PD-1 Antibody (Tislelizumab) Combined With VEGFR 1/2/3 Inhibitor (Fruquintinib) for ARID1A-mutated Metastatic pMMR/MSS Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial

This is an open-label phase II study, with the aim of investigating the efficacy and safety of Tislelizumab + Fruquintinib combination therapy in ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan. Patients with hypermutated CRC that carries POLE/POLD1 mutations cannot be included.

开始日期2025-07-01

申办/合作机构

中山大学

[+2]

NCT06470178 / Not yet recruitingN/AIIT

A Real-World Study of Neoadjuvant/Conversion Therapy for Locally Advanced or Metastatic Colorectal Cancer With Chemotherapy Combined With Anti-Angiogenic Targeted Agents

Fruquintinib is already the standard third-line treatment for metastatic colorectal cancer, but the efficacy of fruquintinib in neoadjuvant and conversion therapy for locally advanced/advanced colorectal cancer has not yet been reported. This study aims to observe the efficacy and safety of fruquintinib combined with chemotherapy in neoadjuvant or conversion therapy for colorectal cancer patients in the real world.

开始日期2025-05-01

申办/合作机构

武汉大学

NCT06464601 / Not yet recruitingN/AIIT

A Real-World Study of Neoadjuvant/Conversion Therapy for Locally Advanced or Metastatic Gastric Cancer With Chemotherapy Combined With Immune Checkpoint Inhibitors and Anti-Angiogenic Targeted Agents

Chemotherapy, immune checkpoint inhibitors, and anti-angiogenic targeted therapies have been explored in combination for neoadjuvant and conversion therapies. However, the efficacy of the novel anti-angiogenic agent fruquintinib in combination with immune checkpoint inhibitors and chemotherapy in the neoadjuvant and conversion treatment of locally advanced or metastatic gastric cancer has not been reported. This study aims to observe the efficacy and safety of fruquintinib combined with immune checkpoint inhibitors and chemotherapy in real-world settings.

开始日期2025-04-01

申办/合作机构

武汉大学

100 项与呋喹替尼相关的临床结果

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100 项与呋喹替尼相关的转化医学

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100 项与呋喹替尼相关的专利（医药）

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135

项与呋喹替尼相关的文献（医药）

2025-01-01·Nature Reviews Clinical Oncology

Late-line options for patients with metastatic colorectal cancer: a review and evidence-based algorithm

Review

作者: Cremolini, Chiara ; Ciracì, Paolo ; Studiale, Vittorio ; Antoniotti, Carlotta ; Taravella, Ada

Over the past few years, several novel systemic treatments have emerged for patients with treatment-refractory metastatic colorectal cancer, thus making selection of the most effective later-line therapy a challenge for medical oncologists. Over the past decade, regorafenib and trifluridine-tipiracil were the only available drugs and often provided limited clinical benefit compared to best supportive care. Results from subsequent practice-changing trials opened several novel therapeutic avenues, both for unselected patients (such as trifluridine-tipiracil plus bevacizumab or fruquintinib) and for subgroups defined by the presence of actionable alterations in their tumours (such as HER2-targeted therapies or KRAS^G12C inhibitors) or with no acquired mechanisms of resistance to the previously received targeted agents in circulating tumour DNA (such as retreatment with anti-EGFR antibodies). In this Review, we provide a comprehensive overview of advances in the field over the past few years and offer a practical perspective on translation of the most relevant results into the daily management of patients with metastatic colorectal cancer using an evidence-based algorithm. Finally, we discuss some of the most appealing ongoing areas of research and highlight approaches with the potential to further expand the therapeutic armamentarium.

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.

2024-12-01·Journal of Gastrointestinal Cancer

Synergistic Effects of Fruquintinib Combined with Immune Checkpoint Inhibitors on Metastatic Colorectal Cancer

Article

作者: Xie, Ming-Zhi ; Huang, Shi-Ying ; Li, Yong-Qiang ; Hu, Bang-Li ; Qin, Shan-Yu ; Liang, Rong

BACKGROUND:

Fruquintinib has received approval for the management of patients with chemotherapy-resistant metastatic colorectal cancer (mCRC). However, combination of fruquintinib with immune checkpoint inhibitors (ICIs) is yet to be extensively studied. This study aims to assess the clinical efficacy, safety, and prognostic indicators of treatment regimen combining fruquintinib with ICIs in mCRC patients.

METHODS:

We analyzed data from mCRC patients who were administered fruquintinib either as a monotherapy or in conjunction with ICIs following conventional chemotherapy. Parameters such as the objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and incidence of adverse events were meticulously evaluated. Furthermore, the relationship between blood markers and patient prognosis was examined.

RESULTS:

A total of 72 mCRC patients were included in this study, with a median observation period of 48 months, 19 were treated with fruquintinib alone, while 53 received a combination therapy involving fruquintinib and ICIs. The combined therapy group exhibited superior ORR and DCR compared to the fruquintinib monotherapy group. Additionally, significant improvements in OS and PFS were observed in the combined treatment group. The occurrence of adverse events was generally manageable and well-tolerated across both groups, with no significant difference in incidence rates. Notably, albumin levels were identified as a prognostic marker for PFS and OS in the univariate Cox regression analysis.

CONCLUSIONS:

The combination of fruquintinib with ICIs demonstrated enhanced clinical efficacy and improved survival outcomes compared to fruquintinib monotherapy in mCRC patients. The safety of the combination regimen was deemed manageable and acceptable.

685

项与呋喹替尼相关的新闻（医药）

2024-12-19

·肿瘤界

2025 ASCO GI 摘要标题公布！超40项中国研究引领潮流

前言 2025年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）将于2025年1月23日至25日在加利福尼亚州旧金山举行，旨在为世界肿瘤学者传递国际消化肿瘤领域的最新研究进展。目前大会官网已披露了摘要标题，大会首日聚焦胃食管癌，超过40项中国研究入选，医脉通特此整理相关摘要标题，期待与广大读者一同抢先体验即将响起的中国强音。 Oral Abstract Session 01 摘要号：327 Intraperitoneal and intravenous paclitaxel plus S-1 versus intravenous paclitaxel plus S-1 in gastric cancer patients with peritoneal metastasis: Results from the multicenter, randomized, phase 3 DRAGON-01 trial 腹膜内和静脉注射紫杉醇联合S-1对比静脉注射紫杉醇联合S-1治疗腹膜转移胃癌患者：多中心、随机、III 期DRAGON-01试验的结果讲者：严超上海交通大学医学院附属瑞金医院 02 摘要号：LBA329 Preliminary results from the multicenter, randomized phase III trial (SCIENCE): Comparing chemotherapy plus sintilimab and chemoradiotherapy plus sintilimab versus chemoradiotherapy for neoadjuvant treatment in resectable locally advanced esophageal squamous cell carcinoma 多中心、随机 III 期试验（SCIENCE）的初步结果：对比化疗联合信迪利单抗、放化疗联合信迪利单抗与单独放化疗在可切除局部晚期食管鳞状细胞癌新辅助治疗中的疗效讲者：冷雪峰四川省肿瘤医院 Rapid Oral Abstract Session 01 摘要号：333 Efficacy and safety of albumin-bound docetaxel vs. docetaxel in patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma: A multicenter, randomized, phase II study. 白蛋白结合多西他赛对比多西他赛单药在既往接受过治疗的晚期胃或胃食管结合部腺癌患者中的疗效和安全性：一项多中心、随机、II 期研究讲者：王志强中山大学肿瘤防治中心 02 摘要号：334 Conversion effects of PD-1 inhibitor camrelizumab (Cam) combined with Nab-POF regimen in patients (pts) with initially unresectable locally advanced or limited metastatic gastric or gastroesophageal junction adenocarcinoma: FDZL-001 trial PD-1抑制剂卡瑞利珠单抗（Cam）联合 Nab-POF 方案作为初始不可切局部晚期或局限性转移性胃或胃食管结合部腺癌患者的转化治疗：FDZL-001试验讲者：耿其荣复旦大学附属肿瘤医院 03 摘要号：335 Effect of SHR-1701 on chemotherapy (chemo)-induced myelosuppression: Data from a phase 3 study in HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJA) SHR-1701对化疗（chemo）诱导的骨髓抑制的影响：来自HER2阴性胃/胃食管结合部腺癌（G/GEJA）的III 期研究数据讲者：彭智北京大学肿瘤医院 Poster session 01 摘要号：342 Real world data and biomarker analysis of the efficacy and safety of PD-1 inhibitor combined with chemotherapy in first-line treatment of advanced gastric cancer 讲者：马晓婷中国医学科学院肿瘤医院 02 摘要号：343 Retreatment with immune checkpoint inhibitors (ICIs) for patients with advanced gastric cancer: A retrospective, real-world study 讲者：贾永旭郑州大学第一附属医院 03 摘要号：344 Nimotuzumab combined with chemotherapy plus immunotherapy as first-line treatment for advanced esophageal squamous cell carcinoma 讲者：Qi Wang 中国人民解放军总医院 04 摘要号：346 Prognostic analysis of pathological complete response after neoadjuvant therapy for locally advanced gastric cancer: A national, multicenter, retrospective study 讲者：陈洁复旦大学附属肿瘤医院 05 摘要号：361 Preliminary results of the ALTER-E009 study: Efficacy and safety of anlotinib combined with radiotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)—A multicenter, multi-cohort retrospective exploratory study 讲者：王鑫中国医学科学院肿瘤医院 06 摘要号：367 Anlotinib combined with penpulimab and nab-paclitaxel as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, open-label phase II clinical trial 讲者：常志伟郑州大学第一附属医院 07 摘要号：368 Safety and efficacy of perioperative chemotherapy combined with PD-1 inhibitor versus chemotherapy with D2 gastrectomy plus PAND in gastric cancer with PALD metastasis: A single-center retrospective cohort study 讲者：叶泽耀浙江省肿瘤医院 08 摘要号：375 Envafolimab in combination with lenvatinib and albumin paclitaxel for previously treated advanced GEJ adenocarcinoma: Latest analysis of a phase II, two-cohort study 讲者：赵晓莹复旦大学附属肿瘤医院 09 摘要号：390 An exploratory phase II trial of low-dose decitabine and sintilimab combined with chemotherapy in HER2-negative gastric or gastroesophageal junction adenocarcinoma 讲者：杜云毅长治医学院附属长治人民医院 10 摘要号：392 First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) vs chemo in patients (pts) with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC): 5-year (y) follow-up of Chinese pts from CheckMate 649 讲者：沈琳北京大学肿瘤医院 11 摘要号：395 Does chemotherapy regimen matter for first-line immunochemotherapy in low programmed cell death ligand 1 (PD-L1)-expressing esophageal squamous cell carcinoma (ESCC)? A systemic review and meta-analysis 讲者：Jhe-Cyuan Guo 台湾大学癌症中心 12 摘要号：396 Perioperative chemotherapy with either S-1 or 5-fluorouracil plus oxaliplatin and docetaxel for locally advanced gastric or gastroesophageal junction adenocarcinoma: A prospective trial and matched comparison 讲者：Chih Chieh Yen 台湾成功大学 13 摘要号：406 PD-1 inhibitor (sintilimab) and fruquintinib plus SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated results from a single-arm, phase 2 clinical trial 讲者：马飞河南省肿瘤医院（中国医学科学院肿瘤医院河南医院） 14 摘要号：407 A phase II study of fruquintinib plus sintilimab as a second-line therapy for advanced gastric and gastroesophageal junction adenocarcinoma (GC/GEJC): Updated results 讲者：金敏华中科技大学同济医学院附属协和医院 15 摘要号：410 Neoadjuvant SHR-1701 (a bifunctional anti-PD-L1/TGF-βRII agent) combined with chemoradiotherapy for resectable locally advanced esophageal squamous cell carcinoma (ESCC): A phase II trial 讲者：刘成新山东省肿瘤医院 16 摘要号：411 Bifunctional anti-PD-L1/TGF-βRII agent SHR-1701 plus chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Survival results of a phase II trial 讲者：Yi Wang 山东大学齐鲁医院 17 摘要号：413 Response characteristics of tislelizumab (TIS) plus chemotherapy (chemo) in first-line (1L) treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC): A post hoc analysis of RATIONALE-306 讲者：Yi Li 中国人民解放军总医院 18 摘要号：414 Tislelizumab (TIS) + chemotherapy (chemo) vs placebo (PBO) + chemo as first-line (1L) treatment in gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) patients with/without peritoneal or liver metastases: A post hoc analysis of RATIONALE-305 study 讲者：邱妙珍中山大学肿瘤防治中心 19 摘要号：421 Perioperative adebrelimab combined with chemotherapy for locally advanced resectable esophageal squamous cell carcinoma: A single-arm, open-label, multicenter study 讲者：戴亮北京大学肿瘤医院 20 摘要号：423 Updated results from the phase Ib/II study of fruquintinib combined with SOX and toripalimab in patients with advanced metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) 讲者：孟祥瑞郑州大学第一附属医院 21 摘要号：424 An organ-preserving strategy in patients with esophageal squamous cell carcinoma treated with immunochemotherapy 讲者：张博中国医学科学院肿瘤医院 22 摘要号：436 Transarterial infusion chemotherapy and embolization (TAICE) as a pre-operative therapy for patients with locally advanced gastric cancer (LAGC): A prospective, single-arm, pilot study 讲者：Zheng Liu 复旦大学附属中山医院 23 摘要号：437 Chemoimmunotherapy plus radiotherapy in advanced esophageal squamous-cell carcinoma 讲者：Keke Nie 青岛市中心医院 24 摘要号：440 HLX22 plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): Updated results with additional patients 讲者：李进中国药科大学附属上海高博肿瘤医院 25 摘要号：442 Paclitaxel oral solution versus paclitaxel injection as a second-line therapy in advanced gastric cancer: A randomized, open-label, non-inferiority phase 3 trial 讲者：李进中国药科大学附属上海高博肿瘤医院 26 摘要号：443 Neoadjuvant adebrelimab plus chemotherapy for resectable locally advanced esophageal squamous cell carcinoma: A phase 2 trial 讲者：李志刚上海交通大学医学院附属胸科医院 27 摘要号：444 Preliminary results of benmelstobart plus anlotinib combined with SOX in the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with low PD-L1 expression: A single-arm, multicenter phase II clinical trial 讲者：贾永旭郑州大学第一附属医院 28 摘要号：445 Fruquintinib plus camrelizumab combined with paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, phase II clinical trial 讲者：顾艳宏江苏省人民医院 29 摘要号：450 Tislelizumab (Tisle) combined with POFI (irinotecan, paclitaxel, oxaliplatin and 5-FU/levoleucovorin) as first-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma (AGC): OS analysis results of the SYLT-023 讲者：Liyu Su 福建医科大学肿瘤医院 30 摘要号：454 Updated efficacy results of ASKB589 combined with CAPOX and PD-1 inhibitor as first-line treatment for metastatic gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma from a phase Ib/II study 讲者：彭智北京大学肿瘤医院 31 摘要号：459 Anlotinib plus benmelstobart as adjuvant therapy in patients with esophageal squamous cell carcinoma: A phase II clinical trial (ALTER-E005) 讲者：郭昌莹江西省肿瘤医院 32 摘要号：460 Clinical study of radiotherapy combined with tegafur bolus synchronization in the treatment of inoperable elderly middle and advanced esophageal cancer 讲者：Xixi Zhao 西安交通大学第二附属医院 33 摘要号：461 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 2 study 讲者：Chenchen Wang 复旦大学附属肿瘤医院 34 摘要号：463 Efficacy, safety and DNA methylation analysis of cadonilimab combined with taxane and cisplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from an open-label, multicenter phase II trial (AK104-IIT-014) 讲者：Wang Qu 中国医学科学院肿瘤医院 35 摘要号：464 Pembrolizumab or placebo plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: An updated analysis of KEYNOTE-859 for patients enrolled in Asia 讲者：CHIA JUI YEN 台湾成功大学 36 摘要号：472 Unraveling the role of interferon-stimulated neutrophils: A promising biomarker for immunotherapy efficacy and prognosis in gastric adenocarcinoma 讲者：潘宏达复旦大学附属肿瘤医院 37 摘要号：475 Effect of tRF-28-ZJ47D112Z4DZ on the pathogenesis of gastric cancer through targeting cyclin D1/CDK4 and its early diagnostic value 讲者：Xiuchong Yu 宁波大学附属第一医院 38 摘要号：483 Use of nucleotyping and tumor stroma ratio to predict prognosis in patients with resected intestinal-type gastric cancer 讲者：沙丹山东第一医科大学附属省立医院 39 摘要号：484 Histopathological growth patterns of gastric cancer liver metastasis and their association with patient prognosis 讲者：沙丹山东第一医科大学附属省立医院 40 摘要号：488 Use of immune repertoire sequencing analysis to detect differences in treatment responses for advanced esophageal squamous cell carcinoma treated with camrelizumab and platinum-based chemotherapy 讲者：赵军长治医学院附属长治人民医院 Trials in Progress Poster Session 01 摘要号：TPS506 Neoadjuvant cadonilimab plus anlotinib followed by surgery for locally advanced esophageal squamous cell carcinoma: A single arm, phase 2 trial 讲者：翁文翰北京大学人民医院备注：排名不分先后，按照摘要号进行排序如有遗漏或任何问题，请给我们留言~ 来源：医脉通消化系统肿瘤

临床结果ASCO会议临床3期

2024-12-17

·癌度

免费用药：AL2846胶囊联合TQB2450免疫治疗耐药的肺癌！

对于肺癌患者来说，如果没有靶向药的治疗机会，在免疫治疗联合化疗治疗后病情进展，就比较难以有好的治疗办法。因为没有靶向药可以用，免疫治疗药物用过了，再去换一个免疫药物不一定起效。现在有了一个可以申请免费使用的临床试验，AL2846联合TQB2450。一、AL2846和TQB2450是啥？ AL2846胶囊是正大天晴与爱德程合作的一款多靶点的酪氨酸激酶受体抑制剂，在分子水平对c-MET、c-KIT、VEGFR1和RET均具有明显的抑制作用，对KDR、PDGFRβ、VEGFR3也有抑制活性，作用机制和强度与卡博替尼相当。 TQB2450注射液是人源化PD-L1单克隆抗体，可阻止PD-L1与免疫T细胞表面的PD-1和B7.1受体结合，使免疫T细胞恢复杀肿瘤细胞的活性，从而增强免疫应答。早期多项探索临床数据证明TQB2450注射液联合盐酸安罗替尼胶囊在多个瘤种（如非小细胞肺癌、软组织肉瘤、肾细胞癌、子宫内膜癌、卵巢癌、肝细胞癌、胆管癌等）起到协同增效作用。图片来源：摄图网下面是一项三期临床试验，就是将AL2846和TQB2450联合起来使用，全国多个地方可以筛选，大家可以积极去报名申请。二、入选标准 1、病理为非小细胞肺癌，排除：EGFR突变、ALK融合、ROS1融合等有意义的驱动基因突变(鳞癌无需检测基因突变）； 2、经过一种以上系统治疗后病情进展，最多不能超过二种系统治疗后进展。之前接受过含铂化疗和免疫检查点抑制剂治疗，既往治疗仅接受过一种抗PD-1 (L1)抗体（可靶向PD-1/(L1)的双特异性抗体视为一种抗PD-1/(L1)抗体)）治疗。 3、有可测量肿瘤病灶，直径大于1厘米。三、排除标准 1、既往免疫联合化疗治疗后3个月内疾病发生 RECIST标准的进展或免疫单药治疗最佳疗效为PD（进展，也就是首次用的PD-1无效）。 2、既往接受过多西他赛或卡博替尼或TQB2450注射液治疗 3、既往使用过安罗替尼、阿帕替尼、仑伐替尼、索拉非尼、舒尼替尼、瑞戈非尼、呋喹替尼等抗血管生成TKI 4、既往接受过超过一种抗PD-1或抗PD-L1单抗（包括含上述靶点的双特异性抗体，融合蛋白）（新辅助/诱导阶段使用过可以） 5、既往接受过其他免疫治疗包括但不限于抗CTLA-4 单抗，抗TIGIT单抗，抗LAG-3单抗，抗Tim-3单抗或作用于上述靶点的融合蛋白或靶向TGF-β的抗体/融合蛋白 6、局晚期NSCLC在根治性治疗后使用过免疫检查点抑制剂维持（辅助）治疗 7、既往免疫治疗的疗效符合下述两种情况之一：①最佳疗效为PD；②含免疫治疗的联合治疗：PFS<12周。如您满足上面的情况，可以扫描下面图片二维码，添加癌度医学微信咨询临床试验的报名！

免疫疗法临床3期临床结果

2024-12-16

·健识局

礼来又拉了信达一把

12月16日，礼来发布公告，和信达生物就BTK抑制剂匹妥布替尼达成合作，信达生物将负责匹妥布替尼在中国大陆的销售。这个决定应该是早就做好的。2022年3月，信达从礼来手里拿下两款肿瘤产品的中国销售权益，当时匹妥布替尼还没上市，但其在中国大陆的商业优先谈判权已经到了信达手里。今年10月，匹妥布替尼在国内获批上市，用于既往接受过至少两种系统性治疗的复发或难治性套细胞淋巴瘤成人患者。这款药物想象空间不小，礼来预测其2030年年销售额能达到30亿美元，信达于是选择再度与礼来牵手。事实上，礼来和信达已经是第六次合作。早在2012年，礼来亚洲基金就曾为信达提供资金。后续礼来又引进了信达生物的PD-1，还先后给了信达多款药物的权益。又给产品又给钱，说信达这一路缺不了礼来也不算夸张。如今，信达距离2027年国内营收200亿元的目标又近了一步。被卖掉的潜力产品本次交易主角匹妥布替尼，是一款第三代BTK抑制剂，相比于前两代产品最大的亮点在于对抗耐药性。 BTK抑制剂在血液瘤领域广泛应用，市场规模超百亿美元，诞生了伊布替尼、泽布替尼等重磅炸弹药物，但BTK抑制剂耐药问题无法避免。有研究显示，伊布替尼用药4年后约有19%的慢性淋巴细胞白血病患者会发生疾病进展。匹妥布替尼设计思路与前两代BTK抑制剂不同，作用位点不再是与C481结合，而是以非共价结合BTK，对前两代BTK抑制剂耐药患者仍然有效。在名为BRUIN的1/2期研究中，匹妥布替尼展现出了惊艳的效果，在既往接受过BTK抑制剂治疗、治疗基线中位值为四线的患者中，总缓解率（ORR）为81.6%，中位无进展生存期（mPFS）为19.4个月。 2023年1月，匹妥布替尼在美国获批上市，成为全球首个且唯一获批的非共价BTK抑制剂。目前，匹妥布替尼已经获批治疗套细胞淋巴瘤、慢性淋巴细胞白血病、小淋巴细胞性淋巴瘤。2024年上半年，匹妥布替尼全球销售额达到1.42亿美元，增长迅猛。礼来也对匹妥布替尼充满期待，在2023年财报中，礼来将其看成新的增长引擎之一。预计2030年匹妥布替尼将在慢淋市场占据60%市场份额，对应30亿美元的年销售额。为了证明自身实力，也为了进一步打开市场想象空间，礼来还在BRUIN CCL-321的临床试验，头对头挑战伊布替尼、泽布替尼、阿卡替尼三款BTK抑制剂，预计2025年底将会获得顶线数据。如果匹妥布替尼真能成功以一敌三，那等着它的将会是一个巨大的市场。这么一款潜力产品，礼来为什么要把中国销售权益交给信达生物？礼来为何选择信达？礼来的选择其实不算意外。在2012年6月，信达生物获得的3000万美元B轮融资就由礼来亚洲基金领投。2015年起，礼来和信达生物频繁进行管线上的合作，信达将自研产品PD-1授权给了礼来，同时也引进礼来的产品进入中国。又给钱又给产品，可以说没有礼来，就难有今天的信达。 2022年3月，礼来与又将雷莫西尤单抗注射液、塞普替尼胶囊在国内的商业化权利给了信达。匹妥布替尼的商业优先谈判权也一并给了信达生物。可以看出，礼来从头到尾就没想过自建销售团队在国内卖这款产品。这不难理解。虽然礼来在代谢、自免领域实力强悍，有多款重磅药物，但在一众跨国大药企中，礼来的肿瘤领域并不算突出，仅有CDK4/6抑制剂阿贝西利这一大单品。眼下，礼来在中国的重心也基本放在了代谢领域。今年10月，礼来表示将投资约15亿元用于苏州工厂产能升级，扩大2型糖尿病和肥胖创新药物的生产规模。至于肿瘤，本就不是礼来当下的重点。礼来中国官网显示，其肿瘤领域共有信迪利单抗、利妥昔单抗、塞普替尼胶囊、雷莫西尤单抗、贝西利片、呋喹替尼胶囊、注射用盐酸吉西他滨、注射用培美曲塞二钠8款产品，其中前四款产品的商业化权益都在信达手里。为了这一款药物自建血液瘤销售团队，显然性价比不高。更何况，礼来在国内的销售能力并不算强悍。有业内人员告诉健识局：“礼来产品力很强这是无可置疑的，但其销售比较佛性，指标定的不算激进。” 相比之下，信达的销售能力是有目共睹。截至2024年6月30日，信达拥有超3000人的销售团队。尤其是在血液瘤领域已经建立了完善的产品组合，涵盖信迪利单抗、利妥昔单抗、奥雷巴替尼、伊基奥仑赛注射液、匹妥布替尼片多款产品。不论是血液瘤领域的商业化能力还是广阔的渠道覆盖，信达生物都是礼来的优选。对于信达而言，产品线又多了一款潜力产品，公司2027年国内产品收入达到200亿元的目标变得更近了一步。撰稿丨方涛之编辑丨江芸贾亭运营｜廿十三插图｜视觉中国声明：健识局原创内容，未经许可请勿转载国家医保局公布2025工作重点；跨国械企中国区大裁员；第一三共投资11亿元国内建厂美国药店也不行了砍掉所有临床管线，又一跨国药企退出乙肝领域？

财报上市批准医药出海引进/卖出

100 项与呋喹替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11977	-	L01XE	DB11679

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
晚期子宫内膜癌	中国	和记黄埔医药（上海）有限公司	2024-12-01
结直肠癌	日本	Takeda Pharmaceutical Co., Ltd.	2024-09-24
转移性结直肠癌	中国	和记黄埔医药（上海）有限公司	2018-09-04

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
胃食管交界处腺癌	申请上市	中国	和记黄埔医药（上海）有限公司	2023-04-18
胃癌	申请上市	中国	和记黄埔医药（上海）有限公司	2023-04-18
肾细胞癌	临床3期	中国	和记黄埔医药（上海）有限公司	2022-10-14
结肠转移性腺癌	临床3期	美国	和记黄埔医药（上海）有限公司	2020-08-12
结肠转移性腺癌	临床3期	日本	和记黄埔医药（上海）有限公司	2020-08-12
结肠转移性腺癌	临床3期	澳大利亚	和记黄埔医药（上海）有限公司	2020-08-12
结肠转移性腺癌	临床3期	奥地利	和记黄埔医药（上海）有限公司	2020-08-12
结肠转移性腺癌	临床3期	比利时	和记黄埔医药（上海）有限公司	2020-08-12
结肠转移性腺癌	临床3期	捷克	和记黄埔医药（上海）有限公司	2020-08-12
结肠转移性腺癌	临床3期	爱沙尼亚	和记黄埔医药（上海）有限公司	2020-08-12

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临床结果

适应症

分期

评价

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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


NCT06202417 (Pubmed \| ESMO Open)	N/A	结直肠癌末线	520	Fruquintinib monotherapy	齋糧鏇艱選糧艱廠夢簾(遞鬱遞餘遞繭構齋鏇觸) = Adverse events were reported by 91.3% (457/520) of patients. The rate of grade 3 or 4 toxicity was 42.4% (237/520). No treatment-related death occurred. 憲齋簾齋製網簾簾艱繭 (餘醖鏇構願觸鬱鹹鑰製 )	积极	2024-11-01
NCT03251378 (CTgov)	临床1期	直肠癌 \| 晚期恶性实体瘤 \| 结肠转移性腺癌 ... 更多	129	Fruquintinib (Dose Escalation Phase: Fruquintinib 3 mg)	憲蓋淵獵窪獵餘鹽選憲(顧鏇構範襯鬱鬱顧壓齋) = 齋壓廠願顧繭鏇顧齋顧襯構醖積鹽獵憲繭淵構 (願獵齋鹹觸網壓範願鬱, 構鹽遞網構鏇願鑰廠繭 ~ 淵襯壓糧製醖蓋衊積鑰) 更多	-	2024-09-25
				Fruquintinib (Dose Escalation Phase: Fruquintinib 5 mg)	憲蓋淵獵窪獵餘鹽選憲(顧鏇構範襯鬱鬱顧壓齋) = 範襯餘膚醖襯鹽鏇膚願襯構醖積鹽獵憲繭淵構 (願獵齋鹹觸網壓範願鬱, 艱膚鹽齋廠獵觸構鏇積 ~ 選夢壓網鑰衊遞衊衊構) 更多
NCT03223376 (FRUTIGA, ESMO2024) 人工标引	临床3期	晚期胃食管交界处腺癌二线	351	Fruquintinib 4 mg + Paclitaxel 80 mg/m2	鏇鏇餘壓願壓蓋壓鏇壓(餘築獵鑰憲齋鏇夢願網) = 範淵遞獵鏇獵鬱餘廠蓋鹹憲淵觸顧艱餘夢構鬱 (壓鑰衊壓簾衊觸襯範蓋, 9.3 ~ 16.2) 更多	积极	2024-09-16
				Fruquintinib 4 mgFruquintinib fruquintinibPaclitaxel 80 mg/m2Paclitaxel 80 mg/m2 (experienced fruquintinib-induced hypertension)	鏇鏇餘壓願壓蓋壓鏇壓(餘築獵鑰憲齋鏇夢願網) = 觸夢醖獵蓋願糧憲鏇範鹹憲淵觸顧艱餘夢構鬱 (壓鑰衊壓簾衊觸襯範蓋, 8.4 ~ 10.4) 更多
NCT05763927 (ESMO2024) 人工标引	临床2期	局部晚期直肠癌新辅助	23	Fruquintinib 5mg	範鹹廠遞鏇膚淵獵製遞(鹽範蓋鏇餘積鬱鹽製衊) = 鬱淵願齋顧糧憲糧醖鏇鏇襯範鑰窪範衊餘餘鬱 (廠選範艱願艱鹽衊膚簾, 13.8% ~ 61.2%) 更多	积极	2024-09-16
NCT04948034 (RIFLE, ESMO2024) 人工标引	临床2期	转移性结直肠癌二线	35	Stereotactic ablative radiotherapy fruquintinibtislelizumab	壓壓獵鹹壓鬱簾鏇衊遞(襯鑰鏇願夢窪構夢憲顧) = 鏇憲窪艱網膚齋範鑰繭蓋構遞願繭積願鑰艱膚 (鹽醖觸繭齋簾鹹構餘繭 ) 更多	积极	2024-09-16
NCT04322539 (FRESCO-2, ESMO2024) 人工标引	临床3期	结直肠癌	691	Fruquintinib + best supportive care	憲淵觸蓋餘衊鹹壓構築(衊選壓窪鹹選鹹憲構顧) = 鑰醖憲鏇積淵鏇糧糧築製蓋鏇餘鬱憲齋醖壓鹹 (餘鑰繭膚膚繭夢選夢窪 ) 更多	积极	2024-09-16
				Placebo + best supportive care	憲淵觸蓋餘衊鹹壓構築(衊選壓窪鹹選鹹憲構顧) = 觸齋憲膚艱壓膚夢願艱製蓋鏇餘鬱憲齋醖壓鹹 (餘鑰繭膚膚繭夢選夢窪 ) 更多
NCT03223376 (FRUTIGA, ESMO2024)	临床3期	晚期胃食管交界处腺癌	703	Fruquintinib plus Paclitaxel	築艱鏇獵顧選鏇製製艱(齋鬱夢構鑰鹹齋鏇夢獵) = 製膚遞築簾選鹽醖積獵蓋膚鏇淵蓋餘範鑰鹽簾 (襯築鹹鹹簾觸艱築構襯 )	不佳	2024-09-16
				Placebo plus Paclitaxel	築艱鏇獵顧選鏇製製艱(齋鬱夢構鑰鹹齋鏇夢獵) = 糧製鬱膚繭觸獵網選膚蓋膚鏇淵蓋餘範鑰鹽簾 (襯築鹹鹹簾觸艱築構襯 )
NCT06329973 (FUNCTION, ESMO2024)	临床1/2期	胃食管交界处癌一线 \| 维持	-	Fruquintinib	壓繭醖窪鹽網糧繭壓顧(廠艱觸鬱糧選壓淵鏇遞) = 壓廠醖窪夢廠鑰網願顧製獵廠積夢積鹽鹽鑰醖 (積窪糧範艱廠鏇遞選齋 ) 更多	-	2024-09-16
ESMO2024	N/A	转移性结直肠癌	-	Fruquintinib + Best Supportive Care	鹹壓構選範鏇鹽廠鹹繭(蓋鹹齋顧選襯淵壓餘簾) = 14% for pts aged <55, 15% for pts aged 55−64, 12% for pts aged 65−74 艱鬱製窪艱鏇獵艱獵觸 (夢鏇淵遞網網鹽艱壓網 ) 更多	-	2024-09-16
				Placebo + Best Supportive Care
NCT03223376 (FRUTIGA, ESMO2024)	临床3期	晚期胃癌	703	Fruquintinib plus paclitaxel (F+PTX)	簾獵製築艱衊網遞鹽襯(憲鹹鬱廠願淵衊製鬱憲) = 艱願選鹽糧願獵夢顧鬱淵構遞繭糧獵獵膚淵遞 (夢糧憲顧齋齋範壓艱醖, 66.4 ~ 93.4) 更多	积极	2024-09-16
				Placebo plus paclitaxel (PBO+PTX)	簾獵製築艱衊網遞鹽襯(憲鹹鬱廠願淵衊製鬱憲) = 簾積獵簾衊鬱築壓窪願淵構遞繭糧獵獵膚淵遞 (夢糧憲顧齋齋範壓艱醖, 28.3 ~ 57.8) 更多