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

NCT06446154 / Not yet recruiting临床2期IIT

FOLFOX Chemotherapy (Oxaliplatin, Fluorouracil, and Leucovorin), Fruquintinib and Sintilimab After First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma: A Single-arm, Single-center, Phase II Study

Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a single-arm, single-center and phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC.
Previous studies had shown that FOLFOX systemic chemotherapy tended to increase the median survival time of patients with advanced HCC, and significantly improved the progression-free survival and tumor response rate. Therefore, FOLFOX systemic chemotherapy has become one of the recommended treatments for advanced HCC in Chinese guidelines.
A phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment, with a median progression-free survival of 7.4 months and a tumor response rate of 31.6%. Furthermore, there was a synergistic effect among chemotherapy, immunotherapy and anti-angiogenic therapy. Our previous phase II study showed that the median progression-free survival was 9.73 months, the median overall survival time was 14.63 months, and the tumor response rate was 43.3% in HCC patients extrahepatic metastasis who received FOLFOX systemic chemotherapy combined with targeted and immunotherapy. The results from our study suggested that the combination therapy had excellent anti-tumor efficacy and safety profile.
Therefore. We intend to conduct this clinical study to explore the efficacy and safety of FOLFOX systemic chemotherapy combined with fruquintinib and sintilimab in second-line treatment for patients with unresectable HCC after first-line treatment.

开始日期2024-07-01

申办/合作机构

中山大学

NCT06457477 / RecruitingN/AIIT

The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients

This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.

开始日期2024-06-15

申办/合作机构

No 302 Hospital Of The People Liberation Army Of China

100 项与信迪利单抗相关的临床结果

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100 项与信迪利单抗相关的转化医学

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100 项与信迪利单抗相关的专利（医药）

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2,193

项与信迪利单抗相关的文献（医药）

2024-12-31·Oncoimmunology

A phase 2, multicenter, open-label study of anti-LAG-3 ieramilimab in combination with anti-PD-1 spartalizumab in patients with advanced solid malignancies

Article

作者: Lin, Chia-Chi ; Kyi, Chrisann ; Chiu, Joanne ; Askoxylakis, Vasileios ; Carvajal, Richard D ; Spratlin, Jennifer ; Chowdhury, Niladri Roy ; Gusenleitner, Daniel ; Garralda, Elena ; Maur, Michela ; Esaki, Taito ; Siu, Lillian L ; Sarantopoulos, John ; Rolland, Fréderic ; Cassier, Philippe A ; Zhang, Tian ; Soo, Ross A ; Schöffski, Patrick ; Ma, Brigette ; Martin, Miguel ; Deschler-Baier, Barbara ; Weickhardt, Andrew ; De Braud, Filippo ; Hui, Rina ; Akerley, Wallace ; Rispoli, Lawrence ; Hong, David S ; Samant, Tanay S ; Tan, Daniel Sw ; Kwak, Eunice L

Ieramilimab, a humanized anti-LAG-3 monoclonal antibody, was well tolerated in combination with the anti-PD-1 antibody spartalizumab in a phase 1 study. This phase 2 study aimed to further investigate the efficacy and safety of combination treatment in patients with selected advanced (locally advanced or metastatic) solid malignancies. Eligible patients with non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), mesothelioma, and triple-negative breast cancer (TNBC) were grouped depending on prior anti-PD-1/L1 therapy (anti-PD-1/L1 naive or anti-PD-1/L1 pretreated). Patients received ieramilimab (400 mg) followed by spartalizumab (300 mg) every 3 weeks. The primary endpoint was objective response rate (ORR), along with safety, pharmacokinetics, and biomarker assessments. Of 235 patients, 142 were naive to anti-PD-1/L1 and 93 were pretreated with anti-PD-1/L1 antibodies. Durable responses (>24 months) were seen across all indications for patients naive to anti-PD-1/L1 and in melanoma and RCC patients pretreated with anti-PD1/L1. The most frequent study drug-related AEs were pruritus (15.5%), fatigue (10.6%), and rash (10.6%) in patients naive to anti-PD-1/L1 and fatigue (18.3%), rash (14.0%), and nausea (10.8%) in anti-PD-1/L1 pretreated patients. Biomarker assessment indicated higher expression of T-cell-inflamed gene signature at baseline among responding patients. Response to treatment was durable (>24 months) in some patients across all enrolled indications, and safety findings were in accordance with previous and current studies exploring LAG-3/PD-1 blockade.

2024-12-31·Oncoimmunology

LFA-1 regulated by IL-2/STAT5 pathway boosts antitumor function of intratumoral CD8 ⁺ T cells for improving anti-PD-1 antibody therapy

Article

作者: Shen, Chunyi ; Jing, Wei ; Zhang, Yi ; Shan, Jiqi ; Ping, Yu ; Liu, Yaqing ; Liu, Fengsen ; Han, Dong ; Li, Congcong

Anti-PD-1 antibody therapy has achieved success in tumor treatment; however, the duration of its clinical benefits are typically short. The functional state of intratumoral CD8⁺ T cells substantially affects the efficacy of anti-PD-1 antibody therapy. Understanding how intratumoral CD8⁺ T cells change will contribute to the improvement in anti-PD-1 antibody therapy. In this study, we found that tumor growth was not arrested after the late administration of anti-PD-1 antibody and that the antitumor function of CD8⁺ T cells decreased with tumor progression. The results of the RNA sequencing of CD8⁺ T cells infiltrating the tumor site on days 7 and 14 showed that the cell adhesion molecule Lymphocyte Function-associated Antigen-1 (LFA-1) participates in regulating the antitumor function of CD8⁺ T cells and that decreased LFA-1 expression in intratumoral CD8⁺ T cells is associated with tumor progression. By analyzing the Gene Expression Omnibus (GEO) database and our results, we found that the antitumor function of intratumoral CD8⁺ T cells with high LFA-1 expression was stronger. The formation of immune synapses is impaired in Itgal-si CD8⁺ T cells, resulting in decreased anti-tumor function. LFA-1 expression in intratumoral CD8⁺ T cells is regulated by the IL-2/STAT5 pathway. The combination of IL-2 and anti-PD-1 antibody effectively enhanced LFA-1 expression and the antitumor function of intratumoral CD8⁺ T cells. The adoptive transfer of OT-1 T cells overexpressing LFA-1, STAT5A, or STAT5B resulted in higher antitumor function, deferred tumor growth, and prolonged survival. These findings indicate that LFA-1-mediated immune synapse acts as a regulator of the antitumor function of intratumoral CD8⁺ T cells, which can be applied to improve anti-PD-1 antibody therapy.

2024-04-01·Endocrine, metabolic & immune disorders drug targets

Hypophysitis Induced by Sintilimab in the Treatment of Bladder Cancer: A Case Report

作者: Zhou, Yaru ; Yang, Shijie ; Zhu, Yiran ; Li, Ran ; Gao, Likuan ; Jiang, Baichuan

Background::

Immune checkpoint inhibitors (ICIs), as novel antitumor drugs, have been widely used in the clinic and have shown good antitumor effects. However, their wide-spread use has also led to the emergence of various immune-related adverse events (IrAEs). Hypophysitis is a rare but serious IrAE. Due to its complex and changeable clinical manifestations, hypophysitis may be easily overlooked, leading to delayed diagnosis and treatment

Case Presentation::

A 68-year-old male patient was diagnosed with bladder cancer (T2bNXM0) in October 2021. He received two cycles of immunotherapy with sintilimab and chemotherapy with gemcitabine and cisplatin (GC). One month after the second treatment, he gradually developed recurrent fever, anorexia, drowsiness, and delirium. Laboratory examination revealed hyponatremia, decreased adrenocorticotropic hormone, and hypocortisolemia. The pituitary MRI showed no abnormality. The patient was diagnosed with immunotherapy-induced hypophysitis (IH) caused by sintilimab, leading to downstream endocrine disorders. With hormone replacement therapy, he was in a good mood, had a good appetite, and made an overall recovery.

Conclusion::

Immunotherapy-induced hypophysitis (IH) can result in a severe adrenal crisis, and prompt recognition and diagnosis are crucial. Clinicians must remain vigilant for the possibility of IH in patients who exhibit recurrent fever, anorexia, cognitive decline, and personality changes following ICI treatment. It is imperative to consider this diagnosis early to initiate appropriate management promptly.

1,742

项与信迪利单抗相关的新闻（医药）

2024-07-01

·奇点网

EGFR突变NSCLC患者有了新辅助治疗策略！

*仅供医学专业人士阅读参考表皮生长因子受体（EGFR）突变是非小细胞肺癌（NSCLC）中最常见的驱动突变之一，特别是在亚洲人群中。尽管EGFR-酪氨酸激酶抑制剂（TKIs）的靶向治疗已显示出良好的疗效，但许多患者最终会发展出耐药性。此外，多项II期研究表明，EGFR-TKIs可能也不是新辅助治疗的有效策略，主要病理反应（MPR）率范围仅为10%-15%。因此，免疫检查点抑制剂与化疗相结合的新辅助治疗策略，提供了新的希望。近日，广东省人民医院钟文昭教授团队发起的II期临床研究NEOTIDE/CTONG2104的中期结果，发表在Cell Reports Medicine期刊上[1]。结果显示，PD-1抑制剂信迪利单抗和化疗的新辅助治疗方案在EGFR突变的局部晚期NSCLC患者中具有可接受的安全性和初步的临床有效性，44%的患者达到了MPR，大多数不良事件为轻至中度。他们发现，利用循环肿瘤DNA（ctDNA）检测可以帮助识别对这种疗法不响应的患者，并根据肿瘤微环境的组成定义了一种对免疫治疗高度耐药的EGFR突变NSCLC亚型，或可作为预测免疫治疗效果的潜在标志物。论文首页截图论文主要结果 Checkmate-816研究已经开创性地证明，新辅助免疫治疗联合化疗在局部晚期NSCLC中能够显著提高病理缓解率，与传统的新辅助化疗相比表现出更佳的效果。然而，鉴于通常认为携带致癌突变的患者很难从免疫疗法中获益，许多相关试验通常会排除携带EGFR或间变性淋巴瘤激酶（ALK）突变的患者。钟文昭教授团队发起的名为NEOTIDE/CTONG2104的II期临床试验，采用了Simon两阶段设计，旨在评估PD-1抑制剂信迪利单抗和化疗的新辅助治疗方案在局部晚期EGFR突变NSCLC患者中的临床疗效和安全性。试验共招募18名局部晚期的EGFR突变NSCLC患者。所有患者在广东省肺癌研究所接受为期3个周期的信迪利单抗联合卡铂+白蛋白紫杉醇的新辅助治疗后，均接受根治性切除手术。从临床反应来看，术前56%的患者在接受新辅助治疗后实现病理降期。44%的患者实现了主要病理反应（MPR），但没有患者实现病理完全缓解（pCR）。其中，携带不同类型EGFR突变的患者，MPR率有显著差异：携带EGFR敏感性突变、20号外显子插入以及其他非常见EGFR突变的患者，MPR率分别为30%、75%和50%。临床反应所有患者均经历了与治疗相关的不良事件（TRAEs），其中39%的患者出现了3/4级不良事件。虽然所有18名患者均进行了手术，但有3名患者由于术中发现隐匿的胸膜转移而未能实现R0切除。通过对手术前后的肿瘤样本进行基因组学分析，研究团队发现最常见的与EGFR突变伴随的基因变异是TP53（83.3%）和TTN（41.7%）。相比于未实现MPR，携带TP53/RB1/RBM10基因突变、染色体拷贝数扩增变异或无吸烟史，在达到MPR的患者中更常见。获取患者的血液和组织样本，检测循环肿瘤DNA（ctDNA）的结果显示，新辅助治疗期间几乎所有患者的ctDNA水平都有所下降。尤其是达到MPR的患者，其ctDNA水平的降幅比未达到MPR的患者高出671倍。此外，在治疗的各个阶段，ctDNA的阳性预测值（PPV）普遍高于阴性预测值（NPV）。这些结果突显了ctDNA的动态监测有助于识别潜在治疗受益者。检测ctDNA水平研究团队还结合来自真实世界队列的34个肿瘤样本等数据，分析了治疗前后肿瘤微环境的变化。结果提示，CCR8+调节性T细胞（Treg）和CXCL13+耗竭型T细胞（Tex）的浸润模式可以预测EGFR突变的NSCLC免疫治疗效果。治疗前具有CCR8+Treg hi/CXCL13+Texhi相关表型的患者与更高的反应率和长期益处相关，无论PD-L1状态如何；治疗中肿瘤表现为CCR8+Treghi/CXCL13+Texlo表型，与疗效和生存期较差相关。找到两种细胞可以作为免疫治疗的潜在预测生物标志物最后，研究团队对残余肿瘤进行了表征。他们发现，HLA杂合性缺失水平较高，是疗效不完全、残余肿瘤发生免疫逃逸的机制。同时，他们指出，TACSTD2（Trop2）和CEACAM5/6是在残留肿瘤中表达相对较高的分子，这暗示可以使用抗体偶联药物（ADC）进行联合治疗。总之，该研究结果支持了在EGFR突变NSCLC患者中使用信迪利单抗+化疗的新辅助治疗策略的可行性。未来研究需关注长期生存数据，并探索不同生物标志物在预测疗效和监测疾病进展中的作用，以优化治疗方案和提高患者生活质量。参考文献： [1]Zhang, C., Sun, Y. X., Yi, D. C., Jiang, B. Y., Yan, L. X., Liu, Z. D., Peng, L. S., Zhang, W. J., Sun, H., Chen, Z. Y., Wang, D. H., Peng, D., Chen, S. A., Li, S. Q., Zhang, Z., Tan, X. Y., Yang, J., Zhao, Z. Y., Zhang, W. T., Su, J., … Zhong, W. Z. (2024). Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant NSCLC: Phase 2 trial interim results (NEOTIDE/CTONG2104). Cell reports. Medicine, 101615. Advance online publication. https://doi-org.libproxy1.nus.edu.sg/10.1016/j.xcrm.2024.101615 本文作者丨张艾迪

免疫疗法临床2期临床结果

2024-06-28

·医药观澜

2024年优先审评，17款抗癌新药被纳入，来自辉瑞、默沙东、正大天晴、恒瑞等！

▎药明康德内容团队编辑优先审评是中国国家药品监督管理局药品审评中心（CDE）推出的加速药物获批上市的重要政策之一。根据CDE发布的《2023年度药品审评报告》，获得优先审评审批的药物上市注册申请的审评时限由常规程序的200日缩短为130日，获批速度显著提升。根据CDE官网公示信息，截至6月27日，2024年上半年共计有26个创新药的上市申请正式被纳入优先审评。从治疗领域来看，抗肿瘤药物最多，有17个，占比超65%。本文中就让我们来看看这些抗肿瘤药物都有哪些？它们都有望惠及哪些癌症患者？数据来源：CDE官网，《医药观澜》梳理。本表仅统计正式被纳入优先审评的药物，不含拟纳入药品。统计截至日期：2024年6月27日辉瑞：elranatamab注射液作用机制：BCMA×CD3双特异性抗体适应症：多发性骨髓瘤 2024年1月，辉瑞（Pfizer）公司的elranatamab注射液上市申请被CDE纳入优先审评，用于治疗既往接受过至少三种治疗的复发或难治性多发性骨髓瘤（MM）成人患者。Elranatamab是一款皮下注射BCMA×CD3双特异性抗体，其一端与骨髓瘤细胞上的BCMA相结合，另一端与T细胞表面的CD3受体结合，使它们结合在一起并激活T细胞杀死骨髓瘤细胞。该药已于2023年获FDA加速批准，用于治疗复发/难治性MM患者。正大天晴：TQB2450、安罗替尼作用机制：抗PD-L1单抗、酪氨酸激酶抑制剂适应症：子宫内膜癌 2024年1月，正大天晴申报的TQB2450注射液和安罗替尼胶囊联合疗法的一项上市申请被CDE纳入优先审评，拟用于治疗既往接受过一、二线化疗方案治疗失败或不能耐受的非微卫星高度不稳定（非MSI-H）或非DNA错配修复缺陷（非dMMR）的复发性或转移性子宫内膜癌患者。贝莫苏拜单抗（TQB2450）是一款抗PD-L1人源化单克隆抗体，已于今年5月获批联合安罗替尼胶囊和依托泊苷及卡铂一线治疗广泛期小细胞肺癌。安罗替尼是一种新型小分子多靶点酪氨酸激酶抑制剂，此前已在中国获批用于治疗多种肿瘤适应症。默沙东：belzutifan片作用机制：HIF-2α抑制剂适应症：血管母细胞瘤或胰腺神经内分泌肿瘤 2024年2月，默沙东（MSD）的belzutifan片上市申请被CDE纳入优先审评，拟用于治疗von Hippel-Lindau（VHL）病相关肾细胞癌、中枢神经系统血管母细胞瘤或胰腺神经内分泌肿瘤。VHL是一种罕见遗传疾病，它可异常激活癌症患者体内的缺氧诱导因子（HIF-2α）。Belzutifan是一款选择性新型口服HIF-2α抑制剂，此前已获FDA批准用于治疗VHL疾病相关癌症。强生：塔奎妥单抗作用机制：GPRC5D×CD3双抗适应症：多发性骨髓瘤 2024年2月，强生（Johnson & Johnson）公司申报的塔奎妥单抗注射液被CDE纳入优先审评，单药治疗既往接受过至少三种治疗的复发或难治性多发性骨髓瘤成人患者。公开资料显示，塔奎妥单抗（talquetamab）是一款皮下注射双特异性抗体，靶向GPRC5D和CD3，已于2023年8月获美国FDA加速批准上市，用于治疗复发性或难治性多发性骨髓瘤成人患者。图片来源：123RF 第一三共、阿斯利康：德曲妥珠单抗作用机制：HER2靶向ADC 适应症：非小细胞肺癌 2024年2月，第一三共（Daiichi Sankyo）公司申报的注射用德曲妥珠单抗被CDE正式纳入优先审评，拟定适应症为：存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除或转移性成人NSCLC患者。德曲妥珠单抗是阿斯利康（AstraZeneca）和第一三共联合开发的一款靶向HER2的抗体偶联药物（ADC），此前已在中国获批治疗HER2阳性和HER2低表达成人乳腺癌患者。葆元医药/信达生物：泰莱替尼作用机制：ROS1抑制剂适应症：非小细胞肺癌 2024年2月，葆元医药（现已被Nuvation Bio收购）申报的泰莱替尼胶囊上市申请被CDE纳入优先审评，用于未经ROS1-TKI治疗的ROS1阳性局部晚期或转移性NSCLC成人患者的治疗。泰莱替尼是新一代口服选择性ROS1抑制剂，具有脑渗透潜力。2021年6月，葆元与信达生物签订了独家许可协议，在大中华区（包括中国大陆、香港、澳门和台湾地区）共同开发和商业化泰莱替尼。信达生物、和黄医药：信迪利单抗、呋喹替尼作用机制：PD-1抑制剂、VEGFR抑制剂适应症：子宫内膜癌 2024年3月，信达生物的PD-1抑制剂信迪利单抗与和黄医药的VEGFR抑制剂呋喹替尼的联合疗法上市申请被CDE纳入优先审评，拟用于既往系统性抗肿瘤治疗后疾病进展且不适合进行根治性手术治疗或根治性放疗的晚期pMMR或non MSI-H子宫内膜癌患者。公开资料显示，信达生物与和黄医药曾在2018年达成合作，开展信迪利单抗与呋喹替尼用于实体瘤联合治疗的研究。复星医药：FCN-159 作用机制：MEK1/2抑制剂适应症：树突状细胞和组织细胞肿瘤、神经纤维瘤 2024年4月，复星医药的FCN-159片（复迈替尼）上市申请被CDE纳入优先审评，拟用于治疗成人树突状细胞和组织细胞肿瘤。2024年5月，FCN-159片的新适应症上市申请再次被CDE纳入优先审评，用于治疗2岁及2岁以上儿童1型神经纤维瘤病（NF1）相关的丛状神经纤维瘤。FCN-159为一款MEK1/2选择性抑制剂，可以抑制RAS通路异常引起的肿瘤增殖，拟开发主要用于治疗晚期实体瘤、I型神经纤维瘤、树突状细胞和组织细胞肿瘤、低级别脑胶质瘤等适应症。图片来源：123RF 百时美施贵宝：伊匹木单抗、纳武利尤单抗作用机制：CTLA-4抗体、PD-1抑制剂适应症：MSI-H/dMMR结直肠癌 2024年3月和4月，伊匹木单抗注射液和纳武利尤单抗注射液的联合疗法上市申请先后两次被CDE纳入优先审评，针对的适应症均为两种药物联合用于一线治疗不可切除或转移性微卫星高度不稳定性（MSI-H）或错配修复缺陷型（dMMR）结直肠癌患者。伊匹木单抗是一款CTLA-4抗体，纳武利尤单抗是一款PD-1抑制剂。今年3月，伊匹木单抗联合纳武利尤单抗一线治疗MSI-H/dMMR结直肠癌的申请已被CDE纳入突破性治疗药物品种。恒瑞医药：阿帕替尼、氟唑帕利作用机制：VEGFR2靶向药物、PARP抑制剂适应症：HER2阴性乳腺癌 2024年4月，恒瑞医药的甲磺酸阿帕替尼片和氟唑帕利胶囊各有一项新适应症上市申请被CDE纳入优先审评。其中，阿帕替尼是一款VEGFR2靶向药物，本次申报上市的适应症是联合氟唑帕利用于治疗伴有胚系BRCA突变（gBRCAm）的HER2-乳腺癌患者。氟唑帕利是一款PARP抑制剂，本次申报上市的适应症是单药或联合阿帕替尼用于治疗伴有胚系BRCA突变的HER2-乳腺癌患者。罗氏：GDC-0077 作用机制：PI3Kα抑制剂适应症：乳腺癌 2024年4月，罗氏（Roche）GDC-0077（inavolisib）的上市申请被CDE纳入优先审评，拟与CDK4/6抑制剂哌柏西利和内分泌疗法联合用药，用于治疗PIK3CA突变、HR阳性/HER2阴性的局部晚期或转移性乳腺癌成人患者。公开资料显示，PIK3CA基因突变在大约40%的HR阳性乳腺癌中被发现，GDC-0077是一种具有双重作用机制的口服疗法，具有高度的体外PI3Kα抑制效力和选择性，且能够特异性触发PI3Kα蛋白突变体的分解。图片来源：123RF 加科思：格来雷塞作用机制：KRAS抑制剂适应症：非小细胞肺癌（NSCLC） 2024年5月，加科思格来雷塞片（JAB-21822片）的上市申请被CDE纳入优先审评，拟用于既往接受过至少一线系统性治疗的KRAS G12C突变的局部晚期或转移性NSCLC成人患者的治疗。格来雷塞是一款KRAS G12C抑制剂，本次上市申请是基于在中国开展的2期注册性临床研究结果。数据显示，格来雷塞单药治疗KRAS G12C突变NSCLC患者，确认的客观缓解率（ORR）为47.9%，疾病控制率（DCR）为86.3%，中位无进展生存期（mPFS）为8.2个月，中位总生存期（mOS）为13.6个月。诺诚健华：坦昔妥单抗作用机制：抗CD19单抗适应症：弥漫性大B细胞淋巴瘤（DLBCL） 2024年6月，诺诚健华注射用坦昔妥单抗的上市申请被CDE纳入优先审评，拟联合来那度胺用于治疗复发或难治性且不适合自体干细胞移植的DLBCL成人患者。坦昔妥单抗是诺诚健华从Incyte公司引进的一款靶向CD19的Fc结构域优化的人源化单克隆抗体，此前已获得美国FDA以和欧洲药品管理局（EMA）批准上市，联合来那度胺治疗不适合自体干细胞移植条件的复发/难治性DLBCL患者。除了上述正式被纳入优先审评的抗肿瘤药物，近日还有三款抗肿瘤新药被CDE纳入了拟优先审评公示名单，分别为：和黄医药递交的EZH2甲基转移酶抑制剂他泽司他，拟用于治疗EZH2突变阳性且既往接受过至少两种系统性治疗的复发或难治性滤泡性淋巴瘤成人患者；阿斯利康的第三代EGFR-TKI奥希替尼的新适应症上市申请，拟用于接受含铂放化疗期间或之后未出现疾病进展、具有EGFR外显子19缺失或外显子21（L858R）置换突变的局部晚期、不可切除（III期）NSCLC成人患者的治疗；精准生物的pCAR-19B细胞自体回输制剂（普基仑赛注射液），拟用于治疗3～21岁CD19阳性的复发或难治性B细胞急性淋巴细胞白血病患者。希望这些抗肿瘤新药能够早日获批，为广大癌症患者带来新的治疗选择。优先审评之外，2024年上半年，中国创新药领域还迎来了许多其它方面的进展。为方便读者了解今年上半年中国创新药行业的整体动态，《医药观澜》特地制作了《2024年上半年中国创新药领域亮点概览》白皮书，供读者参阅。内容包含： 2024上半年NMPA批准上市的新药数据分析 2024上半年NMPA纳入优先审评的新药分析 2024上半年NMPA纳入突破性治疗品种的新药分析 2024上半年在中国获批IND的1类新药分析 2024上半年中国公司就创新药达成的授权合作数据分析 2024上半年中国创新药投融资数据分析 2024上半年获FDA快速通道资格的中国新药分析 2024上半年获FDA孤儿药资格的中国新药分析如欲了解上半年更多中国创新药领域的进展，请扫描下方二维码，您将可以获取由我们整理的《2024年上半年中国创新药发展白皮书》（限时下载）。参考资料： [1]中国国家药监局药品审评中心（CDE）官网. Retrieved June 27，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c [2] 各公司官方资料及公开新闻稿。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「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。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。

优先审批申请上市上市批准加速审批

2024-06-27

·GlobeNewswire-Health Care

BioAtla to Host Virtual R&D Day on Clinical Program and Pipeline Updates on July 25, 2024

SAN DIEGO, June 27, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced it will host a virtual R&D Day around the Company’s clinical programs and pipeline updates on Thursday, July 25, 2024 at 10:00 AM ET. To register, click here. A live question and answer session will follow the presentation. About BioAtla®, Inc.BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with greater than 765 active patent matters, more than 485 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing, mecbotamab vedotin, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 2 stage CAB-CTLA-4 antibody, evalstotug, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. The company’s first dual CAB bispecific T-cell engager antibody, BA3182, is currently in Phase 1 development. BA3182 targets EpCAM, which is highly and frequently expressed on many adenocarcinomas while engaging human CD3 expressing T cells. To learn more about BioAtla, Inc. visit www.bioatla.com. Forward-looking statements Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects and whether our clinical trials will support registration; plans to form collaborations and other strategic partnerships for selected assets; achievement of milestones; results, conduct, progress and timing of our research and development programs and clinical trials; expectations with respect to enrollment and dosing in our clinical trials, plans and expectations regarding future data updates, clinical trials, regulatory meetings and regulatory submissions; the potential regulatory approval path for our product candidates; expectations about the sufficiency of our cash and cash equivalents to fund operations; and expectations regarding R&D expenses and cash burn. Forward-looking statements are based on BioAtla's current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; our ability to form collaborations and partnerships with third parties and the success of such collaborations and partnerships; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; potential adverse impacts due to any resurgence of COVID-19 and its variants; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 26, 2024 and our other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law. Internal Contact:Richard WaldronChief Financial OfficerBioAtla, Inc.rwaldron@bioatla.com858.356.8945 External Contact:Bruce MackleLifeSci Advisors, LLCbmackle@lifesciadvisors.com

临床1期抗体药物偶联物临床2期

100 项与信迪利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15765

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
典型霍奇金淋巴瘤	中国澳门	信达生物制药（苏州）有限公司	2024-02-22
胃食管交界处腺癌	中国澳门	信达生物制药（苏州）有限公司	2024-02-22
非小细胞肺癌	中国澳门	信达生物制药（苏州）有限公司	2024-02-22
EGFR阳性非鳞状非小细胞肺癌	中国	信达生物制药（苏州）有限公司	2023-05-09
胃癌	中国	信达生物制药（苏州）有限公司	2022-06-24
食管鳞状细胞癌	中国	Innovent Biologics, Inc.	2022-06-20
肝细胞癌	中国	信达生物制药（苏州）有限公司	2021-06-28
霍奇金淋巴瘤	中国	信达生物制药（苏州）有限公司	2018-12-24

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
晚期子宫内膜癌	申请上市	中国	信达生物制药（苏州）有限公司	2024-04-02
非鳞状非小细胞肺癌	申请上市	美国	信达生物制药（苏州）有限公司	2022-02-11
EGFR-T790M 突变非小细胞肺癌	申请上市	中国	信达生物制药（苏州）有限公司	2022-01-30
食管癌	申请上市	中国	信达生物制药（苏州）有限公司	2021-09-22
小细胞肺癌	临床3期	中国	信达生物制药（苏州）有限公司	2024-03-07
局部晚期食管鳞状细胞癌	临床3期	中国	信达生物制药（苏州）有限公司	2022-11-01
进展期胃腺癌	临床3期	中国	上海市第二医科大学瑞金医院	2021-08-07
肿瘤转移	临床3期	中国	上海市第二医科大学瑞金医院	2021-08-07
转移性胃食管结合部腺癌	临床3期	中国	信达生物制药（苏州）有限公司	2021-03-10
胃腺癌	临床3期	中国	信达生物制药（苏州）有限公司	2021-03-10

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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


NCT05527821 (ESMO_GI2024) 人工标引	临床2期	胆道肿瘤二线	8	surufatinib+sintilimab+SBRT	餘鬱衊淵範淵築艱製繭(網顧醖觸餘夢積網鏇製) = 鬱餘觸積繭鹽鏇範衊醖齋鹽觸鹹範糧餘範窪鏇 (鬱願齋衊繭窪齋齋積鏇 ) 更多	积极	2024-06-27
NCT04194359 (BBCAPX-II, ASCO2024) 人工标引	临床2期	结直肠癌一线 Microsatellite Stable (MSS)	25	sintilimab+ bevacizumab + oxaliplatin + capecitabine	糧糧衊構遞窪網範糧衊(醖積築憲廠壓積製鑰鬱) = 廠蓋鏇顧餘獵淵醖築鑰遞觸願齋簾艱窪壓鏇鬱 (築衊範製範憲網鏇齋淵 ) 更多	积极	2024-05-24
ChiCTR2200058650 (ASCO2024) 人工标引	临床2期	口咽肿瘤新辅助 HPV+	27	Neoadjuvant sintilimab + platinum-doublet chemotherapy	鑰淵築遞願壓觸夢繭觸(餘鹽鑰鑰顧廠繭遞膚衊) = 鹽衊鬱築壓壓觸築襯製鹽壓遞鹽獵齋齋膚蓋齋 (壓夢觸廠網糧鹹積選壓 ) 更多	积极	2024-05-24
NCT04387500 (SAFH, ASCO2024)	临床2期	富马酸水合酶缺乏型肾细胞癌一线 FH mutation status	52	Sintilimab	鑰觸鏇選獵積餘齋鏇範(憲衊鏇膚夢鹹襯窪齋鏇) = 壓餘顧範艱膚願膚繭鑰簾顧範簾顧衊願鏇窪齋 (鏇蓋膚廠願糧淵鑰廠築 ) 更多	积极	2024-05-24
ChiCTR1900023015 (ALTER-C201, ASCO2024)	临床2期	PD-L1阳性宫颈癌 PD-L1-positive \| PIK3CA \| KMT2C	42	Sintilimab 200 mg	衊餘鬱膚膚築繭鬱鏇廠(願膚夢鹽繭膚廠願鑰淵) = 簾願遞構網觸鹹艱餘壓鏇簾鹽餘窪醖憲蓋齋艱 (選範構鏇觸膚艱糧顧膚 ) 更多	积极	2024-05-24
NCT04459611 (neoSCORE, ASCO2024)	临床2期	非小细胞肺癌新辅助	55	Two cycles of neoadjuvant treatment with sintilimab plus chemotherapy	顧願鹹醖齋齋鑰鏇選齋(鏇糧選觸網憲淵願築選) = 齋簾範遞憲觸淵選遞選襯鹽願醖襯蓋襯繭簾範 (膚壓憲積醖範簾鏇壓壓 ) 更多	积极	2024-05-24
NCT04459611 (neoSCORE, ASCO2024)	临床2期	非小细胞肺癌新辅助	55	Three cycles of neoadjuvant treatment with sintilimab plus chemotherapy	顧願鹹醖齋齋鑰鏇選齋(鏇糧選觸網憲淵願築選) = 繭壓襯鬱鹹憲鬱齋築遞襯鹽願醖襯蓋襯繭簾範 (膚壓憲積醖範簾鏇壓壓 ) 更多	积极	2024-05-24
ChiCTR2000041081 (ASCO2024)	临床2期	局部晚期食管鳞状细胞癌辅助 PD-L1 CPS	24	Neoadjuvant sintilimab, albumin-bound paclitaxel, and carboplatin	壓夢積範鏇淵衊鑰範願(夢繭獵艱製廠遞選願蓋) = 餘襯鏇繭簾願鬱窪觸淵構鏇網鹹鏇網鹽構齋餘 (艱顧糧觸鹽顧鹹積鏇願 ) 更多	积极	2024-05-24
ChiCTR2100049523 (Phase II clinical study, ASCO2024)	临床2期	肾细胞癌	19	Sintilimab	夢糧膚顧願蓋積夢築製(遞簾觸膚窪蓋顧鹽襯簾) = 範齋築顧繭窪構築夢顧鏇襯遞襯齋築衊製蓋窪 (窪蓋簾餘鬱窪齋糧選衊 ) 更多	积极	2024-05-24
ChiCTR1900023015 (ALTER-C201, ASCO2024)	临床2期	晚期宫颈癌 CRP \| D-dimer	41	Sintilimab plus Anlotinib	獵選鹹衊窪壓蓋鹽餘構(簾製顧憲鬱蓋膚夢顧鹹) = 淵遞鏇選淵艱選壓夢艱艱糧艱遞壓繭積顧膚簾 (鑰築選顧願觸範膚繭顧 ) 更多	积极	2024-05-24
EHA2024	N/A	外周T细胞淋巴瘤 PD-1 \| PD-L1 positive	31	Sintilimab + GemOx	願簾觸齋範鬱範膚積窪(繭鏇窪膚構夢鹽夢選選) = 壓鏇鏇鏇鏇壓艱膚鹽衊鑰蓋窪鑰餘製簾鹽鑰憲 (淵製糧鏇憲衊廠鹽膚觸 ) 更多	积极	2024-05-14