Jinan Central Hospital

2025年美国临床肿瘤学会（ASCO）年会将于5月30日至6月3日在美国芝加哥McCormick会展中心举办。一年一度的ASCO年会汇聚来自全球临床肿瘤学的精英，将展示国际最前沿的临床肿瘤学研究成果和肿瘤治疗技术。美国中部时间2024年4月24日，ASCO在线公布了入选年会的研究摘要标题。华昊中天的核心产品优替德隆注射液和优替德隆口服胶囊相关的四项最新临床研究数据将以口头报告、壁报展示等方式亮相ASCO 2025。优替德隆注射液于2021年3月在中国上市，首个获批适应症为复发或转移性晚期乳腺癌，成为10年来全球唯一获批的具有新型分子结构的微管抑制剂类抗肿瘤新药。基于优替德隆具有可穿透血脑屏障、抗癌谱广、血液学毒性低、可口服给药等特性和优势，华昊中天在新适应症拓展、口服剂型临床开发等方面在海内外深入布局。本次入选的四项研究分别针对优替德隆胶囊治疗晚期乳腺癌1/2期临床（中国注册研究）、优替德隆胶囊治疗晚期实体瘤1期临床（美国注册研究）、优替德隆注射液1线治疗晚期胃癌和食管癌2期临床（中国注册研究），以及优替德隆注射液治疗乳腺癌脑转移2期临床（中国研究）。具体信息如下：口头报告摘要题目Utidelone in combination with etoposide and bevacizumab in HER2 negative breast cancer patients with brain metastasis: a prospective, single-arm, Phase II trial.摘要编号2012会议环节Central Nervous System Tumors展示时间2025.5.31 下午3:00（美国中部时间）演讲者史业辉（天津医科大学肿瘤医院）壁报展示摘要题目Efficacy and safety results of a multi-center Phase I study of utidelone capsule, a novel oral microtubule inhibitor, in advanced solid tumors patients.摘要编号3030会议环节Developmental Therapeutics-Molecularly Targeted Agents and Tumor Biology展示时间2025.6.2 下午1:30-4:30（美国中部时间）演讲者Judy S. Wang（Florida Cancer Specialists/Sarah Cannon Research Institute）壁报展示摘要题目Efficacy and safety results of a multi-center Phase II study of utidelone injection in combination with PD-1 inhibitor and chemotherapy for the first-line treatment of advanced gastric and esophagus cancers.摘要编号4040会议环节Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary展示时间2025.5.31 上午9:00-12:00（美国中部时间）演讲者孙美丽（济南市中心医院）在线发表摘要题目Effcacy and safety results of a multi-center Phase I/II study of utidelone capsule, a novel oral microtubule inhibitor.摘要编号e13110会议环节Breast Cancer-Metastatic第一作者徐兵河（中国医学科学院肿瘤医院）往期回顾FDA批准华昊中天优替德隆胶囊一线治疗晚期胃癌II/III期国际多中心临床一图回顾华昊中天2024年度进展 Biostar 2024 Annual Review华昊中天荣获“年度卓越创新力IPO”奖强强联合，携手共赢丨华昊中天与百洋医药达成战略合作华昊中天成功登陆香港联交所主板，合成生物学引领创新药研发新时代华昊中天“优替德隆注射液乳腺癌新辅助Ⅲ期注册临床试验”研究者会议圆满召开亦庄路书｜一支“创新药”的健康答卷冲击癌王 ▏优替德隆一线治疗晚期胰腺癌临床研究初步数据公布华昊中天优替德隆注射液治疗肺癌脑转移II期临床获批

iStock, Baurzhan Ibrashev Eli Lilly’s shares shot up 11% pre-market on Thursday after orforglipron became the first small-molecule GLP-1 drug to ace a late-stage study in type 2 diabetes, eliciting significant reductions in body weight and improvements in glucose control. Eli Lilly’s oral GLP-1 receptor agonist orforglipron can significantly lower blood sugar levels in patients with type 2 diabetes, according to preliminary Phase III data released Thursday. The Big Pharma’s stock price rose 11% on the news, while its main competitor in the GLP-1 space, Novo Nordisk, dropped 6%. “Has the tortoise caught the hare?” analysts at BMO Capital Markets mused in a note to investors. The group called Thursday’s findings a “positive readout” for orforglipron, adding that “Lilly achieves goal of reaching injectable like efficacy from oral orforglipron.” In the Phase III ACHIEVE-1 trial, once-daily 36-mg orforglipron lowered average blood glucose levels (A1C) by 1.5% from baseline at 40 weeks, according to Lilly’s Thursday release. Placebo comparators, on the other hand, saw only a 0.1% decrease in A1C over this time period. Orforglipron also hit key secondary endpoints, cutting body weight by 7.9% over 40 weeks versus 1.6% in placebo. As for safety, orforglipron’s side effect pro consistent with that of the GLP-1 class. Adverse events were mostly gastrointestinal in nature and were largely mild or moderate in severity. At the 36-mg dose level, 8% of treated patients dropped out due to side effects, as compared with 1% in the placebo arm. There were no liver safety signals detected. BMO noted that orforglipron’s safety profile “looks clean,” though there remains “some concern” of higher rates of nausea and vomiting. Overall, however, the readout from ACHIEVE-1 “firmly validate the tolerable pro orforglipron.” Lilly plans to submit approval applications for orforglipron for weight management by the end of the year, while a regulatory filing in diabetes is slated for 2026. Like the two GLP-1 leaders—Lilly’s tirzepatide and Novo Nordisk’s semaglutide—orforglipron is an analog of the GLP-1 hormone, and it works by promoting the secretion of insulin from the pancreas in response to a spike in blood sugar. The drug also suppresses appetite and hunger. Uniquely, however, orforglipron is available orally, which presents several advantages. In addition to allowing patients to avoid regular injections, orforglipron can be taken “any time of the day without restrictions on food or water intake,” according to Lilly’s announcement. Moreover, as a small-molecule drug, orforglipron is also easier to manufacture . “Unlike the injectables, supply is not likely to be an issue,” analysts at Truist Securities told investors in a Thursday note. Lilly has also long been preparing its manufacturing infrastructure for orforglipron, investing money and expanding its production capacity as early as February 2024 . In its press announcement on Thursday, the pharma noted that if orforglipron wins regulatory approval, it is ready to launch the drug worldwide “without supply constraints.” “[W]e believe obesity competitor Lilly has made sizable advancements in its commercial and clinical portfolio, causing it to overtake Novo’s early lead,” BMO analysts wrote.

3月19日，贝达药业口服小分子PD-L1抑制剂BPI-371153研究进入Ib期扩大入组阶段并完成首例受试者入组，目标适应症为非小细胞肺癌和腺泡状软组织肉瘤。 该研究是“BPI-371153胶囊在晚期实体瘤或复发/难治性淋巴瘤患者中安全性、耐受性、药代动力学和有效性的剂量递增、开放的I期研究”。牵头单位为中国医学科学院肿瘤医院，主要研究者为石远凯教授。I期临床研究分为两个阶段：剂量递增和扩大入组研究。剂量递增阶段已完成，扩大入组阶段是在剂量递增研究的前提下，在晚期非小细胞肺癌（NSCLC）和复发/转移性/不可手术切除的腺泡状软组织肉瘤（ASPS）进一步评价BPI-371153胶囊的安全性、耐受性、PK特征及疗效。 △BPI-371153作用机理图 BPI-371153是一种口服小分子PD-L1抑制剂，可诱导PD-L1的二聚化和内吞，从而降低细胞膜上的PD-L1水平，有效地破坏PD-1/PD-L1的相互作用。在2024年欧洲肿瘤内科学会亚洲年会（ESMO ASIA）上，中国医学科学院肿瘤医院石远凯教授团队首次口头报告了BPI-371153的人体剂量递增试验的结果。在≥600mg剂量组，观察到了初步的抗肿瘤活性。17例疗效可评估受试者中，客观缓解率（ORR）为23.5%（95% CI：6.8-49.9），疾病控制率（DCR）为64.7%（95% CI：38.3-85.8）。最新的试验结果显示，在4例PD-L1高表达的NSCLC患者中，3例患者出现肿瘤缓解，ORR为75%（95% CI：19.4-99.4）。 中国医学科学院肿瘤医院石远凯教授表示， BPI-371153作为口服剂型的PD-L1小分子抑制剂，展现出了良好的安全性与耐受性，已观察到令人鼓舞的抗肿瘤活性 和 药代动力学特性。接下来的重点开发领域主要集中在晚期非小细胞肺癌和腺泡状软组织肉瘤上，确保能够最大程度地惠及最有可能获益的患者群体，以进一步验证前期临床研究中观察到的疗效，并探索更广阔的应用潜力。 贝达药业研发总裁兼首席医学官毛力教授表示，BPI-371153 Ib期扩大入组阶段首例受试者入组，是新药研发迈出的重要一步。 特别感谢中国医学科学院肿瘤医院作为组长单位提供的专业领导、济南市中心医院作为首个扩大入组中心的高效执行，以及 患者的支持。该药物在前期研究中展现的积极结果，为后续临床研究奠定了坚实的基础。期待BPI-371153在晚期非小细胞肺癌和腺泡状软组织肉瘤领域中顺利推进临床开发，为晚期癌症患者提供更多的治疗选择，进一步提升患者生存获益。