The aim of this research study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab, with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers.
The names of the study drugs used in this research study are:
* Toripalimab (a type of monoclonal antibody)
* Carboplatin (a type of antineoplastic agent)
* Docetaxel (a type of antineoplastic agent)
* Cisplatin (a type of antineoplastic agent)

开始日期2025-10-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06682780

/ Not yet recruiting临床1/2期

An Open-label, Dose-escalation, and Dose-expansion Phase I/II Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors

This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.

开始日期2025-06-05

申办/合作机构

礼新医药科技（上海）有限公司

NCT06987123

/ Not yet recruiting临床2期IIT

Toripalimab in Combination With Capecitabine as Adjuvant Therapy After Surgery for Locally Recurrent Resectable Nasopharyngeal Carcinoma: a Single-arm Clinical Trial

Regarding the application value of capecitabine metronome chemotherapy's regulatory effect on the immune microenvironment in nasopharyngeal carcinoma, many studies in recent years have confirmed that metronome chemotherapy and immunotherapy are safe and effective in resectable recurrent nasopharyngeal carcinoma. Therefore, the investigators plan to conduct a "single-arm clinical study on adjuvant therapy of toripalimab combined with capecitabine after Surgery for locally recurrent resectable nasopharyngeal carcinoma" to explore the efficacy and safety of toripalimab combined with capecitabine as adjuvant therapy after salvage surgery for resectable recurrent nasopharyngeal carcinoma. If this study is confirmed, it is expected to provide a new treatment model for patients with resectable recurrent nasopharyngeal carcinoma.

开始日期2025-05-18

申办/合作机构

中山大学

100 项与特瑞普利单抗相关的临床结果

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100 项与特瑞普利单抗相关的转化医学

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100 项与特瑞普利单抗相关的专利（医药）

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2,388

项与特瑞普利单抗相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis

Article

作者: Zhang, Lingli ; Xu, Kai ; Yu, Man ; Lin, Yingtao ; Li, Xin ; Su, Dan ; Shang, Jingjing ; Sun, Qingli ; Gong, Jinhong ; Qian, Xiaodan

BACKGROUND:

Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.

METHODS:

A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.

RESULTS:

The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.

CONCLUSION:

Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.

2025-12-01·Journal of Gastrointestinal Cancer

90Y-Transarterial Radioembolization Combined with Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: A Systematic Review

Review

作者: Shobeiri, Parnian ; Lewandowski, Robert J ; Fowler, Kathryn J ; Behnoush, Amir Hossein ; Hosseini Shabanan, Sedighe ; Haghshomar, Maryam

BACKGROUND:

Transarterial radioembolization with yttrium-90 (⁹⁰Yt-TARE) and immune checkpoint inhibitors (ICIs) are emerging as treatment modalities for intermediate to advanced hepatocellular carcinoma (HCC) based on randomized controlled trials. Herein, we systematically reviewed the published literature on the effects of ⁹⁰Yt-TARE and ICIs combined on clinical outcomes of HCC.

METHODS:

Medical databases of PubMed, Embase, and Cochrane Library were systematically searched for all studies assessing the use of concomitant immunotherapy of ICI with TARE in patients with HCC. Patient characteristics, treatment protocols, treatment outcomes, treatment adverse events, and survival outcomes were extracted after the screening phase. The primary outcomes were overall survival (OS) and patient-free survival (PFS), while the secondary outcomes were imaging objective response (OR) and adverse events.

RESULTS:

Among 3432 reviewed, ten studies were included in this systematic review, including four randomized controlled trials and six retrospective studies. These consisted of 413 patients with HCC, and seven studies included patients with Child-Pugh A or B7 scores. Most studies allowed advanced or intermediate HCC stages, but only two specified BCLC stages (B and C). Median tumor sizes ranged from 56 to 78.5 mm. Various agents with different administration schedules were used as ICIs for immunotherapy by different studies for the combination of ⁹⁰Yt-TARE with ICIs. Median OS ranged from 16.2 to 27 months between different studies while the PFS also ranged from 5.6 to 13.3 months. The OR rates according to imaging-based response assessments were reported between 31 and 89%, and the incidence rate of any grade toxicities was between 50 and 80%.

CONCLUSION:

Concomitant treatment with ⁹⁰Yt-TARE and ICIs has shown promising results in the treatment of patients with HCC. Further studies are required to reach a consensus on the optimal treatment protocol and the outcome of these treatments for patients with intermediate to advanced HCC.

2025-06-01·INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Immune-mediated hepatitis caused by toripalimab: A case report

Article

作者: Zheng, Ping ; Li, Yilei ; Cai, Jing ; Lin, Taoyan

Toripalimab, a humanized anti-PD-1 monoclonal antibody, is widely employed in the treatment of non-small cell lung cancer (NSCLC) and various other malignancies. However, there have been no reported cases linking prolonged administration of toripalimab to immune-mediated hepatitis (IMH). Typically, immune checkpoint inhibitor (ICI)-related IMH manifests within the first few weeks or months following the initiation of therapy. In this report, we presented a case of IMH in a patient with NSCLC following ~ 17 months of toripalimab treatment. IMH induced by toripalimab may occur at any time during treatment, underscoring the need for clinicians to remain vigilant in monitoring for adverse reactions. Throughout toripalimab treatment, careful attention must be paid to the symptoms, diagnosis, and pathological features of IMH. Glucocorticoids, such as methylprednisolone, can effectively reduce liver enzyme markers like aspartate aminotransferase and alanine aminotransferase in patients experiencing toripalimab-induced IMH.

1,639

项与特瑞普利单抗相关的新闻（医药）

2025-06-03

·亚盛医药

亚盛医药MDM2-p53抑制剂Alrizomadlin单药和联合治疗实体瘤数据积极|直击ASCO 2025

亚盛医药（纳斯达克代码：AAPG；香港联交所代码：6855）宣布，公司已在第61届美国临床肿瘤学会（ASCO）年会上，以壁报展示形式公布了MDM2-p53抑制剂alrizomadlin（APG-115）单药或联合PD-1抑制剂特瑞普利单抗治疗晚期腺样囊性癌（ACC）或其它实体瘤患者的II期临床研究最新进展。Alrizomadlin为公司细胞凋亡管线重点品种，是首个在中国进入临床阶段的MDM2-p53抑制剂，具有全球First-in-class潜力。一年一度的ASCO年会是全球肿瘤领域最重要的、最为权威的学术交流盛会，将展示当前国际最前沿的临床肿瘤学科研成果和肿瘤治疗技术。今年是亚盛医药连续第八年亮相ASCO年会，此次公司共有两项研究入选，包括细胞凋亡管线重点品种Bcl-2抑制剂lisaftoclax（APG-2575）和MDM2-p53抑制剂alrizomadlin，其中lisaftoclax获口头报告，alrizomadlin获壁报展示。此次展示的alrizomadlin治疗ACC等实体瘤患者的临床研究数据显示：alrizomadlin单药在晚期ACC或恶性外周神经鞘膜瘤（MPNST）患者中显示出潜在抗肿瘤活性；同时alrizomadlin联合特瑞普利单抗耐受性良好，在MPNST、胆道肿瘤（BTC）和脂肪肉瘤（LPS）中均显示出临床治疗潜力。郭晔教授该项临床研究的主要研究者上海东方医院肿瘤内科ACC作为一种罕见肿瘤，缺乏有效的治疗方案，临床常用的抗血管生成TKI治疗存在一定的局限性和安全性隐患。本次ASCO年会上我们团队公布的这项研究显示，alrizomadlin治疗ACC的客观缓解率（ORR）为16.7%，疾病控制率（DCR）为100%，提示靶向MDM2-p53通路治疗ACC具有潜在抗肿瘤活性，可能是ACC领域的新疗法。李宁教授该项临床研究的主要研究者中国医学科学院肿瘤医院MPNST、LPS等肉瘤患者可供选择的方案有效限。本研究中，alrizomadlin单药或联合PD-1治疗MPNST均显示出较好的抗肿瘤活性，特别是联合治疗，使2例MPNST患者获得了长期缓解（1例>60周，1例>96周）；alrizomadlin联合PD-1治疗LPS也显示出一定的疗效。这些结果提示alrizomadlin单药或联合治疗可能在肉瘤领域使更多患者获益。翟一帆博士亚盛医药首席医学官作为全球First-in-class潜力品种， alrizomadlin在此次ASCO年会上展示的数据表明其在ACC及多种实体瘤患者中具有良好的单药和联合治疗潜力，并再一次体现了该品种与现有免疫肿瘤药物之间的协同效应，有望为多种实体瘤患者带来新的治疗选择。未来，我们将继续秉持初心，坚守“解决中国乃至全球患者尚未满足的临床需求”这一使命，加快临床开发，早日惠及全球患者。在此次ASCO年会上展示的该临床研究核心要点如下：A Phase 2 Study of Novel MDM2 Inhibitor Alrizomadlin (APG-115) With or Without Toripalimab in Patients with Advanced Adenoid Cystic Carcinoma (ACC) or Other Solid Tumors一项评估新型MDM2抑制剂APG-115（Alrizomadlin）单药或联合特瑞普利单抗治疗晚期腺样囊性癌（ACC）或其它实体瘤患者（Pts）的II期临床研究摘要编号：6102展示形式：壁报展示分会场标题：头颈癌（Head and Neck Cancer）主要作者：上海东方医院肿瘤内科郭晔博士；中国医学科学院肿瘤医院李宁博士；中山大学肿瘤防治中心黑色素瘤与肉瘤内科张星博士；浙江省肿瘤医院方美玉博士；中国医学科学院肿瘤医院王书航博士等核心要点： - Alrizomadlin是一款在研新型口服MDM2抑制剂，已在ACC中显示出可控的安全性和初步抗肿瘤活性。 - 截至2025年2月13日，研究共入组57例晚期ACC、恶性周围神经鞘瘤（MPNST）、晚期脂肪肉瘤（LPS）和胆管癌（BTC）等肿瘤的患者。Alrizomadlin单药在晚期ACC和MPNST患者中显示了抗肿瘤活性。Alrizomadlin联合特瑞普利单抗在MPNST、BTC和LPC患者中显示了良好的耐受性和抗肿瘤活性。 - 单药治疗组17例疗效可评估患者中，12例ACC患者的ORR为16.7%， DCR为100%；5例MPNST患者中，4例达到疾病稳定（SD），DCR为80%。24例安全可评估患者中，33.3%发生了≥3级与治疗相关的不良事件（TRAE）；研究中发生3例（12.5%）与治疗相关的SAE。1例受试者因TRAE终止治疗。 - 联合治疗组29例疗效可评估患者中，6例BTC患者的ORR为16.7%，DCR为100%；6例LPS患者的ORR为16.7%，DCR为66.7%； 2例MPNST患者达到经确认的PR且无进展生存期（PFS）显著延长（1例>60周，1例>96周）。150mg剂量组27例安全可评估患者中，12例（44.4%）患者发生了≥3级TRAE， 8例（29.6%）患者发生了与治疗相关的SAE，1例受试者因TRAE终止治疗。关于亚盛医药亚盛医药是一家综合性的全球生物医药企业，致力于研发创新药，以解决肿瘤等领域全球患者尚未满足的临床需求。2019年10月28日，公司在香港联交所主板挂牌上市，股票代码：6855.HK；2025年1月24日，公司在美国纳斯达克证券交易所挂牌上市，股票代码：AAPG。亚盛医药已建立丰富的创新药产品管线，包括抑制Bcl-2和 MDM2-p53 等细胞凋亡通路关键蛋白的抑制剂；新一代针对癌症治疗中出现的激酶突变体的抑制剂等。公司核心品种耐立克®是中国首个获批上市的第三代BCR-ABL抑制剂，且获批适应症均被成功纳入国家医保药品目录，目前，亚盛医药正在开展耐立克®一项获美国FDA许可的全球注册III期临床研究（POLARIS-2），用于治疗既往接受过治疗的慢性髓细胞白血病慢性期（CML-CP）成年患者。此外，耐立克®联合治疗新诊断费城染色体阳性急性淋巴细胞白血病（Ph+ ALL）患者和治疗琥珀酸脱氢酶（SDH）缺陷型胃肠道间质瘤（GIST）患者的全球注册III期研究正在开展中。公司另一重磅品种，新型Bcl-2选择性抑制剂APG-2575（Lisaftoclax）的新药上市申请（NDA）已获CDE受理，并被纳入优先审评。目前，亚盛医药正在开展APG-2575（Lisaftoclax）四项注册III期临床研究，分别为获美国FDA许可的治疗经治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者的全球注册III期临床研究（GLORA）；治疗初治CLL/SLL患者的全球注册III期临床研究；一线治疗新诊断老年或体弱急性髓系白血病（AML）的全球注册III期临床研究；以及治疗新诊断中高危骨髓增生异常综合征（MDS）患者的注册III期研究。截至目前，公司4个在研新药共获16项FDA和1项欧盟孤儿药资格认定，2项FDA快速通道资格以及2项FDA儿童罕见病资格认证。凭借强大的研发能力，亚盛医药已在全球范围内进行知识产权布局，并与武田、默沙东、阿斯利康、辉瑞、信达等领先的生物制药公司，以及梅奥医学中心（Mayo Clinic）、丹娜法伯癌症研究院（Dana-Farber Cancer Institute）、美国国家癌症研究所（NCI）和密西根大学等学术机构达成全球合作关系。亚盛医药已在原创新药研发与临床开发领域建立经验丰富的国际化人才团队，以及成熟的商业化生产与市场营销团队。亚盛医药将不断提高研发能力，加速推进公司产品管线的临床开发进度，真正践行"解决中国乃至全球患者尚未满足的临床需求"的使命，以造福更多患者。前瞻性声明本新闻稿包含根据美国《1995年私人证券诉讼改革法案》，以及经修订的《1933年证券法》第27A条和《1934年证券交易法》第21E条所界定的前瞻性陈述。除历史事实陈述外，本新闻稿中的所有内容均可能构成前瞻性陈述，包括亚盛医药对未来事件、经营成果或财务状况所发表的意见、预期、信念、计划、目标、假设或预测。这些前瞻性陈述受到诸多风险和不确定性的影响，具体内容已在亚盛医药向美国证券交易委员会（SEC）提交的文件中详细说明，包括2025年1月21日提交的经修订的F-1表格注册说明书和2025年4月16日提交的20-F表格中的"风险因素"和"关于前瞻性陈述及行业数据的特别说明"章节、2019年10月16日提交的首次发行上市招股书中的“前瞻性声明”、“风险因素”章节，以及我们不时向SEC或HKEX提交的其他文件。这些因素可能导致实际业绩、运营水平、经营成果或成就与前瞻性陈述中明示或暗示的信息存在重大差异。本前瞻性声明中的陈述不构成公司管理层的利润预测。因此，该等前瞻性陈述不应被视为对未来事件的预测。本新闻稿中的前瞻性陈述仅基于亚盛医药当前对未来发展及其潜在影响的预期和判断，且仅代表截至陈述发表之日的观点。无论出现新信息、未来事件或其他情况，亚盛医药均无义务更新或修订任何前瞻性陈述。

ASCO会议临床结果临床1期临床2期引进/卖出

2025-06-03

·PRNewswire

2025 ASCO ｜Oral Presentation: Disitamab Vedotin Achieves Stellar Efficacy as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Gastric Cancer

YANTAI, China, June 2, 2025 /PRNewswire/ -- On June 2 (Chicago time), in an oral presentation at the 2025 ASCO Annual Meeting, Dr. Lin Shen from Beijing Cancer Hospital presented the results of a Phase 2 clinical study conducted in China evaluating the efficacy and safety of disitamab vedotin (DV), developed by Remegen Co., Ltd., and toripalimab (PD-1) combined with CAPOX or trastuzumab as the first-line therapy for HER2-expressing patients with locally advanced or metastatic (la/m) gastric cancer. Comparing to the control group who received standard-of-care therapy, the DV combination therapy demonstrated clinically meaningful efficacy improvement, potentially to benefit patients who are non-responders to traditional targeted therapies. The data presented are from the Phase 2 part of a randomized, multi-cohort, seamlessly connecting Phase 2/3 study, which enrolled systematic chemotherapy-native patients with different HER2 expression levels. As of April 7, 2025, the results showed: Among HER2-overexpressing gastric cancer patients, compared to the PD-1-trastuzumab-CAPOX combination therapy, DV and PD-1 + chemotherapy as well as DV and PD-1 + trastuzumab both demonstrated statistically significant efficacy and favorable safety profiles. Objective response rate (ORR): 66.7% vs 82.4% vs 68.8%; Median progression-free survival (mPFS): NR vs NR vs 14.1 months, with risk of disease progression decreasing by 54%（HR=0.46）and 41% (HR: 0.59); 12-month PFS rate: 66.3%, 67% and 53.6%； Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. In patients with HER2-low-expressing gastric cancer, promising efficacy was observed with DV + PD-1 + CAPOX comparing to PD-1 + CAPOX, with a manageable safety profile. ORR: 72.0% vs 47.8%; mPFS: 9.9 vs 7.2 months, with risk of disease progression decreasing by 31% (HR: 0.69); Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. Dose optimization conducted in patients with HER2-median/low-expressing gastric cancer. Compared to PD-1 + CAPOX, DV at 2.5 mg/kg or 2.0 mg/kg combined with PD-1 + reduced-dose CAPOX showed significant efficacy, and better safety over the full-dose chemotherapy. ORR: 71.4% vs 66.7% vs 56.3%; 6-month PFS rate: 71.4%，72.7% and 53.3%. Globally, this is the first study to explore the triple combination therapy of "HER2 ADC + PD-1 + targeted medication" as first-line treatment of patients with la/m gastric cancer, pioneering a new mode of synergistic therapy. The multi-cohort design of this study provides precision treatment regimen for gastric cancer patients with different level of HER2 expression. For the HER2-overexpressing gastric cancer patients, DV + PD-1 + trastuzumab has the potential to become the new standard first-line treatment; for the HER2-low-expressing gastric cancer patients, DV + PD-1 + chemotherapy has the potential to fill the treatment gap of these patients. Based on the data obtained from the phase 2 study, the phase 3 clinical study of the triple combination therapy in patients with HER2-median/low-expressing gastric cancer has been initiated in April, 2025, in which 616 participants were planned to be enrolled, to further validate the efficacy of the DV combination therapy. Gastric cancer is the fifth most common malignant tumor in the world, and China accounts for about 42.6% of new cases and 45.0% of deaths worldwide. HER2 is an important target in the treatment of gastric cancer, while the traditional targeted drug trastuzumab is only effective in the population with high expression (IHC 3+ or IHC 2+/FISH+), and can easily become resistant. There is a lack of effective targeted therapy options for patients with low/median HER2 expression (IHC 1+ or IHC 2+/FISH-), and the efficacy of chemotherapy combined with immunotherapy is not satisfactory. As the first domestic HER2-targeted ADC drug in China, DV not only precisely kills tumor cells with HER2 over expression but also attacks adjacent cells with HER2 low expression through the bystander effect. Preclinical studies have also shown that the combination of DV with PD-1 inhibitor and trastuzumab can enhance anti-tumor activity. SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床2期临床3期免疫疗法抗体药物偶联物

2025-06-02

·科伦博泰生物

石远凯教授：聚焦中国高发癌种，看塔戈利单抗如何续写R/M NPC生命华章

引言2025年美国临床肿瘤学会（ASCO）年会已于芝加哥当地时间5月30日正式拉开帷幕，千余项来自全球各地的基础研究与临床试验轮番呈现，为肿瘤治疗提供了更多的循证支持与探索指引。其中，由中国医学科学院肿瘤医院石远凯教授牵头的KL167-Ⅲ-08研究以口头报告的形式登陆本场会议，为全球复发/转移性鼻咽癌（R/M NPC）治疗提供“中国思路”。值此，医脉通特邀石远凯教授就该项研究成果以及塔戈利单抗在NPC治疗中的治疗优势进行解析。NPC是我国高发的头颈部恶性肿瘤之一。尽管同步放化疗策略显著改善了局部晚期NPC患者的总体生存率，但仍约有20%的患者在治疗后的3年内出现疾病进展。针对R/M NPC，请问当前的临床诊疗现状及研究进展如何？石远凯教授NPC是我国常见的头颈部恶性肿瘤之一，全球超过半数的NPC患者集中在中国，并呈现出显著的地域分布特征，其中广西和广东地区发病率最高[1]。部分早期NPC患者在采用同步放化疗的标准治疗后，5年生存率可达90%以上[2]。然而，NPC也是复发和远处转移风险较高的头颈部恶性肿瘤之一。相关研究结果显示，约30%-40%的局部晚期NPC患者在接受根治性治疗后出现局部或远处转移[3]。R/M NPC在既往标准一线含铂化疗方案下，大部分患者在治疗后较短时间内即发生疾病进展，化疗为患者带来的生存获益已达瓶颈[4,5]。因此，针对R/M NPC患者，亟需探索更为有效的治疗策略以改善预后。多项临床研究结果表明，以PD-1/PD-L1抑制剂为代表的免疫治疗在R/M NPC的一线及后线治疗中均展现出较高的抗肿瘤活性和良好的安全性。与单纯化疗相比，PD-1/PD-L1抑制剂单药或者联合化疗可显著改善R/M NPC患者的无进展生存期（PFS），部分研究甚至初步显示患者总生存也得到了显著改善[6-9]。基于多项既往研究结果，PD-1/PD-L1单抗联合化疗目前已成为R/M NPC患者的一线标准治疗选择，并纳入国内外诊疗指南[10,11]。越来越多的研究证明，以PD-1/PD-L1抑制剂为代表的免疫治疗药物在R/M NPC治疗中展现出了明确优势，塔戈利单抗作为一款国产PD-L1抑制剂，目前已获得国家药品监督管理局（NMPA）批准用于R/M NPC一线及后线治疗，您认为其在R/M NPC的治疗中有何优势？石远凯教授塔戈利单抗作为我国自主研发的创新性人源化PD-L1抑制剂，展现出良好的稳定性特质，其稳定性相较于天然IgG4足以提升超过100倍，且不与其他IgG结合，进而削减免疫逃逸的风险。在抗体设计层面上，经亲水性优化设计的塔戈利单抗，在体内环境中的稳定性得到显著增强。此外，研究者针对塔戈利单抗Fc段进行了定点突变优化操作，去除了抗体依赖的细胞介导细胞毒性（ADCC）效应以及补体依赖的细胞毒性（CDC）效应，这一系列优化举措为其临床应用中疗效与安全性提供了充分的保障。在一项单臂、开放标签、多中心II期临床研究中，塔戈利单抗单药在R/M NPC三线及以上治疗中展现出了良好的疗效与安全性。该研究结果显示，至少二线化疗失败的R/M NPC患者接受塔戈利单抗单药治疗的客观缓解率（ORR）为26.5%，中位PFS为2.8个月，中位OS为16.2个月，并且患者整体安全性良好、可控[12]。KL167-Ⅲ-08研究进一步验证了塔戈利单抗在R/M NPC患者一线治疗中的临床应用价值。该研究是一项多中心、双盲、随机对照的III期注册临床试验。研究共纳入295例患者，按照2:1的比例随机分组，分别接受塔戈利单抗或安慰剂联合吉西他滨+顺铂（GP）。研究结果显示，与安慰剂组相比，塔戈利单抗联合GP组的PFS显著延长，OS亦观察到明显的获益趋势，并且具有可控、可耐受的安全性表现[9]。基于上述结果，塔戈利单抗于2024年12月以及2025年1月先后获得国家药品监督管理局（NMPA）批准，用于R/M NPC患者的后线及一线治疗，为该患者群体提供了全方位的治疗新选择[13,14]。在本次的2025 ASCO年会上。首次公布了您牵头的KL167-Ⅲ-08研究的数据。能否请您简要介绍一下该研究的重要数据结果？石远凯教授此次2025 ASCO年会上，KL167-Ⅲ-08研究公布的结果显示，截至2024年2月4日，塔戈利单抗联合GP组中47.2%的患者仍在接受治疗，而安慰剂组这一比例仅为23.5%，且安慰剂组中36.7%患者在疾病进展后交叉接受塔戈利单抗单药治疗[9]。在预先设定的中期分析中，经盲态独立中心评审（BICR）的PFS成功达成既定目标。深入分析可见，相较于安慰剂组，塔戈利单抗联合GP组的mPFS显著改善，且疾病进展或死亡风险大幅降低，降幅达53%（mPFS：NR vs. 7.9个月，HR：0.47；95%CI：0.33-0.66；P＜0.0001）。此外，塔戈利单抗联合GP组的12个月PFS率较安慰剂组提升达一倍以上（56.7% vs. 26.7%）。在衡量肿瘤缓解效果的关键指标方面，塔戈利单抗联合GP组的ORR（BICR评估，81.7% vs. 74.5%）、中位缓解持续时间（mDoR，11.7个月 vs. 5.8个月，HR：0.48；95%CI： 0.32-0.70）均优于安慰剂组患者。此外，在安慰剂组超1/3患者疾病进展后交叉接受塔戈利单抗单药治疗的前提下，塔戈利单抗联合GP组仍初步展现出了更佳的OS获益趋势（HR：0.62；95%CI： 0.32-1.22）。该结果全面体现出了塔戈利单抗在R/M NPC患者一线治疗中卓越的疗效优势。整体而言，塔戈利单抗联合GP方案在安全性方面表现良好，不良反应多在可控范围内，未出现显著影响治疗进程的安全性隐患，为该方案在临床应用中的安全性提供有力支撑。结合您的临床实践经验，您认为R/M NPC的临床诊疗中还有哪些亟待深入探索的方向？此外，您对塔戈利单抗在未来临床应用中的表现有何期待？石远凯教授诱导化疗联合同步放化疗已成为局部晚期NPC标准治疗模式[15,16]。随着免疫治疗在R/M NPC中的重要性日益凸显，将其引入局部晚期NPC的治疗已成为当前临床研究的热点话题，多项前瞻性Ⅱ/Ⅲ期临床试验正在开展。未来还需要进一步探索免疫治疗在局部晚期NPC中的应用时机及其在不同类型（T分期、N分期）局部晚期NPC患者中的可行性，以及局部晚期NPC去化疗策略的可能性。塔戈利单抗因其独特的作用机制，在R/M NPC治疗领域已取得了令人瞩目的进展。作为NPC领域首个获批的PD-L1抑制剂，塔戈利单抗的成功有力地证明了其在该领域的价值。未来，临床工作者有望在更多临床试验中深入探索塔戈利单抗的应用价值。一方面，可尝试将其应用于局部晚期NPC的治疗，通过与放化疗联合应用，进一步提升治疗效果，降低复发风险。另一方面，也期待其在其他肿瘤类型中的研究能取得突破，为更多患者提供新的治疗选择。专家简介- 石远凯教授 -肿瘤学博士肿瘤内科主任医师博士研究生导师中国医学科学院北京协和医学院长聘教授中国医师协会肿瘤医师分会第一届、第二届会长中国抗癌协会肿瘤临床化疗专业委员会第三届、第四届主任委员中国抗癌协会淋巴瘤专业委员会第五届主任委员中国药学会抗肿瘤药物专业委员会第一届、第二届主任委员中国医疗保健国际交流促进会肿瘤内科分会第一届主任委员国家药监局药品审评专家咨询委员会委员上海证券交易所科技创新咨询委员会第一届、第二届委员中国癌症基金会第八届理事长雄安新区医学会第一届会长雄安新区癌症中心主任参考文献[1]. BRAY F, LAVERSANNE M, SUNG H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA: a cancer journal for clinicians, 2024, 74(3): 229-263.[2]. LIU Y P, LV X, ZOU X, et al. Minimally invasive surgery alone compared with intensity-modulated radiotherapy for primary stage I nasopharyngeal carcinoma[J]. Cancer communications, 2019, 39(1): 75.[3]. Ahn MJ, Chirovsky D, Kuyas H, et al. Global longitudinal assessment of treatment outcomes in recurrent/metastatic nasopharyngeal carcinoma: GLANCE-NPC study. Future Oncol. 2021;17(16):2015-2025.[4]. Lee AW, Ma BB, Ng WT, Chan AT. Management of Nasopharyngeal Carcinoma: Current Practice and Future Perspective. J Clin Oncol. 2015;33(29):3356-3364.[5]. Pan Y, Wang R, Hu D, et al. Comparative safety and efficacy of molecular-targeted drugs, immune checkpoint inhibitors, hepatic arterial infusion chemotherapy and their combinations in advanced hepatocellular carcinoma: findings from advances in landmark trials. Front Biosci (Landmark Ed). 2021;26(10):873-881.[6]. YANG Y P, QU S, LI J G, et al. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial[J]. The lancet oncology, 2021, 22(8): 1162-1174.[7]. MAI H Q, CHEN Q Y, CHEN D P, et al. Toripalimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: the JUPITER-02 randomized clinical trial[J].JAMA, 2023, 330(20): 1961-1970.[8]. YANG Y P, PAN J J, WANG H, et al. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: a multicenter phase 3 trial (RATIONALE-309) [J]. Cancer cell, 2023, 41(6): 1061-1072.e4.[9]. Yuankai Shi, Hai-Qiang Mai, Chuanben Chen, et al. Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study. 2025 ASCO, 6004.[10].CACA鼻咽癌指南（2025版）；[11].NCCN头颈部肿瘤诊疗指南（2025 v2版）[12].Shi Y, Qin X, Peng X, et al. Efficacy and safety of KL-A167 in previously treated recurrent or metastatic nasopharyngeal carcinoma: a multicenter, single-arm, phase 2 study. Lancet Reg Health West Pac. 2022, 31:100617.[13].https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241231171042135.html[14].https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250120135327192.html[15]. AL-SARRAF M, LEBLANC M, GIRI P G, et al. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099[J]. Journal of clinical oncology: official journal of the American society of clinical oncology,2023, 41(24): 3965-3972.[16].HUI E P, MA B B, LEUNG S F, et al. Randomized phase II trial of concurrent cisplatin-radiotherapy with or without neoadjuvant docetaxel and cisplatin in advanced nasopharyngeal carcinoma[J]. Journal of clinical oncology: official journal of the American society of clinical oncology,2009, 27(2): 242-249.文章转载自：医脉通

ASCO会议临床结果免疫疗法

100 项与特瑞普利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15043

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
不可切除的黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
晚期肝细胞癌	中国	上海君实生物医药科技股份有限公司	2025-03-18
转移性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	欧盟	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	冰岛	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	挪威	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
三阴性乳腺癌	中国	上海君实生物医药科技股份有限公司	2024-06-18

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
肿瘤	申请上市	加拿大	Apotex, Inc.	2024-12-01
复发性鼻咽癌	申请上市	欧盟	Tmc Pharma (Eu Ltd.	2022-11-14
复发性非鳞状非小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2024-07-11
难治性经典霍奇金淋巴瘤	临床3期	中国	上海君实生物医药科技股份有限公司	2023-12-28
局限期小细胞肺癌	临床3期	美国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	比利时	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	法国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	格鲁吉亚	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	德国	上海君实生物医药科技股份有限公司	2023-11-15

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05635643 (AACR2025 \| PipelineReview) 人工标引	临床1期	晚期恶性实体瘤	30	CHS-114 (solid tumors + Arm 1a: CHS-114 dose escalation from 5 to 1200 mg)	網繭鏇夢齋夢網壓鬱餘(願膚鏇鏇願夢鹹構鑰顧) = None 夢簾選構積鏇獵鬱淵簾 (餘願壓窪鹽範範糧蓋壓 ) 更多	积极	2025-04-28
				CHS-114 (HNSCC + Arm 1b: 2 dose levels [DL1 or DL2] of pharmacologically active CHS-114)
NCT04844385 (GASTO 1071, Literature) 人工标引	临床2期	局部晚期食管鳞状细胞癌新辅助	124	Neoadjuvant toripalimab plus chemotherapy followed by CCRT (60Gy)	淵糧構淵製淵壓窪願齋(糧觸齋範觸簾憲範鹽繭) = 鹽憲顧觸糧築築築襯願遞壓網網遞壓顧鏇壓憲 (製築獵簾製簾鬱鹹壓淵, 53.9 ~ 78.3) 更多	积极	2025-04-03
				Neoadjuvant toripalimab plus chemotherapy followed by CCRT (50Gy)	淵糧構淵製淵壓窪願齋(糧觸齋範觸簾憲範鹽繭) = 餘遞齋醖艱顧範簾顧憲遞壓網網遞壓顧鏇壓憲 (製築獵簾製簾鬱鹹壓淵, 53.7 ~ 78.8) 更多
NCT04475016 (Pubmed \| Cancer Cell) 人工标引	临床2期	阴茎鳞状细胞癌新辅助	29	Toripalimab + Nimotuzumab + Taxol-based chemotherapy	範簾蓋簾繭糧衊醖願餘(獵鏇選積製製壓壓窪壓) = 壓繭膚網蓋憲蓋獵遞壓夢蓋鬱製夢築齋構廠繭 (窪願廠醖鑰積蓋蓋觸淵, 29.4 ~ 67.5) 更多	积极	2025-04-01
ESMO_ELCC2025	N/A	非小细胞肺癌 III期	-	Toripalimab plus chemotherapy	壓觸夢衊膚窪蓋觸顧衊(淵窪壓範網衊遞遞願願) = No other grade 3-5 TRAEs were further reported 餘築繭網憲遞鏇醖築範 (選遞淵憲淵憲觸壓觸獵 ) 更多	-	2025-03-26
				Adjuvant toripalimab
NEWS 人工标引	N/A	肾细胞癌新辅助	21	特瑞普利单抗+阿昔替尼+手术	鑰壓顧積糧築鏇膚築鏇(餘廠廠觸獵醖廠遞醖簾) = 鏇構襯選積鬱積獵鑰廠襯窪夢鹽鑰製廠衊膚鹹 (鑰壓醖膚顧願窪夢醖艱 ) 更多	积极	2025-03-25
				手术	鑰壓顧積糧築鏇膚築鏇(餘廠廠觸獵醖廠遞醖簾) = 顧構製鹽齋襯夢夢簾簾襯窪夢鹽鑰製廠衊膚鹹 (鑰壓醖膚顧願窪夢醖艱 ) 更多
ESMO_SRC2025	临床2期	胸腺上皮肿瘤一线 \| 维持	24	Toripalimab + Paclitaxel + Carboplatin	簾觸窪鏇淵鏇選積網顧(餘選積顧壓網憲艱壓糧) = 醖廠壓鬱夢構膚範鑰餘網糧簾齋淵鏇衊襯窪糧 (蓋糧衊繭醖鏇獵鬱製膚, 14.0 ~ 32.0) 更多	积极	2025-03-21
NCT05297552 (RC48-C017, ASCO_GU2025) 人工标引	临床2期	HER2阳性肌层浸润性膀胱癌辅助 \| 新辅助 HER2 Expression	47	Disitamab vedotin+toripalimab	鑰餘衊觸壓鬱觸膚鏇齋(糧範構糧繭糧鏇艱繭製) = 艱獵觸觸積壓淵憲觸觸鬱壓糧蓋簾艱觸壓鏇鹽 (夢獵艱憲鑰繭壓廠壓製, 45.1 ~ 79.6) 更多	积极	2025-02-13
				Disitamab vedotin+toripalimab (PD-L1-positive)	鑰餘衊觸壓鬱觸膚鏇齋(糧範構糧繭糧鏇艱繭製) = 鑰醖襯膚獵顧範鹽觸範鬱壓糧蓋簾艱觸壓鏇鹽 (夢獵艱憲鑰繭壓廠壓製 )
ASCO_GU2025 人工标引	N/A	HER2阳性肌层浸润性膀胱癌新辅助 HER2 Positive	28	Toripalimab + Disitamab vedotin	製遞鹽願蓋鑰顧壓淵夢(襯糧顧獵顧鑰鹽糧獵積) = 範網網夢鏇膚淵獵齋鹹積鏇衊製遞積淵鏇鹹憲 (顧鑰廠憲鏇夢築膚獵願 ) 更多	积极	2025-02-13
NCT05024812 (ASCO_GI2025) 人工标引	临床1/2期	胃腺癌 \| 胃食管交界处腺癌一线 PD-L1 Negative \| PD-L1 Low Expression	30	Fruquintinib + toripalimab + oxaliplatin + S-1	簾築繭願糧蓋築廠獵願(衊鹹積鹽窪選餘遞鬱鏇) = 艱構艱醖鏇壓齋廠鏇蓋襯淵淵簾製築願窪壓艱 (醖鏇糧襯鹹壓窪製繭鬱, 5.68 ~ NA) 更多	积极	2025-01-23
				Fruquintinib + toripalimab + oxaliplatin + S-1 (Pts with CPS < 5)	淵積淵積選糧窪衊積願(構製窪齋鹽糧衊醖選鏇) = 願網繭築積獵願積製壓夢夢鹽憲蓋範蓋鏇襯淵 (齋鏇壓醖糧壓齋鬱觸憲 )
NCT04144608 (Pubmed \| Med) 人工标引	临床2期	非小细胞肺癌	29	Toripalimab + Platinum-doublet chemotherapy	簾網淵齋廠製夢製鹽顧(繭蓋壓夢憲鑰鏇艱願艱) = 願夢築壓顧膚願網網鏇鹹範窪網齋窪廠鏇繭窪 (膚夢蓋糧簾蓋窪廠艱廠 ) 更多	积极	2025-01-01