A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Surufatinib in Combination With KN046 and AG Regimen Chemotherapy for the First-Line Treatment of Unresectable Advanced Pancreatic Cancer

Advanced pancreatic cancer is a highly aggressive and fatal disease with an extremely low 5-year survival rate. Combined chemotherapy is the mainstay of treatment for patients with unresectable advanced pancreatic cancer, and the combination of nab-paclitaxel and gemcitabine (AG regimen) has been one of the most commonly used regimens for more than a decade. However, chemo-resistance often occurs within half a year and the efficacy remains unsatisfied with an overall survival of only 9
11 months.
Immune checkpoint inhibitors (ICIs) such as anti-PD-1/L1 antibody and anti-CTLA-4 antibody have demonstrated encouraging anti-tumor efficacy in multiple solid tumors including lung cancer, gastric cancer, and esophageal cancer, while obtained controversial results when combined with chemotherapy in pancreatic cancer. Recently, the immune-suppression tumor microenvironment (TME) of pancreatic cancer has been described in several pre-clinical studies, which may explain the resistance against ICIs and chemotherapy.
KN046 is a recombinant humanized PD-L1/CTLA-4 bispecific antibody with innovative designs include a proprietary CTLA-4 domain antibody with a significantly improved safety profile, a bispecific antibody fused with PD-L1 antibody targeting the TME with high PD-L1 expression. Recent clinical studies have shown promising anti-tumor activity of KN046 in pancreatic cancer.
Surufatinib, also known as HMPL-012 or Sulfatinib, is a small molecular tyrosine kinase inhibitor (TKI) targeting the Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor (FGFR) and Colony Stimulating Factor-1 Receptor (CSF-1R), which has a dual mechanism of action of anti-angiogenesis and regulation of immune microenvironment. Previous studies have suggested synergic effect of surufatinib in combination with anti-PD-1 antibodies.
This phase Ib/II clinical trial is intended to investigate the activity and safety of the combination of surufatinib combined with KN046 and the AG regimen chemotherapy as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer.

开始日期2023-11-01

申办/合作机构

复旦大学附属中山医院

[+1]

NCT05985109

/ Recruiting临床2期IIT

A Phase II Multi-cohort Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib for Metastatic Microsatellite-Stable Colorectal Cancer: a Phase II Multi-cohort Study

The study is an interventional Phase II clinical trial aiming to optimize immunotherapy strategies for microsatellite-stable colorectal cancer. We will include three types of metastatic colorectal cancer patients: those without liver metastasis, or carrying BRAF V600E mutation, or unable to tolerate chemotherapy as their initial or second-line treatment. The participants will receive a combination treatment of regorafenib and KN046 which is a PD-L1/CTLA-4 bispecific antibody. Treatment efficacy and safety profile would be evaluated in this study.

开始日期2023-10-26

申办/合作机构

北京市肿瘤防治研究所

NCT06099821

/ Recruiting临床2期IIT

A Phase II Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib or Apatinib for Microsatellite Instability-High Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

The study is an interventional phase II clinical trial aiming to evaluate the efficacy and safety of KN046, a PD-L1 and CTLA-4 bispecific antibody, in combination with regorafenib or apatinib for microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade. KN046 plus regorafenib will be given for patients with colorectal cancers, and KN046 plus apatinib will be given for patients with gastric cancers (including esophageal-gastric junction cancers) and other kinds of digestive system cancers.

开始日期2023-10-25

申办/合作机构

北京肿瘤医院（北京大学肿瘤医院）

100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的临床结果

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100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的转化医学

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100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的专利（医药）

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项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Crescioli, Silvia ; Kaplon, Hélène ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-07-01·CANCER TREATMENT REVIEWS

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies

Review

作者: Jiménez-Labaig, Pablo ; Braña, Irene ; Hernando-Calvo, Alberto ; Harrington, Kevin J ; Bhide, Shreerang ; Rullan, Antonio ; O'Leary, Ben ; Llop, Sandra

INTRODUCTION:

There is a need to improve the outcomes of patients with head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC), especially in recurrent unresectable and metastatic (R/M) setting. Antibody-drug conjugates (ADC) and bispecific antibodies (BsAb) may deliver promising results.

METHODS:

We conducted a systematic literature review to identify ADC and BsAb clinical trials, involving patients with HNSCC and NPC, from database creation to December 2023. We reported trial characteristics, overall response rate (ORR), overall survival (OS), and grade ≥ 3 treatment-related adverse events (trAEs).

RESULTS:

23 trials (65 % phase I) were found, involving 540 R/M patients (355 [20trials] HNSCC and 185 [5trials] NPC). There were 13 ADC (n = 343) and 10 BsAb (n = 197) trials. 96 % patients were refractory to standard of care treatments. ORR ranged from 0 to 100 %, with the highest ORR for GEN1042 plus chemoimmunotherapy. ORRs for monotherapies were 47 % for ADC, and 0-37 % for BsAb. MRG003 reached in HNSCC 43 % and NPC 47 %. BL-B01D1 54 % in NPC. Longest median OS was seen with MRG003 and KN046. Grade ≥ 3 trAEs were 28-60 % in ADC trials, and 3-33 % BsAb. Grade ≥ 3 myelosuppressive trAEs were typically seen in 8 ADC trials, while 4 BsAb showed infusion-related reactions (IRR). Four treatment-related deaths were reported (1 pneumonitis), all ADC trials.

CONCLUSION:

ADC and BsAb antibodies show promise in R/M HNSCC and NPC. Results are premature by small sample sizes and lack of control arm. ADC mainly caused myelosuppression and a pneumonitis case, and BsAb IRR. Further research is warranted in this setting.

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项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的新闻（医药）

2025-05-26

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国产双抗/三抗霸榜ASCO 2025

5月30日-6月3日，2025年美国临床肿瘤学会（ASCO）年会将在美国芝加哥举行。ASCO年会是全球肿瘤领域最权威的学术交流盛会，每年都会展示当前国际最前沿的临床肿瘤学科研成果和治疗技术。5月22日，ASCO年会摘要全文公布，以中国为主的全球诸多双抗/三抗项目披露了临床数据，医药魔方从中挑选数据亮眼的10项进行介绍。产品：petosemtamab（MCLA-158）药物靶点+类型：LGR5/EGFR双抗公司：Merus全球研发赛道排名：1/1本次公布结果的II期研究评估了petosemtamab联合帕博利珠单抗作为PD-L1+复发/转移性（r/m）头颈部鳞状细胞癌（HNSCC）一线治疗方案的疗效和安全性，共纳入45例患者，截至2024年9月16日数据截止时，仍有18例患者继续接受治疗。在43例可评估疗效的患者中，客观缓解率（ORR）为60%（26/43），其中5例为完全缓解；中位缓解持续时间（DOR）为11个月。在8例p16+口咽疾病患者中，4例有确认缓解（ORR：50%）。尚未达到中位总生存期（OS），6个月的OS率估计为93%。结果显示，petosemtamab联合帕博利珠单抗一线治疗PD-L1+ r/m HNSCC患者具有良好的临床疗效和耐受性安全性。一项全球III期LiGeR-HN1研究正在进行，以继续评估该联合治疗方案一线治疗PD-L1+ r/m HNSCC患者的疗效。产品：LBL-024药物靶点+类型：PDL1/4-1BB双抗公司：维立志博全球研发赛道排名：3/22本次公布结果的是一项Ib/II期研究，其中Ib期剂量递增研究纳入既往未治疗的晚期肺外神经内分泌癌（EP-NEC）和小细胞肺癌（SCLC）患者，II期剂量优化/剂量扩展研究纳入既往未治疗的晚期EP-NEC患者。截至2024年12月26日，53例（Ib期13例，II期40例）患者入组接受治疗。结果显示，在49例可评估疗效的患者中，所有剂量组总ORR为77.6%，疾病控制率（DCR）为93.9%。在21例EP-NEC患者中，所有剂量组总ORR为81.0%，DCR为95.2%。此外，2例SCLC患者均实现ORR。结果提示LBL-024联合化疗的耐受性良好，在EP-NEC中观察到的疗效显著高于历史报道（约30%-55%）。产品：TQB2930药物靶点+类型：HER2双抗公司：正大天晴全球研发赛道排名：3/9本次公布结果的Ib/II期研究纳入了55例至少接受过两种系统治疗的复发或转移性HER2阳性乳腺癌患者。结果显示，中位随访4.14个月时，在52例可评估疗效的患者中，ORR为48.1%（25/52），88.5%（46/52）患者的目标病灶体积减小，PFS和OS尚未达到，6个月PFS率估计为71%。在接受过恩美曲妥珠单抗治疗的亚组中，ORR为36.8%（7/19）；在其他HER2 ADC（德曲妥珠单抗、维迪西妥单抗等）治疗失败的亚组中，ORR为50.0%（8/16）。安全性方面，3级及以上TRAE包括白细胞计数减少、中性粒细胞计数减少、血小板计数减少和输注相关反应。没有3级及以上心脏毒性事件发生，窦性心动过缓或 QT 间期延长的发生率低于3%。产品：TQB2868药物靶点+类型：PD-1/TGF-β双抗公司：正大天晴全球研发赛道排名：2/7本次公布的II期研究旨在评估TQB2868联合安罗替尼以及白蛋白结合型紫杉醇和吉西他滨一线治疗转移性胰腺导管腺癌（mPDAC）的有效性和安全性，共纳入40例患者，其中36例患者符合疗效评估条件。结果显示，中位随访5.9个月时，中位PFS和中位OS尚未达到，6个月PFS率和6个月OS率分别为86%和95%。ORR为63.9%（23/36），其中23例患者达到PR；DCR为100%（36/36）。在探索性分析中，给药后大多数病例中TGF-β1的抑制率超过90%，且几乎没有反弹。产品：ZG006药物靶点+类型：CD3/DLL3三抗公司：泽璟制药全球研发赛道排名：1/1这项II期研究评估了ZG006单药（10mg或30mg，每2周1次）治疗既往接受过至少二线标准系统治疗的小细胞肺癌（SCLC）患者的疗效。截至2024年12月31日，40例患者入组，其中27例可评估疗效。结果显示，18例患者实现PR（其中5例已确认，其余待确认），总体ORR为66.7%（18/27），DCR为92.6%。10mg剂量组和30mg剂量组ORR分别为53.8%（7/13）和78.6%（11/14），DCR分别为84.6%（11/13）和100.0%（14/14）。DoR和PFS数据尚未成熟，需进一步随访更新。此外，在21例（77.8%）DLL3低表达（17例）或DLL3中表达（4例）患者中，ZG006抗肿瘤疗效显著，15例患者达到PR，ORR为71.4%。安全性方面，TRAE发生率为87.5%（35/40），3级及以上TRAE发生率为12.5%（5/40），SAE发生率为12.5%（5/40），没有患者因TRAE停药或死亡。产品：ZG005药物靶点+类型：PD-1/TIGIT双抗公司：泽璟制药全球研发赛道排名：2/7本次公布结果的I/II期研究分为两部分，Part 1为剂量递增研究，Part 2评估ZG005（10mg/kg或20mg/kg）+化疗±贝伐珠单抗的疗效和安全性。截至2024年12月19日，Part 1和Part 2分别纳入了12例和29例晚期宫颈癌患者，其中53.7%的患者在研究中接受了贝伐珠单抗治疗。在28例可评估疗效的患者中，10mg/kg和20mg/kg剂量组未确认的客观缓解率（ORR）分别为69.2%（9/13）和80.0%（12/15）。Part 1未观察到剂量限制性毒性（DLT）。在41例患者中评估的安全性数据显示，治疗相关不良事件（TRAE）发生率为75.6%（31/41），1-2级TRAE最为常见，3级及以上TRAE发生率为29.3%（12/41）。没有患者因TRAE停药或死亡。10mg/kg剂量组有1例患者报告严重不良事件（SAE）——双侧肺部肺炎，20mg/kg剂量组未发生SAE。产品：erfonrilimab药物靶点+类型：PD-L1/CTLA-4双抗公司：康宁杰瑞全球研发赛道排名：1/2本次公布结果的单臂Ib/II期研究纳入了18例符合接受化疗条件的不可切除的局部晚期或转移性胰腺癌患者，旨在评估erfonrilimab（KN046）联合索凡替尼和化疗作为一线治疗的疗效和安全性。结果显示，在16例可评估疗效的患者中，ORR为68.8%，DCR为100%。中位随访7.43个月时，PFS和OS分别为8.25个月和11.14个月，6个月PFS率和6个月OS率分别为72.9%和82.5%。此外，在探索性分析中，携带DNA损伤反应（DDR）相关突变的患者（n=7）似乎有着更好的应答效果，ORR显著更高（85.7% vs 55.6%，P = 0.308），6个月PFS率更高（100% vs 53.3%，对数秩检验P = 0.519），6个月OS率也更高（100% vs 62.5%，对数秩检验P = 0.116）。安全性方面，TRAE发生率为77.8%，最常见的 TRAE（发生率≥20%）包括白细胞计数减少（44.4%）、高血压（38.9%）和血小板计数减少（22.2%）。3 级及以上TRAE包括白细胞计数减少（11.1%）、中性粒细胞计数减少（11.1%）、血小板计数减少（11.1%）和高血压（11.1%）。没有患者因治疗死亡。产品：acimtamig（AFM13）药物靶点+类型：CD30/CD16a双抗公司：Affimed全球研发赛道排名：1/1该II期研究在剂量探索部分纳入了24例在标准治疗后疾病进展的复发或难治性经典霍奇金淋巴瘤（R/R cHL）患者，旨在评估acimtamig（200mg或300mg）联合AB-101的疗效和安全性。结果显示，14例患者实现完全缓解（CR），ORR为88%（21/24）。安全性方面，最常见的TRAE是输注相关反应。没有患者因TRAE停药或死亡。产品：ISB 2001药物靶点+类型：BCMA/CD38/CD3三抗公司：Ichnos Sciences全球研发赛道排名：1/2本次披露了ISB 2001 I期研究剂量递增阶段的数据，评估其在RRMM患者中的安全性、耐受性、疗效、药代动力学（PK）和药效动力学（PD）。截至2025年1月13日，24例患者接受了8个剂量水平（5-1800μg/kg）的治疗，中位随访6个月（范围2-12）。最高剂量组DL9（2700μg/kg）目前正在入组。所有8个剂量组的ORR达75%，包括严格完全缓解（sCR）率13%、完全缓解（CR）率为13%、非常好的部分缓解（VGPR）率为38%、部分缓解（PR）率为13%。从最低50μg/kg剂量组即观察到缓解（MRD阴性sCR），≥50μg/kg剂量组ORR达82%。中位缓解时间36天。ISB 2001呈现近似剂量线性的PK特征、>10 天的半衰期和一致的T细胞活化，支持其作用机制。安全性方面，未观察到DLT、导致停药的不良事件（AE）或死亡病例。33%（8/24）患者报告严重AE。54%（13/24）患者出现药物相关3-4级AE。70.8%（17/24）患者发生细胞因子释放综合征（CRS），主要为1-2级，中位发生时间3天，中位持续时间2天。未报告神经毒性或免疫效应细胞相关神经毒性综合征（ICANS）。产品：obrixtamig药物靶点+类型：DLL3/CD3双抗公司：勃林格殷格翰全球研发赛道排名：2/12Obrixtamig联合拓扑替康治疗晚期小细胞肺癌（SCLC）患者的Ib期AREONTM-9研究中期分析结果显示，可评估患者（n=23）中，未确认的ORR为70%（95% CI 47–87），其中CR1例（4%），PR15例（65%）；DCR为87%（95% CI 66–97）。在13例接受≥2次基线后肿瘤评估（随访>13周）的患者中，确认的ORR为69%。中位缓解持续时间未达到。安全性方面，obrixtamig相关不良事件（AEs；任意级别/≥3级）发生率为23例（92%）和7例（28%），无5级AEs。无患者因治疗相关AEs停用obrixtamig。未观察到≥2级神经系统事件。所有CRS均为低级别：1级（44%）和2级（4%）。此外，还有一项obrixtamig针对高或低DLL3表达的肺外神经内分泌癌（epNEC）患者的I期研究披露了相关数据。截至2024年6月21日，共纳入60例epNEC患者（胃肠胰来源[GEP]：45.0%，泌尿生殖系统来源[GU]：30.0%，其他/原发灶不明：25.0%），其中DLL3高表达组与低表达组各30例。所有患者均接受过系统性治疗，其中DLL3高表达组30.0%、低表达组50.0%的患者既往接受过＞2线治疗。Obrixtamig治疗后，DLL3高表达患者的ORR、DCR和DOR均优于DLL3低表达患者。DLL3高表达的GEP（50.0%）和GU（60.0%）来源epNEC患者缓解率最高。7例DLL3高表达患者仍在接受治疗。两组中大多数治疗相关不良事件（TRAEs）为轻度至中度。Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

临床结果ASCO会议临床2期

2025-05-23

·和黄医药官微

和黄医药将于美国临床肿瘤学会(ASCO)2025年年会公布数据

中国香港、上海和美国新泽西州：2025年5月23日，星期四：和黄医药(中国)有限公司 (简称 "和黄医药" 或 "HUTCHMED") (纳斯达克/伦敦证交所: HCM; 香港交易所: 13) 今日宣布和黄医药自主研发的化合物赛沃替尼、HMPL-306 (ranosidenib)、呋喹替尼和索凡替尼的数项研究的最新及更新后的数据将于2025年5月30日至6月3日在美国芝加哥召开的2025年美国临床肿瘤学会(ASCO) 年会上公布。SACHI中国III期研究的结果将以最新突破性口头报告的形式公布，该研究旨在评估赛沃替尼联合奥希替尼用于一线表皮生长因子受体 ("EGFR") 抑制剂治疗后疾病进展的EGFR突变阳性伴MET扩增的局部晚期或转移性非小细胞肺癌患者。 SACHI 在预设的中期分析中已达到预设的主要终点无进展生存期 ("PFS")。SACHI研究的数据支持了该口服疗法的新药上市申请，该申请已于中国获受理并纳入优先审评。赛沃替尼联合奥希替尼用于治疗既往接受奥希替尼治疗后疾病进展、伴有MET过表达和/或扩增的EGFR突变的非小细胞肺癌患者的SAVANNAH II期研究中高MET过表达和/或扩增亚组的进一步数据，以及根据脑转移状态分层的分析结果亦于大会公布。与赛沃替尼加安慰剂相比，赛沃替尼和奥希替尼的联合疗法显示出更佳的疗效。此联合疗法显示出良好的中枢神经系统活性，延缓中枢神经系统进展并减少新的中枢神经系统病灶。HMPL-306的I期临床试验剂量递增阶段的结果将于大会公布。HMPL-306是一种新型、高选择性的小分子口服异柠檬酸脱氢酶 ("IDH")1和IDH2酶双重抑制剂，正于伴有IDH突变的局部晚期或转移性实体瘤患者中开展研究。结果显示，该药物耐受性良好，在患者中显示出靶点抑制和持久的缓解。研究观察到疗效信号，且在低级别胶质瘤的疗效评估组 (N=14)中尤其显著，客观缓解率 ("ORR")为7.1%，疾病控制率 ("DCR")为100%。FRUSICA-1 开放标签、单臂、关键性II期临床试验的亚组分析结果亦将公布，该研究旨在评估呋喹替尼联合信迪利单抗用于治疗经治的晚期错配修复完整 (pMMR) 子宫内膜癌患者的疗效和安全性。浆液性癌患者 (N=27) 中观察到具有临床意义的疗效结果，与整体研究人群 (N=98) 中观察到的缓解情况相似。独立审查委员会 ("IRC") 评估的ORR为37.0%，DCR为88.9%。在缓解是否会受到既往新辅助/辅助化疗 ("NACT/ACT") 影响的分析中表明，无论患者既往是否曾接受 NACT/ACT治疗，均显示出持久且具有临床意义的缓解。接受过和未接受NACT/ACT治疗的患者的结果相若，IRC 评估的ORR分别为34.0%和31.4%，DCR分别为85.1%和82.4%。两项来自呋喹替尼在中国2798名结直肠癌患者中开展的IV期研究的亚组分析结果将会公布。在评估呋喹替尼单药疗法和联合疗法安全性的亚组分析中，呋喹替尼在两组中均显示出可控的安全性。3级以上治疗期间不良事件 (TEAE) 在呋喹替尼单药治疗组中发生率为23.94%，与其他抗癌药物联合疗法组则为26.06%。两组中最常见的治疗相关不良事件 (TRAE) 均为掌跖红肿感觉异常 (PPES) 和高血压。联合疗法组的治疗持续时间更长，这可能表明患者的治疗结果有所改善。在按年龄分组的亚组分析中，评估了呋喹替尼在较年轻患者 (年龄<50岁) 和高龄患者 (年龄≥75岁) 中的安全性。两个年龄组中的安全性相似，较年轻患者接受了更为密集的治疗。呋喹替尼联合疗法的治疗持续时间在两个年龄组中也均优于单药疗法，这可能表明带来更高的生存获益。报告详情包括已公布的摘要链接如下：公司申办的研究标题：赛沃替尼联合奥希替尼对比化疗用于治疗EGFR TKI治疗后疾病进展的EGFR突变伴MET扩增的晚期非小细胞肺癌：SACHI III期随机研究的结果Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study主要作者：陆舜，上海交通大学医学院附属胸科医院上海肺癌中心，中国上海会议环节：口头报告 | Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic摘要编号：LBA8505时间：2025年6月1日 (星期日) 北美中部夏令时上午9:48标题：赛沃替尼联合奥希替尼对比赛沃替尼联合安慰剂的SAVANNAH II期研究中随机亚组的疗效和中枢神经系统结果Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) 主要作者：Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 会议环节：快速口头报告 | Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic摘要编号：8513时间：2025年6月2日 (星期一) 北美中部夏令时上午8:06标题：IDH1/IDH2突变抑制剂HMPL-306用于治疗晚期IDH突变的实体瘤 (包括神经胶质瘤) 西方患者的I期研究Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma主要作者：Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX会议环节：快速口头报告 | Rapid Oral Session: Central Nervous System Tumors摘要编号：2013时间：2025年5月31日 (星期六) 北美中部夏令时下午3:06标题：FRUSICA-1研究中浆液性癌的亚组分析: 呋喹替尼联合信迪利单抗用于治疗晚期pMMR子宫内膜癌患者Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status主要作者：吴小华，复旦大学附属肿瘤医院，中国上海会议环节：海报展示 | Poster Session: Gynecologic Cancer摘要编号：5596 标题：既往新辅助/辅助化疗 (NACT/ACT) 对呋喹替尼联合信迪利单抗在晚期pMMR子宫内膜癌患者中治疗结果的影响: FRUSICA-1研究的亚组分析The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1主要作者：王静，湖南省肿瘤医院，中国长沙会议环节：海报展示 | Poster Session: Gynecologic Cancer摘要编号：5611标题：真实世界临床实践中呋喹替尼治疗年轻和高龄结直肠癌中国患者的安全性: 呋喹替尼IV期研究的年龄亚组分析Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study主要作者：王奕，宁波市第二医院，中国宁波会议环节：线上发表| Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15512标题：真实世界临床实践中呋喹替尼单药疗法和联合疗法治疗中国结直肠癌患者的安全性: IV期研究的亚组分析Safety of fruquintinib monotherapy and combination therapy in Chinese patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study主要作者：王志强，中山大学肿瘤防治中心，中国广州会议环节：线上发表| Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15515标题：血管生成抑制剂和化疗用于晚期胃腺癌或胃食管结合部腺癌患者的适当治疗顺序: FRUTIGA III期研究的探索性分析The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study主要作者：李进，同济大学附属东方医院，中国上海会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16011标题：FRUTIGA研究中呋喹替尼联合紫杉醇对比紫杉醇用于治疗胃食管结合部腺癌的疗效和安全性亚组分析: 一项二线治疗胃/胃食管结合部腺癌的随机III期临床试验Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/ gastroesophageal junction 主要作者：刘天舒，复旦大学附属中山医院，中国上海会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16012研究者发起的研究标题：呋喹替尼联合卡瑞利珠单抗和紫杉醇脂质体和奈达铂用于一线治疗晚期食道鳞状细胞癌: 一项单臂II期研究Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study 主要作者：顾艳宏，江苏省人民医院 (南京医科大学第一附属医院)，中国南京会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4042标题：呋喹替尼联合PD-1抑制剂及化疗用于一线治疗HER2阴性的晚期胃癌或胃食管结合部腺癌(FDZL-FIX)的更新结果: 一项单臂、开放标签II期研究Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study主要作者：王辰辰，复旦大学附属肿瘤医院，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4046标题：呋喹替尼联合曲妥珠单抗及XELOX方案用于一线治疗晚期HER2阳性的转移性胃腺癌或胃食管结合部腺癌的开放标签、单臂、单中心Ib/II期临床试验Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma主要作者：吕慧芳，河南省肿瘤医院 (郑州大学附属肿瘤医院)，中国郑州会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：TPS4203标题：转移性结直肠癌治疗的多队列真实世界研究: 整体疗效分析以及既往是否使用贝伐珠单抗的亚组分析A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not 主要作者：吕汪霞，浙江省肿瘤医院，中国杭州会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15530标题：呋喹替尼联合伊立替康和卡培他滨用于二线治疗晚期结直肠癌的真实世界观察性研究Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer主要作者：徐玲，中国医科大学附属第一医院，中国沈阳会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15539 标题：呋喹替尼联合FOLFIRI方案用于二线治疗RAS突变的转移性结直肠癌的初步结果: 一项前瞻性单中心II期研究 Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study主要作者：贾茹，解放军总医院第五医学中心，中国北京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15541标题：评估呋喹替尼对比瑞戈非尼和曲氟尿苷/替吡嘧啶用于治疗晚期转移性结直肠癌的疗效: 匹配调整间接比较Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/ tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison主要作者：秦叔逵，中国药科大学附属南京天印山医院，中国南京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15550标题：呋喹替尼联合信迪利单抗和SOX方案作为初始不可切除的胃/胃食管结合部腺癌的转化治疗: 单臂II期临床试验的更新疗效和手术结果Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial主要作者：马飞，河南省肿瘤医院 (郑州大学附属肿瘤医院)，中国郑州会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16016标题：一项评估呋喹替尼联合恩沃利单抗用于治疗晚期或不可切除的局部晚期骨肉瘤和软组织肉瘤患者的疗效和安全性的II期研究A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma主要作者：周陈亮，上海交通大学附属第六人民医院，中国上海会议环节：线上发表 | Publication Only: Sarcoma摘要编号：e23506标题：索凡替尼联合紫杉醇用于二线治疗晚期胃癌的疗效和安全性: II期研究的最终结果Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial主要作者：肖秀英，上海交通大学医学院附属仁济医院，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4028标题：索凡替尼联合KN046和化疗用于一线治疗晚期胰腺的疗效和安全性:一项单臂Ib/II期研究Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial主要作者：王文权，复旦大学附属中山医院，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4157标题：索凡替尼、卡瑞利珠单抗、白蛋白结合型紫杉醇和替吉奥用于一线治疗局部晚期或转移性胰腺导管腺癌患者: 一项Ib/II期随机研究First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study主要作者：贾茹/戴广海，解放军总医院第五医学中心，中国北京会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4161标题：一项探索帕米帕利联合索凡替尼作为新辅助疗法用于治疗晚期不可切除卵巢癌的前瞻性、单臂、II期临床研究 (PASSION)A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) 主要作者：夏百荣，中国科学技术大学附属第一医院，中国合肥会议环节：海报展示 | Poster Session: Gynecologic Cancer摘要编号：5589标题：索凡替尼单药疗法用于三线治疗晚期肝细胞癌的疗效及安全性: 一项单臂、开放标签、多中心II期研究The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study 主要作者：周福祥，武汉大学中南医院，中国武汉会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16209标题：索凡替尼联合吉西他滨与顺铂和免疫检查点抑制剂用于治疗不可切除的局部晚期或转移性胆管细胞癌Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma主要作者：钟敬涛/石学涛，山东第一医科大学附属肿瘤医院，中国济南会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16222标题：索凡替尼联合信迪利单抗和IBI310用于治疗高级别晚期神经内分泌肿瘤患者的多中心、单臂II期研究的最新结果Updated results from a multicenter, single-arm Phase ll study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN)主要作者：陆明/沈琳，北京大学肿瘤医院，中国北京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16342标题：索凡替尼联合吉西他滨和白蛋白结合型紫杉醇作为可切除和临界可切除胰腺癌新辅助治疗的前瞻性、单臂II期研究A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer主要作者：高松/郝继辉，天津医科大学肿瘤医院，中国天津会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16442前瞻性陈述本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对赛沃替尼、HMPL-306、呋喹替尼、和索凡替尼的治疗潜力的预期，赛沃替尼、HMPL-306、呋喹替尼和索凡替尼的进一步临床研究计划，对赛沃替尼、HMPL-306、呋喹替尼和索凡替尼的研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。此类风险和不确定性包括下列假设：入组率、满足研究入选和排除标准的受试者的时间和可用性；临床方案或监管要求变更；非预期不良事件或安全性问题；赛沃替尼、HMPL-306、呋喹替尼和索凡替尼 (包括作为联合疗法) 达到研究的主要或次要终点的疗效；获得不同司法管辖区的监管批准及获得监管批准后获得上市许可；赛沃替尼、HMPL-306、呋喹替尼和索凡替尼用于目标适应症的潜在市场，以及资金充足性等。此外，由于部分研究可能依赖于与其他药物联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、香港联合交易所有限公司以及AIM提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。医疗信息本新闻稿所提到的产品可能并未在所有国家上市，或可能以不同的商标进行销售，或用于不同的病症，或采用不同的剂量，或拥有不同的效力。本文中所包含的任何信息都不应被看作是任何处方药的申请、推广或广告，包括那些正在研发的药物。和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来，和黄医药致力于将自主发现的候选药物带向全球患者，首三个药物现已在中国上市，其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情，请访问：www.hutch-med.com/sc。

ASCO会议临床结果优先审批临床2期临床3期

2025-05-23

·EINPresswire

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA. Results from the SACHI China Phase III study of savolitinib in combination with osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy will be presented at a late breaking oral presentation. SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China. Further data with additional analysis stratified by brain metastasis status from a high MET overexpression and/or amplification treatment subset of the SAVANNAH Phase II study of the savolitinib and osimertinib combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression after progressing on osimertinib were reported. The savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo. The combination showed promising central nervous system (“CNS”) activity, with reduced CNS progression and fewer new CNS lesions. Results will be presented from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (“IDH”) 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations. Results show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients (N=14), with an objective response rate (“ORR”) of 7.1% and a disease control rate (“DCR”) of 100%. Results will also be presented from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with pMMR (proficient mismatch repair) status. Efficacy findings for patients with serous carcinoma (N=27) were clinically meaningful and characterized by responses similar to those observed in full trial population (N=98), with an Independent Review Committee (“IRC”)-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the response was affected by prior neoadjuvant/adjuvant chemotherapy (“NACT/ACT”) showed durable and clinically meaningful responses regardless of whether the patient had received NACT/ACT. Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively. Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. In the subgroup analysis evaluating the safety of fruquintinib as monotherapy and in combination therapy, fruquintinib demonstrated a manageable safety profile in both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the combination therapy group with other anti-cancer treatments. The most common treatment related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes. In the subgroup analysis by age, the safety of fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75) patients. The safety profile was comparable across both age groups, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, which may suggest improved survival potential. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET -amplification ( MET amp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China LBA8505 Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Sunday, June 1, 2025 9:48 AM CDT Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 8513 Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic Monday, June 2, 2025 8:06 AM CDT Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX 2013 Rapid Oral Session: Central Nervous System Tumors Saturday, May 31, 2025 3:06 PM CDT Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China 5596 Poster Session: Gynecologic Cancer The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1 Jing Wang, Hunan Cancer Hospital, Changsha, China 5611 Poster Session: Gynecologic Cancer Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study Yi Wang, Ningbo No.2 Hospital, Ningbo, China e15512 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Safety of fruquintinib monotherapy and combination therapy in Chinese Patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China e15515 Publication Only: Gastrointestinal Cancer - Colorectal and Anal The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China e16011 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/gastroesophageal junction Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China e16012 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary INVESTIGATOR-INITIATED STUDIES Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 4042 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China 4046 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China TPS4203 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China e15530 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer Ling Xu, the First Hospital of China Medical University, Shenyang, China e15539 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China e15541 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital, China Pharmaceutical University, Nanjing, China e15550 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial Fei Ma, Henan Cancer Hospital, Zhengzhou, China e16016 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China e23506 Publication Only: Sarcoma Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 4028 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China 4157 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study Ru Jia/ Guanghai Dai, the Fifth Medical Center of the PLA General Hospital, Beijing, China 4161 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) Bairong Xia, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China 5589 Poster Session: Gynecologic Cancer The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China e16209 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Jingtao Zhang/ Xuetao Shi, Cancer Hospital of Shandong First Medical University, Jinan, China e16222 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results from a multicenter, single-arm Phase II study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN) Ming Lu/ Lin Shen, Peking University Cancer Hospital, Beijing, China e16342 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer Song Gao/ Jihui Hao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China e16442 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, ranosidenib, fruquintinib and surufatinib, the further clinical development for savolitinib, ranosidenib, fruquintinib and surufatinib, its expectations as to whether any studies on savolitinib, ranosidenib, fruquintinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, ranosidenib, fruquintinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib, ranosidenib, fruquintinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果临床2期ASCO会议临床3期临床1期

100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
HER2阳性胃食管交界处癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2022-10-27
晚期胰腺导管腺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2022-01-20
晚期非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2021-10-11
鳞状非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2020-09-14
转移性结直肠癌	临床2期	中国	北京市肿瘤防治研究所	2023-10-26
转移性微卫星稳定结直肠癌	临床2期	中国	北京市肿瘤防治研究所	2023-10-26
HER2阳性胆道肿瘤	临床2期	中国	北京市肿瘤防治研究所	2023-08-15
HER2阳性结直肠癌	临床2期	中国	北京市肿瘤防治研究所	2023-08-15
不能切除的胆道癌	临床2期	中国	北京市肿瘤防治研究所	2023-08-15
结肠癌肝转移	临床2期	中国	浙江瑞臻医药有限公司	2023-04-27

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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


NCT04542837 (Pubmed) 人工标引	临床2期	肝细胞癌	55	KN046 + Lenvatinib	觸壓範壓蓋顧蓋簾簾衊(艱顧築壓遞壓顧窪膚遞) = 齋憲蓋製衊壓繭願製獵積窪餘艱餘觸鹽蓋壓窪 (廠選構醖繭鹽鬱淵顧網, 31.97 ~ 59.45) 更多	积极	2025-02-07
NCT05420220 (ESMO_IO2024) 人工标引	临床2期	晚期非小细胞肺癌	85	KN046 + Axitinib (Cohort A (previously untreated and PD-L1 TPS ≥1%))	醖艱襯淵鑰製夢壓蓋鬱(糧鬱糧積簾糧壓衊衊鏇) = 窪夢觸壓鏇鬱範壓鹹獵製憲壓衊衊鏇廠築簾壓 (選餘願範願顧淵簾簾獵, 38.8 ~ 69.6) 更多	积极	2024-12-12
NCT05420220 (ESMO_IO2024) 人工标引	临床2期	晚期非小细胞肺癌	85	KN046 + Axitinib (Cohort A (previously untreated and PD-L1 TPS ≥50%))	醖艱襯淵鑰製夢壓蓋鬱(糧鬱糧積簾糧壓衊衊鏇) = 憲鬱顧獵獵構鏇餘壓構製憲壓衊衊鏇廠築簾壓 (選餘願範願顧淵簾簾獵, 38.4 ~ 88.2) 更多	积极	2024-12-12
NCT05149326 (KN046-303, Corporate Publications) 人工标引	临床3期	胰腺导管腺癌一线	-	KN046+白蛋白紫杉醇+吉西他滨	鑰艱齋觸選構觸襯製餘(鏇壓醖衊夢淵觸齋醖夢) = 未达到预设的统计学终点壓鹹繭遞觸繭網蓋醖繭 (遞醖築構選願製壓齋餘 ) 未达到	不佳	2024-05-28
NCT05149326 (KN046-303, Corporate Publications) 人工标引	临床3期	胰腺导管腺癌一线	-	安慰剂+白蛋白紫杉醇+吉西他滨		不佳	2024-05-28
NCT04925947 (CTgov)	临床2期	胸腺癌	4	KN046	製積齋願鬱獵蓋衊憲齋 = 築網衊顧淵膚齋鹹鑰醖艱構廠選壓鏇網選積夢 (壓壓壓艱襯齋築壓醖簾, 衊膚鬱壓艱艱齋積範繭 ~ 膚淵鬱顧製鹹網襯構鹽) 更多	-	2024-04-16
NCT04054531 (Cell Rep Med) 人工标引	临床2期	转移性非小细胞肺癌一线	-	KN046+chemotherapy	醖淵艱壓膚網積積窪獵(夢構憲憲遞簾顧衊遞積) = 獵廠齋艱衊範簾艱憲積壓蓋襯蓋廠積襯鹽範襯 (窪憲衊範鑰襯膚糧製艱 ) 更多	积极	2024-03-19
NCT03872791 (Pubmed) 人工标引	临床2期	转移性三阴性乳腺癌一线 ER Negative \| PR Negative \| HER2 Negative	25	KN046+nab-paclitaxel	築簾構網遞範壓鏇範網(鹹獵襯夢衊顧鏇築範簾) = 遞範範簾窪築遞獵醖簾蓋選觸衊憲艱膚顧築蓋 (鹽夢衊鑰壓齋觸鏇淵構, 24.4 ~ 65.1) 更多	积极	2024-02-03
NCT03872791 (Pubmed) 人工标引	临床2期	转移性三阴性乳腺癌一线 ER Negative \| PR Negative \| HER2 Negative	25	KN046+nab-paclitaxel (PD-L1 positive)	製範襯憲淵蓋膚衊觸網(積廠築憲繭選簾衊壓壓) = 襯構淵淵廠築憲鬱醖鑰積簾獵衊膚顧簾憲齋餘 (齋壓製獵鬱襯夢簾遞膚 ) 更多	积极	2024-02-03
NCT05420220 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	非小细胞肺癌一线 PD-L1 expression	22	KN046 5mg/kg + Axitinib 5mg	範遞夢遞窪選鹹構構遞(鬱鑰鹽壓夢顧糧蓋鹹壓) = 築獵製醖簾蓋製網構鹽遞築鏇鬱簾壓醖夢繭範 (壓構鑰獵網壓廠鑰鹽選 ) 更多	积极	2023-10-23
NCT03733951 \| NCT03838848 (KN046-201, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	转移性非小细胞肺癌	31	KN046	窪蓋願窪觸製觸範糧壓(醖鬱鹹積蓋遞窪醖窪齋) = 膚鬱鬱壓網廠築鹽遞範窪築餘鬱繭鏇鹹網製範 (衊繭鏇積壓淵簾簾蓋積, 0.1 ~ 16.7) 更多	积极	2023-10-23
NCT03838848 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	转移性非小细胞肺癌 EGFR L858R \| EGFR Exon 19 Deletion	26	KN046 5 mg/kg + Pemetrexed 500 mg/m2+carboplatin AUC5	衊醖繭積廠餘壓簾鏇糧(餘齋鏇製齋鏇夢製壓淵) = 窪觸糧壓蓋壓網醖膚獵鹹衊積顧繭簾蓋鑰餘壓 (獵鑰獵艱餘鹽壓齋簾鏇, 11.6 ~ 47.8) 更多	积极	2023-10-23
NCT04469725 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	胸腺癌 PD-L1 Expression	46	KN046	選膚窪願壓窪鹹觸觸製(壓獵鏇齋簾蓋積襯簾獵) = 構簾積糧餘繭夢襯鹽製遞夢壓艱憲窪鑰憲願蓋 (範鏇範齋願網築選艱繭, 6.8 ~ 30.7) 更多	积极	2023-10-21
NCT04469725 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	胸腺癌 PD-L1 Expression	46	KN046 (PD-L1-positive)	選膚窪願壓窪鹹觸觸製(壓獵鏇齋簾蓋積襯簾獵) = 願鏇餘淵憲網齋鑰糧鹹遞夢壓艱憲窪鑰憲願蓋 (範鏇範齋願網築選艱繭 ) 更多	积极	2023-10-21