This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.
A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.

开始日期2025-03-01

申办/合作机构

Evergreen Therapeutics, Inc

NCT06409637 / Not yet recruiting临床1/2期IIT

A Prospective, Single-arm Clinical Study of FOLFOX Combined With Lenvatinib as Adjuvant Chemotherapy to Prevent Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma Beyond Milan Criteria

Liver transplantation not only removes the liver tumor (seed) but also eliminates the underlying diseased liver (soil), making it an essential therapeutic approach for hepatocellular carcinoma (HCC). However, the tumor recurrence post-liver transplantation significantly jeopardizing the long-term survival of transplant recipients. Given the scarcity of donor livers, exploring effective measures to prevent tumor recurrence after liver transplantation holds significant clinical and societal value. Currently, there is no consensus on adjuvant therapy for preventing tumor recurrence post-liver transplantation for HCC, and the quantity and quality of studies on systemic chemotherapy are limited. In recent years, administration of the FOLFOX regimen combined with lenvatinib has been widely used in the treatment of advanced HCC, showing remarkable efficacy. The aim of this study is to investigate the efficacy and safety of adjuvant chemotherapy with FOLFOX combined with lenvatinib in preventing tumor recurrence after liver transplantation for HCC beyond Milan criteria.

开始日期2025-01-01

申办/合作机构

Sun Yat-Sen Memorial Hospital

NCT05077215 / Not yet recruiting临床3期

A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).
Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:
Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer)
ECOG score at baseline (0 vs 1)
Geographic region (Asia vs ROW)

开始日期2024-12-01

申办/合作机构

Evergreen Therapeutics, Inc

100 项与甲磺酸仑伐替尼相关的临床结果

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100 项与甲磺酸仑伐替尼相关的转化医学

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100 项与甲磺酸仑伐替尼相关的专利（医药）

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2,238

项与甲磺酸仑伐替尼相关的文献（医药）

2024-12-31·Bioengineered

Establishment and characterization of a highly metastatic hepatocellular carcinoma cell line

Article

作者: Hu, Zhenhua ; Zhang, Yu ; Sun, Mengqing ; Qiao, Yiting ; Yu, Anning ; Zheng, Huilin ; Huang, Jiacheng ; Bu, Chiwen ; Zhou, Jie ; Wang, Menglan

The prevalence of alcohol-related hepatocellular carcinoma (HCC) has been increasing during the last decade. Cancer research requires cell lines suitable for both in vitro and in vivo assays. However, there is a lack of cell lines with a high in vivo metastatic capacity for this HCC subtype. Herein, a new HCC cell line was established, named HCC-ZJ, using cells from a patient diagnosed with alcohol-related HCC. The karyotype of HCC-ZJ was 46, XY, del (p11.2). Whole-exome sequencing identified several genetic variations in HCC-Z that occur frequently in alcohol-associated HCC, such as mutations in TERT, CTNNB1, ARID1A, CDKN2A, SMARCA2, and HGF. Cell counting kit-8 assays, colony formation assays, and Transwell assays were performed to evaluate the proliferation, migration, and sensitivity to sorafenib and lenvatinib of HCC-Z in vitro. HCC-ZJ showed a robust proliferation rate, a weak foci-forming ability, a strong migration capacity, and a moderate invasion tendency in vitro. Finally, the tumorigenicity and metastatic capacity of HCC-Z were evaluated using a subcutaneous xenograft model, an orthotopic xenograft model, and a tail-veil injection model. HCCZJ exhibited strong tumorigenicity in the subcutaneous xenograft and orthotopic tumor models. Moreover, HCC-ZJ spontaneously formed pulmonary metastases in the orthotopic tumor model. In summary, a new HCC cell line derived from a patient with alcohol-related HCC was established, which showed a high metastatic capacity and could be applied for in vitro and in vivo experiments during pre-clinical research.Highlights• An alcohol-related HCC cell line, HCC-ZJ, was established• HCC-ZJ was applicable for in vitro functional experiment and gene editing• HCC-ZJ was applicable for in vivo tumor growth and spontaneous metastasis models.

2024-07-01·Tzu Chi Medical Journal

Efficacy of PD-1/PD-L1 inhibitors in advanced hepatocellular carcinoma: A systematic review and meta-analysis

Article

作者: Wu, Ta-Wei ; Yang, Li-Jou ; Peng, Tzu-Rong

ABSTRACT:

Objectives::

This study aimed to investigate the efficacy and safety of programmed cell death-1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors in patients with advanced hepatocellular carcinoma (HCC).

Materials and Methods::

PubMed, EMBASE, and the Cochrane Library were searched for articles published until November 2022. Studies reporting the efficacy of PD-1/PD-L1 inhibitors in patients with advanced HCC were eligible for inclusion. The outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and ≥ Grade 3 treatment-related adverse events (TrAEs).

Results::

Fourteen trials with 4515 patients with HCC were included. Our results showed that treatment with PD-1/PD-L1 inhibitors was associated with better ORR and DCR than that with control (placebo or sorafenib or lenvatinib) (odds ratio [OR], 3.89; 95% confidence interval (CI), 2.55–5.95 and OR, 1.47; 95% CI, 1.11–1.95, respectively). The overall hazard ratio (HR) of PFS and OS were 0.66 (95% CI 0.56–0.78) and 0.65 (95% CI 0.55–0.77), respectively. In subgroup analysis, PD-1/PD-L1 inhibitor combination therapy had an advantage in terms of PFS (HR: 0.57 vs. 0.81) compared to that of PD-1/PD-L1 monotherapy. The incidence of grade 3–5 TrAEs was not significantly higher with PD-1/PD-L1 inhibitors than that with the control (OR, 1.12; 95% CI, 0.70–1.81). However, the combination of PD-1inhibitor with higher incidence of Grade 3–5 TrAEs (OR: 2.04, 95% CI 0.66–6.32) than the combination PD-L1 inhibitor (OR: 0.95, 95% CI 0.50–1.81).

Conclusion::

The combination of PD-1/PD-L1 inhibitors and targeted agents significantly improved the clinical outcomes in patients with advanced HCC. However, the incidence of Grade 3–5 TrAEs with PD-1 inhibitor combination therapy was higher than the combination PD-L1 inhibitor.

2024-06-01·Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

Conversion surgery for initially unresectable hepatocellular carcinoma using lenvatinib combined with TACE plus PD-1 inhibitor: A real-world observational study

Article

作者: Li, Lequn ; Wu, Feixiang ; Wang, Xiaobo ; Lu, Shaolong ; Wei, Tao ; Chen, Jie ; Li, Xingzhi ; Tang, Zhihong ; Bai, Tao ; Lu, Huaze ; Zhao, Guilin

BACKGROUND:

Conversion therapy for initially unresectable hepatocellular carcinoma (iuHCC) using lenvatinib combined with transcatheter arterial chemoembolization (TACE) plus a PD-1 inhibitor (LTP) has achieved promising results. However, further comparative research is necessary to evaluate the effectiveness and safety of conversion surgery (CS) for iuHCC.

METHODS:

Data for 32 consecutive patients with iuHCC receiving CS and 419 consecutive patients with resectable HCC receiving initial surgery (IS) between November 2019 and September 2022 were collected retrospectively. After propensity score matching (PSM), 65 patients were selected.

RESULTS:

Before matching, the CS group had longer EFS (not reached vs. 12.9 months, P < 0.001) and similar OS (not reached vs. not reached, P = 0.510) compared with the IS group. Similar results for EFS (P = 0.001) and OS (P = 0.190) were obtained after matching. The multivariable Cox model (HR = 0.231, 95% CI: 0.105-0.504; P < 0.001) and subgroup analyses confirmed that CS could improve EFS. The CS group had significantly lower incidence of microvascular invasion (MVI) than the IS group (3.1% vs. 50.4%, P < 0.001). Moreover, the two groups had similar safety profiles.

CONCLUSIONS:

CS is effective and safe for patients with iuHCC receiving LTP. LTP has the potential to reduce risk factors for postoperative recurrence, especially MVI, which may influence surgical decision-making.

755

项与甲磺酸仑伐替尼相关的新闻（医药）

2024-09-17

·药明康德

延缓肝癌进展，延长胃癌患者生命，Keytruda一线组合疗法最新临床结果发布

▎药明康德内容团队编辑日前，默沙东在欧洲肿瘤内科学会（ESMO）大会上公布了重磅PD-1抑制剂Keytruda的多项进展。其中，Keytruda联合卫材（Eisai）研发的口服多靶点受体酪氨酸激酶抑制剂（TKI）Lenvima，并与肝动脉化疗栓塞术（TACE）联合治疗不可切除，非转移性肝细胞癌（HCC）患者的3期临床试验的中期分析结果显示，与单独使用TACE相比，Keytruda/Lenvima组合加TACE显著改善患者的无进展生存期（PFS）。在中位随访时间为25.6个月时，组合疗法组与单独TACE相比，将患者疾病进展或死亡风险降低了34%（HR=0.66，95% CI，0.51-0.84，p=0.0002）。组合疗法组的中位PFS为14.6个月（95% CI，12.6-16.7），而单独TACE组为10.0个月（95% CI，8.1-12.2）。在此次分析中，组合疗法组在总生存期（OS）这一试验的另一主要终点方面显示出改善趋势（HR=0.80，95% CI，0.57-1.11，p=0.0867），但OS数据尚不成熟，且在本次中期分析中未达到统计学显著性。该试验仍在继续进行，OS的随访也在进行中。此外，默沙东还公布了3期临床试验KEYNOTE-811的最终分析结果，该试验评估Keytruda联合曲妥珠单抗、含氟嘧啶和铂类化疗药物，一线治疗局部晚期不可切除或转移性HER2阳性胃癌或胃食管交界处（GEJ）腺癌的效果。这些数据也同时在《新英格兰医学杂志》上发表。 ▲3期临床试验KEYNOTE-811的总生存期分析结果（图片来源：参考资料[3]）在中位随访时间为50.2个月时，Keytruda组合疗法显著改善患者的总生存期（OS）。与单独使用曲妥珠单抗和化疗相比，加入Keytruda将患者死亡风险降低了20%（HR=0.80，95% CI，0.67-0.94，p=0.0040）。接受Keytruda联合治疗的患者中位OS为20.0个月（95% CI，17.8-22.1），而接受曲妥珠单抗加化疗的患者中位OS为16.8个月（95% CI，14.9-18.7）。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Combination With Transarterial Chemoembolization Significantly Improved Progression-Free Survival Compared to TACE Alone in Patients With Unresectable, Non-Metastatic Hepatocellular Carcinoma. Retrieved September 16, 2024, from https://www.merck.com/news/keytruda-pembrolizumab-plus-lenvima-lenvatinib-in-combination-with-transarterial-chemoembolization-significantly-improved-progression-free-survival-compared-to-tace-alone-in-patients-w/ [2] KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy Significantly Improved Overall Survival (OS) Versus Trastuzumab and Chemotherapy Alone in First-Line Treatment of Patients With HER2-Positive Advanced Gastric or GEJ Adenocarcinoma. Retrieved September 16, 2024, from https://www.merck.com/news/keytruda-pembrolizumab-plus-trastuzumab-and-chemotherapy-significantly-improved-overall-survival-os-versus-trastuzumab-and-chemotherapy-alone-in-first-line-treatment-of-patients-with-her2-po/、 [3] Janjigian et al., (2024). Pembrolizumab in HER2-Positive Gastric Cancer. NEJM, doi: 10.1056/NEJMc2408121 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床结果临床成功临床2期

2024-09-16

·E药经理人

默沙东、AZ难“守城”，BMS、罗氏“偏安一隅”，君实、百济率先突围，这个市场还有机会吗？

随着ADC、双抗疗法的突破升级，属于PD-(L)1单抗的时代或许已成历史，但这段历史始终值得铭记，它揭示了无论是中国药企还是跨国药企，为分得更大蛋糕，锚定优势，匹配资源的全过程，历史上再无任何一个靶点比PD-(L)1更具代表性。撰文| Erin 过去一周，康方生物双抗依沃西单抗在非小细胞肺癌一线治疗上打败K药的消息刷屏国内外。该研究不仅对于康方来说是走向国际的一大亮点。对于中国PD-(L)1类产品来说，也预示着一个新战场的开辟——敢于“正面刚”的差异化临床优势或许是进入国际战场的入场券。不过，在越来越多国产PD-(L)1新药走入国际市场前，明晰老牌跨国药企的布局至关重要，默沙东在转移性非小细胞肺癌、BMS在黑色素瘤、AZ在晚期非小细胞肺癌维持治疗、罗氏在肝癌治疗领域都形成了坚固的城墙，此外他们还有哪些“守城”策略，本土药企该如何“见缝插针”？ ▲2024年H1全球销售额最高四款PD-(L)1销售情况 PD-(L)1“四霸主”分庭抗礼前不久，在世界肺癌大会（WCLC）上，康方生物公布了自研全球首创PD-1/VEGF双抗新药依沃西（AK-112）单药对比K药（帕博利珠单抗）单药一线治疗PD-L1表达阳性（PD-L1 TPS≥1%）的局部晚期或转移性非小细胞肺癌（NSCLC）的注册性III期临床研究成果，中位无进展生存期（mPFS）近乎是K药组翻倍（11.14个月vs 5.82个月）。该研究不仅使得依沃西成为全球首个且唯一在III期单药“头对头”临床研究中证明疗效显著优于K药的药物，也让默沙东K药的危机再次搬到台前，毕竟相比2028年核心专利到期，距离更近的是竞争对手蚕食市场份额。这场战役或许只是全球PD-(L)1战场的一个缩影，因为自默沙东、BMS、阿斯利康、罗氏确立各自优势，并逐渐攻城略地之后，以适应证为核心的攻城、守城之战每时每刻都在发生。先是默沙东与BMS之间的肺癌“霸主”之战。2016年到2018年，默沙东的K药凭借KN024、KN189、KN407三大临床研究在一线非小细胞肺癌上接连取得成功，相反，BMS的O药自CM026研究失败之后就在非小细胞肺癌领域逐渐落幕。默沙东K药随着在一线非小细胞肺癌上的先发优势，以及之后不断的适应证拓展，不仅实现在2018年销售额反超O药，也为其成为“药王”奠定基础。据默沙东财报显示，截至2023年，其转移性非小细胞肺癌约占K药销售额的三分之一。肺癌作为发病率最高的癌种，几乎是PD-(L)1厂家的兵家必争之地，因此故事的第二幕也发生在肺癌领域。通过在一线非小细胞肺癌上取得优势的经验，默沙东通过精细的人群划分与扬长避短的临床设计，逐渐占领在辅助/新辅助治疗、转移性肺癌治疗的高地。而另一款AZ的PD-L1度伐利尤单抗（Y药），则差异化的突出K药包围圈，将重点放到无法手术切除的III期非小细胞肺癌维持治疗领域，PFS对照放化疗直接延长了一年之久。当然，在肺癌战场之外，BMS的O药和罗氏的阿替利珠单抗（T药）也分别开辟了优势癌种，例如BMS的O药早在2015年，Opdivo+Yervoy免疫组合疗法获批，就成为首个治疗转移性黑色素瘤的免疫肿瘤学联合治疗方案，截至目前，O药不仅覆盖转移性转移性黑色素瘤，还获批了术后辅助治疗。罗氏的T药也是最早布局一线肝癌治疗的PD-(L)1产品。截至2023年年底，全球的PD-(L)1也被这四款产品占据绝大部分。根据IQVIA统计，2019年到2023年，全球PD-(L)1市场规模由240亿美元增至520亿美元，而来自默沙东、BMS、AZ、罗氏的四款产品2023年净销售额合计超过450亿美元，其中K药净销售额250亿美元，占比59%，是市占率第一的产品。默沙东、AZ“攻城易，守城难” 康方的PD-1/VEGF双抗产品并非第一个与K药正面刚的PD-1选手，也绝非最后一个。阿斯利康也在开发PD-1/CTLA-4双抗Volrustomig，并且直击K药的优势领域转移性非小细胞肺癌。除此之外，Volrustomig还布局了宫颈癌、胸膜间皮瘤、头颈鳞癌等领域。事实上，早在产品适应证拓展初期，默沙东、BMS、AZ、罗氏就进行了生命周期管理，根据海通证券总结，他们的生命周期管理主要分为三大策略：联用ADC、mRNA肿瘤疫苗等进行疗法升级；通过IO组合、双抗等，实现PD-(L)1抗体升级；可及性升级，拓展前线疗法潜在带动皮下剂型的处方转换。 PD-(L)1早期主要与化疗、抗血管生成药物进行联用。以K药为例，其联合抗血管生成药物(阿昔替尼、仑伐替尼等)，将PD-(L)1在肾细胞癌的应用从二线推进一线；同时，K药联合化疗在2017、2018年分别获批一线非鳞状非小细胞肺癌、一线鳞状非小细胞肺癌，将适应证在一线非小细胞肺癌的应用从生物标志物富集的TPS≥50%人群拓展至全人群。现如今，PD-(L)1的联合疗法已经越来越丰富，ADC产品、肿瘤疫苗是目前进展最快的两种联合疗法，适应证范围覆盖非小细胞肺癌、尿路上皮癌、三阴乳腺癌等多项大适应证，横跨末线治疗到一线、辅助治疗。例如K药与Moderna的mRNA肿瘤疫苗V940联用，就显著延长了无复发生存期(RFS)及无远处转移生存期(DMFS)。K药与Seagen的Nectin-4 ADC治疗尿路上皮癌适应证也已经获得FDA的加速批准。对于PD-(L)1抗体升级，四位霸主则采用了不同策略： BMS、默沙东主要采取单抗联用的开发思路，分别为与免疫抑制剂联用、研发固定复方制剂；阿斯利康主要采取基于PD-(L)1双抗的开发思路；罗氏的PD-(L)1升级兼顾两种开发思路。不过，固然抗体升级的开发策略诞生出O药+Yervoy 免疫“双子星”这样的明星疗法，在黑色素瘤、肺、肾、胃等癌种中都取得显著临床获益，同时也诞生出康方的依沃西这样能够打败K药的双抗。但四位霸主的开发过程中，失败也屡屡发生。罗氏就曾在PD-L1与TIGIT联用上屡屡受挫，在其上半年财报中就披露，终止了TIGIT抗体Tiragolumab治疗NSCLC的两项三期临床，一项为PD-L1+TIGIT+化疗一线治疗NSCLC，另一项为PD-L1+TIGIT术后辅助治疗NSCLC。其进展最快的SKYSCRAPER-01研究，也曾在2022年受困于未达到PFS终点。此外，BMS的复方制剂Opdualag（O药+LAG-3单抗的复方制剂）和罗氏的双抗Lomvastomig也曾因开发不利无奈终止。不过，由于双抗的机制所带来的在疗效和安全性上的升级，全球无数PD-(L)1研发瞄准到该领域，力图蚕食老牌四位霸主的市场份额。除了上述康方的AK112，还有来自三生国健、普米斯/BioNTech、华奥泰等公司的PD-(L)1/VEGF双抗都进行到了关键临床阶段，想要在非小细胞肺癌、三阴乳腺癌等领域分一杯羹。此外，罗氏、BMS和默沙东也都在进行皮下剂型的升级，海通证券统计，罗氏T药皮下制剂已于2024年1月在欧洲获批上市；BMS的O药皮下剂型目前在美国处于NDA阶段；默沙东K药目前处于III期临床。根据默沙东披露，K药皮下剂型的专利保护可持续至2039年，到2028年，皮下剂型的患者潜力可占K药总处方量的50%。中国PD-(L)1另辟新战场过去一周，康方PD-1/VEGF双抗打败K药的消息在业界刷屏，其实释放出国产PD-(L)1产品竞争已经进入“Next level”的信号。同时，头部PD-(L)1产品的竞争格局似乎也已经定型。回顾历史，从2018年年底首个国产PD-1君实的特瑞普利单抗获批，到2019年信达生物的信迪利单抗首入医保，再到2020年年底，国产PD-1“四小龙”全部被纳入医保目录，市场空间猛增。国内PD-1市场在这四年间达到最大化，总体市场份额将近百亿元。但分水岭在2021年，这一年，恒瑞卡瑞利珠单抗凭借公司的强大销售能力与最多的适应证布局一举成为了国产PD-1销冠，年销售额超过40亿元。但也是在这一年，来自康方生物、誉衡生物、康宁杰瑞、基石药业的PD-(L)1产品纷纷涌入市场，不管是后来者的蚕食，还是“四小龙”之间的竞争，恒瑞的销售增速开始疲软。进入2023年，恒瑞卡瑞利珠单抗的市场份额已经沦为第三名，同时，随着信达拿下一线食管癌、一线胃癌和非小细胞肺癌等适应证，放大产品销售空间，其市场增速得以恢复。根据前不久IQVIA发布的2024上半年中国PD-(L)1药物市场回顾，以百济神州为首，信达第二，恒瑞第三的格局延续到了今天。不过，PD-(L)1竞争格局定型的背后，其实暗示着战场的转移。毕竟IQVIA统计，2024上半年PD-(L)1的市场患者使用占比呈现较大的增长，恢复到之前的两位数增长率。与2023上半年相比，同比增长率为13.7%；与2023下半年环比，增长率为12.4%。头部的市场销售额变化不大，整体市场份额却呈现两位数上升，新适应证与新晋竞争者的作用不言而喻。据悉，截至今年8月，共有3款新产品登陆国内市场，包括第5个国产PD-L1正大天晴的贝莫苏拜单抗，于5月初首次获批上市；国内首个VEGFR-A/PD-1双抗康方的依沃西单抗5月末获批上市；第9个国产PD-1石药的恩朗苏拜单抗，于6月末获批上市。此外，已上市产品中还有10余个新适应证获批。除了康方的两款双抗外，来自齐鲁的CTLA4/PD-1组合抗体艾帕洛利托沃瑞利单抗也预计将于2024年下半年获批。截至目前，包括进口产品在内，中国市场获批的PD-(L)1药物已达20个，不仅有PD-1、PD-L1，还有VEGF-A/PD-1双抗、CTLA4/PD-1双抗。过去拼价格、卷医保、卷适应证的年代已经不复，未来的PD-(L)1产品竞争将围绕两个方面：一是国际化；二是产品升级。当然，面对单抗产品的层层逼近，以及双抗、组合制剂的围剿，“四小龙”也正在采用同跨国药企们同样的防守策略。例如信达生物正在研发PD-1/IL-2双抗、PD-L1/CD47双抗；恒瑞在探索其PD-L1阿得贝利单抗与CTLA-4、TROP2 ADC、HER2 ADC、Nectin-4 A DC的联合疗法；百济神州则在开发替雷利珠单抗的皮下剂型。除此之外，国产PD-(L)1也在登陆国际化战场。根据Coherus年报，君实的特瑞普利单抗在今年Q1销售额达到了199万美元，Q2实现环比增长89.94%，销售额378万美元。百济神州的替雷利珠单抗也在今年上半年获得美国FDA批准，用于食管鳞状细胞癌。参考资料：海通国际《大药的诞生系列报告——K药临近专利到期，全球PD-(L)1相关市场可能出现哪些机会？》 IQVIA《2024上半年中国PD-(L)1药物市场回顾》一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

临床3期财报抗体药物偶联物免疫疗法专利到期

2024-09-16

·PRNewswire

MEDSIR presents new studies at ESMO that advance treatment of patients with poor prognosis cancers

MEDSIR together with Oncoclinicas & Co., leads independent clinical research at the largest European congress of medical oncology, with the presentation of 12 studies, marking a new scientific milestone for the company. The ABIGAIL study stands out for its innovative strategy, evaluating the combination of abemaciclib with endocrine therapy as an alternative treatment without chemotherapy in first-line HR+/HER2- advanced breast cancer with poor prognosis criteria. The PECATI study, focused on patients with advanced thymic tumors, a rare type of cancer, has demonstrated an 88% rate of progression-freedisease in the first 5 months. The company hosted MEDTalks, a satellite symposium dedicated to advancing brain metastasis research, addressing a critical unmet need in solid tumors such as lung, breast, and skin cancers. BARCELONA, Sept. 16, 2024 /PRNewswire/ -- MEDSIR, a leading company dedicated to promoting independent clinical research in oncology internationally and part of Oncoclinicas & Co, the largest hospital group dedicated to cancer treatment in Latin America, participated this year in the congress of the European Society for Medical Oncology (ESMO), held in Barcelona, presenting 12 new studies addressing different types of cancer. Continue Reading Dr. Juan de la Haba presenting ABIGAIL study at ESMO The studies presented by MEDSIR reflect its pivotal approach and commitment to innovation in personalized treatments, highlighting advances in prostate (ZZFIRST study), breast (ABIGAIL), thymic (PECATI) and lung (I3Lung.) cancers. Among these, the I3Lung study, funded by the European Union, integrates artificial intelligence models to optimize individualized treatments, reaffirming MEDSIR's commitment to cutting-edge research. These studies underscore the strong commitment to significantly expand therapeutic options for patients facing complex and difficult-to-treat cancers. Among the most relevant studies is ABIGAIL, in patients with HR+/HER2- advanced breast cancer and poor prognosis criteria. Its objective is to provide consistent evidence that the treatment strategy with abemaciclib (a CDK4/6 inhibitor) in combination with endocrine therapy as first-line treatment in advanced breast cancer is not inferior to paclitaxel (the standard chemotherapy commonly used in this type of patient) in terms of overall response rate and safety during the first 12 weeks. The aim of this study is to provide hope to patients by offering a chemotherapy-free treatment option. The overall response rate at 12 weeks was markedly better in the group treated with the combination of abemaciclib and endocrine therapy (59%) compared to the group receiving chemotherapy (40%). "The data from the ABIGAIL study are a crucial step forward for patients with HR+/HER2- advanced breast cancer. The possibility of offering a chemotherapy-free alternative not only improves quality of life, but also offers new perspectives for these patients with poor prognostic criteria. This study reinforces our commitment to finding more effective and less aggressive therapeutic solutions for those who need it most," adds Dr. Juan de la Haba, principal investigator of the study and oncologist at the Reina Sofia University Hospital in Córdoba (Spain). Another highlight of the congress was the oral presentation of the PECATI study, aimed at patients with thymic tumors, a rare disease that includes thymomas and thymic carcinomas. To date, there have been no standard treatments for metastatic thymic carcinomas beyond chemotherapy, and therapeutic advances in this field have been scarce due to the low prevalence of the disease. The study, an international initiative conducted in 10 hospitals in Spain, Italy and France, evaluated the efficacy of combining two drugs, lenvatinib and pembrolizumab (immunotherapy treatment), in patients with advanced and previously treated thymic tumors. The results were positive, as 88% of the patients had no disease progression during the first 5 months of treatment, and in more than half of the patients (62%) the disease had not progressed at 12 months after the start of treatment. These findings highlight the potential efficacy of this combination therapy and could be considered a future gold standard treatment for this pathology. "These results are truly promising. Thanks to research, we are opening up new therapeutic possibilities that make a difference in patients' lives. While research is essential to improve treatments in any type of cancer, it becomes even more relevant in rare tumors such as thymomas, where treatment options are more limited," says Dr. Jordi Remon, principal investigator of the study and medical oncologist at the Institut Gustave Roussy in Paris, France. These positive results not only reflect a significant advance in the treatment of patients with limited therapeutic options, but also consolidate the importance of innovation and the integration of new treatments in the optimization of therapeutic regimens. MEDSIR is thus positioned at the forefront of oncology research, pushing the frontier of scientific knowledge towards new therapeutic possibilities. Advancing research in the area of brain metastases In addition, the company led a symposium on brain metastasis (September 14th), which addressed the essential role of Investigator-Initiated Trials (IITs) and pharmaceutical industry-sponsored trials in revolutionizing our understanding and treatment strategies for one of the biggest challenges, brain metastasis. This remains a critical unmet need, particularly in solid tumors such as lung, breast, and skin cancers. As a tough challenge in oncology, brain metastasis requires innovative solutions and collaborative efforts. The event, named MEDTalks, featured chairs like Prof. Antonio Llombart, MEDSIR Senior Scientific Lead, and Prof. Mathias Preusser, Head of the Clinical Division of Oncology at the Medical University of Vienna. During a 360° overview of the biology, pathology, and development of brain metastases, along with recent advancements in systemic management, speakers focused on groundbreaking new drugs, such as Antibody-Drug Conjugates (ADCs) and radio-ligands, delving into the emerging field and potential of theranostics in oncology. About MEDSIR Established in 2012, MEDSIR is distinguished by its close collaboration with strategic partners to drive innovation in oncology research. Based in Spain and the United States, the company provides end-to-end management of clinical trials, spanning from study design to subsequent publication, relying on an extensive global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that enables research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials. With the aim of promoting independent research globally, MEDSIR has established a strategic alliance with Oncoclinicas, the leading oncology group in Brazil with outstanding research potential in South America. For more information: About Oncoclinicas & Co. Oncoclínicas&Co. is the largest group dedicated to cancer treatment in Latin America, with a specialized and innovative model focused on the entire oncology care journey, combining operational efficiency, humanized care and specialization through a medical team composed of more than 2,700 medical specialists with emphasis in oncology. With the mission of democratizing oncology treatment, it offers a comprehensive system that integrates outpatient clinics with highly complex oncology centers. The company operates 145 units in 39 Brazilian cities, allowing high quality access in all regions where it operates, aligned with world reference standards. With a focus on technology, precision medicine and genomics, Oncoclinicas performed approximately 635,000 treatments in 2023. It is the exclusive partner in Brazil of the Dana-Farber Cancer Institute, affiliated with Harvard Medical School, one of the world's leading cancer research and treatment centers. The company also owns Boston Lighthouse Innovation, a bioinformatics company based in Cambridge, USA, and has a stake in MedSir, a company dedicated to the development and management of clinical trials for independent cancer research, based in Barcelona, Spain. Recently, Oncoclinicas expanded its operations to Saudi Arabia through a joint venture with the Al Faisaliah Group, bringing its mission of defeating cancer to a new continent and providing advanced cancer care on a global scale by combining oncology hyperspecialization with innovative treatment approaches. The company is part of the IDIVERSA index, launched by B3, which highlights companies committed to gender and racial diversity. For more information, visit: SOURCE MEDSIR WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果

100 项与甲磺酸仑伐替尼相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D09920	甲磺酸仑伐替尼	L01XE	DB09078

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	欧盟	Eisai GmbH	2023-07-25
晚期子宫内膜癌	冰岛	Eisai GmbH	2023-07-25
晚期子宫内膜癌	列支敦士登	Eisai GmbH	2023-07-25
晚期子宫内膜癌	挪威	Eisai GmbH	2023-07-25
复发性子宫内膜癌	欧盟	Eisai GmbH	2023-07-25
复发性子宫内膜癌	冰岛	Eisai GmbH	2023-07-25
复发性子宫内膜癌	列支敦士登	Eisai GmbH	2023-07-25
复发性子宫内膜癌	挪威	Eisai GmbH	2023-07-25
胸腺肿瘤	日本	Eisai Co., Ltd.	2021-03-23
晚期肾细胞癌	欧盟	Eisai GmbH	2016-08-25
晚期肾细胞癌	冰岛	Eisai GmbH	2016-08-25
晚期肾细胞癌	列支敦士登	Eisai GmbH	2016-08-25
晚期肾细胞癌	挪威	Eisai GmbH	2016-08-25
子宫内膜癌	澳大利亚	Eisai Co., Ltd.	2016-01-28
肾细胞癌	澳大利亚	Eisai Co., Ltd.	2016-01-28
晚期肝细胞癌	欧盟	Eisai GmbH	2015-05-28
晚期肝细胞癌	冰岛	Eisai GmbH	2015-05-28
晚期肝细胞癌	列支敦士登	Eisai GmbH	2015-05-28
晚期肝细胞癌	挪威	Eisai GmbH	2015-05-28
分化型甲状腺癌	欧盟	Eisai GmbH	2015-05-28

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
食管鳞状细胞癌	临床3期	美国	Eisai, Inc.	2021-07-28
食管鳞状细胞癌	临床3期	美国	Merck Sharp & Dohme Corp.	2021-07-28
食管鳞状细胞癌	临床3期	中国	Merck Sharp & Dohme Corp.	2021-07-28
食管鳞状细胞癌	临床3期	中国	Eisai, Inc.	2021-07-28
食管鳞状细胞癌	临床3期	日本	Eisai, Inc.	2021-07-28
食管鳞状细胞癌	临床3期	日本	Merck Sharp & Dohme Corp.	2021-07-28
食管鳞状细胞癌	临床3期	阿根廷	Eisai, Inc.	2021-07-28
食管鳞状细胞癌	临床3期	阿根廷	Merck Sharp & Dohme Corp.	2021-07-28
食管鳞状细胞癌	临床3期	加拿大	Eisai, Inc.	2021-07-28
食管鳞状细胞癌	临床3期	加拿大	Merck Sharp & Dohme Corp.	2021-07-28

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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


NCT04763408 (STELLAR, ESMO2024) 人工标引	临床4期	肝细胞癌一线	242	Lenvatinib	憲餘襯憲艱網繭憲鬱顧(遞鏇膚製壓壓遞範襯糧) = 廠廠鏇淵繭積遞繭糧壓築範積鹽願積構廠膚簾 (齋網餘鹽繭壓積遞願糧 ) 更多	积极	2024-09-16
				Sorafenib	憲餘襯憲艱網繭憲鬱顧(遞鏇膚製壓壓遞範襯糧) = 壓簾顧鹽衊餘鹹餘艱製築範積鹽願積構廠膚簾 (齋網餘鹽繭壓積遞願糧 ) 更多
LINK Research Network (ESMO2024)	N/A	肝细胞癌一线	-	Lenvatinib (LEN)	遞糧壓膚鹹壓繭選齋製(遞鑰範憲淵獵壓製觸鹹) = 餘襯糧蓋艱願鏇襯鏇獵網觸網蓋網廠壓膚築蓋 (網網製鬱簾構鏇襯膚繭 ) 更多	积极	2024-09-16
				Sorafenib (SOR)	遞糧壓膚鹹壓繭選齋製(遞鑰範憲淵獵壓製觸鹹) = 襯觸壓衊蓋製鏇餘鏇積網觸網蓋網廠壓膚築蓋 (網網製鬱簾構鏇襯膚繭 ) 更多
ESMO2024	N/A	-	201	Lenvatinib plus DEB-TACE plus HAIC	鹹鹹製膚製醖顧鹹構範(獵糧夢築醖壓獵簾蓋鹹) = 膚醖夢遞艱襯鑰鑰遞鹹糧鏇廠築顧積鹽夢醖壓 (齋夢繭糧廠鹽鏇糧繭鹹 ) 更多	积极	2024-09-16
				Lenvatinib plus DEB-TACE	鹹鹹製膚製醖顧鹹構範(獵糧夢築醖壓獵簾蓋鹹) = 膚範鹹鏇觸鑰廠廠醖膚糧鏇廠築顧積鹽夢醖壓 (齋夢繭糧廠鹽鏇糧繭鹹 ) 更多
ESMO2024	N/A	肝细胞癌二线	137	Lenvatinib	齋醖構壓製餘衊醖餘繭(遞獵鏇構遞糧網鏇鑰築) = 壓簾鏇夢鏇積築構餘糧積憲觸繭糧鹹簾積壓艱 (淵鬱鑰糧鏇餘鑰構網襯 ) 更多	积极	2024-09-16
				Sorafenib	齋醖構壓製餘衊醖餘繭(遞獵鏇構遞糧網鏇鑰築) = 窪餘願鑰製窪鬱齋糧淵積憲觸繭糧鹹簾積壓艱 (淵鬱鑰糧鏇餘鑰構網襯 ) 更多
ESMO2024	N/A	不可切除的肝细胞癌二线	151	Lenvatinib	獵醖觸簾蓋鏇襯獵鬱廠(窪獵顧選網繭窪醖蓋醖) = 膚齋壓範顧築願鏇壓憲夢簾壓膚窪夢淵窪製顧 (鬱鏇範簾觸願願襯顧糧 ) 更多	积极	2024-09-16
				Sorafenib	獵醖觸簾蓋鏇襯獵鬱廠(窪獵顧選網繭窪醖蓋醖) = 製蓋壓簾夢積鑰選窪鏇夢簾壓膚窪夢淵窪製顧 (鬱鏇範簾觸願願襯顧糧 ) 更多
TrinetX platform (ESMO2024)	N/A	晚期肝细胞癌一线	7,038	Atezolizumab plus bevacizumab (A+B)	襯積簾醖觸壓鏇選簾簾(夢鹽選鹹構鏇膚襯齋觸) = 鹹範壓選淵淵選壓餘鬱淵淵觸膚鹹顧繭遞淵鑰 (繭簾遞鹹壓襯鏇觸選艱 )	积极	2024-09-16
				Lenvatinib (L)	襯積簾醖觸壓鏇選簾簾(夢鹽選鹹構鏇膚襯齋觸) = 餘選蓋艱憲蓋廠觸簾觸淵淵觸膚鹹顧繭遞淵鑰 (繭簾遞鹹壓襯鏇觸選艱 )
NCT04745988 (EPOC2001, ESMO2024)	临床2期	胃食管交界处腺癌新辅助 \| 辅助 dMMR	32	Lenvatinib	遞齋網構選願築膚壓選(艱築範衊網獵鏇範壓餘) = 餘餘構範蓋餘鬱憲廠鹹蓋夢餘顧衊膚夢範鬱網 (壓積鏇願顧築糧獵壓築, 34 ~ 60) 更多	积极	2024-09-16
NCT04699071 (LARA \| GCGS-OV4 \| APGOT-OV3, ESMO2024) 人工标引	临床2期	女性生殖器官肿瘤 MMR protein expression \| microsatellite stable	27	Pembrolizumab+lenvatinib	廠窪蓋醖廠艱糧鏇選網(糧網窪鏇齋遞觸窪簾製) = 遞膚艱築選廠構鑰簾衊簾壓選獵壓襯鑰鹹鏇遞 (壓鏇顧醖壓觸鬱網獵範, 24.4 ~ 65.1) 更多	积极	2024-09-14
JPRN-UMIN000051645 (ESMO2024)	N/A	复发性胸腺癌一线	107	Lenvatinib	鏇構醖憲範蓋觸獵鏇衊(築夢鹹餘繭糧鬱衊膚願) = AE leading to dose interruption or reduction occurred in 16 patients (80%), the most common being proteinuria (45%) and decreased platelet count (15%) 範願壓醖範衊憲築壓糧 (構夢夢憲餘襯繭願廠繭 ) 更多	积极	2024-09-14
NCT03884101 (ENGOT-en9/LEAP-001, ESMO2024)	临床3期	一线 pMMR	420	Lenvatinib plus Pembrolizumab	膚鹽膚鑰窪鑰鹽網範膚(鏇繭窪衊鑰顧鹹膚膚鹽) = 鑰網願鑰餘鬱醖繭構廠衊獵夢壓積齋製窪鬱襯 (鏇艱簾窪製顧鹹鑰窪製, 1.0+ ~ 48.7+) 更多	积极	2024-09-14