This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

开始日期2025-01-31

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT06401330 / Not yet recruiting临床3期IIT

Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.

开始日期2024-12-31

申办/合作机构-

NCT06620302 / Not yet recruiting临床1/2期IIT

DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma

This phase I/II trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking BCL-XL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and/or effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.

开始日期2024-12-20

申办/合作机构

The Children's Oncology Group Foundation, Inc.

100 项与盐酸伊立替康相关的临床结果

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100 项与盐酸伊立替康相关的转化医学

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100 项与盐酸伊立替康相关的专利（医药）

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11,476

项与盐酸伊立替康相关的文献（医药）

2025-12-01·Journal of Gastrointestinal Cancer

Network Meta-analysis of Randomized Controlled Trials in Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer: Comparisons Involving Ramucirumab

Review

作者: Taipale, Kaisa ; Paine, Abby ; Gupta, Palvi ; D'yachkova, Yulia ; Liepa, Astra M ; Earley-Valovic, Veronika ; Goel, Rajat

PURPOSE:

With relatively few direct comparisons among treatment options for previously treated advanced gastric cancer or gastroesophageal junction (GEJ) cancer, network meta-analysis (NMA) may inform evidence-based decision-making. Ramucirumab plus paclitaxel (RAM + PTX) is a preferred regimen in guideline recommendations. NMA of key outcomes may further characterize the relative clinical value of RAM + PTX.

METHODS:

A systematic literature review of randomized controlled trials of adult patients with previously treated advanced gastric/GEJ cancer informed a NMA which compared overall survival, progression-free survival, and discontinuations due to adverse events. Comparisons were reported relative to placebo/best supportive care (BSC) when possible, otherwise relative to RAM + PTX.

RESULTS:

The base-case NMA focused on second-line treatment only, from 19 of 28 studies identified. For overall survival, seven of 16 regimens were favorable relative to placebo/BSC, with RAM + PTX as the most favorable. For progression-free survival, five of 14 regimens were unfavorable relative to RAM + PTX. For discontinuations due to adverse events, two of 13 regimens were similar to placebo/BSC: ramucirumab monotherapy and fluorouracil; relative to RAM-PTX, all regimens were similar except ramucirumab monotherapy which was favorable and irinotecan + cisplatin which was unfavorable.

CONCLUSION:

This NMA of trials of previously treated gastric/GEJ cancer suggests that RAM + PTX has one of the more favorable clinical profiles.

2024-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact analysis of introducing fruquintinib for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and biologics in the United States from the payer perspective

Article

作者: Asfaw, Alemseged Ayele ; Hernandez, Luis ; Li, Shujun ; Zou, Denise ; Paly, Victoria Federico ; Khanduri, Pratishtha

AIMS:

Fruquintinib is a selective small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 recently approved in the United States (US) for the treatment of adult patients with metastatic colorectal cancer (CRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type and medically appropriate, anti-epidermal growth factor receptor therapy. This study aimed to estimate the 5-year budget impact of fruquintinib from a US payer perspective (commercial and Medicare).

MATERIALS AND METHODS:

A budget impact model was developed to compare two scenarios: a reference scenario in which patients received regorafenib, trifluridine/tipiracil, or trifluridine/tipiracil with bevacizumab and an alternative scenario in which patients received reference scenario treatments or fruquintinib. Market shares were evenly divided across available options. A 5-year time horizon and a hypothetical health plan of 1 million members was assumed. The model included epidemiological inputs to estimate the eligible population; clinical inputs for treatment duration, progression-free survival, overall survival, and adverse event (AE) frequency; and cost inputs for treatment, AEs, disease management, subsequent therapy, and terminal care costs. Budget impact was reported as total, per member per year (PMPY), and per member per month (PMPM).

RESULTS:

The model estimated an eligible population of 194 patients (39 per year) over 5 years. In the base case, the estimated 5-year budget impact of fruquintinib was $4,077,073 ($0.82 PMPY and 0.07 PMPM) for a commercial health plan. During the first year, the estimated budget impact was $627,570 ($0.63 PMPY and 0.05 PMPM). Results were robust across sensitivity analyses. PMPM costs from the Medicare perspective were greater than the base-case (commercial) ($0.17 vs. $0.07) due to higher incidence of CRC in that population.

CONCLUSIONS:

Fruquintinib is associated with a low budget impact for payers based on proposed thresholds in the US.

2024-12-15·INTERNATIONAL JOURNAL OF CANCER

A multicenter, prospective, phase II trial of second‐line aflibercept plus FOLFIRI in patients with metastatic colorectal cancer refractory to an anti‐EGFR antibody: HGCSG1801

Article

作者: Dazai, Masayoshi ; Yoshikawa, Ayumu ; Yuki, Satoshi ; Muranaka, Tetsuhito ; Sogabe, Susumu ; Sakata, Yu ; Kotaka, Masahito ; Takagi, Ryo ; Sagawa, Tamotsu ; Kawamoto, Yasuyuki ; Ando, Takayuki ; Nakamura, Michio ; Harada, Kazuaki ; Hatanaka, Kazuteru ; Sasaki, Yusuke ; Tateyama, Miki ; Komatsu, Yoshito ; Nakatsumi, Hiroshi ; Sawada, Kentaro ; Muto, Osamu ; Ishiguro, Atsushi

Abstract:

Aflibercept (AFL) plus FOLFIRI prolongs overall survival (OS) in patients with metastatic colorectal cancer (mCRC). However, there is limited evidence on the efficacy and safety of AFL plus FOLFIRI previously treated with anti‐epidermal growth factor receptor (EGFR) agents. Therefore, we conducted a prospective open‐label phase II trial evaluating the efficacy and safety of AFL plus FOLFIRI in Japanese patients with mCRC failing a prior oxaliplatin‐based chemotherapy plus an anti‐EGFR agent. AFL (4 mg/kg iv) followed by FOLFIRI (irinotecan 180 mg/m2, leucovorin 200 mg/m2 iv, bolus 5‐fluorouracil [5‐FU] 400 mg/m2, and infusional 5‐FU 2400 mg/m2/46 h) was given every 2 weeks until progression or unacceptable toxicities. The primary endpoint was progression‐free survival (PFS) rate at 6 months. Forty three patients were enrolled between November 2019 and October 2022. The primary endpoint was met: 6‐month PFS rate was 58.8% (90% confidence interval [CI], 45.7%–72.0%). Median PFS and OS were 7.3 months (95% CI, 5.5–11.0 months) and 18.8 months (95% CI, 12.9–26.6 months), respectively. The overall response rate was 20.9% (95% CI, 10.0–36.0%) and disease control rate was 88.4% (95% CI, 74.9–96.1%). The main grade ≥3 adverse events included hypertension (62.8%), neutropenia (55.8%), leukopenia (25.6%), febrile neutropenia (11.6%), fatigue (9.3%), anorexia (9.3%), proteinuria (9.3%), and diarrhea (7.0%). No deaths and no new safety signals with a causal relation to the study treatment were observed. This study suggests that AFL plus FOLFIRI shows a high response rate and a manageable safety profile in Japanese patients with mCRC who failed prior oxaliplatin‐based chemotherapy plus an anti‐EGFR agent.

917

项与盐酸伊立替康相关的新闻（医药）

2024-11-14

·ioncology

2024 ESMO ASIA丨一文纵览上消化道肿瘤领域精彩壁报！

编者按 2024年欧洲肿瘤内科学会亚洲年会（ESMO ASIA 2024）将于当地时间12月6~8日在新加坡召开，届时将公布多项全球及亚太地区的最新科研和临床进展，进一步推动领域内的学术交流。目前大会官网已披露了摘要标题，《肿瘤瞭望消化时讯》特此整理了食管癌、胃癌、胰腺癌等上消化道肿瘤领域的摘要标题，带您快速浏览大会的精彩资讯！胃癌 183P-HER2过表达或无过表达时胃腺癌对新辅助化疗的反应：一项前瞻性观察研究作者：Pratap K.Deb（印第安纳州加尔各答） 157P-腹膜转移胃癌分化轨迹和耐药特征的单细胞表征作者：Haoxin Peng（中国北京） 158P-SOX方案联合伊尼妥单抗一线治疗HER2阳性晚期胃癌的最新疗效与安全性作者：Ying Kong（中国济南） 159P-B细胞的空间组织在胃癌预测和预后中的作用作者：Ryan Tay（新加坡） 160P-胃癌腹膜转移的腹膜生态位进化和微环境重塑作者：Joseph J.Zhao（新加坡） 161P-评估口服维生素B12治疗胃癌患者全胃切除术后维生素B12缺乏症的多中心随机对照试验的Ⅱ期研究作者：Three Aoyama（日本横滨） 162P-围手术期FLOT治疗胃癌和胃食管交界处癌实现PCR的疗效：单机构经验的回顾性分析作者：Xue Ru Ting（乔治市，MY） 163P-腹腔镜辅助胃切除术和常规胃切除术胃癌患者术后饮食摄入量的比较作者：Junya Morita（日本横滨） 164P-一项评估安罗替尼联合特瑞普利单抗作为一线方案治疗PS 2晚期胃癌患者的疗效和安全性的开放标签、单臂、Ⅱ期试验作者：刘可（中国上海） 165P-局部晚期胃癌新辅助治疗后病理完全缓解的预后分析：一项全国性、多中心、回顾性研究作者：Jie Chen（中国上海） 166P-幽门螺杆菌感染胃癌样本中CHOP、GRP94和干性状态之间的相互作用作者：Fatemeh Alizadeh（马什哈德，爱尔兰） 167P-与老年Ⅱ/Ⅲ期胃癌患者早期复发相关的因素：一项回顾性队列研究作者：Yu-Hsuan Shih（台中市） 168P-肌肉减少症作为接受手术和辅助化疗的Ⅱ~Ⅲ期胃癌患者的预后指标作者：Jeong Eun Kim（韩国光明） 169P-真实世界研究中PD-1抑制剂、曲妥珠单抗和一线化疗治疗HER-2阳性晚期胃癌的疗效和预后作者：刘宝瑞（中国南京） 170P-通过多模式血浆游离DNA分析鉴别恶性和良性胃病变作者：Ho D.Vo（越南胡志明市） 171P-一项关于80岁及以上Ⅱ/Ⅲ期胃癌患者辅助S-1化疗的多中心调查作者：Ai Harinauchi（日本） 172P-环状RNA谱确定circATXN1失调可作为胃癌的一个增殖因子和预后标志物作者：Jie Chen（中国上海） 173P-胃腺癌位置重要吗？来自单个肿瘤中心的回顾性研究作者：Alaaeldin Shablak（英国南安普敦） 175P-副干酪乳杆菌ZJUZ2-3通过3-IAA抑制NF-κB通路来抑制胃肿瘤发生作者：Rui Yang（中国杭州） 176P-DHX9及其靶基因AURKA通过PI3K/AKT和TNF信号通路在胃癌中的功能和机制作者：Zuhua Chen（中国武汉） 177P-HGF介导的MAP17在胃癌细胞增殖和转移中的重要作用作者：ByeongIl Jang（韩国大邱）食管癌 178P-KEYNOTE-859研究更新：帕博利珠单抗+化疗治疗晚期HER2阴性胃癌或胃食管结合部（G/GEJ）癌作者：Lina Yin（美国凯尼尔沃思） 179P-个性化微小残留病分析可预测接受根治性放疗的食管癌的预后作者：Lin-Rui Gao（中国北京） 180P-微创海绵细胞学检查在食管鳞状细胞癌和胃贲门腺癌筛查中的应用评估作者：Zhiyuan Fang（中国北京） 181P-围手术期亚叶酸、奥沙利铂、多西紫杉醇和S-1（LOTS）治疗局部晚期胃癌或胃食管结合部腺癌的疗效、安全性及游离DNA分析：一项前瞻性Ⅱ期试验作者：Chih Chieh Yen（台南市中环） 182P-东亚地区HER2阳性局部晚期或转移性胃或胃食管结合部腺癌患者的真实世界治疗模式作者：Do-Youn Oh（韩国首尔） 144P-辅助放化疗在食管角化鳞状细胞癌治疗中的作用作者：Mohamed Z.Elkarany（亚历山大市，EG） 186P-每周对比每月新辅助顺铂和氟尿嘧啶放化疗方案在局部区域食管鳞状细胞癌中的疗效和安全性作者：Cheng-Lun Lai（台湾台中市） 187P-卡瑞利珠单抗在晚期食管癌中的有效性、安全性和使用模式：基于来自三项前瞻性观察性队列研究的987例患者的个体病例数据（IPD）汇总分析作者：鲁智豪（中国北京） 188P-原发肿瘤和淋巴结病理消退对新辅助化疗免疫治疗后局部晚期食管鳞状细胞癌患者复发和生存率的影响作者：Yixin Li（中国南京） 189P-NC18（一种新型HER2靶向ADC）对Enhertu耐药CDX模型的优越的抗肿瘤活性作者：Zhi Li（中国北京） 190P-替雷利珠单抗治疗食管癌的系统评价和荟萃分析作者：Hashim Talib Hashim（Karbala） 191P-来自印度南部的资源有限环境中接受多模式治疗的非转移性癌食管患者的真实世界数据作者：Ravi Teja R.Matta（印第安纳州拉贾蒙德里） 192P-探索氯硝柳胺在食管鳞状细胞癌中对EHMT2的调节作用作者：I-Chen Wu（台湾高雄市） 193P-DCLK1的激酶活性驱动其在食管鳞状细胞癌中的促干性作用作者：Yuping Yang（中国福州） 194P-呋喹替尼联合S-1治疗一线免疫治疗失败后ESCC患者的剂量探索结果更新作者：Ningning Li（中国北京） 195P-miR-10a-5p靶向TFAP2C促进食管癌的顺铂耐药作者：Kiran Pasbola（印第安纳州新德里） 196P-可切除胃和胃食管结合部癌的围手术期FLOT+免疫治疗的系统评价和荟萃分析作者：Lorenz Fort E.Revillas（奎松市，菲律宾） 198P-新辅助多西他赛加顺铂、5-FU治疗可切除局部晚期食管鳞状细胞癌后，辅助纳武利尤单抗治疗的疗效和安全性作者：Nozomu Ogura（日本） 244P-基因组分析检测对胃肠道神经内分泌癌治疗结果的影响作者：Toshiki Ozato（日本冈山） 263TiP-TroFuse-015：TROP2定向抗体-药物偶联物sac-TMT对比医生选择的方案治疗经治转移性胃食管腺癌的Ⅲ期研究作者：Kohei Shitara（日本） 264TiP-一项评估德曲妥珠单抗（trastuzumab deruxtecan，T-DXd）联合rilvegostomig和化疗治疗HER2阳性（HER2+）和HER2低表达的胃或胃食管结合部腺癌（GEJA）患者的Ⅰb/Ⅱ期开放标签研究：DESTINY-Gastric03研究第4部分作者：Yelena Y.Janjigian（美国纽约） 265TiP-Ⅰ/Ⅱ期开放标签、伞式平台设计的研究药物联合或不联合pembrolizumab和/或化疗对既往接受过PD-（L）1抑制剂治疗的晚期食管癌患者的研究：KEYMAKER-U06子研究作者：Sean Kato（日本） 266TiP-替雷利珠单抗联合S-1对于新辅助免疫化疗后根治性切除术后残留原发病灶和淋巴结阴性食管鳞状细胞癌患者的疗效：一项Ⅱ期多中心试验（PPIO-008）作者：Yingjian Wang（中国重庆） 267TiP-CHAPTER-GIST-101：pimitespib联合伊马替尼治疗伊马替尼难治性胃肠道间质瘤患者的Ⅰ期研究作者：WeiPeng Yong（新加坡）胰腺癌 250P-评估液体活检衍生的循环肿瘤DNA（ctDNA）作为预测生物标志物对早期胰腺癌治疗反应的影响作者：Hashim Talib Hashim（Karbala） 252P-XELOXIRI方案在不可切除胰腺导管腺癌患者中的安全性和有效性作者：Biyang Cao（中国北京） 253P-预后营养指数是接受新辅助化疗和手术切除的胰腺癌患者继续S-1辅助化疗的独立危险因素作者：Shinnosuke Kawahara（日本横滨） 255P-NALLONG研究的亚洲队列中既往接受过脂质体伊立替康治疗的转移性胰腺导管腺癌长期幸存者的真实世界结果作者：Chang hoon Yoo（韩国首尔） 256P-胰腺导管腺癌中的PIK3CA突变作者：Omali Pitiyarachchi（澳大利亚兰德威克） 257P-“H”至“H”精准新辅助化疗可提高胰腺癌的可切除率作者：Yonggang He（中国重庆） 258P-真实世界背景下晚期胰腺癌患者治疗方案和总生存期的当前趋势作者：Hiroshi Imaoka（日本） 259P-伊立替康脂质体为基础的方案在中国晚期胰腺癌患者中的应用：一项前瞻性、多中心、观察性真实世界研究作者：Jin Xu（中国上海） 260P-NALIRIFOX作为基于吉西他滨的化疗后转移性胰腺癌的后续治疗：单中心真实世界经验作者：Hisn-Chen Lin（台湾嘉义市）（来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期放射疗法

2024-11-11

·BFC医疗投资资讯

Capital market and BD weekly update from BFC Group

BFC Capital Market Update (November 2 - November 8) Market Overview Global Markets and Healthcare Sectors Post Strong Gains Amid Mixed Performance Last week, U.S. markets saw notable gains, with the Dow Jones Industrial Average up 4.6%, the S&P 500 rising 4.7%, and the Nasdaq Composite gaining 5.7%. In China, the Shanghai Composite Index and CSI 300 Index advanced by 5.5%, while the Hang Seng Index increased by 1.1%. In the healthcare sector, the U.S. Nasdaq Biotechnology Index rose 4.1%. Chinese healthcare indices also posted gains, with the SSE Health Care Index up 4.9%, the CSI Healthcare Index rising 6.4%, and the Hang Seng Healthcare Index recording a weekly increase of 2.9%. Major Biopharma Updates CARsgen Therapeutics Stock Rises 57.8% as Promising Preliminary Data for Off-the-Shelf CAR-T Therapy CT0590 Unveiled at 66th ASH Annual Meeting CARsgen Therapeutics（02171.HK, 科济药业） saw a cumulative increase of 57.8% last week. On November 6, the company announced that data for Zevor-cel (Zevorcabtagene autoleucel), CT071, and CT0590 would be presented in poster format at the 66th ASH Annual Meeting, with abstracts now available on the ASH website. Notably, this is the first human Phase I trial data for CT0590, an off-the-shelf CAR-T therapy targeting BCMA and NKG2A. Among the five enrolled participants, with a median follow-up of 16.6 months (ranging from 5.1 to 24.2 months), three patients achieved remission, including two with stringent complete response (sCR) and one with partial response (PR). Of the two patients with sCR, one with relapsed/refractory multiple myeloma (RRMM) has maintained remission for 23 months (sCR ongoing), while another with primary plasma cell leukemia (pPCL) has a duration of response (DOR) of 20 months. These preliminary results suggest that the CT0590 off-the-shelf CAR-T cell therapy is safe and capable of achieving deep and durable clinical remission. Hengrui Pharmaceuticals' Irinotecan Liposome Combination Therapy Shows 37% Reduction in Mortality Risk for Advanced Pancreatic Cancer in Phase III Trial On November 6, Hengrui Pharmaceuticals（600276.SH,恒瑞医药） announced results from a randomized, double-blind, parallel-controlled, multicenter Phase III clinical trial of Irinotecan Liposome (II) combined with 5-FU/LV as a second-line treatment for locally advanced or metastatic pancreatic cancer in patients who had previously failed gemcitabine treatment. The results indicated that the Irinotecan Liposome (II) combination therapy reduced the risk of death by 37% compared to the control group in pancreatic cancer patients. Business Development Updates In the past week, PharmaEngine secured Taiwan distribution rights for LIPORAXEL from Shanghai RMX Biopharma. Novo Nordisk partnered with Ascendis Pharma to use TransCon technology for semaglutide and other therapies. Royalty Pharma acquired U.S. royalty rights for Syndax's Niktimvo against GVHD. Nobelpharma licensed Y-mAbs' Danyelza for neuroblastoma in Japan. DRI Healthcare acquired global royalty rights for KalVista's sebetralstat for HAE. Nxera and Antiverse are collaborating on AI-based GPCR antibodies. Aditum Bio and Leads Biolabs formed Oblenio Bio for a tri-specific T-cell engager. Santen gained rights to Arctic Vision’s ARVN-001 for eye conditions in China. Zhida Pharma secured an option for Vivesto’s Apealea in Greater China. PharmaEngine to distribute Shanghai RMX Biopharma’s LIPORAXEL in China Nov 4, 2024 – PharmaEngine and Shanghai RMX Biopharma (a subsidiary of Haihe Biopharma) entered into an exclusive distribution agreement for LIPORAXEL (paclitaxel oral solution) in the Taiwan market. Novo Nordisk to use Ascendis Pharma' TransCon Technology to develop, manufacture and commercialize therapeutics including Semaglutide for metabolic diseases and cardiovascular diseases worldwide Nov 4, 2024 – Novo Nordisk entered into an exclusive worldwide research and development collaboration and license agreement with Ascendis Pharma for TransCon technology to develop, manufacture and commercialize therapeutics including semaglutide , by reducing their dosing frequency for the treatment of metabolic diseases and a product-by-product exclusive license in cardiovascular diseases. Royalty Pharma to acquire royalty rights of Syndax's Niktimvo against GVHD in the US Nov 4, 2024 –Royalty Pharma entered into a synthetic royalty funding agreement for Syndax Pharmaceuticals ' Niktimvo (axatilimab) against chronic graft-versus-host disease (GVHD) in the United States. Nobelpharma to commercialize Y mAbs Therapeutics' Danyelza for relapsed/refractory high risk neuroblastoma in Japan Nov 4, 2024 –Nobelpharma entered into an exclusive license and distribution agreement with Y-mAbs Therapeutics to commercialize Danyelza for the treatment of relapsed/refractory high risk neuroblastoma in Japan. DRI Healthcare to acquire royalty rights of KalVista's sebetralstat against HAE worldwide Nov 4, 2024 – DRI Healthcare signed a synthetic royalty financing agreement to acquire rights of KalVista Pharmaceuticals ' sebetralstat against hereditary angioedema (HAE) worldwide. Nxera and Antiverse to design and globally commercialize AI based antibodies for GPCRs Nov 5, 2024 – Nxera agreed with Antiverse to design and globally commercialize AI based antibodies for G-protein coupled receptors (GPCRs). Aditum Bio and Leads Biolabs Announce the Formation of Oblenio Bio to Develop a Tri-Specific T-Cell Engager for Autoimmune Disorders Nov 7, 2024 – Aditum Bio and Leads Biolabs today announced the formation of Oblenio Bio, which is being formed in conjunction with an exclusive option and license agreement to develop LBL-051, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager antibody for autoimmune diseases. Aditum Bio will fund Oblenio Bio and the parties will collaborate to rapidly bring LBL-051 into clinical studies. Santen to commercialize Arctic Vision' ARVN-001 for UME and other ophthalmic indications in China excluding Taiwan, Hong Kong and Macau Nov 7, 2024 – Santen signed an agreement with Arctic Vision to commercialize ARVN-001 for uveitic macular edema (UME) and certain other ophthalmic indications in China excluding Taiwan, Hong Kong and Macau. Zhida Pharma to sign an option to develop and commercialize Vivesto’s Apealea for ovarian cancer in China, Hong Kong, Macau and Taiwan Nov 7, 2024 –Zhejiang Zhida Pharmaceutical signed an exclusive license option agreement with Vivesto to develop and commercialize anticancer product Apealea (paclitaxel micellar) for ovarian cancer in China, Hong Kong, Macau and Taiwan. References： 1.https://www.carsgen.com/en/news/carsgen-to-present-zevor-cel-ct071-and-ct0590-at-ash-2024-annual-congress/ 2.https://www.hengrui.com/media/detail-665.html

细胞疗法临床2期免疫疗法引进/卖出

2024-11-10

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正大天晴今年第四款1类创新药！KRAS G12C靶向药格索雷塞获批上市

晚期非小细胞肺癌患者迎来又一重磅靶向药物。11月8日，国家药监局官网显示，正大天晴联合开发的KRAS G12C抑制剂格索雷塞片（商品名：安方宁）获批准上市，适用于治疗至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因（KRAS）G12C 突变型的晚期非小细胞肺癌（NSCLC）成人患者。这是正大天晴今年获批的第四款1类创新药，也是公司在肺癌领域取得的又一突破。攻克“不可成药”靶点，格索雷塞重塑KRAS G12C突变治疗格局肺癌是全球第一大癌种。国家癌症中心发布的数据显示，2022年中国肺癌新发病例达106万人，是我国发病率和死亡率最高的恶性肿瘤。其中，非小细胞肺癌（NSCLC）约占所有肺癌的85%[1]。 KRAS突变是非小细胞肺癌中除EGFR之外最常见的驱动基因突变，G12C又是KRAS突变中发生率最高的亚型[2,3]。该人群在现有非靶向治疗方案中的获益有限，存在明确未被满足的临床需求。受KRAS基因结合点不明显、蛋白结构近似球形等因素影响，KRAS一度被认为是最难攻克的“不可成药”靶点，是肺癌治疗中的“老大难”。格索雷塞片是国内首个自主研发并进入临床试验阶段的KRAS G12C抑制剂，也是首个获得CDE（国家药监局药品审评中心）突破性治疗品种的国产KRAS G12C抑制剂，并且在今年1月被CDE纳入优先审评。此次格索雷塞获批上市，将进一步提升国内肿瘤精准靶向治疗水平，重塑KRAS G12C突变治疗格局。 2023年8月，正大天晴与益方生物签订许可与合作协议，获得KRAS G12C靶向药物D-1553产品在中国大陆地区开发、注册、生产和商业化的独家许可权。研发数据亮眼：中位ORR 52%、中位OS 14.1个月格索雷塞采用一种创新的分子结构设计——采用双甲基取代哌嗪，能量更低且构象更稳定。其和血浆蛋白结合率低，提高血浆和脑组织中游离药物浓度和总暴露量，在多种KRAS G12C突变的体外及动物模型中展现出抗肿瘤活性。格索雷塞能选择性地与KRAS G12C的SWITCH II蛋白中的二磷酸鸟苷结合，从而抑制KRAS的致癌信号传导，抑制肿瘤细胞增殖，从而实现抗肿瘤作用，是一款具有创新结构特点的KRAS G12C抑制剂。今年9月，格索雷塞在2024世界肺癌大会（WCLC）上公布了治疗KRAS G12C突变的非小细胞肺癌Ⅱ期临床研究数据：客观缓解率（ORR）为52%，疾病控制率（DCR）为88.6%，中位缓解持续时间（DOR）为12.5个月，中位无进展生存期（PFS）为9.1个月，中位总生存期（OS）为14.1个月[4]。上述数据显示，格索雷塞在携带KRAS G12C突变的NSCLC患者中持续表现出较高的肿瘤缓解率和较长的缓解持续时间。深挖临床应用潜力，新适应症加速推进中除了这次获批的适应症，格索雷塞单药和联合用药在非小细胞肺癌一线治疗以及结直肠癌等其他实体肿瘤中的国际多中心临床研究也正在进行中。 2024年6月，格索雷塞另外两个适应症被CDE纳入突破性治疗药物程序，分别为：（1）用于治疗经一线治疗失败的伴KRAS G12C突变局部晚期或转移性胰腺导管腺癌；（2）联合西妥昔单抗注射液用于经二线标准治疗（包括奥沙利铂、伊立替康、5-氟尿嘧啶和抗VEGF单抗）失败的、KRAS G12C突变阳性的、手术无法切除的局部晚期或转移性结直肠癌。今年以来，正大天晴迎来创新产品收获期，上半年已有安奈克替尼、伊奉阿克、贝莫苏拜单抗三款抗肿瘤1类新药获批上市，同期国内企业第一。肺癌领域是正大天晴的发力重点之一，随着格索雷塞获批，公司在肺癌领域创新药数量已达6个。参考文献： [1] 揭光灵,杨莹,虞永峰,等. 非小细胞肺癌治疗年度进展2023[J]. 中华医学杂志,2024,104(36)：3446-3454. [2] 农靖颖, 李小雪, 姚舒洋, 等. KRAS突变非小细胞肺癌的生物学和治疗研究进展 [J] . 肿瘤研究与临床, 2021, 33(1): 69-73. [3] Tang D,et al. Oncogenic KRAS blockade therapy:renewed enthusiasm and persistent challenges[J]. Mol Cancer,2021,20(1): 128. [4] Li Z, et al. Garsorasib in KRAS G12C-Mutated Non-Small-Cell Lung Cancer: Updated Results from a Phase 2 Study. 2024 WCLC Abstract OA14.03. 声明： 1. 本新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2. 本公司不对任何药品和/或适应症作推荐。 3. 本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ●亚洲肺癌大会 | 谢承润：让香港成为中国医药创新的“超级增值人” ● Ⅰ类创新药三连发！正大天晴新一代ALK抑制剂依奉阿克获批上市 ● 重磅！正大天晴创新药贝莫苏拜单抗获批上市，安罗替尼获批第6个适应症 ● 创新突破！正大天晴首个国产ROS1靶向药获批上市

优先审批上市批准突破性疗法申请上市临床2期

100 项与盐酸伊立替康相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01061	盐酸伊立替康	L01XX19	DBSALT000103

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性胰腺腺癌	澳大利亚	SERVIER LABORATORIES (AUST.) PTY. LTD.	2024-03-06
胰腺腺泡癌	日本	Daiichi Sankyo Co., Ltd.	2013-12-20
儿童恶性实体瘤	日本	Yakult Honsha Co., Ltd.	2013-03-25
儿童恶性实体瘤	日本	Daiichi Sankyo Co., Ltd.	2013-03-25
肠肿瘤	中国	江苏恒瑞医药股份有限公司	1998-01-01
结肠癌	美国	Pfizer Inc.	1996-06-14
直肠癌	美国	Pfizer Inc.	1996-06-14
乳腺癌	日本	Yakult Honsha Co., Ltd.	1995-09-29
乳腺癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
乳腺癌	日本	Alfresa Pharma Corp.	1995-09-29
结直肠癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
结直肠癌	日本	Yakult Honsha Co., Ltd.	1995-09-29
结直肠癌	日本	Alfresa Pharma Corp.	1995-09-29
非霍奇金淋巴瘤	日本	Yakult Honsha Co., Ltd.	1995-09-29
非霍奇金淋巴瘤	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
非霍奇金淋巴瘤	日本	Alfresa Pharma Corp.	1995-09-29
鳞状细胞癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
鳞状细胞癌	日本	Alfresa Pharma Corp.	1995-09-29
鳞状细胞癌	日本	Yakult Honsha Co., Ltd.	1995-09-29
胃癌	日本	Alfresa Pharma Corp.	1995-09-29

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
小细胞肺癌复发	临床3期	中国	绿叶制药	2024-03-03
食管癌	临床3期	加拿大	Pfizer Inc.	2009-04-01
结肠转移性腺癌	临床3期	美国	Bristol Myers Squibb Co.	2003-12-01
结肠转移性腺癌	临床3期	美国	Eli Lilly & Co.	2003-12-01
直肠腺癌	临床3期	美国	Bristol Myers Squibb Co.	2003-12-01
直肠腺癌	临床3期	美国	Eli Lilly & Co.	2003-12-01
原发部位不明恶性肿瘤	临床3期	美国	Pharmacia & Upjohn, Inc.	2003-09-01
原发部位不明恶性肿瘤	临床3期	美国	Eli Lilly & Co.	2003-09-01
原发部位不明恶性肿瘤	临床3期	美国	AstraZeneca PLC	2003-09-01
EGFR阳性癌症	临床3期	美国	Eli Lilly & Co.	2003-04-01

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临床结果

适应症

分期

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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


NCT04117945 (CTgov)	临床2期	遗传性非息肉病性结直肠癌1型 \| 转移性结直肠癌	22	Regorafenib (Arm A (Regorafenib))	願糧壓鏇淵構製構鑰網(觸糧艱鹽艱窪鏇艱夢蓋) = 夢鏇願選構鏇選製獵壓淵艱積築觸網範鹽壓齋 (獵鹽鏇艱願鹽範範糧鑰, 製蓋齋憲醖構顧襯鬱壓 ~ 遞膚鑰簾遞願蓋鏇簾構) 更多	-	2024-09-27
				Cetuximab+Irinotecan+Panitumumab (Arm B (Cetuximab, Panitumumab, Irinotecan))	願糧壓鏇淵構製構鑰網(觸糧艱鹽艱窪鏇艱夢蓋) = 積壓齋餘醖製鹹顧遞蓋淵艱積築觸網範鹽壓齋 (獵鹽鏇艱願鹽範範糧鑰, 鏇衊廠觸觸壓糧顧選築 ~ 製蓋艱選鬱繭餘鑰積鑰) 更多
NCT03483038 (NEO-Nal-IRI, CTgov)	临床2期	胰腺腺癌	45	LEUCOVORIN CALCIUM+Liposomal Irinotecan+Oxaliplatin+Fluorouracil	製襯築遞鹹淵夢蓋夢艱(鑰觸簾獵願艱襯糧鹹遞) = 廠齋憲獵觸窪憲製鏇願衊憲糧夢壓糧繭範襯網 (憲壓壓鏇獵築範獵觸夢, 網醖齋構襯艱遞膚積淵 ~ 遞淵鏇鹹簾積糧簾淵鬱) 更多	-	2024-09-23
EUCTR2019-000922-23-DE (IRITACE, ESMO2024) 人工标引	临床2期	肝细胞癌	20	DEB-TACE with Irinotecan and Mitomycin C	積顧構艱夢簾衊艱鬱鹽(願齋憲糧窪壓襯築築繭) = 願餘鹹憲築憲窪願繭廠鹽糧齋齋簾願觸鑰糧鬱 (網觸簾鑰憲鬱襯淵夢艱 ) 更多	不佳	2024-09-16
				DEB-TACE with Doxorubicin	積顧構艱夢簾衊艱鬱鹽(願齋憲糧窪壓襯築築繭) = 構構襯蓋積網積簾襯艱鹽糧齋齋簾願觸鑰糧鬱 (網觸簾鑰憲鬱襯淵夢艱 ) 更多
NCT02605265 (CinClare, ESMO2024)	临床3期	局部晚期直肠癌	356	Capecitabine only	繭夢窪鬱選憲簾廠範積(糧選糧築顧觸製鑰遞膚) = 網選鑰艱壓積鑰鏇範鏇鑰觸遞糧艱窪顧製遞淵 (遞選壓積鹽憲鏇構衊觸 ) 更多	积极	2024-09-16
				1-3 cycles of weekly irinotecan	繭夢窪鬱選憲簾廠範積(糧選糧築顧觸製鑰遞膚) = 網醖簾選願獵艱鹽簾積鑰觸遞糧艱窪顧製遞淵 (遞選壓積鹽憲鏇構衊觸 ) 更多
NCT05153239 (LAGOON, ESMO2024) 人工标引	临床2期	小细胞肺癌复发二线	101	Lurbinectedin 2.0 mg/m^2 + Irinotecan 75 mg/m^2 (All pts with CTFI>30)	廠鏇製淵鏇繭範襯願糧(鏇願鹽鏇鹽鏇壓顧餘製) = 壓積積鑰範廠餘選衊製憲範積窪製餘鹽築積鹽 (簾鬱憲繭淵觸積鹹鑰鑰, 9.1 ~ 14.1) 更多	积极	2024-09-14
				Lurbinectedin 2.0 mg/m^2 + Irinotecan 75 mg/m^2 (CTFI 30-90 d)	廠鏇製淵鏇繭範襯願糧(鏇願鹽鏇鹽鏇壓顧餘製) = 餘獵選築齋鹹廠鹹鹹壓憲範積窪製餘鹽築積鹽 (簾鬱憲繭淵觸積鹹鑰鑰, 3.7 ~ 13.6) 更多
CITRIC (ESMO2024) 人工标引	临床2期	转移性结直肠癌	114	Cetuximab and irinotecan	獵鏇壓壓淵選鬱鏇餘願(衊製壓鹹鏇願製醖製鹽) = 餘鏇夢觸糧壓築淵鏇鹽齋選獵鏇壓醖積齋網鏇 (蓋顧窪鬱蓋構壓築顧構 ) 更多	积极	2024-09-14
				Investigator's choice (excluding anti-EGFR)	獵鏇壓壓淵選鬱鏇餘願(衊製壓鹹鏇願製醖製鹽) = 選膚夢衊憲糧憲網醖選齋選獵鏇壓醖積齋網鏇 (蓋顧窪鬱蓋構壓築顧構 ) 更多
JPRN-jRCTs031180216 (JCOG1205/1206, ESMO2024) 人工标引	临床3期	肺神经内分泌肿瘤	221	Etoposide/cisplatin (EP)	顧壓艱淵餘夢積選餘製(觸醖醖觸構艱窪願鏇鹹) = 壓構廠壓壓糧範觸遞遞壓網築積齋顧鏇鑰艱艱 (餘襯遞築築構淵願衊獵 ) 更多	不佳	2024-09-14
				Irinotecan/cisplatin (IP)	顧壓艱淵餘夢積選餘製(觸醖醖觸構艱窪願鏇鹹) = 鏇鹹憲繭觸網夢壓夢選壓網築積齋顧鏇鑰艱艱 (餘襯遞築築構淵願衊獵 ) 更多
NCT03053167 (Pubmed \| BMC Cancer) 人工标引	临床2期	结直肠癌二线	108	Raltitrexed+Irinotecan	積艱膚衊夢廠繭範蓋憲(衊鑰觸獵鬱築憲壓網艱) = 糧衊觸餘鹽觸網遞衊鹹簾憲醖餘積夢壓膚夢鹽 (壓蓋繭製醖夢鑰顧鑰膚, 4.1 ~ 5.7) 更多	积极	2024-09-02
NCT01595321 (CTgov)	临床2期	胰腺腺癌	19	Stereotactic Body Radiation+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (Cohort 1: SBRT and FOLFIRINOX)	鬱鹹膚鏇醖構獵淵積築(蓋鏇顧製壓鑰積夢廠餘) = 餘窪憲糧選餘艱襯鏇襯餘艱壓遞壓廠簾夢糧簾 (夢網蓋廠鹽衊淵窪壓壓, 築齋齋壓醖獵範網遞糧 ~ 壓夢積積憲鑰鏇廠繭齋) 更多	-	2024-08-14
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	鬱鹹膚鏇醖構獵淵積築(蓋鏇顧製壓鑰積夢廠餘) = 築繭顧窪鹹網壓艱醖糧餘艱壓遞壓廠簾夢糧簾 (夢網蓋廠鹽衊淵窪壓壓, 構糧鬱糧鏇蓋膚壓觸網 ~ 範繭膚衊網鹹壓廠積鬱) 更多
NCT02842580 (HIGH-LIGHT, CTgov)	临床2期	转移性结直肠癌	21	acide folinique+Bevacizumab+irinotecan+Oxaliplatin+capécitabine+5FU (Standard Arm (Escalation Strategy - Arm A))	顧構製壓遞壓範鑰網範(糧獵繭襯簾遞襯糧鏇選) = 淵憲蓋壓窪鏇鏇壓觸醖壓顧憲築獵選選襯鹽夢 (網夢鬱醖觸遞鬱糧構鹹, 餘鏇鏇襯鑰糧繭艱鑰壓 ~ 網選廠簾鹽鬱憲顧齋鏇) 更多	-	2024-07-10
				acide folinique+Bevacizumab+irinotecan+Oxaliplatin+capécitabine+5FU (Experimental Arm (De-escalation Strategy -Arm B))	顧構製壓遞壓範鑰網範(糧獵繭襯簾遞襯糧鏇選) = 齋廠蓋範鏇觸憲憲鑰齋壓顧憲築獵選選襯鹽夢 (網夢鬱醖觸遞鬱糧構鹹, 網窪夢觸獵膚膚獵醖鹹 ~ 選廠範簾醖鏇憲製廠觸) 更多