisions about which method to use. Imaging Tests: DLI's cutting-edge imaging analysis tools aid in early cancer detection. By integrating artificial intelligence (AI) and machine learning, DLI helps identify subtle anomalies that might be indicative of malignancies. Blood Tests and Genetic Testing: DLI provides access to extensive genetic databases, facilitating genetic testing to assess cancer risk and guide personalized treatment plans. Diagnosis by DLI: DLI supports healthcare teams with access to advanced diagnostic techniques and insights, aiding in the accurate identification of cancer types. By providing information on innovative diagnostic tools and approaches, DLI ensures that patients receive swift and precise diagnoses. Cancer Treatment Chemotherapy and Radiation Therapy: DLI's databases house a wealth of information on chemotherapy and radiation therapy regimens, including oncology drug development challenges, drug profiles, drug insights, side effects, and the latest advancements in treatment protocols. This enables oncologists to tailor treatments to individual patient's oncology unmet needs. Surgery: DLI supports surgeons with the latest surgical techniques and insights into tumor removal, minimizing damage to healthy tissue and improving post-surgical outcomes. Immunotherapy and Targeted Therapy: As these cutting-edge treatments gain prominence, DLI offers in-depth information on their mechanisms, patient selection criteria, and clinical trial assessment, enabling healthcare providers to stay at the forefront of oncology. Treatment Decision-Making: DLI's wealth of information on cancer treatments, including chemotherapy, radiation therapy, immunotherapy, and targeted therapy, empowers healthcare professionals to make informed decisions tailored to each patient's unique needs. By staying up-to-date on emerging treatment options and clinical trial management, DLI enhances treatment planning, outcomes, and clinical trial feasibility analysis. Cancer Prevention DLI understands that prevention is as important as treatment. By compiling data on lifestyle choices, vaccination options, and early detection methods, DLI empowers individuals and healthcare providers to take proactive measures against cancer. DLI assists in disseminating knowledge about cancer prevention strategies, including lifestyle modifications and vaccination options. By promoting awareness and proactive measures, DLI helps individuals reduce their risk of developing cancer. Cancer Survivorship Surviving cancer is just the beginning of the journey. DLI offers resources on coping with cancer, managing treatment side effects, and returning to normal activities. Emotional support resources are also available to help patients and their families navigate the post-treatment phase. Support Throughout the Journey: From the moment of diagnosis, DLI provides resources and information to support patients in coping with cancer's physical and emotional challenges. DLI's commitment to cancer survivorship ensures that patients receive guidance on managing side effects, returning to normal activities, and accessing emotional support when needed. Cancer Research DLI actively contributes to cancer research by offering funding opportunities and facilitating access to oncology clinical pathways and trails. By connecting researchers with valuable data and insights, DLI accelerates the development of new treatments and therapies. DLI actively contributes to the advancement of oncology research by connecting researchers with funding opportunities and providing access to critical data. By facilitating collaboration and knowledge-sharing, DLI accelerates the development of new treatments and therapies. Cancer Support Cancer can be emotionally and financially draining. DLI provides information on financial assistance programs, support groups, and oncology drug products and drug launch strategies, practical help for patients and their families, ensuring that they receive the support they need during their journey. Price and Market Access Cancer Resources DLI maintains an extensive database of websites, hotlines, and support groups dedicated to cancer. This resource directory connects individuals with reputable sources of information and assistance. DLI offers a repository of resources, including websites, hotlines, and support groups, making it easier for patients and their families to access reliable information and assistance. This resource directory is a lifeline for those seeking guidance and support and ones looking for new product launch services. Cancer Statistics Finally, DLI's commitment to oncology extends to providing up-to-date cancer statistics, including incidence, prevalence, and mortality rates. These statistics are crucial for understanding the current landscape of cancer and tracking progress over time. In essence, DLI stands as a steadfast partner throughout the entire oncology research journey, supporting both patients and healthcare professionals with the tools, data, and expertise needed to navigate the complexities of oncology. By facilitating early detection, informed decision-making, and access to cutting-edge research, DLI plays a pivotal role in the fight against cancer, offering hope and improved outcomes to those affected by this challenging disease landscape. Some of the oncology solutions consulting & strategy report by DLI covers oncology portfolio and pipeline management along with below-mentioned topics: Oncology pipeline Lilly Eli Lilly and Company, a pharmaceutical giant, has a robust oncology pipeline. They are actively researching and developing innovative cancer treatments and therapies aimed at addressing various types of cancer. Oncology pipeline Pfizer Pfizer has a diverse and promising oncology pipeline. They are conducting research and clinical trials on a range of cancer treatments, including targeted therapies, immunotherapies, and novel compounds. Oncology pipeline Gilead Gilead Sciences has a growing presence in the field of oncology with a focus on developing innovative therapies for various types of cancer. They are actively conducting research and clinical trials to advance their oncology pipeline, which included investigational drugs and potential treatments targeting different cancer pathways and mechanisms. Oncology pipeline AstraZeneca AstraZeneca has been actively involved in oncology research and development, with a focus on delivering breakthrough cancer therapies. They have a diverse oncology pipeline that encompasses a range of innovative treatments, including targeted therapies, immunotherapies, and precision medicine approaches. Oncology pipeline LOXO Loxo Oncology is a biopharmaceutical company known for its focus on developing targeted cancer therapies. They are actively working on several investigational drugs and precision medicine approaches aimed at treating various forms of cancer. Oncology pipeline AbbVie AbbVie, a pharmaceutical company, has a robust oncology pipeline. They are dynamically engaged in research and development efforts focused on innovative cancer treatments and therapies. This pipeline includes a range of investigational drugs and targeted therapies designed to address different types of cancer. Oncology pipeline Novartis Novartis, a global pharmaceutical company, has consistently been a major player in the field of oncology research and development. They have maintained a robust oncology pipeline with a strong emphasis on precision medicine and innovative therapies. Novartis has been involved in the development of various cancer treatments, including targeted therapies, immunotherapies, and combination therapies. Pharma consulting Services Conclusion DLI's comprehensive approach to oncology research and disease insights with its oncology therapeutic expertise ensures that every aspect of the cancer journey is supported, from early diagnosis to survivorship, oncology regulatory strategy along with regulatory consulting, and beyond. By providing access to vital information with cancer consulting services, cutting-edge technologies, and a wealth of resources, DLI is a driving force in the fight against cancer providing FDA oncology guidance with its oncology regulatory expertise. As we continue to advance our understanding of cancer, DLI remains a trusted partner, propelling us closer to a world where cancer is preventable, treatable, and ultimately curable. About Disease Landscape:  Disease Landscape, a pioneering company specializing in Disease Intelligence, Pricing, and Market Access. Utilizing the power of data analytics, Disease Landscape Insights is dedicated to the healthcare sector with invaluable, finely crafted insights and recommendations regarding global pricing and market access strategies. As a specialized firm, we are committed to delivering unparalleled insights into pricing and market access, custom-tailored to the healthcare and pharmaceutical industries. Our data-driven solutions and cutting-edge technology position us as your trustworthy partner, offering swift, adaptable, and evidence-based alternatives to traditional market access and pricing research methods.  Our core competencies encompass Market Research Services, Consulting Services, Global Pricing and Market Access, Epidemiology Studies, as well as Product Portfolio and Pipeline Services. Our expertise lies in furnishing comprehensive data intelligence throughout every phase of drug and device research.  Contact Us:  Disease Landscape Insights LLP  6th Floor, Sr No.207, Office A H 6070 Phase 1  Solitaire Business Hub, Viman Nagar  Pune, Maharashtra, 411014  Email: [email protected]    Email: [email protected]  Blog:   Case Study:    Pharma consulting Services  Follow Us: LinkedIn | Twitter | Facebook Logo: SOURCE Disease Landscape Insights

2023年是礼来大放光彩的一年，截止9月1日收盘，股价从2月底低点311美元涨到约557美元，涨幅高达79%。8月初，礼来公布了半年报，报告显示第二季度的总收入同比增长28%，受此强劲财报影响，礼来盘中股价一度跳涨18%，市值更是超过5000亿美元，成为全球第一家市值超过5000亿美元的药企。不止步于此，礼来还在继续酝酿下一个目标：冲击万亿市值。礼来能做到吗？众所周知，支撑一个公司股价和市值上升的主要因素是营业收入和未来预期，今年上半年，礼来就有多款药物突破十亿美元大关，包括度拉糖肽（Trulicity）、阿贝西利（Verzenio）、替尔泊肽（Mounjaro）、恩格列净（Jardiance）和依奇珠单抗（Taltz）等。司美格鲁肽的成功给了GLP-1类降糖减重药物无限想象的可能，替尔泊肽是首款获批的GLP-1/GIP双重激动剂，有望获得比司美格鲁肽更强的效果，自去年获批上市以来销售额急剧上升，替尔泊肽今年上半年销售额就达到15.48亿美元，目前正在迅速放量，今年有望突破40亿美元，未来更是不可限量。礼来在肿瘤领域也有多款重磅产品，其中阿贝西利销售额最高，今年上半年卖了16.78亿美元。它是目前唯一一个被FDA批准的用于辅助治疗以及被NMPA批准用于早期乳腺癌高危患者的CDK4/6抑制剂，销售额正在放量增长。自免领域不满足已有的皮下注射IL-17单抗药物，8月9日礼来完成了对DICE的收购，希望开发口服小分子IL-17抑制剂，进一步扩充自免领域产品管线。不仅如此，礼来的阿尔兹海默症药物Donanemab的3期临床取得积极结果，给人无限的想象和预期，如果获批，肯定会进一步推动的市值的上升。  01  度拉糖肽增速放缓替尔泊肽潜力无限有望冲刺40亿美元大关度拉糖肽是由礼来研发的一款长效GLP-1类降糖药，GLP-1类药物因其出色的降糖作用，在糖尿病药物领域占比逐年增加。而度拉糖肽自2014年上市以后，市场份额迅速扩张，2019年，度拉糖肽以41.3亿美元销售额超过利拉鲁肽成为全球GLP-1类降糖药销售冠军，不过它遇到了强大的竞争对手司美格鲁肽，司美格鲁肽曾在头对头试验中打败了度拉糖肽（SUSTAIN 7试验）[1]，并于去年销售额超过了度拉糖肽，未来度拉糖肽增速不容乐观。不过好在礼来又于去年5月获批了首款GIP/GLP-1受体双重激动剂替尔泊肽，替尔泊肽上市不到半年，销售额已超2亿美元，今年上半年替尔泊肽销售额已达到15.48亿美元，放量速度惊人。GLP-1类药物不仅有优异的降糖效果，也有显著的减重作用，目前在肥胖症适应症中，只有诺和诺德的利拉鲁肽减肥针Saxenda和司美格鲁肽减肥针Wegovy获批上市，减肥针Wegovy自获批以来销售额急剧上升，今年上半年销售额已达18亿美元，超过前两年销售额的总额，放量迅速，供不应求，更是曾被世界首富马斯克在推特上推荐，体现GLP-1类减肥药巨大的市场前景（图1）。 图1. 减肥针Saxenda和Wegovy的销售额（数据来源于诺和诺德财报）替尔泊肽目前只获批了2型糖尿病适应症，正在积极开展肥胖症临床，希望早日获批肥胖症适应症。SURMOUNT系列 III 期临床是礼来开展的针对替尔泊肽长期体重管理的开发项目，已于 2019 年底开始，临床注册研究中招募了超过5000名肥胖或超重患者，包括SURMOUNT1-5，SURMOUNT-CN，SURMOUNT-J和SURMOUNT-MMO（图2）。 图2. SURMOUNT系列 III 期临床SURMOUNT-1 主要研究结果及SURMOUNT-2研究结果已分别发表于《新英格兰医学杂志》[2]及《柳叶刀》[3]， SURMOUNT-3 和 SURMOUNT -4 的研究结果预计于今年内公布。SURMOUNT-5是礼来开展的替尔泊肽对比司美格鲁肽2.4mg在成人肥胖或超重且伴有相关并发症患者中的有效性和安全性3b期临床试验，是首个3期替尔泊肽与司美格鲁肽头对头试验，预计于2024年12月完成。SURMOUNT-1 已有的结果显示替尔泊肽优异的减重效果，最初的72 周试验已经完成，目前继续进行SURMOUNT-1额外104周的治疗，以评估使用替尔泊肽治疗3年后，对体重的影响及进展为2型糖尿病的潜在差异。SURMOUNT-2的研究结果显示治疗72周后，安慰剂组、10mg剂量组和15mg剂量组受试者分别减重约3.18kg、13.5kg、15.6kg。基于此，礼来已在向FDA滚动提交替尔泊肽用于治疗肥胖或超重并伴有体重相关合并症的成人患者。8月21日，国家药监局药品审评中心（CDE）官网显示，替尔泊肽注射液的减重适应症在国内申报上市并获受理，一旦获批替尔泊肽销售额会急剧上升。除了度拉糖肽和替尔泊肽，在GLP-1类降糖减重药物领域，礼来还布局了GLP-1R/GCGR/GIPR三重激动剂Retatrutide和口服小分子GLP-1R激动剂Orforglipron，并且7月份以高达19.25亿美元收购Versanis Bio加码减重药物投资。7月14日，礼来宣布与Versanis Bio达成一项协议，根据协议条款，礼来将支付高达19.25亿美元的现金，包括预付款和在实现某些开发和销售里程碑后的后续付款来收购Versanis Bio，加码其在肥胖症领域投入。随后8月14日，礼来宣布成功完成对Versanis Bio的收购。此次收购扩大了礼来的产品组合，包括Versanis的主要资产bimagrumab，目前正在一项2b期研究中进行评估，并与司美格鲁肽联合用于超重或肥胖的成年人[4]。  02  肿瘤领域阿贝西利遥遥领先塞尔帕替尼和吡托布鲁替尼等后续发力礼来在肿瘤领域主要有阿贝西利（Verzenio）、雷莫芦单抗（Cyramza）、塞尔帕替尼（Retevmo）和信迪利单抗（Sintilimab）等产品，其中阿贝西利上半年销售收入达到16.78亿美元，同比增长59%。阿贝西利是一款CDK4/6抑制剂，目前全球有5款CDK4/6抑制剂获批上市，包括辉瑞的哌柏西利、礼来的阿贝西利、诺华的瑞博西尼、G1 Therapeutics/先声药业的曲拉西利以及恒瑞的达尔西利。在这几款药物中，由于哌柏西利上市时间早，其销售额一直遥遥领先，然而近期因为专利以及其它CDK4/6抑制剂的竞争销售额有所下滑，阿贝西利近些年来由于出色的疗效和适应症的扩增销售额逐年上升，去年更是突破20亿美元大关，今年上半年销售额就已经达到16.78亿美元，放量迅速，有望冲刺40亿美元（图3）。 图3. CDK4/6抑制剂销售额截止目前，阿贝西利是首个也是唯一一个获FDA批准用于乳腺癌辅助治疗的CDK4/6抑制剂，今年3月，FDA取消了对患者的Ki-67评分要求，进一步扩大了阿贝西利辅助治疗的范围，而且在临床上，阿贝西利对哌柏西利耐药后的患者仍能发挥疗效，克服哌柏西利耐药问题。阿贝西利于2020年12月30日在国内获批上市，商品名唯择，成为国内首个且唯一获批用于早期乳腺癌高危患者的CDK4/6抑制剂，又于近期被NMPA批准扩展适应症，联合内分泌治疗用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性、淋巴结阳性、高复发风险的早期乳腺癌成人患者的辅助治疗。种种迹象都显示出阿贝西利巨大的市场前景，相信其销售额会继续高歌猛进。除此之外，小分子肿瘤药物吡托布鲁替尼（pirtobrutinib）和塞尔帕替尼（Retevmo）也显示潜力，吡托布鲁替尼是首款获批上市的第三代非共价BTK抑制剂，BTK抑制剂在血液瘤治疗中取得巨大成功，其首款共价药物伊布替尼曾在2021年达到销售峰值97.8亿美元，然而伊布替尼治疗患者可能会对其耐药，吡托布鲁替尼在治疗经共价BTK抑制剂（cBTKi）预治疗的CLL/小淋巴细胞淋巴瘤（SLL），套细胞淋巴瘤（MCL），华氏巨球蛋白血症（WM）和边缘区淋巴瘤等患者时显示有效，有望解决cBTKi的耐药问题 [5]。塞尔帕替尼（Retevmo）是礼来于2019年以80亿美元收购Loxo Oncology获得的一款强效、口服、高度选择性转染期间重排（RET）激酶抑制剂， 2022年9月，塞尔帕替尼获FDA加速批准新适应症，成为全球首个且唯一一个不限癌种用于治疗RET基因融合实体瘤的RET抑制剂。今年8月22日，礼来宣布了LIBRETTO-531研究的主要结果，该研究评估了塞尔帕替尼与多激酶抑制剂（MKI）cabozantinib或vandetanib作为晚期或转移性RET突变甲状腺髓样癌（MTC）患者的初始治疗。该研究达到了其主要终点，表明无进展生存期（PFS）有统计学意义和临床意义的改善，这些临床试验的成功可能会进一步扩增塞尔帕替尼的市场空间[6]。除了小分子肿瘤药物之外，礼来还有雷莫芦单抗（Cyramza）和信迪利单抗（Sintilimab）等多种单抗肿瘤药物，给其营收做出贡献，尤其是雷莫芦单抗，今年上半年贡献了4.97亿美元。  03  依奇珠单抗一马当先礼来收购DICE扩展自免领域管线自身免疫疾病是以局部或全身性异常炎症免疫反应为特征的炎症免疫性疾病，是仅次于肿瘤的研发热门领域。礼来在自免领域也有诸多布局，靶点涉及IL-17、JAK和IL-23等。在自免领域中IL-17单抗依奇珠单抗（Ixekizumab，Taltz）销售额最高，今年上半年达到12.31亿美元，随后是口服JAK1/2抑制剂巴瑞替尼（Olumiant /Baricitinib），今年上半年销售额为4.48亿美元。除此之外，还有在日本上市的米吉珠单抗（Mirikizumab）以及正在被FDA审评的药物lebrikizumab等，涉及类风湿性关节炎、严重斑秃、中重度特应性皮炎、银屑病等自身免疫疾病。依奇珠单抗是由礼来开发的一种靶向IL-17A的人源化`lgG4单克隆抗体，于2016年3月首次获得FDA批准，用于治疗强直性脊柱炎、中度至重度斑块状银屑病和活动性银屑病关节炎（PsA）等。目前全球范围内共上市5款靶向IL-17A/IL-17RA药物，分别是司库奇尤单抗（Cosentyx）、依奇珠单抗、尼塔奇单抗（Efleira）、比吉利珠单抗（Bimekizumab）和布罗利尤单抗（brodalumab）。在这几款药物中司库奇尤单抗和依奇珠单抗卖的最好。今年6 月 20日，礼来以总计约 24 亿美元收购DICE Therapeutics，随后8月9日，礼来宣布成功完成对DICE Therapeutics的收购。此次收购扩大了礼来的免疫学产品组合，包括目前正在临床开发的口服IL-17抑制剂DC-806和DC-853，用于治疗免疫学中的慢性疾病[7]。  04  下一款重磅药物：Donanemab支撑股价上升的一重要因素就是预期，俗话说买就买有未来的，礼来在研的阿尔茨海默症药物Donanemab给人无限想象。随着全球老龄化加剧，阿尔茨海默症药物这一片蓝海令无数药企前仆后继，礼来在阿尔茨海默症十年如一日，经过无数的失败和努力，阿尔茨海默病（AD）是一种起病隐匿的进行性发展的神经退行性疾病，对大脑造成损害，占所有痴呆症病例的60 - 70%。先后终止了γ-分泌酶semagacestat、口服β分泌酶裂解酶（BACE）抑制剂lanabecestat和Aβ单抗solanezumab的开发。功夫不负有心人，今年礼来终于看到了希望，在今年阿尔茨海默氏症协会国际会议（AAIC）上和JAMA杂志上，礼来发布了其研发的donanemab的3期TRAILBLAZER-ALZ 2研究取得积极结果，显示donanemab显着减缓了早期症状性阿尔茨海默病（AD）患者的认知和功能下降，为迫切需要新治疗方案的阿尔茨海默病患者带来了希望[8]。研究结果显示Donanemab显着减缓淀粉样蛋白阳性早期症状性阿尔茨海默病患者的认知和功能下降，降低疾病进展的风险；在Donanemab治疗的疾病早期阶段，近一半的受试者在1年时没有临床进展；其他亚群分析表明，那些处于疾病早期阶段的研究参与者具有更大的益处，与安慰剂相比，下降速度减缓了60%，已向FDA提交上市申请，预计年底前将采取监管行动，如果获得批准，相信donanemab可以为患有这种疾病的人提供具有临床意义的益处，并且一旦淀粉样蛋白斑块被清除，最早可以在6个月内完成他们的治疗过程。在1736名随机参与者中，1320（76%）人完成了试验。在低/中tau人群中donanemab组在76周时iADRS评分的最小二乘均值（LSM）变化为-6.02，安慰剂组为-9.27和在合并人群中donanemab和安慰剂组分别为-10.2和的-13.1。在低/中tau人群中，76周时donanemab组CDR-SB评分的LSM变化为1.20，安慰剂组为1.88，在合并人群中donanemab组为1.72，安慰剂组为2.42（图4）[9]。 图4. 综合阿尔茨海默病评定量表 （iADRS） 和临床痴呆评定量表 （CDR-SB）的总和  小结  礼来以糖尿病药物发家，然而2022年，它的两款胰岛素产品赖脯胰岛素Humalog（优泌乐）和人胰岛素Humulin（优泌林）销售额分别下降16%和17%，降至20.61亿美元和10.19亿美元。不过其GLP-1王牌产品度拉糖肽销售额依然坚挺，2022年销售额同比增长15%至73.4亿美元，但是还是被诺和诺德的司美格鲁肽反超了。好在礼来还有GLP-1/GIP双重激动剂替尔泊肽可以补上，替尔泊肽现有的临床试验显示其优异的降糖减重效果，自去年上市以来，销售额也呈现放量增长，分析师给予其超过的预期，未来有可能成为突破200亿美元销售额的重磅药物。除了糖尿病和肥胖领域，礼来在肿瘤、自免领域以及神经领域持续发力，多款药物显示优异的临床意义，未来更是有无限可能，进一步推动礼来市值的上升，使其冲向万亿市值。References1.Richard E Pratley et.al, Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial, Lancet Diabetes Endocrinol. 2018 Apr;6(4):275-286.2.Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med 2022; 387(3): 205-16.3.Garvey WT, Frias JP, Jastreboff AM, et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 20234.https://investor.lilly.com/news-releases/news-release-details/lilly-completes-acquisition-versanis-bio5.Philip A. Thompson and Constantine S. Tam, Pirtobrutinib: a new hope for patients with BTK inhibitor–refractory lymphoproliferative disorders, Blood (2023) 141 (26): 3137–3142.6.https://investor.lilly.com/news-releases/news-release-details/lillys-retevmor-selpercatinib-demonstrates-superior-progression7.https://investor.lilly.com/news-releases/news-release-details/lilly-completes-acquisition-dice-therapeutics8.http://lilly.mediaroom.com/2023-07-17-Results-from-Lillys-Landmark-Phase-3-Trial-of-Donanemab-Presented-at-Alzheimers-Association-Conference-and-Published-in-JAMA9.John R. Sims, MD; Jennifer A. 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Pictured: Eli Lilly sign on building/iStock, jetcityimage Eli Lilly has scored a win against its competitors in the narrow but focused space of rearranged during transfection (RET)-mutant medullary thyroid cancer. The drugmaker announced topline results Tuesday showing that Retevmo (selpercatinib), its FDA-approved RET kinase inhibitor, beat out Exelixis’ Capometyx (cabozantinib) and Sanofi’s Caprelsa (vandetanib) in progression-free survival based on late-stage clinical trial results. Lilly’s Phase III LIBRETTO-531 trial tested its RET kinase inhibitor against the first-line multikinase inhibitor treatments, evaluating the relative efficacy and safety of the drugs. The drugmaker said Retevmo beat out the other two treatments in progression-free survival—the primary endpoint of the study—based on a pre-specified interim efficacy analysis conducted by an independent data monitoring committee. The trial also had secondary endpoints of treatment failure-free survival, overall response rate, duration of response, and overall survival. Lilly’s press release did not mention whether any of these endpoints were met in the study. Lilly did note in the announcement that adverse events observed in LIBRETTO-531 “were generally consistent with those identified across the previously reported Retevmo development program.” Retevmo’s labeling contains warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, hypertension, QT interval prolongation, hemorrhagic events, hypersensitivity, tumor lysis syndrome, risk of impaired wound healing, hypothyroidism and embryo-fetal toxicity. David Hyman, chief medical officer of Loxo Oncology, a wholly-owned subsidiary of Lilly, said in a statement that the “data from the LIBRETTO-531 trial confirm the importance of selectivity in targeting RET-driven cancers and suggest Retevmo should be considered the preferred first-line treatment for people with advanced RET-mutant medullary thyroid cancer.” According to Lilly, medullary thyroid cancer (MTC) accounts for just 1% to 2% of thyroid cancers in the U.S., while RET mutations are found in approximately 60% of sporadic MTC and over 90% of hereditary MTC. The win comes on the heels of other good news for Retevmo, which recently demonstrated in the LIBRETTO-431 trial superior progression-free survival for patients with RET fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC) compared to platinum-based chemotherapy combined with pemetrexed and/or pembrolizumab. Tuesday’s topline results from the LIBRETTO-531 trial also marks something of a coup for Lilly against Roche, which recently withdrew its own RET-mutant medication Gavreto, co-developed with Blueprint Medicines. In a June 30 SEC filing, Blueprint said a planned Phase III trial would “no longer be pursued due to feasibility.” This decision came not long after Roche decided to end its partnership with Blueprint in February this year, which takes effect in February 2024, and will hand Gavreto back. Both results build on Lilly’s LIBRETTO-001 trial, which is treating RET-driven cancers with Retevmo, with the company saying in a September 2022 release that the drug “demonstrated clinically meaningful and durable responses across a variety of tumor types” including pancreatic, colon and other cancers. Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.