Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: the Phase 2 Solids-01 Trial

For locally advanced gastric and gastroesophageal junction adenocarcinoma (cT3-4bNanyM0), perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage, increase the R0 resection rate, and may improve the long-term survival. Combination of perioperative surufatinib, sintilimab and chemotherapy for locally advanced gastric and gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. Surufatinib, as the oral drug in this study is a small molecule kinase inhibitor that mainly acts on vascular growth factor receptor (VEGFR1, 2,3), fibroblast growth factor receptor 1(FGFR1) and colony stimulating factor 1 receptor (CSF1R). It is a proprietary product developed by Hutchison Whampoa Pharmaceutical (Shanghai, China) Co., LTD. Surufatinib has been approved for neuroendocrine tumor. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.

开始日期2024-08-01

申办/合作机构

复旦大学

ChiCTR2400085032 / Suspended临床4期IIT

A single-arm, single-center, exploratory study of Serplulimab combined with surufatinib and chemotherapy in the first-line treatment of extensive-stage small cell lung cancer

开始日期2024-06-05

申办/合作机构

郑州大学第一附属医院

NCT06414915 / Not yet recruiting临床2期IIT

A Single-arm, Open, Single-center, Prospective and Exploratory Clinical Study of Surufatinib Combined With Tislelizumab in the Treatment of Advanced Lung Cancer With Neuroendocrine Differentiation

Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.

开始日期2024-06-01

申办/合作机构-

100 项与索凡替尼相关的临床结果

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100 项与索凡替尼相关的转化医学

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100 项与索凡替尼相关的专利（医药）

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项与索凡替尼相关的文献（医药）

2024-03-01·Anti-cancer drugs

Surufatinib combined camrelizumab as a valuable third-line rescue therapy for a patient with extensive-stage for small-cell lung cancer: a case report and literature review

Review

作者: Chu, Laili ; Yu, Tao ; Pan, Chi ; Li, Lin ; Yang, Ming ; Ni, Qingtao ; Han, Li ; Hao, Daxuan

Lung cancer is one of the most common malignant tumors with the highest incidence. Gene mutations are rare in small-cell lung carcinoma (SCLC), resulting in targeted therapy being only a third-line recommendation. Surufatinib (Sulanda) is an oral angio-immune kinase inhibitor used to treat solid tumors. We report a case of SCLC treated with surufatinib combined with camrelizumab, with good therapeutic results in our department. The patient experienced over 18 months of progression-free survival and over 28 months of overall survival. This suggests that surufatinib combined with camrelizumab is an effective third-line treatment for SCLC patients. However, the response rate to surufatinib treatment in all patients with SCLC remains unknown and needs to be determined in a large population.

2024-03-01·European journal of cancer (Oxford, England : 1990)

Surufatinib plus toripalimab in patients with advanced neuroendocrine tumours and neuroendocrine carcinomas: An open-label, single-arm, multi-cohort phase II trial

Article

作者: Zhang, Xing ; Shi, Si ; Cheng, Ying ; Zhang, Panpan ; Yin, Fei ; Song, Lijie ; Xu, Qian ; Weng, Desheng ; Fan, Songhua ; Tan, Panfeng ; Ma, Yue ; Ye, Feng ; Zhang, Yanqiao ; Gao, Heli ; Zhao, Yaqin ; Chen, Zhendong ; Chen, Wei ; Yang, Minjie ; Su, Weiguo ; Li, Zhiping ; Yin, Xiaolei ; Sheng, Wang ; Li, Yi ; Wu, Chunjiao ; Ji, Dongmei ; Shen, Lin ; Lu, Ming ; Shi, Michael ; Shen, Weina ; Xu, Jianming

BACKGROUND:

The programmed death 1 inhibitor toripalimab plus the angio-immuno kinase inhibitor surufatinib revealed a tolerable safety profile and preliminary efficacy in patients with advanced solid tumours in a phase I study.

PATIENTS AND METHODS:

This was an open-label, single-arm, multi-cohort phase II study in China. Patients with advanced neuroendocrine tumours (NETs) or neuroendocrine carcinomas (NECs) or mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs) who had failed or were intolerable of standard treatment were given surufatinib (250 mg orally, once daily) plus toripalimab (240 mg intravenously, once every 3 weeks). Primary end-point was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary end-points included duration of response (DoR), disease control rate, progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

Forty patients were enrolled into two cohorts by tumour types (NET, n = 19; NEC-MiNEN, n = 21). ORRs (95% CIs) were 21.1% (6.1-45.6) and 23.8% (8.2-47.2) in the NET and NEC-MiNEN cohorts, respectively. Median DoR was 7.1 months (6.9-not evaluable [NE]) and 4.1 months (3.0-NE), respectively. Median PFS was 9.6 months (4.1-NE) and 4.1 months (1.5-5.5); median OS was 27.3 (15.3-NE) and 10.9 months (9.1-14.6), respectively. Overall, grade ≥ 3 treatment-related adverse events occurred in 18 (45.0%) patients.

CONCLUSIONS:

Surufatinib plus toripalimab showed antitumour activity and a tolerable safety profile in patients with previously treated NETs/NECs/MiNENs. Further study of this combination regimen is ongoing for advanced NECs, for which current therapeutic options remain limited.

CLINICALTRIALS:

gov: NCT04169672.

2023-11-27·Open life sciences

Favorable response to surufatinib in a patient with necrolytic migratory erythema: A case report

作者: Li, Guiling ; Guo, Shuang ; Zhang, Peng ; Qin, You ; Hu, Feng ; Liu, Zhongan

Abstract:

Necrolytic migratory erythema (NME) is usually associated with paraneoplastic syndrome caused by functional pancreatic neuroendocrine tumor (PNET). Accurate diagnosis and effective treatment of NET-related NME is challenging due to its rarity and lack of typical clinical symptoms and specific pathological manifestations. Here we report a rare case of PNET with NME as the initial manifestation. 68Ga-DOTA-TATE PET/MR was used to detect the primary pancreatic and metastatic liver tumors. Finally, the patient was diagnosed as PNET via liver biopsy. After four cycles of standard capecitabine plus temozolomide chemotherapy combined with long-acting octreotide, the patient’s skin lesions on both lower extremities improved only slightly, while tumors remained stable and unchanged in size. Then the patient was treated with surufatinib. Two months later, the skin lesions healed completely, and tumors responded significantly. This rare case suggests that surufatinib may be a promising therapy for patients with PNET-associated NME.

157

项与索凡替尼相关的新闻（医药）

2024-06-24

·BioSpace

Save the Date: HUTCHMED to Present R&D Updates on July 9, 2024

HUTCHMED will host in-person presentation and online webinar on Tuesday, July 9 HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 24, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will host a R&D update in Shanghai, China, and via webcast on Tuesday, July 9, 2024. During the event, the senior management team will share insights into the Company’s R&D strategy and vision. Additionally, the team will provide updates on certain programs within HUTCHMED’s extensive and innovative pipeline. This will include updates on the Phase III ESLIM-01 and Phase II/III ESLIM-02 studies of our Syk inhibitor sovleplenib in immune thrombocytopenia (“ITP”) and warm antibody autoimmune hemolytic anemia, (“wAIHA”) respectively; the surufatinib Phase II/III study for metastatic pancreatic ductal adenocarcinoma (“PDAC”); and the Phase III RAPHAEL study of our IDH1/2 inhibitor HMPL-306 in acute myeloid leukemia (“AML”). The in-person event will take place from 3:00 p.m. to 5:00 p.m. HKT in Chinese (Putonghua) in Shanghai. A live webcast will be held simultaneously. Attendance for the in-person event is by invitation only. An English language webcast will take place from 8:30 p.m. HKT / 8:30 a.m. EDT / 1:30 p.m. BST on Tuesday, July 9, for approximately two hours. Both webcasts will be live and can be accessed via . Investors interested in listening to a webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days. 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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs marketed in China, the first of which is also marketed in the U.S. For more information, please visit: 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 U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties. 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 U.S. 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. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Gordon +44 (20) 7886 2500

临床3期免疫疗法

2024-06-13

·CPHI制药在线

浅谈胰腺导管癌治疗进展：在研药物多样，诺华放弃，康宁杰瑞惨败

关注并星标CPHI制药在线胰腺癌是一组主要起源于胰腺导管上皮及腺泡细胞的恶性肿瘤，恶性程度极高，起病隐匿，早期诊断困难，进展迅速，生存时间短，是预后最差的恶性肿瘤之一，被称为"癌中之王"。即使在新疗法不断涌现的今天，胰腺癌的治疗也并未取得突破进展。下面笔者将浅谈下胰腺癌的主要类型--胰腺导管腺癌的治疗现状，以及近年该领域药物的研究进展。关于胰腺导管癌胰腺导管腺癌（PDAC）是一种发生于胰腺导管上皮的肿瘤，是胰腺癌中的主要类型，约占90%以上。PDAC起病隐匿，且具有高度侵袭性，大多患者确诊时已处于晚期。由于缺乏有效的治疗手段，PDAC患者总体5年生存率< 12 %。据2024年2月中国国家癌症中心（NCC）发布的2022年中国新发癌症病例数和死亡人数数据：2022年中国胰腺癌新发病例11.87万，死亡人数10.63万。手术和化疗是PDAC的主要治疗手段，但只有15%-20%的患者在诊断时符合手术条件。不过据《Nature》官网发布的相关研究论文数据，即便能手术，近90% 的PDAC患者在治疗平均7~9个月内会面临复发。而晚期PDAC标准治疗是化疗，常采用联合治疗方案，如AG（白蛋白紫杉醇联合吉西他滨）方案、改良FOLFIRINOX（mFOLFIRINOX，奥沙利铂+伊立替康+亚叶酸钙+氟尿嘧啶）方案或S-IROX（替吉奥+伊立替康+奥沙利铂）方案。据2023年6月美国国家综合癌症网络（NCCN）指南发表的2023年第2版胰腺癌诊治指南：（1）对于部分可切除性胰腺癌，指南推荐先行新辅助治疗（NAT）再手术，推荐方案包括FOLFIRINOX或改良FOLFIRINOX方案，以及吉西他滨联合白蛋白结合紫杉醇方案（AG方案），其中FOLFIRINOX或mFOLFIRINOX方案适用于美国东部肿瘤协作组（ECOG）评分0~1分的病人。术后指南建议患者常规开展化疗，化疗首选方案包括FOLFIRINOX/mFOLFIRINOX方案或吉西他滨联合卡培他滨方案；（2）对于晚期或转移性胰腺癌：PS评分良好（0~1分）局部晚期/转移性胰腺癌一线治疗新增NALIRIFOX方案，即脂质体伊立替康+5-氟尿嘧啶+亚叶酸+奥沙利铂，PS评分中等（2分）局部晚期胰腺癌一线治疗首选卡培他滨或吉西他滨单药化疗或AG方案，PS评分中等（2分）转移性胰腺癌首选AG方案，其次卡培他滨或吉西他滨，NALIRIFOX方案在某些情况下也可使用；（3）对于复发的局部进展期/转移性胰腺癌，PS评分良好者，当NTRK融合基因阳性，首选恩曲替尼或拉罗替尼；当存在微卫星高度不稳定（MSI-H）、错配修复缺陷（dMMR）或肿瘤突变负荷（TMB）≥10 mut/Mb者，建议使用帕博丽珠单抗。新版指南建议在其他治疗方案中新增以下内容：对于合并MSI-H、dMMR者，可使用多塔利单抗；若TMB≥10 mut/Mb，也可使用纳武利尤单抗+伊匹木单抗；PS评分中等者，无首选方案。胰腺导管癌药物研究进展上述方案对PDAC治疗效果有限，且有些药物只适用于特定患者。药企对PDAC新疗法的探索从未止步，今年2月FDA批准NALIRIFOX（脂质体伊立替康 (Onivyde)+奥沙利铂+氟尿嘧啶 (5-FU)/亚叶酸）方案一线治疗转移性PDAC。此外，目前全球还有多款在研PDAC新疗法，详见下表。这些在研疗法作用靶点各异，具体适应症有所不同，且药物类型多样，涉及化药、单抗、双抗、CAR-T疗法、疫苗以及溶瘤病毒等。研发进度上，NIS793、KN046等处于3期临床。其中NIS793是一种完全人源的单克隆抗体，通过阻断TGFβ细胞因子而发挥作用，2021年被FDA授予治疗胰腺癌的孤儿药资格，其联合吉西他滨和Nab-紫杉醇一线治疗PDAC的临床试验已进入3期阶段。值得一提的是，诺华曾于2015年从Xoma引进NIS793，但2024年诺华宣布停止研发NIS793，并将其退还给Xoma。 KN046是康宁杰瑞研发的一款PD-L1/CTLA-4靶向双抗。已公布的2期临床研究（NCT04324307）数据显示：对于31例无法切除的晚期胰腺癌患者，KN046联合AG方案的ORR为45.2%，DCR为93.5%。遗憾的是，今年5月，康宁杰瑞宣布KN046联合AG方案一线治疗不可切除局部晚期或转移性PDAC的3期临床试验KN046-303惨遭失败，OS结果未达到统计学终点。索凡替尼治疗胰腺癌方面处于2/3期临床，2024年5月其联合卡瑞利珠单抗和化疗（白蛋白结合型紫杉醇+吉西他滨)一线治疗转移性PDAC的2/3期临床试验启动。该药是和黄医药开发的一种新型的口服酪氨酸激酶抑制剂，已被NMPA批准用于无法手术切除的局部晚期或转移性、进展期非功能性、分化良好（G1、G2）的非胰腺（2020年12月）和胰腺（2021年6月）来源的神经内分泌瘤。已公布的索凡替尼治疗胰腺癌的临床试验结果显示：索凡替尼联合TAS-102三线或后线治疗方案对mPDAC患者有令人鼓舞的抗肿瘤活性，特别是对无肝转移患者。此外，与索凡替尼仅联合化疗相比，索凡替尼联合卡瑞利珠单抗和化疗一线治疗胰腺癌可显著延长患者的OS和PFS。 CAN-2409、Motixafortide等处于2期临床。其中CAN-2409是一种复制缺陷的腺病毒，旨将单纯疱疹病毒胸苷激酶（HSV-tk）基因递送至患者的肿瘤并诱导个体化的全身抗肿瘤免疫反应。HSV-tk是一种酶，可局部将口服伐昔洛韦转化为杀死附近癌细胞的有毒代谢物，从而释放多种癌症抗原。该疗法通过局部注射将免疫应答局部聚焦于肿瘤，能够最大限度地减少与全身静脉给药相关的全身毒性。2024年4月，CAN-2409被FDA授予治疗胰腺癌的孤儿药资格。已公布的CAN-2409联合抗病毒药物与标准护理（SoC）放化疗用作可切除PDAC术前辅助治疗的2期临床试验结果显示：截至2024年3月29日数据，在边缘性可切除PDAC中，CAN-2409组患者的mOS为28.8个月（Vs 对照组的12.5个月）；24个月时，CAN-2409治疗组患者的生存率为71.4%（Vs 对照组的16.7%），；36个月时，CAN-2409治疗组的生存率为47.6%（Vs 对照组的16.7%）。CAN-2409还显示出良好的耐受性，没有显著的额外局部或全身毒性。而且，对切除肿瘤的分析显示，患者在使用CAN-2409联合疗法后，其PDAC组织中出现密集的免疫细胞聚集，包括CD8+细胞、细胞毒性肿瘤浸润淋巴细胞和树突状细胞，这证实该疗法能够激活强大的抗肿瘤免疫反应。安全性方面，在SoC中添加CAN-2409方案显示出良好的耐受性，没有观察到剂量限制性毒性。 Motixafortide是Biokine Therapeutics 研发的一款靶向CXCR4的长效合成多肽拮抗剂，后授权给BioLineRx。2023年9月，该疗法被FDA批准联合filgrastim（G-CSF），以在多发性骨髓瘤患者中动员造血干细胞到外周血进行采集，辅助进行自体干细胞移植。治疗PDAC方面，已公布的临床研究结果显示：Motixafortide联合帕博利珠单抗和化疗在治疗PDAC方面表现出良好的安全性和耐受性，且在预后不良和病情凶险的PDAC人群中显示出疗效。 2023 AACR上公布的Motixafortide联合帕博利珠单抗和AG方案一线治疗转移性胰腺癌的单臂2期临床试验结果显示：可评估患者(11人)的ORR为55%，36%患者出现PR，1例患者的肝转移病灶得到缓解。此外，27%的患者(3例)病情稳定，DCR为82%。 Mitazalimab是一种靶向CD40的单克隆抗体，通过激活树突状细胞、B细胞和巨噬细胞等免疫细胞，使肿瘤对化疗敏感，大幅增强抗肿瘤的能力。今年2月，该药被欧盟授予孤儿药资格，联合与mFOLFIRINOX方案一线治疗转移性PDAC。 2024年1月，Alligator Bioscience宣布Mitazalimab联合mFOLFIRINOX化疗一线治疗胰腺癌的2期临床研究达到主要研究终点。具体数据为：57名可评估患者的ORR为40.4%，DCR为79%，mOS为14.3个月，中位缓解持续时间为12.5个月（优于FOLFIRINOX标准治疗的5.9个月）。 CEND-1是一种由9个氨基酸构成的环肽药物，可与肿瘤中选择性表达的alpha-v整合素结合，然后被肿瘤微环境中表达的蛋白酶切割，释放出被称为CendR片段的肽片段，该片段再与第2个受体neuropilin-1结合，从而激活一种新的摄取途径（CendR途径），使抗癌药物能够穿透实体瘤。CEND-1改变肿瘤微环境以增强联合治疗药物的递送和功效的能力已在一系列实体瘤模型中得到证实。2021年2月，齐鲁制药与Cend Therapeutics签订合作和许可协议，获得CEND-1在大中华区开发和商业化权益。柳叶刀杂志上发表的CEND-1联合标准治疗化疗（吉西他滨和白蛋白紫杉醇）一线治疗转移性PDAC的1期临床研究数据显示：29例疗效可评估患者中的ORR为59%，mOS为13.2个月。 Efineptakin Alfa治疗胰腺癌方面处于1/2期临床。该药是一种长效人类白细胞介素 7，其联合帕博利珠单抗对胰腺癌患者展示出良好的疗效：7.7％的患者肿瘤大幅缩小或消失，34.6％的患者疾病得到有效控制。2024年2月，该疗法被FDA授予治疗晚期胰腺癌的孤儿药资格。 ELI-002、D-1553等处于1期临床。其中ELI-002是一款针对KRAS突变的治疗型疫苗，主要针对KRAS突变阳性实体瘤，尤其是PDAC、结直肠癌。该疫苗由两个关键组件构成，即AMP-CpG（一种特有的免疫激活剂，可刺激免疫系统产生强烈的反应）和AMP-mKRAS-肽。其中AMP-mKRAS-肽是一种经修饰的KRAS突变肽，可特异性地引导机体免疫系统，追踪并摧毁携带KRAS突变的癌细胞。 2024年1月《Nature》杂志上发表的1期临床试验AMPLIFY-201结果显示：ELI-002可显著降低患者肿瘤标志物水平，并产生强烈的T细胞应答，从而降低患者复发及死亡的风险，且总体上被认为是安全可控的。 IBI389是信达生物自主研发的一种抗CLDN18.2/CD3双特异性抗体。2024 ASCO上公布的IBI389治疗晚期不可手术或转移性PDAC的1期临床数据显示：600μg/kg治疗组疗效更佳，在27例至少进行了一次基线后肿瘤评估的受试者中，ORR为29.6% ，确认的客观缓解率（cORR）为25.9%，DCR达70.4%（95%CI：49.8-86.2）。在CLDN18.2 IHC 2/3+≥40%的18例受试者中，cORR达38.9%。此外，截至2024年5月1日，中位随访时间为4个月，mPFS尚未成熟，3个月的PFS率达57.1%。 CT041是一种潜在全球同类首创、靶向CLDN18.2蛋白的自体CAR-T细胞疗法，用于治疗Claudin18.2阳性实体瘤，主要治疗胃癌/食管胃结合部腺癌及胰腺癌。最近公布的CT041治疗难治性转移性胰腺癌的两项多中心、开放标签的1/1b期临床试验数据显示：24例患者中有12例观察到肿瘤靶病灶不同程度缩小，ORR为16.7%，DCR为70.8%，临床获益率为37.5%。mDoR为9.5个月，12个月的DoR率为50%，mPFS为3.3个月，mOS为10.0个月，12个月时OS率为45.8%。 D-1553是益方生物自主开发的一款新型、高效、口服KRAS G12C抑制剂。已公布的D-1553针对KRAS G12C突变晚期胰腺癌的早期临床试验结果显示：D-1553单药治疗在KRAS G12C突变胰腺癌患者中展现出良好的耐受性和临床活性，确认的ORR为35.7%（5/14），DCR为85.7%（12/14），mPFS为8.54个月。今年5月，该药被CDE纳入突破性治疗品种，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PDAC。 IMM-1-104是Immuneering 开发一款高选择性第三代小分子MEK抑制剂，每日口服一次。该药通过深度循环抑制MAPK途径，实现对RAS基因的通用抑制活性。在一项1/2a期研究中，IMM-1-104对包括PDAC、恶性黑色素瘤、NSCLC在内的多种实体瘤展现出良好的初步疗效。2024年2月，该药被FDA授予一线治疗PDAC的快速通道认定。总结整体来看，多款在研PDAC新疗法进入临床试验，且早期临床试验结果积极。监管机构也通过授予突破性疗法、快速通道资格等方式加速PDAC的研发进程。但PDAC的治疗较其他恶性肿瘤，如NSCLC、黑色素瘤，并未取得很大突破。而且，与其他恶性肿瘤在研药物不同，在研PDAC药物作用靶点相当分散，笔者分析这可能与PDAC自身的特性，以及诊断上缺乏特异的生物标志物有关。期待在研究人员的不懈努力下，PDAC治疗可以早日迎来新局面。【企业推荐】【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

上市批准

2024-05-30

·echemi

Overcoming the Decline: Alphamab Oncology's Approach to Conquering the

The recent 40% drop in Alphamab Oncology's stock price following the failure of its Phase III clinical trial for KN046 in the treatment of advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) has sent shockwaves through the oncology community. Pancreatic cancer, often referred to as the "King of Cancers," has long been a formidable challenge, with limited effective treatment options and dismal survival rates. However, Alphamab Oncology's setback has not dampened the industry's efforts to find breakthrough therapies for this deadly disease. Unmet Clinical Needs in Pancreatic Cancer: Pancreatic cancer is a highly aggressive malignancy, characterized by rapid progression, early metastasis, and a low early detection rate. Less than 5-7% of patients are diagnosed in the early stages, and more than 80% lose the opportunity for surgical resection by the time of diagnosis. Current first-line treatment regimens, such as the combination of gemcitabine and albumin-bound paclitaxel, offer a median overall survival (OS) of only 6-9 months, highlighting the significant unmet clinical needs in this disease. Promising Investigational Therapies: Despite the recent setback, the pipeline for pancreatic cancer treatments remains promising. Several pharmaceutical companies are actively exploring innovative approaches to address this challenge. For instance, Hutchison MediPharma has initiated a Phase II/III clinical trial to evaluate the combination of the tyrosine kinase inhibitor surufatinib, the PD-1 antibody carrelizumab, and gemcitabine plus albumin-bound paclitaxel as a first-line treatment for PDAC. Moreover, Innovent Biologics has reported promising early-stage data for its anti-CLDN18.2/CD3 bispecific antibody IBI389 and anti-Claudin18.2 antibody-drug conjugate IBI343 in the treatment of advanced pancreatic cancer. These targeted therapies aim to harness the power of the immune system and deliver cytotoxic payloads directly to cancer cells, potentially offering new hope for patients. Overcoming Setbacks and Driving Innovation: The failure of Alphamab Oncology's KN046 trial is a sobering reminder of the challenges faced in the development of new cancer treatments. However, the industry's unwavering commitment to advancing the field of pancreatic cancer research is evident. Companies are diligently analyzing the data from their clinical trials, identifying areas for improvement, and refining their approaches to overcome these setbacks. The battle against the "King of Cancers" is far from over. While the recent disappointment with Alphamab Oncology's KN046 trial is a setback, it has not dampened the industry's determination to find more effective treatments for pancreatic cancer. With a robust pipeline of investigational therapies and a renewed focus on innovation, the oncology community remains dedicated to improving outcomes for patients suffering from this devastating disease.

临床3期ASCO会议抗体药物偶联物

100 项与索凡替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11885	-	L01XX	DB15106

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
晚期胰腺神经内分泌肿瘤	中国	和记黄埔医药（上海）有限公司	2021-06-18
神经内分泌肿瘤	中国	和记黄埔医药（上海）有限公司	2020-12-29

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
神经内分泌癌	申请上市	美国	和黄医药（中国）有限公司	2022-08-17
神经内分泌癌	申请上市	中国	和黄医药（中国）有限公司	2022-08-17
神经内分泌癌	申请上市	欧盟	和黄医药（中国）有限公司	2022-08-17
神经内分泌癌	申请上市	日本	和黄医药（中国）有限公司	2022-08-17
实体瘤	申请上市	美国	和黄医药（中国）有限公司	2022-08-17
实体瘤	申请上市	欧盟	和黄医药（中国）有限公司	2022-08-17
胰岛细胞腺瘤	申请上市	中国	和记黄埔医药（上海）有限公司	2019-11-13
胰腺导管腺癌	临床3期	中国	和黄医药（中国）有限公司	2024-05-14
胰腺继发性恶性肿瘤	临床3期	中国	和黄医药（中国）有限公司	2024-05-08
晚期神经内分泌癌	临床3期	中国	和记黄埔医药（上海）有限公司	2021-09-09

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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


NCT04922658 (ASCO2024) 人工标引	临床2期	晚期非小细胞肺癌三线	44	Surufatinib+Vinorelbine (cohort 1)	淵窪蓋艱簾網糧壓鏇遞(構廠獵積獵構鏇製糧衊) = 觸餘鏇範遞衊衊鬱憲膚顧顧鑰蓋願壓齋鏇觸積 (廠艱積網艱選窪夢顧膚 ) 更多	积极	2024-05-24
				Surufatinib (cohort 2)	淵窪蓋艱簾網糧壓鏇遞(構廠獵積獵構鏇製糧衊) = 鬱襯網鑰願蓋網膚網齋顧顧鑰蓋願壓齋鏇觸積 (廠艱積網艱選窪夢顧膚 ) 更多
NCT04929652 (ASCO2024) 人工标引	临床1/2期	晚期结直肠腺癌二线 BRAF Mutation \| NRAS Mutation \| KRAS Mutation	30	Surufatinib+camrelizumab+irinotecan+GM-CSF	顧壓糧製膚鑰構淵獵簾(獵窪衊願醖鑰憲淵顧獵) = 憲鹹鏇獵糧製獵壓鹹壓膚鏇簾糧遞簾顧觸淵範 (醖範醖膚繭觸遞齋構築, 14.7 ~ 49.4) 更多	积极	2024-05-24
				SurufatinibSurufatinib+camrelizumabcamrelizumab+irinotecanirinotecan+GM-CSF (RAS/BRAF mutations)	顧壓糧製膚鑰構淵獵簾(獵窪衊願醖鑰憲淵顧獵) = 鑰窪淵鹽網艱艱膚窪願膚鏇簾糧遞簾顧觸淵範 (醖範醖膚繭觸遞齋構築 ) 更多
NCT05509699 (ASCO2024) 人工标引	临床2期	广泛期小细胞肺癌一线 \| 维持	21	Surufatinib + PD-1/L1 inhibitors	齋夢窪積遞膚鹹簾餘衊(蓋繭鹽廠夢鑰蓋獵構構) = 膚願鹹鏇膚鏇繭網衊範獵鏇醖鏇窪餘願鏇醖構 (鹽繭製糧觸鏇鑰簾廠顧, 2.0 ~ 5.6) 更多	积极	2024-05-24
NCT05481463 (ASCO2024)	临床2期	胰腺继发性恶性肿瘤三线	11	Surufatinib+TAS-102	網選網簾遞膚繭遞獵鏇(鹹鏇遞鹹獵鏇齋鹹襯積) = 鹽壓積壓憲蓋顧廠夢積憲鹽廠築鑰獵廠夢觸願 (積齋觸觸淵夢構夢鹹衊, 1.91 ~ 3.94) 更多	积极	2024-05-24
				Surufatinib+TAS-102 (without liver metastases)	網選網簾遞膚繭遞獵鏇(鹹鏇遞鹹獵鏇齋鹹襯積) = 齋築顧網淵網選積膚遞憲鹽廠築鑰獵廠夢觸願 (積齋觸觸淵夢構夢鹹衊, 2.14-NA) 更多
NCT05106777 (Phase II study, ASCO2024)	临床2期	骨肉瘤 \| 软组织肉瘤二线	43	Surufatinib 300 mg	淵衊獵簾製襯蓋遞鹹鑰(餘顧顧鬱選獵鑰鑰醖鹽) = 獵積夢憲選鏇築製憲選網遞衊窪鹹鑰繭願襯繭 (繭膚鬱窪夢積廠鏇遞蓋 ) 更多	积极	2024-05-24
ChiCTR2100052020 (ASCO2024)	早期临床1期	难治性甲状腺癌二线	9	Surufatinib	艱淵鹹窪遞構獵顧顧壓(廠餘簾繭餘遞壓鹹遞鬱) = 積願獵鬱蓋鹽糧鬱衊鑰蓋選糧艱製製衊壓窪鑰 (艱鬱積範遞艱窪網築鬱 ) 更多	积极	2024-05-24
				Anlotinib	艱淵鹹窪遞構獵顧顧壓(廠餘簾繭餘遞壓鹹遞鬱) = 觸襯構獵願築鏇鏇繭選蓋選糧艱製製衊壓窪鑰 (艱鬱積範遞艱窪網築鬱 )
ASCO2024	N/A	食管鳞状细胞癌一线 PD-L1 CPS	16	Surufatinib	鑰夢網衊窪範鏇廠餘繭(憲選製齋鏇網顧憲淵窪) = the 12-month PFS rate was 77.14% (95% CI: 48.89%-100%) 築夢憲獵構蓋糧範顧觸 (糧餘簾壓糧鏇蓋繭窪繭 ) 更多	积极	2024-05-24
				Toripalimab
NCT05093322 (CTgov)	临床1/2期	肉瘤 \| 实体瘤 \| 复发性实体肿瘤 ... 更多	13	gemcitabine+surufatinib (Dose Level 1)	壓艱遞窪膚繭觸衊選觸(簾積餘襯網獵醖獵遞衊) = 衊窪憲膚憲壓願積製獵憲築衊鏇艱襯遞衊鬱蓋 (觸齋構醖範繭憲網觸範, 艱構願艱憲範艱鏇積襯 ~ 選廠觸製範蓋壓壓糧衊) 更多	-	2024-05-16
				gemcitabine+surufatinib (Dose Level 2)	壓艱遞窪膚繭觸衊選觸(簾積餘襯網獵醖獵遞衊) = 餘窪壓廠襯繭衊醖膚鏇憲築衊鏇艱襯遞衊鬱蓋 (觸齋構醖範繭憲網觸範, 繭選淵蓋鏇鑰餘繭膚鬱 ~ 顧憲製願廠醖淵蓋獵獵) 更多
NCT04169672 (Pubmed)	临床1期	食管鳞状细胞癌 \| 胆道肿瘤 \| 胃癌 ... 更多	60	Surufatinib plus Toripalimab	憲壓積網顧遞襯廠鑰襯(顧廠觸鏇鏇壓構製鹹繭) = 鹹壓築積淵獵衊鑰餘選齋鏇憲築鏇餘壓襯鏇鹹 (繭壓繭餘築夢簾構繭遞 ) 更多	积极	2024-05-07
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