主要目的：（1）定量分析健康受试者口服[14C] KL590586后排泄物中的总放射性，获得人体放射性回收率和主要排泄途径；（2）考察健康受试者口服[14C] KL590586后全血与血浆总放射性的分配比，以及全血和血浆中总放射性的药代动力学特征；（3）鉴定健康受试者口服[14C] KL590586后在血浆、尿液和粪便中的主要代谢产物，确定主要生物转化途径。次要目的：（1）采用已验证的LC-MS/MS方法定量分析血浆中KL590586及其代谢产物（如适用）的浓度，获得血浆中KL590586及其代谢产物（如适用）的药动学参数；（2）观察健康受试者单次口服[14C] KL590586后的安全性。

开始日期2023-08-29

申办/合作机构

四川科伦博泰生物医药股份有限公司

ChiCTR2300074552

/ Suspended临床1期IIT

To evaluate the randomized, open-label, two-cycle, double-cross food effects of KL590586 capsules in healthy subjects in a phase I clinical trial

开始日期2023-08-21

申办/合作机构-

100 项与 Lunbotinib 相关的临床结果

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100 项与 Lunbotinib 相关的转化医学

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100 项与 Lunbotinib 相关的专利（医药）

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项与 Lunbotinib 相关的文献（医药）

2015-01-01·Mediators of inflammation3区 · 医学

Modulatory Effects of Astragalus Polysaccharides on T‐Cell Polarization in Mice with Polymicrobial Sepsis

3区 · 医学

ArticleOA

作者: Wang, Ming-Yang ; Wu, Jin-Ming ; Hou, Yu-Chen ; Chen, Kuen-Yuan ; Wu, Ming-Hsun ; Lin, Ming-Tsan ; Yeh, Sung-Ling

Background. This study evaluated the impact of different doses of Astragalus polysaccharides (APS) on the functional status and phenotype of T cells during polymicrobial sepsis. Methods. On day 1 after cecal ligation and puncture, mice were treated with either saline, 100 (A100), 200 (A200), or 400 mg APS/kg body weight (BW) (A400) by an intraperitoneal injection daily for 4 days. All mice were sacrificed 5 days after the operation. Results. APS treatment reversed the sepsis‐induced decrement in the T helper (Th) cell population, and the percentage of activated Th cells also increased in the spleen and Peyer’s patches. APS administration downregulated the percentages of circulating Th2 cells and regulatory T cells (Treg), and the percentage of Th17 cells in blood was upregulated in the A400 group. Weight loss and kidney injury were attenuated in the A100 and A200 groups but not in the A400 group at the end of the study. Conclusions. Treatments with 100 and 200 mg APS/kg BW reduced Treg populations and elicited a more‐balanced Th1/Th2 response that consequently attenuated immunosuppression in polymicrobial sepsis. High‐dose APS administration led to excessive responses of Th17 cells which may have adverse effects in sepsis‐induced organ injury.

2013-10-01·Meat science1区 · 农林科学

Effect of the dietary supplementation of essential oils from rosemary and artemisia on muscle fatty acids and volatile compound profiles in Barbarine lambs

1区 · 农林科学

Article

作者: Valentina Vasta ; Giuseppe Luciano ; Alessandro Priolo ; Hichem Ben Salem ; Manuel Scerra ; Dorra Aouadi ; Daniela M.R. Brogna

Eighteen Barbarine lambs (3 months of age), were assigned for 95 days to 3 treatments: six lambs were fed a barley-based concentrate plus oat hay ad libitum (control group, C); other lambs received the control diet plus essential oil (400 ppm DM) either of Rosmarinus officinalis (R400 group; n=6) or of Artemisia herba alba (A400 group; n=6). At slaughter the muscle longissimus dorsi was sampled and subjected to fatty acid and volatile organic compounds (VOC) analyses. The A400 lambs presented a greater amount of vaccenic, rumenic and linolenic acids and of polyunsaturated fatty acids (PUFA) in meat than the C and R400 animals. Essential oils supplementation did not affect meat VOC profile though the sesquiterpenes copaene and β-caryophyllene were detected only in the meat of R400 and A400 lambs. It is concluded that the supplementation of rosemary or artemisia essential oils does not produce detrimental effects on lamb meat VOC profile. The supplementation of artemisia can improve meat healthy properties.

2007-03-01·Burns : journal of the International Society for Burn Injuries3区 · 医学

Effects of early enteral arginine supplementation on resuscitation of severe burn patients

3区 · 医学

Article

作者: Xi Peng ; Mingyue Zhao ; Hong Yan ; Pei Wang ; Yuesheng Huang ; Fangyong Li

OBJECTIVES:

To investigate the effects of dietary supplementation of l-arginine (l-Arg) on shock in severely burned patients.

METHODS:

This was a prospective, randomized, single blind, controlled study. Forty-seven severely burned patients due to various causes with a total burn surface area (TBSA) more than 50% each admitted in early postburn phase (within 10h postburn) were included in this study. All patients were treated by the traditional resuscitation program of our institute. After the nasogastric feeding tube was placed, they were randomly divided into three groups-(1) group A400 (n = 16): giving gastrointestinal feeding with 500 ml 5% GNS, containing l-Arg (400 mg/ kgday) at equal pace with fluid resuscitation; (2) group A200 (n = 16): giving gastrointestinal feeding with 500 ml 5% GNS containing l-Arg (200 mg/ kgday); (3) group C (n = 15): giving gastrointestinal feeding with 500 ml 5% GNS without any supplementation. The feeding started within 12h after burn and lasted for 72 h, the feeding rate was controlled by an enteral feeding pump. The following parameters were observed on days (PBD) 1-4: serum nitric oxide content (NO), mean arterial blood pressure (MAP), oxygenation index (PO2/FiO2), and arterial blood content of lactic acid (LA). Gastric mucosal blood flow was measured by laser Doppler flow-metry on PBD1 and PBD2.

RESULTS:

(1) Enteral feeding of l-Arg did not change MAP of severely burned patients, with no difference in MAP between the l-Arg supplemented and control groups. (2) There were significant changes of the l-Arg supplemented groups (A400 and A200), with an increased gastric mucosa blood flow, oxygenation index, and a decreased LA content in arterial blood, compared with the control group. (3) The serous NO content was significantly decreased in the A400 group on PBD2-4 (P < 0.01), and in the A200 group on PBD4 (P < 0.05) compared with the control group.

CONCLUSIONS:

Enteral feeding with l-arginine supplementation on early stage of burn decreases NO production to a relatively normal level and exerts beneficial effects on the resuscitation of burned shock.

项与 Lunbotinib 相关的新闻（医药）

2025-06-03

·Illumina因美纳

纳新逐光ASCO2025 因美纳每日速报——CGP检测策略和价值全面释放，ctDNA、多组学与AI协同破解临床难题

ASCO第4天速报精彩内容研究速递二代测序（NGS）赋能精准检测：多平台对比解析不同Panel检测与样本类型在晚期实体瘤中的临床指导反馈式肿瘤学咨询模式，显著提升非小细胞肺癌（NSCLC）患者全景变异分析（CGP）检测率，实现靶向与免疫治疗的更优整合。澳洲真实世界证据：CGP助力提升晚期癌症患者生存与质量调整生命年（QALY），展现临床与经济双重价值晚期肺癌成本分析：参与临床研究无明显增加医疗资源利用率（HCRU）与费用，支持试验纳入常规治疗选项中国之声靶免联合治疗新格局，KRAS、RET、NTRK、TROP2靶点齐上阵，CAR-T疗法进军实体瘤ctDNA与MRD，从早筛到复发预测，液体活检重塑癌症管理路径多组学洞察机制，揭示疗效密码AI × NGS赋能TCR-T开发精准医学前沿新辅助治疗展现生存获益ctDNA精准检测助力疗效评估、复发预测耐药机制解析推动个体化策略升级研究速递01通过NGS检测靶标和样本类型优化晚期癌症患者中具有临床可操作性的生物标志物检测（摘要e15042）在精准医疗快速发展的背景下，晚期癌症治疗日益依赖于肿瘤基因特征分析。NGS技术，尤其肿瘤全景变异分析，凭借其广泛的基因覆盖率与高灵敏度，正成为推动精准治疗的重要工具。针对如何为晚期癌症患者选择最合适的NGS策略，本研究纳入82例实体瘤患者，系统比较了不同panel类型（小型扩增子panel与全面基因组分析CGP）以及不同样本类型（肿瘤组织与ctDNA）在可指导治疗突变检测中的表现和临床价值。研究对患者匹配的组织与ctDNA样本进行了NGS检测，涵盖基于杂交捕获的TruSight Oncology 500（523基因DNA+55基因RNA）、oncoReveal Core LBx（104基因）、以及其他多癌种panel（60基因DNA + 18基因RNA）。共检测出6360个COSMIC变异，其中31%仅见于ctDNA、10%仅见于组织、59%的变异在两者中均存在。研究发现，ctDNA含量显著影响检测结果的一致性：52%的样本中ctDNA比例低于1%，30%在1%-10%之间，18%超过10%；非小细胞肺癌（NSCLC）的ctDNA水平相对较高。高ctDNA比例的样本中，组织与血液检测结果一致性更高、灵敏度更强；低ctDNA比例样本中，组织特异性变异更常见，这提示在ctDNA水平预期较低的情境下，优先选择组织样本可能更为理想。研究表明，NGS panel与样本类型应依据肿瘤类型、ctDNA比例及临床情境灵活选择。CGP panel在融合基因检测方面优于小型panel，ctDNA检测有助于识别肿瘤异质性。TruSight Oncology 500凭借广泛覆盖与高检测能力，为临床决策提供有力支持。02反馈式精准肿瘤学咨询显著提升NSCLC的CGP检测率（摘要 e20657）随着精准医疗日益应用于NSCLC治疗，CGP在识别具有临床意义突变、指导个体化方案中逐渐发挥关键作用。然而，目前全美的CGP检测率偏低（仅约39.3%-44%），影响患者治疗和入组机会。此外，CGP的延迟也妨碍了免疫或靶向治疗的及时开展。本研究旨在评估反馈式精准肿瘤学咨询（RPOC）策略在提升CGP检测率、优化检测流程中的可行性和有效性。本研究回顾了2024年1月1日至6月30日期间在社区基础的综合癌症卫生网络Allegheny Health Network中的肺癌患者电子病历，采用反馈式工作流程由病理或肺科团队启动RPOC，在102例患者中，50例因早期疾病、预后不良或非NSCLC被排除，以避免资源浪费。最终52例III/IV期患者纳入分析，CGP检测率达81%，显著高于全国水平，IV期患者中有76%的患者在治疗前获得结果。主要检测障碍为组织不足（62%）。平均周转时间为23天，29%的患者发现可行动突变。该试点研究表明，RPOC驱动的CGP策略显著提升检测率、缩短周转时间，并优化与NCCN指南的一致性。该模式可有效避免早期病例中的过度检测，从而降低了成本，同时实现免疫与靶向治疗的及时整合。TruSight Oncology 500在精准检测中发挥关键作用。该策略为提升晚期NSCLC患者治疗可及性、推动资源优化利用提供了新路径，具备广泛推广价值。03澳大利亚真实世界数据：CGP提升晚期实体瘤患者临床及经济价值（摘要e15084）在精准医学快速发展的背景下，CGP在肿瘤分子诊断中展现出重要潜力，然而在临床实践中，传统单基因检测仍为主流，CGP尚未成为标准流程。TruSight Oncology 500作为CGP方案之一，近年来因其临床与经济价值而受到广泛关注。一项基于2020年7月至2023年6月澳大利亚真实世界数据的回顾性研究，分析了CGP在晚期胆管癌（CCA）、CRC和NSCLC患者中对匹配靶向治疗机会的影响。研究采用分层生存模型，对CGP不可用情形与当前有限CGP使用下的健康结局和医疗成本进行比较。患者依据治疗方案分为匹配治疗组、不匹配治疗组及未治疗组，数据来源包括MoST项目及澳大利亚医保系统。结果显示，匹配治疗组患者的生存期显著延长。与CGP不可用相比，当前CGP的应用可使CCA、CRC和NSCLC患者的生命年分别延长0.30、0.17和0.15年，QALY分别提高0.25、0.13和0.12，相应的每QALY成本分别增加1210澳元、6807澳元、1248澳元。该研究为CGP在提升生存、改善生活质量及成本效益方面的提供了实证支持，推动其在肿瘤精准治疗中的临床转化。04晚期肺癌保险患者的HCRU与费用比较分析：参与试验 vs未参与临床试验（摘要e13526）临床研究为晚期癌症患者带来治疗希望，但全球临床试验（CTP）参与率仍偏低，不仅限制了患者获益，还延长了药物研发周期。在2024年的ASCO摘要11154中，因美纳与Optum团队指出，晚期癌症患者整体CTP比例仅为3%，但接受生物标志物检测者的参与率显著提高。除检测手段外，费用问题也是影响CTP的主要障碍之一。本研究基于Optum数据库，纳入2018年1月至2022年2月间8774例参保晚期肺癌患者，比较参与（n=274）与未参与CTP（n=8500）患者的HCRU与费用上的差异。结果显示，CTP患者更可能在综合癌症中心治疗（在商业保险COM: 40% vs 27%；医保优势计划MA: 33% vs 14%），并接受基线生物标志物检测（COM: 54% vs 35%；MA: 46% vs 34%）。尽管两组患者在住院与急诊资源的使用上相似，但CTP组门诊就诊频率更高。在COM中，CTP组患者的总费用及调整后费用均低于非CTP组；在MA中，调整前费用较低，调整后则无显著差异。大部分费用由保险计划承担（93–98%），患者自付比例仅2–6%。研究表明，在参加保险计划的晚期肺癌人群中，参与CTP不会增加整体医疗费用，为推动CTP提供了重要证据。今日亮点2025ASCO中国之声临床研究进展KRAS G12C 突变非小细胞肺癌摘要：8520讲者：王洁，中国医学科学院肿瘤医院II期研究（ChiCTR2200059986）显示，Sosimerasib单药治疗KRAS G12C突变晚期NSCLC的客观缓解率（ORR）为 52.4%，疾病控制率（DCR）为 87.6%，中位无进展生存期（PFS）为7.2个月，起效迅速（中位TTR为1.4 个月），安全性可控，提供经治患者新的高效靶向治疗选择。RET突变甲状腺癌摘要：6098讲者：郑向前，天津医科大学肿瘤研究所I/II期KL400-I/II-01研究I期数据显示，KL590586单药在晚期RET突变甲状腺髓样癌（MTC）患者中展现出良好疗效与安全性。27例入组患者中，cORR达63.0%，DCR为100%，中位缓解持续时间（DOR）和PFS未达到，24个月的PFS率为77.8%。无治疗中断或死亡相关不良事件，支持其作为该人群潜在治疗方案，II期研究正在多国推进。摘要：3112讲者：阮丹云，中山大学肿瘤防治中心I/II期研究总结了Zurlectrectinib在229例局部晚期或转移性NTRK融合实体瘤成人患者中的疗效与安全性。在49例未接受TRK抑制剂治疗的患者中，ORR达83.7%，CR率为10.2%，12个月DOR和PFS率分别为92.0%和90.5%。对脑转移亦有活性（脑内ORR达66.7%），且安全性良好，TRAEs多为1–2级。该药展现出广谱、持久应答，适用于多瘤种NTRK融合阳性患者。唾液腺癌摘要：6100讲者：郑晓娟，国家癌症中心/国家癌症临床研究中心/北京协和医学院和中国医学科学院肿瘤医院本单中心临床研究显示，TROP2靶向药物ESG401在局部晚期或转移性唾液腺癌（SGC）患者中展现出良好疗效。在12例可评估患者中，疾病控制率（DCR）达100%，其中挽救治疗亚组的客观缓解率（ORR）为50%，脑转移患者IC-ORR为100%。结果支持TROP2阳性SGC开展分子亚型靶向治疗的可行性，值得进一步验证。KRAS 突变实体瘤摘要：3013讲者：艾星浩，上海市胸科医院I/II期研究（NCT06500676）显示，GFH375 治疗 KRAS G12D 突变晚期实体瘤 ORR 为 27.3%，DCR 为 86.4%；PDAC 患者部分缓解率达 42.9%。药物耐受性良好、口服吸收佳，展现出潜在治疗价值，支持后续临床推进。摘要：3113讲者：Wei Sun，华东医药股份有限公司杭州全球药物研发中心本研究基于PROTAC技术开发出新型pan-KRAS降解剂，针对G12C以外的KRAS突变显示出优异活性。在SW620^G12V和GP2D^G12D细胞中低纳摩尔浓度即可实现KRAS降解并抑制下游信号。化合物具备良好药代特性（AUC > 5000 ng·hr/mL，hERG IC50 > 30 µM），在小鼠模型中展现显著抗肿瘤活性，显示出治疗多种KRAS突变肿瘤的潜力。TRK融合阳性实体瘤摘要：3148讲者：徐瑞华，中山大学肿瘤防治中心汇总分析显示，拉罗替尼治疗TRK融合癌的ORR为65%，中位DoR为43个月，4年OS率为63%；不良事件以1-2 级为主，27%患者仍在接受治疗或处于等待观察状态。研究中88%的患者通过NGS检测到NTRK基因融合，证实了高通量测序在肿瘤分子诊断中的重要性，支持其在临床中普及以指导TRK抑制剂的精准应用。摘要：3131讲者：王健，复旦大学附属中山医院本研究比较了两种NTRK融合检测策略的成本效益：先进行pan-TRK IHC筛查，再用NGS确认，与直接应用NGS相比，在中国具有更高的QALY（0.42665 vs 0.42646），成本更低（4176.67美元 vs 5932.57美元），且平均等待时间缩短10天。结果支持IHC+NGS为更具成本效益的检测路径，适用于局晚或转移性实体瘤患者的NTRK筛查策略。实体瘤-CAR-T治疗摘要：8517讲者：Ling Zhou，华中科技大学同济医学院附属同济医院I期试验显示，缺氧响应性CEA CAR-T疗法治疗复发或难治性NSCLC的ORR为47%，DCR为87%，CEA高表达且无脑转移患者预后更佳；CAR-T细胞输注后可在体内持续存在，安全性可控，免疫分析显示应答患者中NK细胞处于较少耗竭状态；研究通过免疫表型分析探讨了疗效相关的免疫细胞状态，为CAR-T疗法的优化提供了方向。前沿技术赋能ctDNA早筛/早诊摘要：3047讲者：Hengzhen Li，哈尔滨医科大学附属肿瘤医院研究基于高通量 cfDNA测序数据，整合重复元件、甲基化、拷贝数变异和片段大小特征，开发了机器学习模型以区分胃良恶性病变，I期胃癌敏感性达92.9%、特异性71%，为无创早筛与风险分层提供新工具。摘要：4534讲者：彭毓璐，中山大学肿瘤防治中心；华南肿瘤国家重点实验室，肿瘤医学协同创新中心基于进行了低通量全基因组测序（WGS，覆盖率为5X）开发了cfDNA片段组学特征（拷贝数变异（CNV）、片段大小比（FSR）和核小体足迹（NFP）构建机器学习模型，实现肾癌早筛新突破：AUC达0.97，I期敏感性87.8%，IV期达100%，展现出高敏感性、高特异性的非侵入性检测潜力。摘要：3050讲者：Xiaosheng He，中山大学附属第六医院多中心研究基于靶向肿瘤特异性高低甲基化标志物的panel对cfDNA进行测序，构建了cfDNA甲基化特征模型。实现精准胃肠癌早筛：AUC达0.959，敏感性86.4%，特异性96.0%，阳性病例肿瘤起源定位准确率近90%，验证其在多癌种早筛中的临床应用潜力。MRD摘要：5038讲者：Zaishang Li，深圳市人民医院一项多中心前瞻性研究（ChiCTR2400081246）通过NGS检测尿cfDNA与外泌体DNA，结合拷贝数变异等特征构建MRD评分模型，验证其在四类尿路上皮癌患者（UTUC、NMIBC、MIBC和TMT后CR）中的有效性，试验招募与随访仍在进行，旨在推进非侵入性MRD监测在UC中的应用。摘要：4584讲者：Xuebin Wan，海普洛斯生物科技有限公司一项前瞻性研究（2022.11–2024.12）招募67例I-IV期膀胱癌患者，基于WES开发个体化Panel检测尿液ctDNA（utDNA），检出率达95.5%。结果显示，utDNA阳性与肿瘤组织突变高度一致，且可较影像提前3–8个月提示复发风险，支持其作为早期复发监测和微小残留病判断的有力工具。摘要：4587讲者：Zihan Xue，天津医科大学第二医院回顾性分析130例HG Ta/T1型膀胱癌患者，评估初次TURBT术后一周内utDNA检测对术后残留病及复发的预测价值。utDNA检测的敏感性为76.1%、特异性为95.2%，与复发显著相关（HR=4.48, P<0.001）。结果显示，utDNA可作为再TURBT获益筛选及复发风险评估的独立预测。摘要：6049讲者：Zi-Cheng Zhen，中山大学肿瘤防治中心本研究提出动态风险预测模型NPC-DRIM，基于1000例EB病毒相关鼻咽癌患者的纵向ctDNA数据，动态评估治疗风险。结果显示，该模型可精准识别对免疫治疗获益的高危人群，优于传统风险模型，为个体化治疗提供新范式。摘要：2547讲者：吴芳，中南大学湘雅第二医院本多中心前瞻性研究纳入42例NSCLC患者，基于个体化NGS捕获设计进行ctDNA动态监测。结果显示，ctDNA阳性显著预测较差PFS（HR=7.65）和OS（HR=68.42），且进展可提前6.6个月被识别，具备90%阳性预测值。克隆突变与更差生存相关，ctDNA监测可辅助早期识别进展并指导治疗调整。摘要：3045讲者：梁乃新，中国医学科学院北京协和医院MUSETALK-Lung01是一项前瞻性研究，评估tumor-naïve ctDNA在术前预测NSCLC预后的价值。对289例I–IIIA期患者进行血浆检测和5年随访。结果显示，在I期肺腺癌（LUAD）中，ctDNA阳性显著预测复发风险（2年RFS: 70% vs 94%，p < 0.001），而在II–IIIA期或非LUAD中无显著关联。ctDNA阳性与术后早期复发高度相关，提示其可作为早期NSCLC高危分层的有力工具。多组学摘要：4015讲者：Haoxin Peng/沈琳，北京大学肿瘤医院通过单细胞 RNA 测序、空间转录组学（ST）和多重免疫荧光检测，多组学分析揭示，Claudin18.2 CAR-T细胞（CT041）治疗胃癌的应答机制涉及GZMK⁺ CD8⁺ Tpex细胞与IRF8⁺ B细胞协同浸润，而耐药机制则关联IQGAP3⁺癌细胞与IL6⁺成纤维细胞共激活EMT通路；NR4A1与CCR9的表达可作为疗效预测标志物。摘要：1022讲者：刘洁琼，中山大学孙逸仙纪念医院多中心II期研究显示，CTLA-4/PD-L1双抗KN046联合抗HER2双抗KN026在HER2阳性乳腺癌中的无化疗治疗ORR达47.2%。单细胞RNA测序（scRNA-seq）和单细胞T细胞受体测序（scTCR-seq）分析揭示，应答患者免疫激活增强，调节性T细胞与巨噬细胞富集提示耐药机制，支持纵向多组学分析预测疗效。摘要：12039讲者：Luoxi He，复旦大学附属肿瘤医院本研究通过单细胞RNA测序分析18例结直肠癌患者，揭示化疗、放化疗（CRT）及放化疗联合免疫治疗（ICRT）诱导的肠损伤机制。结果显示CRT和ICRT可引发肠上皮细胞逆分化，ICRT损伤更严重；CRT激活衰老相关基因，ICRT则激活干扰素和TNF通路。临床肠损伤评分与肿瘤退缩等级正相关，提示肠组织转录特征有望用于预测治疗疗效。摘要：5038讲者：Zaishang Li，深圳市人民医院本研究结合空间转录组、单细胞和批量RNA测序，揭示CD74⁺ B细胞在阴茎鳞癌（PSCC）三级淋巴结构（TLS）中的关键免疫作用。TLS内富集的CD74⁺ B细胞呈早期发育状态，能通过HLA分子激活初始T细胞，增强局部免疫反应。TLS的存在与PSCC患者预后改善显著相关，提示CD74⁺ B细胞可作为潜在生物标志物及治疗靶点，拓展对PSCC免疫机制的理解。肿瘤大panel摘要：596讲者：Cuiyun Zhang，河南省肿瘤医院对2111例HR+乳腺癌患者进行1021基因高通量测序，基于CNV和通路突变将患者分为C组（高CNV）与M组（低CNV）。C组HER2+比例高，对化疗+HER2靶向治疗pCR率更高；M组PAM通路突变富集，化疗单药pCR率较低。研究揭示乳腺癌分子异质性，助力新辅助治疗策略个体化优化。TCR摘要：2566讲者：Chen Huang，中日友好医院本研究通过对2699例肺癌患者与3360名健康者的外周血TCR-β链测序，鉴定出3840个肺癌相关富集TCR克隆，构建肺癌富集评分（LCS）。特异性TCR序列如“CATSRDTGGREKLFF”在肺癌患者中高度富集。LCS在独立队列中验证显示灵敏度96%、特异性95%，且能区分肺癌与非肿瘤疾病。结果表明TCR特征可作为肺癌筛查的潜在免疫标志物。AI摘要：2535讲者：Shuhang Wang，国家癌症中心I期研究利用AI模型TCR-XFinder快速筛选肿瘤反应性TCR并开发KSX01 TCR-T疗法，4例晚期实体瘤患者中DCR达100%、ORR达50%，展现良好安全性及肿瘤微环境改善，验证AI驱动个体化TCR-T治疗的可行性。精准医学前沿-国际药企类研究进展临床研究进展肺癌EGFR突变非小细胞肺癌摘要：8001 讲者：Jamie E. Chaft, Memorial Sloan Kettering Cancer CenterNeoADAURA（NCT04351555）研究旨在评估新辅助奥希替尼±化疗对比单纯化疗在II-IIIB期（AJCC第8版）EGFRm可切除NSCLC中的疗效。本研究纳入358例患者，其中奥希替尼+化疗组121例，单药组117例，安慰剂+化疗组120例。研究表明，新辅助奥希替尼±化疗较单纯化疗显著提高MPR率，安全性可控，无新增风险。尽管 EFS 数据尚未成熟，但已呈现出改善趋势，进一步支持其作为围手术期治疗的新选择，并为EGFR突变NSCLC新辅助治疗提供高级别证据。KRAS G12C突变非小细胞肺癌摘要：8519讲者：Konstantin H, Dartmouth Cancer Center本研究旨在评估第二代KRAS G12C抑制剂奥洛莫拉西联合帕博利珠单抗用于KRAS G12C突变晚期NSCLC一线治疗的安全性与抗肿瘤活性。共纳入43例经组织或血浆确认突变的患者，涵盖PD-L1表达水平0–100%。结果显示，该联合方案具有良好耐受性，在各PD-L1表达亚组中均展现出积极疗效，尤其在PD-L1高表达人群中缓解率显著。基于此结果，全球III期注册研究SUNRAY-01已启动，进一步验证其临床价值。驱动基因阴性非小细胞肺癌摘要：LBA8000 讲者：Patrick M. Forde, MD, PhD， Trinity St. James's Cancer InstituteCheckMate 816五年最终分析显示NIVO联合化疗组OS显著优于化疗组（中位OS未达 vs 73.7月，HR=0.72，P=0.0479），5年OS率65% vs 55%；EFS亦持续获益（中位59.6 vs 21.1月，HR=0.68）。在ctDNA基线阳性患者中，术前ctDNA清除与更优OS相关（NIVO组HR=0.38，化疗组HR=0.39）；达pCR者的5年OS率高达95%，远高于未达pCR者（56%）。长期随访未见新安全性问题。研究确立了无可靶向突变可切除NSCLC中，新辅助免疫治疗的新标准。前列腺癌摘要：5094讲者：David Olmos, Instituto de Investigación Sanitaria Hospital 12 de Octubre旨在评估HRR基因（包括BRCA）突变的流行病学情况及其对患者预后的影响。研究通过配对体细胞与种系测序，并按CHAARTED标准分层分析。结果显示：BRCA突变显著关联更差的总生存（OS）和无进展生存（PFS），无论患者接受的是单药ADT还是联合治疗；而HRR非BRCA突变未见明显预后差异。该研究强调 BRCA突变可作为mHSPC患者的不良预后生物标志物，支持开展HRR检测并探索个体化治疗策略。摘要：5096讲者：Dana Rathkopf, Memorial Sloan Kettering Cancer Center本研究基于Flatiron Health–Foundation Medicine数据库，回顾性分析1630例mHSPC患者中PTEN状态的流行特征及其与预后的关系。患者按PTEN状态分为纯合缺失、突变和未改变三组。结果显示，PTEN基因改变（纯合缺失或突变）与更短的真实世界总生存期（rwOS）显著相关，且该关联不受基线特征或治疗模式影响。研究支持将PTEN状态作为mHSPC患者的重要预后标志物，提示需对PTEN改变患者考虑更积极的治疗策略。头颈部肿瘤摘要： 6023讲者：AartiK. Bhatia, Yale School of Medicine and Yale Cancer Center本研究评估西妥昔单抗联合泛HER抑制剂阿法替尼在复发/转移性头颈鳞癌（HNSCC）中的疗效与安全性。共纳入50例患者，基于HER2/HER3在EGFR单药耐药中的作用，联合治疗旨在通过阻断EGFR/HER二聚体活性克服耐药。结果显示该方案在p16阴性患者中疗效显著，安全性可控，与既有EGFR抑制剂一致。研究为EGFR耐药的头颈部肿瘤患者提供了新的靶向联合治疗思路，未来可进一步探索预测标志物与治疗优化策略。实体瘤HER2突变实体瘤摘要：TPS3185讲者： Vivek Subbiah, Sarah Cannon Research Institute本研究旨在评估BAY 2927088在携带HER2激活突变的不可切除、局部晚期或转移性实体瘤（NSCLC除外）患者中的疗效与安全性。该药为口服可逆TKI，能有效抑制HER2及EGFR突变。panSOHO试验（NCT06760819）为II期多中心篮子研究，已在多地区开展，计划纳入111例患者，涵盖结直肠癌、胆道癌、宫颈癌等多种实体瘤。研究有望为HER2突变实体瘤患者提供新的靶向治疗选择，填补罕见突变治疗空白，助力跨瘤种精准医疗。试验已启动，正在招募中。MAPK通路异常实体瘤摘要：3100讲者：Sarina A. The University of Texas MD Anderson Cancer Center本I期研究（NCT04511845）旨在评估新型MEK1/2抑制剂SPYK04的安全性、耐受性及初步疗效，针对MAPK通路异常的局部晚期或转移性实体瘤患者。SPYK04通过增强RAF-MEK结合并抑制MEK反馈激活，克服传统MEK抑制剂在RAS突变癌症中的局限。研究在美日两地开展，共纳入23例患者，SPYK04每日口服，28天为一个周期，1.3 mg/天剂量耐受性良好，并在卵巢癌中观察到初步抗肿瘤活性。本研究为MAPK异常肿瘤提供新型“分子胶”机制的靶向策略，支持后续疗效验证。前沿技术赋能CtDNA- MRD疗效评估摘要：7515讲者：Suzanne Trudel, Princess Margaret Cancer CentreDREAMM-8研究（NCT04484623）评估了BPd（belantamab mafodotin + pomalidomide + dexamethasone）对比PVd在经来那度胺治疗的复发难治性多发性骨髓瘤（RRMM）患者中的疗效。共纳入302例患者，1:1随机至BPd或PVd组，重点评估MRD阴性率及其对PFS/OS的影响。结果显示，BPd组MRD阴性率显著高于PVd组，且与更优的PFS/OS相关，即使未达MRD阴性，BPd组仍显示PFS获益。研究支持MRD作为治疗终点，BPd方案在深度缓解与生存方面具优势，适用于高危RRMM患者。复发监测摘要：3055讲者：Tae-Kyung R. Yoo, Dana-Farber Cancer InstituteCHiRP研究数据更新，旨在评估ctDNA检测在高危HR+/HER2-乳腺癌患者晚期辅助治疗阶段的复发预测价值。共纳入83例确诊超过5年、无复发迹象的高危II–III期患者，采用RaDaR（基于全外显子测序的个体化ctDNA检测）进行回顾性随访分析。更新数据显示,在高危HR+/HER2-乳腺癌患者的晚期辅助治疗阶段，所有ctDNA阳性患者均发生远处转移，而ctDNA阴性结果与长期无复发高度相关。进一步验证ctDNA在复发监测中的高度预测力, 并明确MRD监测在随访中的最佳应用策略。该研究为ctDNA在早期乳腺癌随访管理中的应用提供了重要依据，并提示其有潜力用于指导未来干预策略。摘要：5502讲者：JyotiMayadev, University of California San Diego Medical Center本研究基于III期CALLA试验，评估个性化超灵敏ctDNA检测在局部晚期宫颈癌（LACC）中的预后价值。研究纳入770例IB2–IVA期LACC患者，随机接受Durvalumab联合放化疗（D+CRT）或单独放化疗（CRT），并在基线、C3D1和治疗后6个月采集血样，采用NeXT Personal WGS ctDNA检测。结果显示，高基线ctDNA水平提示复发风险升高，治疗后ctDNA清除与生存改善相关；PD-L1高表达亚组在D+CRT中获益更显著。研究支持ctDNA作为LACC治疗监测与风险分层工具。ctDNA-耐药机制探索摘要：1047讲者：LorenzoGerratana, Centro di Riferimento Oncologico di Aviano (CRO)本研究为TRINITI临床研究项目的一部分，旨在通过ctDNA检测解析HR+/HER2-转移性乳腺癌（MBC）患者内分泌原发耐药（R1）和继发耐药（R2）的分子机制。共纳入855例患者，均接受FoundationOne Liquid CDx液体活检检测。研究发现：TP53突变和chr11q13.3扩增是R1关键驱动因素，ESR1突变则与R2相关；R1机制涉及P53通路激活与ER通路失活；chr11q13.3为潜在干预靶点。该研究为HR+/HER2- MBC的个体化治疗提供分子分型依据，支持基于ctDNA的分层管理及联合治疗策略设计。摘要：3066讲者：AlexanderE. Drilon, Memorial Sloan Kettering Cancer Center and Weill Cornell MedicalCollege本研究基于三项Larotrectinib（Laro）全球临床试验，系统分析非中枢原发TRK融合癌患者的耐药机制。通过肿瘤组织或ctDNA的NGS检测，发现Laro耐药机制包括NTRK基因突变（如SF、GK、xDFG）及MAPK/PI3K通路等脱靶耐药，部分患者表现出多克隆耐药。结果提示：TRK融合癌治疗中，需动态基因组监测并探索联合靶向NTRK与下游通路的新策略，以应对复杂耐药格局。单细胞测序肝细胞癌摘要：3129讲者： Florence T. University of British Columbia本研究基于II期INTEGRATE研究（NCT04563338），通过单细胞测序分析阿替利珠单抗+贝伐珠单抗治疗的不可切除HCC患者（n=8）样本，探索免疫耐药机制。结果发现肝脏内皮细胞（ECs）广泛表达多种免疫检查点配体，显著超出既往认知，可能通过诱导T细胞耗竭，参与联合治疗耐药。研究揭示ECs在肿瘤免疫微环境中的关键调控作用，为开发靶向ECs的新型联合免疫策略提供了潜在方向。{明日预告}美国时间: 2025年6月3日ASCO 2025 精选研究与前沿进展全景回顾本文转自医脉通肿瘤科公众号因美纳公司致力于推动和激发基因组学的发展而不断改善人类健康。专注创新使我们成为全球基因测序和芯片技术的领导者，并为全球范围的科研、临床和应用市场客户提供专业服务。我们的产品广泛应用于生命科学、肿瘤学、生殖保健、农业及其他新兴领域。欲了解更多信息，请访问www.illumina.com.cn或关注因美纳微信公众号。在肿瘤领域，因美纳致力于推动肿瘤个体化的识别与治疗，以创新技术加速肿瘤基因组学的革新。我们的技术广泛应用于肿瘤基因组学研究，病理学与肿瘤临床研究，肿瘤伴随诊断以及肿瘤精准医学的未来探索。因美纳公司在肿瘤领域的终极目标是：通过科学发现真正改变肿瘤患者及其家庭的生活。本文涉及的研究数据来源为北京时间6月2日ASCO官网披露的摘要（Abstract）数据。本文中所提及的摘要内容均来源于公开发表的学术会议资料。我们已尽力确保所引用内容的准确性，但不对其完全准确性承担任何责任。读者在使用或参考该内容时，应自行核实相关信息的准确性，并承担相关风险。上述摘要内容的版权和知识产权归原作者或相关机构所有。.

ASCO会议免疫疗法细胞疗法

2025-05-26

·同写意

解码成都医学城创新药崛起之路

创新药产业不仅是生物医药产业争夺的蓝海赛道，也是大国科技博弈的重要战场，已经成为推动全球医药行业发展的重要动力。近年来，中国生物医药产业经历了从“仿制跟随”到“创新引领”的深刻变革，政策支持、技术突破与资本驱动共同推动行业进入高速发展期。同时，生物医药作为知识密集型和技术密集型产业，对高水平人才的依赖度高，生物医药产业与人才共生发展。然而，这一产业的全国发展格局正呈现显著分化：长三角、珠三角、京津冀及成渝等核心城市群聚力打造城市特质和产业生态，吸引人才资源集聚，逐步形成生物医药领域的“超级枢纽”；而其他区域缺乏系统性竞争优势，正面临人才流失与产业边缘化的双重挑战。预计未来十年，这种“马太效应”将进一步加剧，生物医药产业的区域发展差距持续扩大，全国创新药产业高地将进一步固化显现。在此趋势中，成渝通过“政策创新+产业协同+服务优化+文化凝聚”的立体化模式，构建人才发展价值生态，形成全国具有影响力的创新药产业集群，目前已聚集生物医药相关企业6700户，上市企业达44家、国家级专精特新“小巨人”企业近60家，集群入选2024年国家先进制造业集群，总规模超万亿元。其中位于成都温江区的成都医学城作为成都市创新药产业的重要承载地，率先在全国提出医学、医药、医疗“三医融合”发展理念，通过培育“以人为本”的产业发展沃土，以人才驱动赛道突围，已形成抗体药物、放射性药物等为主导的产业集群，集聚医药健康类企业超600家，在研在产药物1128个，63款新药进入临床研究阶段。2024年国家药监局批准上市的40款国产1类新药中，就有4款来自成都医学城。01聚焦ADC、RDC、CXO实现产业特色立园目前，创新药产业仍然面临“三高”特征——高风险、高投入、高回报，从I期临床试验到获批上市的成功率仅为7.9%。同时，部分热门赛道企业扎堆，产能过剩风险较高，给园区筛选重点赛道、打造特色优势提出了更高要求。成都医学城以三医融合为引领，引育结合、久久为功，已集聚药明康德、科伦博泰、百利天恒、远大医药等龙头企业，打造形成ADC、RDC、CXO特色赛道。01依托龙头企业做强ADC领域成都医学城依托化药龙头企业基础，支持其发力创新产品。科伦博泰和百利天恒等ADC龙头已有41款在研产品，其中26款进入临床，在研发管线数量、研发进度、市场开发中处于国内先进行列，助力园区成为国内ADC产业的重要集聚地。其中科伦博泰自主原研药芦康沙妥珠单抗成为我国首个获得完全批准上市的国产ADC，有望成为十亿级重磅产品。02发挥资源优势做大RDC领域远大医药核药研发生产基地成都医学城借助临近夹江、绵阳等核素生产基地的区位优势，打造贯通同位素供给—核药研发—GLP/GCP—生产—应用全链条体系，已聚集通瑞生物、远大医药等3个放药甲级环评场所产业化项目，园区在研RDC管线43条，8条进入临床研究阶段。通瑞生物2024年完成超1亿美元A+轮融资，其核药CDMO平台已投入运营。远大医药位于成都医学城的集团全球首个全产业链智能化核药研发生产基地已取得甲级辐安证，即将全面投入运营，其产品易甘泰已覆盖全国50余家医院，2024年核药板块收入近5.9亿港元。03卡位上游服务做优CXO领域成都医学城围绕全球生物医药大发展衍生的外包服务需求，打造以药明康德、药明生物、泓博智源、维亚生物、药康生物等龙头企业引领的西部CXO集聚高地。聚集医药高端研发人才4000人，龙头公司总体量达40万平方米，可提供化学药、生物药、核药、现代中药等领域全链条一体化的药物研发生产服务，覆盖了药物发现、临床前研究、临床试验、生产等全链条环节，让创新梦想能够在园区快速变现。02坚持人才引领激发镇园之宝发展活力创新药的竞争，归根到底是人才的竞争，成都医学城始终把人才作为产业发展的核心动力，区内科伦博泰、百利天恒、海思科等企业国际国内引才、不拘一格用才，在创新、国际化人才的带领下实现产品由仿制到创新、市场由国内到全球的跨越，成为支撑区域发展的镇园之宝。01管线由仿制向创新，抢占新药研发制高点成都医学城将转型升级视为企业的生存之战，作为企业引领全球医疗变革的战略机遇，开辟新赛道、拓展新市场，助力园区企业由仿到创的战略转型，实现企业发展二次起飞。科伦博泰CEO葛均友博士拥有30余年国内外医药工业界经验，主导科伦博泰战略转型，带领团队实现Trop2 ADC（SKB264）等核心产品临床突破，推动与默沙东超100亿美元ADC全球合作，推动公司实现港股上市。百裕制药设立院士（专家）工作站、博士后科研工作站，形成以国家“万人计划”和省“千人计划”专家领衔的高水平团队，董事长孙毅入选国家“万人计划”科技创业领军人才。公司在肿瘤、中枢神经及抗衰领域在研管线达到10条，中药新药银杏总内酯滴丸上市申请近期获NMPA受理。四川海思科药业2010年以来，先后引进美籍科学家邓炳初、上市公司医药开发负责人严庞科等人才，新药化学部、生物团队等核心部门硕博比例高达64%。2020年1类创新药环泊酚注射液获批上市，成为中国首个自主知识产权静脉麻醉药，2024年更是实现苯磺酸克利加巴林胶囊、考格列汀片2款1类新药35天内相继获批上市。02市场由国内到全球，争做新药出海弄潮儿1、BD交易——打造企业第二增长曲线园区企业形成了自主研发+跨国授权发展策略，与默沙东、BMS、诺华等国际医药巨头合作创造了200亿美元的总交易金额，其中，科伦博泰与默沙东、百利天恒与BMS的药物授权合作，均刷新了中国创新药出海记录。而这些巨额交易，离不开两家企业对于人才尤其是高端国际人才的布局，如百利天恒借助西雅图研发中心SystImmune，吸引超200名海外科研人才，其中不乏BMS原高级副总裁Jie DeLia、美国安德森癌症中心免疫学博士Jahan Khalili等顶级人才。2、海外申报——开辟新药销售第二战场近年来，国内医保谈判、药品集采等改革不断拓展，一定程度上压缩了药企盈利空间。成都医学城大力支持企业开拓海外医药市场，对新取得FDA、EMA、PMDA认证，获得境外上市资质的药品最高500万元的资助。近年来龙头企业加速海外研发、申报团队建设，提高国际竞争力。如百利天恒SystImmune首席医学官Jonathan Cheng曾任默沙东肿瘤临床研究副总裁，领导开发帕博利珠单抗等重磅药物；科伦博泰首席医学官金小平曾在阿斯利康等负责开发新药，促进核心产品的全球临床开发。国际化人才的加持，催生一大批园区研发的新药闯关FDA：海思科的环泊酚注射液已在美国完成Ⅲ期临床试验，预计2025年向FDA申请上市；百裕制药的BY101921片于2023年12月获得FDA临床试验许可；百利天恒正在进行治疗NSCLC、晚期实体瘤的Ⅰ/Ⅱ期临床试验，计划最早于2028年向FDA提交首个生物制品许可申请；科伦博泰的A400已经获得FDA快速通道资格，进入Ⅱ期临床。03厚植产业生态加速打造人才发展沃土成都医学城借力省市资源，整体性推进产业政务服务、技术服务、要素服务体系建设，全力为人才团队打造宜业、宜居的产业“摇篮”。01构筑创新策源高地建设高能级研发创新平台。建设国家重点实验室2个，国家级研发中心9个，公共技术服务平台42个，引进药明康德、药明生物、药康生物等重点企业，建成从临床前动物试验到临床试验、注册、生产、流通的全产业链服务体系，大力提升技术转化效率。形成多层次的产业人才体系。背靠全市65所在蓉高等院校（其中生物医药相关高校26所，国家级医学重点学科、专科72个），110万名在校生，园区吸引聚集魏于全、陈士林、陈晔光、刘进等两院院士、国家级领军人才近200人，刘革新、朱义、王俊民、孙毅等领军企业家在此创新创造，汇集生物医药从业人员上万人，让园区创新者在上下楼间就能碰撞思想火花。02优化产业政策服务打造审评审批绿色通道。推进四川省药品检验研究院建设，组建四川省食品药品审查评价及安全监测中心成都医学城分中心等在内的药械服务专班，开通园区企业注册申报、产品检验检测优先审批通道，帮助企业获得注册证时间缩短至6个月，技术审评、产品检验检测报告时效提高50%。中国（成都）知识产权保护中心帮助生物医药创新主体发明专利审查周期从24个月缩短至3个月，实用新型审查周期从8个月缩短至1个月左右，外观设计审查周期从6个月缩短至1个月左右，平均授权时间提升300%以上。搭建多层次政策支撑体系。市区两级协同搭建产业政策体系，全生命周期支持项目落地、建设、发展，如成都市促进生物医药产业高质量发展政策明确支持创新药研发、入院、进保、出海；温江区先后出台三医融合产业政策32条、高校协同创新政策10条、人才工作先行区建设政策10条等，其中支持国内外高层次人才优质项目到温江培育发展，最高可提供1亿元的综合支持。03建设大美宜居金温江生态之美，林水共生。温江以“江水温润”得名，域内四河环抱、千流纵横，拥有“田水绕林盘、花木遍乡野”的田园景观，获评“联合国杰出绿色生态城市”“企业家幸福感最强区”等荣誉称号。幸福之城，品质宜居。持续打造优教温江，汇集11所高校院所，引进3所全国百强中学，义务教育优质学校占比88%。华西医院、省人民医院等9家三级医院构筑区域健康屏障，健康服务成为最普惠的民生。打造CBA国际赛事中心等258个公共服务设施，构建起24个“15分钟便民服务圈”。“半城烟火半城林，一曲江安述古今”，园林、城市与厚重的产业基础相辅相成，共同组成温江支撑产业发展、赋能人才成长基底，让生物医药科学家、企业家在诗画自然中迸发创意，在宜居家园里怡然自得，使温江成为医药人成就理想、事业和人生的乐土。扫码关注成都医学城成都医学城联系人张　荔：13438833336邹　文：13880620307

抗体药物偶联物临床1期放射疗法

2025-05-23

·PRNewswire

Six Abstracts of Kelun-Biotech's Clinical Studies Published at the 2025 ASCO Annual Meeting

CHENGDU, China, May 23, 2025 /PRNewswire/ -- The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is scheduled to take place in Chicago, Illinois, USA from May 30 to June 3. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, the "Company") will present results from six clinical studies, including data on its TROP2 ADC sac-TMT, anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031) during the meeting. The study abstracts were published on the ASCO website on May 22, 2025 (CDT), with key highlights summarized below: 1. Sac-TMT in patients with previously treated advanced epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study Oral Presentation: June 1, 10:12-10:24 CDT (Abstract #8507: Lung Cancer – Non-Small Cell Metastatic) A total of 137 patients with advanced EGFR-mutant NSCLC who had progressed after EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy were randomized (2:1) to receive sac-TMT (5 mg/kg once every 2 weeks (Q2W)) or docetaxel (75 mg/m2 once every 3 weeks (Q3W)). The median follow-up of 12.2 months (data cutoff: December 31, 2024). Sac-TMT achieved statistically significant and clinically meaningful outcomes compare d to docetaxel: confirmed objective response rate (ORR) (blinded independent review committee (BIRC): 45.1% vs 15.6%, one-sided p=0.0004), progression-free survival (PFS) (BIRC: median 6.9 vs 2.8 months, hazard ratio (HR)= 0.30, one-sided p<0.0001; investigator (INV): median 7.9 vs 2.8 months, HR=0.23). With 36.4% of patients in docetaxel group crossing over to receive sac-TMT, median overall survival (OS) was not reached (NR) for both groups (HR 0.49, one-sided p=0.007). The median OS analysed by pre-specified rank-preserving structural failure time (RPSFT) model adjusted for crossover was 9.3 months for docetaxel and NR for sac-TMT (HR=0.36). Grade ≥ 3 treatment-related adverse events (TRAEs) occurred in 56.0% of patients in sac-TMT group vs 71.7% in docetaxel group. No cases of interstitial lung disease (ILD) were reported in sac-TMT group. These results led to the approval of sac-TMT in EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy in China, which marks the first approval for a TROP2 ADC in lung cancer globally. 2. Sac-TMT as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase 2 OptiTROP-Breast05 study Rapid Oral Presentation: May 30, 15:45-15:51 CDT (Abstract #1019: Breast Cancer – Metastatic) As of November 18, 2024, a total of 41 patients with a/m TNBC who had not received prior treatment for advanced disease (median age 55 years; 43.9% Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 1; 78.0% PD-L1 combined positive score (CPS)<10) were enrolled to receive sac-TMT monotherapy at 5 mg/kg Q2W until disease progression or unacceptable toxicity. The median follow-up was 18.6 months. The ORR was 70.7% and the disease control rate (DCR) was 92.7%. Median duration of response (DoR) was 12.2 months, while the median PFS was 13.4 months. Among the 32 patients with PD-L1 CPS <10, the ORR was 71.9% and the DCR was 93.8%. The median PFS in this subgroup was 13.1 months. TRAEs of grade 3 or higher occurred in 63.4% of patients. No treatment-related deaths occurred, and there were no reports of neuropathy or ILD/pneumonitis. 3. Sac-TMT in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced NSCLC: Non-squamous cohort from the Phase 2 OptiTROP-Lung01 study Poster Presentation: May 31, 13:30-16:30 CDT (Abstract #8529: Lung Cancer – Non-Small Cell Metastatic) Advanced NSCLC patients with no prior systemic therapy and no actionable genomic alterations were enrolled to receive sac-TMT (5 mg/kg Q3W or Q2W) plus tagitanlimab (1,200 mg Q3W or 900 mg Q2W) until disease progression or unacceptable toxicity. As of December 30, 2024, 81 patients with non-squamous histology were enrolled. After median follow-up of 17.1 months, confirmed ORR was 59.3%; Median DoR was 16.5 months; Median PFS was 15.0 months. Among patients with PD-L1 tumor proportion score (TPS)≥50%, the confirmed ORR was 77.8%; median PFS was 17.8 months; while for patients with PD-L1 TPS≥1%, the confirmed ORR was 68.1%; median PFS was 17.8 months. Among patients with PD-L1 TPS< 1%, confirmed ORR was 47.1%; median PFS was 12.4 months. Most common Grade≥3 TRAEs were neutrophil count decreased (45.7%), anemia (16.0%), white blood cell count decreased (14.8%) and stomatitis (11.1%). No TRAE led to treatment discontinuation or death. 4. Sac-TMT in patients with previously treated locally advanced or metastatic (LA/M) NSCLC harboring uncommon EGFR mutations: Preliminary results from a Phase 2 Study Poster Presentation: May 31, 13:30-16:30 CDT (Abstract #8615: Lung Cancer – Non-Small Cell Metastatic) As of December 1, 2024, 42 advanced NSCLC patients who had progressed on or after systemic therapy were enrolled, including 23 patients with EGFR G719X in exon 18, S768I in exon 20, or L861Q in exon 21 and 19 patients with EGFR ex20ins. Patients received sac-TMT 5 mg/kg Q2W until disease progression or unacceptable toxicity. After a median follow-up of 9.2 months, the ORR was 35.7% and the DCR was 85.7%. Responses were durable with the median DoR not yet reached. The median PFS was 9.5 months. In the subset of patients with uncommon non-ex20ins, the ORR was 34.8%; the median PFS was 10.9 months. In the subset of patients with ex20ins, the ORR was 36.8% and the median PFS was 9.0 months. Grade ≥3 TRAEs occurred in 52.4% of patients. No TRAEs led to treatment discontinuation or death. No cases of ILD/pneumonitis were reported. 5. Tagitanlimab versus placebo in combination with gemcitabine and cisplatin (GP) as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase Phase 3 study Oral Presentation: May 31, 14:27-14:39 CDT (Abstract #6004: Head and Neck Cancer). Eligible R/M NPC patients who have not previously received systemic therapy were in 2:1 ratio randomly assigned to receive tagitanlimab or placebo (1200 mg, D1) in combination with cisplatin (80 mg/m2, D1) and gemcitabine (1000 mg/m2, D1 and D8) Q3W for up to 6 cycles followed by tagitanlimab or placebo monotherapy Q3W until disease progression, unacceptable toxicity, or withdrawal of consent. The median follow-up time was 11.7 months. The PFS per blinded independent central review (BICR) was met with a 53% reduction in risk of progression or death (HR=0.47, one-sided P <0.0001). The median PFS was not reached in tagitanlimab plus GP arm and 7.9 months in placebo plus GP arm. The ORR per BICR was 81.7% in tagitanlimab plus GP arm and 74.5% in placebo plus GP arm, with a median DoR of 11.7 months and 5.8 months (HR=0.48), respectively. The OS benefit was observed in tagitanlimab plus GP arm vs placebo plus GP arm (median OS not reached for either arm; HR=0.62). Tagitanlimab also showed a manageable safety profile. 6. Results from a Phase 1 study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer (MTC) Poster Presentation: June 2, 9:00-12:00 CDT (Abstract #6098: Head and Neck Cancer) As of September 20, 2024, 27 advanced RET-mutant MTC patients without prior selective RET inhibitors were enrolled and treated in the phase 1 part across 4 dose levels (20 to 90 mg once a day (QD)). The median follow-up was 19.0 months. As of September 20, 2024, the confirmed ORR was 63.0% and the DCR was 100% for overall population. The confirmed ORR was 56.3% (9/16) and 62.5% (5/8) in patients with prior multikinase inhibitor (MKI) or treatment naïve, respectively. Median DoR was not reached, with the longest duration still ongoing at 25.8 months. Similarly, median PFS was not reached, with the 24-month PFS rate of 77.8%. All patients experienced TRAEs, with grade ≥3 TRAEs occurred in 22.2% of patients. No TRAEs led to treatment discontinuation or death. About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestically developed and fully approved for marketing ADC in China with global intellectual property rights. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the National Medical Products Administration (NMPA), and were (to be) reviewed via the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab[1] or other agents for several types of cancer. These studies are sponsored and led by MSD. About Tagitanlimab Tagitanlimab is the first PD-L1 mAb to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively. About KL590586 ( A400/EP0031) KL590586(A400/EP0031) is a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. The Company are currently conducting pivotal clinical studies for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China. In March 2021, The Company granted Ellipses Pharma Limited, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031. In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the Food and Drug Administration (FDA) for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE. About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit . Media: [email protected] SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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临床结果临床1期临床3期ASCO会议引进/卖出

100 项与 Lunbotinib 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
晚期恶性实体瘤	临床2期	中国	四川科伦博泰生物医药股份有限公司	2021-09-06
局部晚期恶性实体瘤	临床2期	中国	四川科伦药物研究院有限公司	2021-06-01
RET突变阳性甲状腺髓样癌	临床申请批准	中国	四川科伦博泰生物医药股份有限公司	2023-07-24

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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


NCT05265091 (KL400-I/II-01, ASCO2025)	临床1/2期	RET突变阳性甲状腺髓样癌 RET-mutant	27	KL590586	夢簾夢壓襯艱構範積廠(築選衊鹹廠鏇醖繭鏇鏇) = 22.2% 鑰繭鹽窪鹹鹹膚壓餘膚 (鹽獵淵齋淵構窪齋衊繭 ) 更多	积极	2025-05-30
NCT05443126 (Phase 1 study of EP0031, ASCO2025)	临床1期	RET突变实体瘤	40	EP0031 20mg QD	夢遞鏇鹹鑰觸夢願蓋憲(衊艱衊窪築醖蓋繭選壓) = seen in 1 (2.5%) pt 鏇願蓋襯鬱顧壓顧繭築 (窪壓遞遞遞膚衊積鏇艱 ) 更多	积极	2025-05-30
				EP0031 60mg QD
NCT05443126 (Phase-1 dose escalation and expansion study of EP0031, ASCO2024)	临床1/2期	非小细胞肺癌	27	EP0031 60mg QD	簾憲選糧鬱繭鏇膚餘廠(鏇顧鬱鹹鑰願繭繭淵壓) = No DLTs were observed 獵選鏇遞構範鹹築製繭 (齋鹹製構餘蓋鹹顧鑰衊 ) 更多	积极	2024-05-24
				EP0031 90mg QD
NCT05265091 (KL400-I/Ⅱ-01, ASCO 12023 \| ASCO 22023) 人工标引	临床1期	RET突变实体瘤 RET Fusion	87	KL590586	糧膚鏇積醖簾壓蓋觸衊(窪廠糧廠膚鏇願觸獵鏇) = Not reached 蓋構構蓋鏇窪糧窪淵範 (蓋積簾選憲淵廠壓製壓 ) 更多	积极	2023-05-31