Study Objectives： Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) combined with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) or Durvalumab (anti-programmed death-ligand 1; anti-PD-L1) combined with tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4; anti-CTLA4) have recently been established as a standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). However, its objective response rate (ORR) is only less than 27% (1, 2), and the majority of patients died of HCC progression and liver failure. Therefore, there is an urgent need to develop a novel combination treatment strategy to overcome resistance to immunotherapy and improve patient outcomes.
Transarterial chemoembolization (TACE) remains the standard treatment for patients with intermediate-stage hepatocellular carcinoma (HCC) (3, 4). However, in our previous retrospective study (5-7), the investigators consistently observed that this combination not only improves therapeutic responses but also significantly prolongs patient survival. The tumor necrosis caused by TACE may enhance the efficacy of systemic therapies by promoting the release of neoantigens, thereby stimulating immune responses (8-14). This concept has been substantiated in two recent trials involving intermediate-stage HCC (15, 16), where the addition of immune checkpoint inhibitors to TACE resulted in improved clinical outcomes. Nevertheless, this promising approach has yet to replace the decades-old standard treatment protocols, underscoring the need for further proof-of-concept studies.
Both immunotherapy (atezolizumab/bevacizumab or durvalumab/tremelimumab) and transarterial chemoembolization (TACE) are approved treatment modalities for unresectable hepatocellular carcinoma (HCC) by the U.S. and Taiwan Food and Drug Administration (FDA). This phase II non-randomized trial is designed to prospectively evaluate the therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with a combination of immunotherapy and TACE. A particular focus of this study is to explore the potential immune-boosting effects of TACE, including its ability to enhance antigen presentation and stimulate anti-tumor immune responses.

开始日期2026-09-15

申办/合作机构

长庚纪念医院

NCT06855225

/ Not yet recruiting临床2期IIT

A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab (STRIDE) Plus Gemcitabine and Cisplatin (GEMCIS) in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma (cHCC-CCA)

This is a single arm phase 2 study of Single Tremelimumab with Regular Interval Durvalumab (STRIDE) plus Gemcitabine and Cisplatin (GEMCIS) in locally advanced unresectable/metastatic combined hepatocellular-cholangiocarcinoma (cHCC-CCA). Cycles 1 through 8 will be in 3 week intervals and Cycles 9+ will be in 4 week intervals. Tremelimumab is administered at 300mg intravenously once at Cycle 1. Durvalumab is administered at 1500mg intravenously every 3 weeks for Cycles 1-8, then every 4 weeks for Cycles 9+. Gemcitabine is administered at 1000mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Cisplatin is administered at 25mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur at screening and then every 9 weeks until the end of Cycle 9. Disease assessments will then occur every 8 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months treatment from Cycle 1 Day 1 is allowed.

开始日期2026-10-01

申办/合作机构

Hoosier Cancer Research Network

[+2]

NCT06824363

/ Recruiting早期临床1期IIT

Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082

This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.

开始日期2026-05-25

申办/合作机构

University of California, Irvine

100 项与曲麦利尤单抗相关的临床结果

登录后查看更多信息

100 项与曲麦利尤单抗相关的转化医学

登录后查看更多信息

100 项与曲麦利尤单抗相关的专利（医药）

登录后查看更多信息

670

项与曲麦利尤单抗相关的文献（医药）

2026-08-01·Liver International

Article

作者: Ishikawa, Toru ; Hatanaka, Takeshi ; Morishita, Asahiro ; Okamura, Jumpei ; Matsuura, Takanori ; Aoki, Tomoko ; Yata, Yutaka ; Ueda, Yoshihide ; Nouso, Kazuhiro ; Tanaka, Hironori ; Tsuji, Kunihiko ; Nagano, Takuya ; Tamai, Hideyuki ; Nakamura, Shinichiro ; Nishikawa, Hiroki ; Koshiyama, Yuichi ; Naganuma, Atsushi ; Ochi, Hironori ; Matsui, Kosuke ; Hiasa, Yoichi ; Tajiri, Kazuto ; Fukumoto, Takumi ; Imai, Michitaka ; Enomoto, Hirayuki ; Kawata, Kazuhito ; Kuroda, Hidekatsu ; Kariyama, Kazuya ; Kaibori, Masaki ; Hiraoka, Atsushi ; Tani, Joji ; Arai, Taeang ; Ohama, Hideko ; Kakizaki, Satoru ; Tsutsui, Akemi ; Noritake, Hidenao ; Nishimura, Takashi ; Kosaka, Hisashi ; Kumada, Takashi ; Okubo, Tomomi ; Tada, Toshifumi ; Itobayashi, Ei ; Komatsu, Shohei ; Takaguchi, Koichi ; Ogawa, Chikara ; Nakamura, Yoshiko ; Matono, Tomomitsu ; Toyoda, Hidenori ; Yoshida, Osamu ; Tanaka, Kazunari ; Atsukawa, Masanori ; Kanayama, Yuki ; Tada, Fujimasa ; Itokawa, Norio ; Kudo, Masatoshi ; Kim, Soo Ki ; Hirooka, Masashi

ABSTRACT:

Background and Aims:

For unresectable hepatocellular carcinoma (HCC), atezolizumab plus bevacizumab (Atez/Bev) and durvalumab plus tremelimumab (Dur/Tre) are widely used first‐line immunotherapies; however, biomarkers to guide regimen selection before treatment initiation remain undefined. We investigated whether baseline des‐γ‐carboxy prothrombin (DCP) modifies objective response rate (ORR) according to treatment regimen.

Methods:

We analysed 1464 patients with unresectable HCC treated with first‐line systemic therapy between 2020 and 2025 across multiple centers. Patients were divided into training and validation cohorts. Restricted cubic spline‐based interaction models were used to evaluate the association between baseline DCP and ORR according to treatment regimen. The predicted absolute difference in ORR (ΔORR) between regimens was examined across continuous DCP values, with a prespecified 10% threshold considered clinically meaningful. Robustness was assessed using leave‐one‐center‐out and repeated random‐split sensitivity analyses.

Results:

Overall ORR did not differ significantly between Atez/Bev and Dur/Tre. However, a significant interaction between baseline DCP and treatment regimen was observed in both cohorts. Atez/Bev showed a relatively stable ORR across DCP concentrations, whereas Dur/Tre showed a DCP‐dependent increase in ORR. At low DCP levels, Atez/Bev was favoured; with increasing DCP levels, the relative benefit shifted toward Dur/Tre. Sensitivity analyses confirmed a consistent DCP‐dependent transition pattern, although the DCP level at which ΔORR exceeded 10% varied across analyses, supporting a transition zone rather than a fixed cutoff.

Conclusions:

Baseline DCP may modify the relative treatment benefit between Atez/Bev and Dur/Tre in unresectable HCC. Rather than defining a rigid cutoff, DCP appears to delineate a continuum in which higher levels increasingly favour Dur/Tre, providing a practical framework for individualized immunotherapy selection.

2026-08-01·EUROPEAN UROLOGY

KIM-1 in Advanced Papillary and Clear Cell Renal Cell Carcinoma

Article

作者: Xu, Wenxin ; Powles, Thomas ; Coca Membribes, Sara ; Mein, Charles ; Suárez, Cristina ; Larkin, James ; Valderrama, Begoña P ; Patel, Poulam M ; Ackerman, Charlotte

Kidney injury molecule 1 (KIM-1) is a promising biomarker in adjuvant clear cell renal cell carcinoma (ccRCC), but its relevance in advanced ccRCC or papillary RCC (pRCC) remains unclear. CALYPSO (NCT02819596) was a prospective, multi-arm trial that evaluated durvalumab alone or in combination with tremelimumab or savolitinib in metastatic ccRCC and pRCC. Circulating KIM-1 levels were measured at baseline and on-treatment. The primary endpoint was to explore if KIM-1 levels were raised in pRCC. Analyses were exploratory and p values were nominal. KIM-1 was measured in 123 patients with ccRCC and 31 patients with pRCC. Higher median concentrations occurred in pRCC compared to ccRCC (7835 vs 5470 pg/ml, p = 0.05). Reductions in KIM-1 levels occurred with systemic therapy in both ccRCC and pRCC (-59.2% and -32% respectively). In pRCC, radiological responders had significantly lower baseline KIM-1 levels (p = 0.025). In ccRCC, high baseline KIM-1 levels were associated with significantly shorter overall survival (OS) (hazard ratio [HR] 1.77; 95% CI, 1.15-2.72; p = 0.01). Also, an increase in KIM-1 during therapy was linked to worse progression-free survival (HR 1.7; 95% CI, 1.13-2.58; p = 0.01) and OS (HR 1.95; 95% CI, 1.23-3.08; p = 0.004) in ccRCC. This exploratory analysis supports the utility of KIM-1 in advanced ccRCC and pRCC.

2026-07-10·JOURNAL OF CLINICAL ONCOLOGY

Neoadjuvant Durvalumab ± Tremelimumab in Combination With Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Muscle-Invasive Bladder Carcinoma: Results of the Phase I/II NEMIO Study

Article

作者: Barthélémy, Philippe ; Huillard, Olivier ; Laguerre, Brigitte ; Fléchon, Aude ; Gravis, Gwenaelle ; Thibault, Constance ; Cancel, Mathilde ; Kaci, Ghalia ; Pouessel, Damien ; Bennamoun, Mostefa ; Audenet, François ; Henriques, Julie ; Loriot, Yohann ; Gross-Goupil, Marine ; Combe, Pierre ; Oudard, Stéphane ; Belhouari, Houda ; Borchiellini, Delphine ; Jaffrelot, Loic ; Vernerey, Dewi ; Le Roy, Audrey ; Lepicard, Eve

PURPOSE:

To evaluate the efficacy and safety of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) combined with durvalumab ± tremelimumab in patients with muscle-invasive bladder cancer (MIBC).

METHODS:

NEMIO (ClinicalTrials.gov identifier: NCT03549715 ) is a multicenter, randomized, noncomparative phase II trial in cT2-T4a N0-1 cisplatin-eligible MIBC planned for radical cystectomy (RC). Patients received ddMVAC (cisplatin 70 mg/m 2 , methotrexate 30 mg/m 2 , doxorubicin 30 mg/m 2 , and vinblastine 3 mg/m 2 on days 1, and pegfilgrastim 6 mg on days 2) once every 2 weeks × four cycles plus durvalumab ± tremelimumab (durvalumab 1,500 mg and tremelimumab 75 mg) once every 4 weeks × two doses (C1D1 and C3D1) before RC. Coprimary end points (local assessment) were pathologic complete response (pCR; ypT0N0) and grade ≥3 treatment-related adverse events (TRAEs). The study was considered positive if the pCR rate was ≥45% and the rate of grade ≥3 TRAEs was ≤30%.

RESULTS:

From 2018 to 2022, 119 patients received ddMVAC + durvalumab (n = 60) or ddMVAC + durvalumab + tremelimumab (n = 59); 113 underwent RC. The overall Bayesian posterior mean pCR rate was 48.70% (95% CI, 35.93 to 61.56) with doublet and 46.27% (95% CI, 33.92 to 58.85) with triplet. Among 103 patients with PD-L1 data (exploratory), Bayesian posterior mean pCR was 68.25% (95% CI, 54.57 to 80.49) in PD-L1–high tumors versus 33.49% (95% CI, 22.13 to 45.91) in PD-L1–low/negative tumors. Bayesian posterior mean grade ≥3 TRAEs occurred in 40.95% (95% CI, 32.50 to 49.69) overall (30.48% [95% CI, 20.00 to 42.08] doublet; 49.63% [95% CI, 37.55 to 61.73] triplet); immune-related adverse events occurred in 26.9% (grade ≥3 4.2%). Two-year event-free survival and overall survival rates were 75% and 85% in the doublet arm, and 77% and 88% in the triplet arm, respectively.

CONCLUSION:

Neoadjuvant ddMVAC plus durvalumab demonstrated encouraging pCR rates, favorable early survival outcomes, and manageable safety profile. Adding tremelimumab provides similar pCR but worse toxicity. These results support further study of ddMVAC plus durvalumab as a neoadjuvant chemoimmunotherapy strategy for localized MIBC, to be evaluated in comparative trials within an evolving perioperative treatment landscape.

855

项与曲麦利尤单抗相关的新闻（医药）

2026-09-01

·腾讯网

当氢原子遇见氘：一款改良靶向药如何重新定义晚期肝癌生存获益

导语：当索拉非尼在晚期肝癌一线治疗中"独孤求败"了整整十三年，临床医生们不禁要问：我们是否真的只能接受这种"疗效有限、毒性显著"的妥协？在免疫联合治疗风起云涌的当下，一款通过"原子级微调"——将氢原子替换为氘——而诞生的改良靶向药物，似乎显得不那么"时髦"。然而，这项研究恰恰用最硬核的III期头对头数据证明，有时候最优雅的突破并非来自全新的机制，而是来自对经典分子的深刻理解与智慧重塑。它的深层价值，远不止于将中位总生存期从10.3个月延长至12.1个月这一数字上的超越。更重要的是，它首次在大型随机对照试验中实现了单药对索拉非尼的统计学优效，打破了晚期肝癌靶向治疗领域长达十三年的沉寂。在中国这样一个以HBV相关肝癌为主、患者基线状态相对更差、对药物耐受性要求更高的国度，多纳非尼以更少的≥3级不良事件、更低的手足皮肤反应和腹泻发生率，让患者不仅"活得更长"，还能"坚持得更久"。这为那些因合并症或特殊体质而无法迈入免疫联合治疗时代的患者，保留了一条切实可行且更"友好"的生命通道，也为全球氘代药物研发策略在实体瘤中的成功应用树立了标杆。01十三年磨一剑——晚期肝癌单药治疗首次突破索拉非尼生存瓶颈肝细胞癌（HCC）是全球范围内最常见的恶性肿瘤之一，而中国更是承担了全球超过半数的新发病例与死亡负担。由于多数患者在确诊时已处于不可切除或转移性晚期阶段，中位生存期往往仅有6至8个月，系统治疗成为延长生命的唯一希望。然而，自2007年索拉非尼获批以来，它长期作为晚期HCC一线治疗的标准标杆，尽管其在全球范围内将中位总生存期（mOS）提升至10.7至14.7个月，但在中国及亚洲人群中这一数字仅为6.5至11.4个月，且常伴随手足皮肤反应、腹泻等令人困扰的不良反应，导致患者耐受性差、治疗中断率高。更令人沮丧的是，在此后长达十三年的时间里，尽管仑伐替尼在REFLECT研究中证实了非劣效性，但没有任何一种单药能在头对头随机对照试验中statistically significant地超越索拉非尼的生存获益。这一僵局背后，折射出晚期HCC药物研发的深层困境：如何在保留多靶点抗血管生成与抗肿瘤增殖作用的同时，优化药代动力学特征、降低毒性代谢物暴露，从而实现"增效减毒"？多纳非尼（Donafenib）正是在这一背景下进入视野的氘代化创新药物。作为索拉非尼的氘代衍生物，它通过在三氘代N-甲基基团上的结构修饰，增强了分子稳定性，减少了肝脏药物代谢酶的降解，从而可能带来更高的血浆药物暴露和更低的毒性代谢产物生成。前期Ia/Ib期研究已初步显示其良好的疗效与安全性轮廓，提示这一"老药新做"的策略或许能为占全球肝癌负担最重的中国患者群体带来真正差异化的治疗选择。2021年6月29日，Journal of Clinical Oncology发表了一篇题为"Donafenib Versus Sorafenib in First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma: A Randomized, Open-Label, Parallel-Controlled Phase II-III Trial"的文章。该研究不仅首次在大型III期头对头试验中实现了单药对索拉非尼的OS优效性突破，更以其对中国HCC人群的高度代表性——近九成患者为乙型肝炎病毒（HBV）相关、基线肝功能与体能状态相对更差——为临床实践提供了极具本土价值的循证依据，标志着晚期HCC靶向治疗从"非劣效时代"正式迈入了"优效单药时代"。02适应性II-III期无缝衔接设计；氘代新药头对头挑战标准靶向治疗本研究是一项随机、开放标签、平行对照、多中心II-III期临床试验，旨在比较多纳非尼与索拉非尼作为一线系统治疗用于中国不可切除或转移性HCC患者的疗效与安全性。研究在全国37个临床研究中心开展，纳入标准为经组织病理学、细胞学或临床确诊的不可切除或转移性HCC患者，要求Child-Pugh肝功能评分≤7分、ECOG体能状态评分为0至1分、至少存在一个可测量病灶（RECIST 1.1标准），且既往未接受过系统治疗。研究采用适应性设计：第一阶段（II期）入组80例患者，若多纳非尼组达到预设的疗效与安全性标准，则无缝扩展至第二阶段（III期），计划总入组660例患者。符合入排标准的患者按1:1比例随机分配至多纳非尼组（口服0.2 g，每日两次）或索拉非尼组（口服0.4 g，每日两次）。随机化分层因素包括基线甲胎蛋白水平（<400 vs ≥400 μg/L）、既往局部治疗史、BCLC分期（B期 vs C期）以及门静脉侵犯和/或肝外转移状态。治疗持续至疾病进展、出现不可耐受毒性、妊娠或研究者决定终止。主要终点为总生存期（OS），采用序贯检验策略：首先检验非劣效性（非劣效界值HR=1.08，对应保留索拉非尼相对安慰剂50%的疗效），若非劣效成立则进一步检验优效性。次要终点包括无进展生存期（PFS）、至疾病进展时间（TTP）、客观缓解率（ORR）、疾病控制率（DCR）、6/9/12/18个月生存率及安全性。肿瘤疗效由独立评审委员会（IRC）按照RECIST 1.1标准进行盲法评估，安全性依据NCI CTCAE v4.0标准评价。统计分析采用分层log-rank检验及Cox比例风险模型，并以全分析集（FAS）作为主要疗效分析人群，意向性治疗人群（ITT）作为支持性分析。图1：研究设计03多纳非尼显著延长总生存期且安全性更优；氘代修饰实现疗效与耐受性双重突破在2016年3月21日至2018年4月16日期间，研究共筛选1,075例患者，最终668例进入随机分配（多纳非尼与索拉非尼各334例），其中全分析集（FAS）纳入659例患者，两组基线特征均衡可比，90%合并HBV感染、87%为BCLC C期、97%为Child-Pugh A级，真实反映了中国晚期HCC患者疾病负荷重、基础状态脆弱的临床现实。疗效分析显示，在全分析集中，多纳非尼组的中位总生存期达到12.1个月，显著优于索拉非尼组的10.3个月（HR 0.831，95%CI 0.699至0.988；P=0.0245），95%置信区间上限不仅低于非劣效界值1.08，更低于1.00，同时满足非劣效与优效假设；在意向性治疗人群中，这一获益趋势保持一致（中位OS 12.0个月 vs 10.1个月；HR 0.839，95%CI 0.706至0.996；P=0.0309）。值得注意的是，18个月生存率多纳非尼组为35.4%，显著高于索拉非尼组的28.1%（P=0.0460），提示长期生存获益更为突出。亚组分析进一步证实，无论是基线AFP水平高低、是否接受过局部治疗、BCLC分期早晚，还是是否存在门静脉侵犯/肝外转移，多纳非尼的OS获益方向在绝大多数预设亚组中保持一致，尤其在未接受局部治疗（HR 0.618）及无大血管侵犯/转移（HR 0.655）的患者中获益更为显著。尽管无进展生存期（中位PFS 3.7个月 vs 3.6个月；HR 0.909；P=0.0570）和至进展时间（中位TTP 3.7个月 vs 3.7个月）两组差异未达统计学显著性，客观缓解率（4.6% vs 2.7%）与疾病控制率（30.8% vs 28.7%）亦数值相近，但第24周时多纳非尼组的疾病控制率更高（20.7% vs 15.7%），且后续分析证实24周疾病控制状态对长期生存具有显著预测价值（P<.0001），提示多纳非尼可能通过更持久的疾病稳定为患者赢得长期生存窗口。在安全性方面，多纳非尼展现出明确的优势：药物相关≥3级不良事件发生率显著低于索拉非尼（38% vs 50%；P=0.0018），其中令临床医生与患者最为头痛的手足皮肤反应发生率从索拉非尼组的67%降至50%，腹泻从47%降至30%，脱发从33%降至22%，且因不良事件导致剂量中断或减量的患者比例亦显著更低（30% vs 42%；P=0.0013），治疗终止率同样呈降低趋势（10% vs 13%）。两组中位药物暴露时间相近（110天 vs 113天），但多纳非尼组在进展后仍能继续接受治疗的患者比例更高，反映出其更好的耐受性为持续用药提供了可能。正如作者所言，"To our knowledge, this pivotal head-to-head comparison study is the first to demonstrate noninferiority and superiority of a monotherapy, donafenib, with statistically significant extension in OS over sorafenib for first-line treatment of advanced HCC."。图2：总生存期（OS）的Kaplan‑Meier分析04总结这项研究是迄今为止中国晚期肝细胞癌领域规模最大的III期头对头随机对照试验，其核心贡献在于首次以高级别循证证据证实，氘代修饰的多纳非尼单药一线治疗不仅在总生存期上显著优于传统标准索拉非尼，打破了十三年间晚期HCC单药治疗无法超越索拉非尼的沉寂局面，更以更低的≥3级不良事件发生率、更少的手足皮肤反应和腹泻负担，实现了疗效与耐受性的双重优化。正如作者在讨论中强调的，多纳非尼作为目前唯一在头对头试验中证明OS优效性的单药，其独特的氘代结构带来了更高的血浆暴露和更低的毒性代谢物生成，这不仅解释了其短期疗效与长期生存优势，也为那些因合并自身免疫性疾病、出血倾向、严重高血压或HBV/HCV共感染等原因不适合接受免疫检查点抑制剂联合抗血管生成治疗的患者，提供了一个切实可行的一线单药选择。在中国HCC人群以HBV相关、基线状态差为主要特征的现实背景下，该研究为临床实践提供了高度契合本土需求的循证武器，重新定义了晚期肝细胞癌一线靶向治疗的获益天花板。此外，该研究采用经验证的EORTC QLQ-C30及HCC特异性QLQ-HCC18量表，以高依从性、长随访期的预设次要终点设计，提供了高质量的PRO循证证据。正如作者讨论中强调的，这些结果进一步支持了STRIDE作为uHCC一线治疗的积极获益-风险特征，为全球范围内不同人群的uHCC患者提供了一个既有效又"友好"的治疗选择。参考文献Sangro B, Galle PR, Kelley RK, Charoentum C, De Toni EN, Ostapenko Y, Heo J, Cheng AL, Wilson Woods A, Gupta C, Abraham J, McCoy CL, Patel N, Negro A, Vogel A, Abou-Alfa GK. Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2024 Aug 10;42(23):2790-2799. doi: 10.1200/JCO.23.01462. Epub 2024 May 28. PMID: 38805668; PMCID: PMC11315407.“医学论坛网”发布医学领域研究成果和解读，供专业人员科研参考，不作为诊疗标准，使用需根据具体情况评估。编辑：常寂光审核：梨九排版：蓝桉

2026-09-01

·阿斯利康中国

泰瑞沙®联合沃瑞沙®一线治疗伴有MET过表达的EGFR突变肺癌患者，显示出有统计学和显著临床意义的无进展生存期改善

中国SANOVO III期临床研究结果延续了SAFFRON全球研究及SACHI中国研究的成功势头，将这一全口服的联合治疗方案的临床价值进一步延伸至一线治疗 SANOVO研究结果进一步巩固了泰瑞沙作为EGFR突变肺癌全程治疗基石的地位重磅发布 SANOVO III期临床研究公布的阳性结果显示，与泰瑞沙®（通用名：甲磺酸奥希替尼，以下简称“奥希替尼”）单药治疗相比，奥希替尼联合沃瑞沙®（通用名：赛沃替尼片，以下简称“赛沃替尼”）在初治伴有表皮生长因子受体（EGFR）突变和MET过表达的局部晚期或转移性非小细胞肺癌（NSCLC）患者，显示出具有统计学和显著临床意义的无进展生存期（PFS）改善。PFS获益在MET高表达（IHC 3+）以及意向治疗（ITT）（IHC 2+、IHC 3+）的受试患者中均得到证实。在这两个患者人群中，该联合疗法亦显示出令人鼓舞的总生存期 (OS) 获益 (该研究的次要终点之一) 。研究将继续对这些结果进行随访。上述数据将于即将召开的学术会议上公布。吴一龙教授该研究的主要研究者广东省人民医院在既往未接受过治疗的EGFR突变NSCLC患者中，伴随MET过表达往往会削弱EGFR酪氨酸激酶抑制剂单药治疗的长期疗效。SANOVO研究的积极结果表明，通过这种全口服、生物标志物为导向的治疗方案，对这两条通路及早进行干预，为此类肿瘤伴有MET过表达的患者提供了一种强有力的全新治疗选择。通过将赛沃替尼和奥希替尼联合用药，我们观察到了明确的临床获益，这有望重塑此类特定患者人群的一线治疗策略。 Leora Horn 阿斯利康全球高级副总裁肿瘤研发后期开发负责人 SANOVO研究结果进一步丰富了现有证据，表明在基石疗法奥希替尼的基础上联合赛沃替尼，可通过阻断MET驱动的耐药机制，延缓疾病进展，改善这类患者的治疗结局。为了在现有标准治疗的基础上进一步提升疗效，阿斯利康通过开发创新的、以生物标志物为导向的联合治疗方案来为EGFR突变肺癌树立更高的治疗标准。苏慰国博士和黄医药首席执行官兼首席科学官很高兴SANOVO研究取得积极结果，这验证了我们在肺癌多个阶段应对 MET 驱动疾病的战略。继早前的SAFFRON全球III期研究以及SACHI中国III期研究在经治患者中奠定的坚实基础之上，SANOVO的数据进一步验证了赛沃替尼和奥希替尼的联合疗法在一线患者中的治疗实力和广泛适用性。我们向所有参与本项研究的患者和研究者致以由衷的感谢，并期待与监管机构分享这些数据，早日将这一创新的全口服联合方案带入一线治疗。奥希替尼与赛沃替尼联合疗法的安全性特征与已知的各药物的安全性一致，未发现新的安全信号。相关数据将于即将召开的学术会议上公布，并与监管机构共享。基于SACHI III期临床试验结果，奥希替尼与赛沃替尼联合疗法已于中国获批用于治疗接受EGFR-TKI治疗后疾病进展的伴有MET扩增的EGFR突变的局部晚期或转移性NSCLC患者。该联合疗法用于治疗奥希替尼治疗后疾病进展的、伴有MET过表达或扩增的EGFR突变NSCLC患者的SAFFRON全球III期研究也于公布了积极的顶线数据，显示出具有统计学和临床意义的PFS和OS改善。赛沃替尼由阿斯利康与和黄医药共同开发，并由阿斯利康商业化。关于非小细胞肺癌及MET异常在全球，肺癌是癌症死亡的主要原因，约占所有癌症死亡人数的四分之一（23%）1。肺癌通常分为NSCLC和小细胞肺癌，其中NSCLC约占所有肺癌患者的80%-85%2。大部分（约75%）NSCLC患者在确诊时已是晚期3。美国和欧洲的NSCLC患者中约有10-25％存在EGFR突变，而亚洲患者中该比例则高达30-40％4-6。 MET是一种受体酪氨酸激酶，在细胞的正常发育过程中发挥重要作用7。MET扩增和/或过表达可导致肿瘤生长以及癌细胞的转移进展7-8。关于SANOVO临床研究 SANOVO是一项由和黄医药在中国开展的、针对伴有EGFR突变及MET过表达的既往未经治疗的局部晚期或转移性NSCLC患者的盲法、随机对照III期临床研究。该研究旨在评估赛沃替尼和奥希替尼的联合疗法对比奥希替尼单药 (当前此类患者的标准疗法) 的疗效及安全性。研究共纳入326例初治的伴有EGFR突变 (外显子19缺失或L858R) 和MET过表达的局部晚期或转移性NSCLC患者。患者按 1:1 的比例随机分组，分别接受奥希替尼80毫克每日一次联合赛沃替尼或安慰剂300/200毫克每日两次 (剂量根据体重而定)。研究的主要终点是研究者评估的PFS。其他终点包括独立审查委员会评估的PFS、OS、客观缓解率 (ORR)、缓解持续时间 (DoR)、疾病控制率 (DCR)、到达疾病缓解的时间 (TTR) 及安全性。关于赛沃替尼赛沃替尼是一种强效、高选择性的口服MET TKI，MET是一种受体酪氨酸激酶，已在晚期实体瘤中显示出临床活性。赛沃替尼可阻断因基因突变（如外显子14跳变或其他点突变）、基因扩增或蛋白质过表达而导致的MET受体酪氨酸激酶信号通路的异常激活。赛沃替尼已在中国获批用于治疗MET外显子14跳跃突变的局部晚期或转移性NSCLC成人患者，成为中国首个获批的选择性MET抑制剂。赛沃替尼还在中国获附条件批准，用于治疗经过至少2种系统治疗后失败的MET基因扩增的局部晚期或转移性胃癌或胃食道连接部（GC/GEJ）腺癌成人患者。基于SACHI III期临床研究的结果，赛沃替尼联合奥希替尼已在中国获批，用于治疗经EGFR TKI治疗后进展且伴MET扩增的局部晚期或转移性非鳞状EGFR突变NSCLC患者。基于SAVANNAH全球II期临床研究的结果，该联合疗法亦于瑞士获得临时授权，用于治疗经奥希替尼治疗后疾病进展的伴有高水平MET过表达或扩增的EGFR突变局部晚期或转移性NSCLC患者。关于奥希替尼奥希替尼是一种不可逆的第三代EGFR-TKI，在治疗EGFR突变非小细胞肺癌（包括伴中枢神经系统转移）患者中有确证的临床活性。奥希替尼（40mg和80mg每日一次口服片剂）在全球获批的各种适应症已治疗了超过100万名患者。阿斯利康正继续探索奥希替尼用于治疗不同疾病分期的EGFR突变NSCLC患者。奥希替尼已在包括美国、欧盟、中国和日本在内的120多个国家获批单药治疗。获批适应症包括：一线治疗局部晚期或转移性EGFR外显子19缺失或外显子21(L858R)置换突变的NSCLC患者；既往经EGFR酪氨酸激酶抑制剂(TKI)治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性NSCLC患者的治疗；IB-IIIA期存在表皮生长因子受体(EGFR)外显子19缺失或外显子21(L858R)置换突变的NSCLC患者的治疗；接受含铂放化疗期间或之后未出现疾病进展，及具有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患者的治疗。奥希替尼联合化疗方案已在包括美国、欧盟、中国和日本在内的80多个国家获批，用于一线治疗局部晚期或转移性EGFR突变NSCLC患者‌。有大量证据支持奥希替尼作为 EGFR突变NSCLC的推荐治疗，它是目前被证实可改善各分期NSCLC患者临床结局的靶向疗法。在晚期患者中，奥希替尼在FLAURA III期研究中作为单药疗法，以及在FLAURA2 III期研究中联合化疗，均显示出临床结局改善。在此类患者中，奥希替尼与德达博妥单抗联合疗法的TROPION-Lung14和TROPION-Lung15 III期研究正在进行中。奥希替尼在针对早期EGFRm NSCLC患者的NeoADAURA和ADAURA III期研究以及针对局部晚期EGFRm NSCLC患者的LAURA III期研究中，均改善了患者的临床治疗结局。作为阿斯利康持续承诺治疗早期肺癌的重要组成部分，ADAURA2 III期临床研究正在进行中，评估奥希替尼用于早期可切除EGFRm NSCLC的辅助治疗。关于阿斯利康在肺癌领域的研究阿斯利康正在努力通过早期阶段疾病的检测和治疗使肺癌患者更接近治愈，并不断突破科学边界，改善耐药性和晚期肺癌患者的预后。公司旨在通过定义新的治疗人群、研究创新疗法，将药物带给能从中受到最大获益的患者。公司全面的产品组合涵盖领先的肺癌药物和新一代创新疗法，包括奥希替尼和吉非替尼度伐利尤单抗和曲麦利尤单抗；与第一三共合作开发的德曲妥珠单抗和德达博妥单抗；与和黄医药合作开发的赛沃替尼以及横跨各种作用机制的新药及其组合的产品管线。阿斯利康是全球Lung Ambition Alliance的创始成员，该联盟致力于加速创新并为肺癌患者带来治疗及治疗以外有意义的改善。关于阿斯利康在肿瘤领域的研究阿斯利康正引领着肿瘤领域的一场革命，致力提供多元化的肿瘤治疗方案，以科学探索肿瘤领域的复杂性，发现、研发并向患者提供改变生命的药物。阿斯利康的肿瘤业务专注于最具挑战性的肿瘤疾病，通过持续不断的创新，阿斯利康已建立了领先全行业的多元化产品组合和管线，持续推动医疗实践变革，改变患者体验。阿斯利康的愿景旨在重新定义癌症治疗，以期未来让癌症不再成为致死主因。关于阿斯利康阿斯利康(LSE/STO/Nasdaq: AZN)是一家科学至上的全球生物制药企业，专注于研发、生产及营销处方类药品，重点关注肿瘤、罕见病以及包括心血管肾脏及代谢、呼吸及免疫在内的生物制药等领域。阿斯利康全球总部位于英国剑桥，业务遍布超过125个国家，创新药物惠及全球数百万患者。更多信息，请访问www.astrazeneca.com。关于阿斯利康中国中国是阿斯利康全球第二大市场，也是其全球创新的战略枢纽。公司在中国设有两个全球战略研发中心，迄今已主导开展了超20项全球临床试验；拥有四个生产供应基地，向全球70多个市场提供优质创新药品；在上海设立中国总部，并在五地设立区域总部开展商业运营。自2023年以来，公司与17家中国创新药企达成20项合作。自1993年进入中国以来，阿斯利康已为中国患者带来近50款创新药物，覆盖肿瘤，心血管、肾脏及代谢，呼吸及免疫，感染性疾病，消化，罕见病等领域。仅2025年，公司的创新药物即惠及6800万中国患者。声明：本文研究中涉及的多种药品用法尚未在中国获批适应症，阿斯利康不推荐任何未被批准的药品使用。内容来源：新闻稿（内部审批号: CN-193681）参考文献（滑动查看更多） 1. World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed August 2026. 2. American Cancer Society. What Is Lung Cancer? Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2026. 3. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. 4. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812. 5. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First- Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011;29:2121-2127. 6. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. 7. Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074) 8. Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. J Hematol Oncol. 2019;63.

2026-09-01

·BioSpace

AstraZeneca completes global license agreement for oral EGFR inhibitor ZEGFROVY® (sunvozertinib) for lung cancer

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced the successful completion of the previously announced exclusive license agreement with Dizal Pharmaceutical Co., Ltd for ZEGFROVY ® (sunvozertinib), an oral irreversible epidermal growth factor receptor ( EGFR ) inhibitor for patients with lung cancer. Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialize ZEGFROVY. ZEGFROVY is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8% underscoring the unmet need for new treatment options. 1 ZEGFROVY is already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during the fourth quarter of 2026 for this indication. Sunvozertinib (ZEGFROVY ) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for NSCLC. It is recommended as a subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines ® for detailed recommendations. 2 A supplemental New Drug Application for approval of ZEGFROVY in the 1st-line setting has been accepted by the US Food and Drug Administration (FDA), supported by positive results from the global WU-KONG28 Phase III trial of ZEGFROVY in 1st-line NSCLC with EGFR exon 20 insertion mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine . ZEGFROVY has also been submitted for approval in the 1st-line setting to China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to ZEGFROVY in this setting. Financial considerations AstraZeneca will make an upfront payment of $600m to Dizal together with additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of ZEGFROVY. This transaction does not impact AstraZeneca’s financial guidance for 2026. IMPORTANT SAFETY INFORMATION Interstitial Lung Disease/Pneumonitis ZEGFROVY can cause severe and life-threatening interstitial lung disease (ILD)/pneumonitis. In the safety population of 121 patients, ILD/pneumonitis occurred in 1.7% of patients. ZEGFROVY was discontinued due to ILD/pneumonitis in 0.8% of patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, and fever). Immediately withhold ZEGFROVY in patients with suspected ILD/pneumonitis and permanently discontinue ZEGFROVY if ILD/pneumonitis is confirmed. Gastrointestinal Adverse Reactions ZEGFROVY can cause severe gastrointestinal adverse reactions including diarrhea, nausea, and vomiting. In the safety population of 121 patients, serious gastrointestinal adverse reactions occurred in 1.7% of patients, including 0.8% Grade 3 nausea. Diarrhea occurred in 73% of patients who received ZEGFROVY, including 2.5% Grade 3. Diarrhea leading to dosage interruption or dose reduction occurred in 5% of patients and required permanent discontinuation of ZEGFROVY in 0.8% of patients. Nausea and vomiting occurred in 43% of patients, including 3.3% Grade 3 events. Nausea and vomiting leading to dosage interruption or dose reduction occurred in 7% of patients and permanent discontinuation of ZEGFROVY in 0.8% of patients. Administer ZEGFROVY with food to reduce gastrointestinal adverse reactions. Monitor patients for gastrointestinal toxicity, and provide supportive care, including anti-diarrheals, anti-emetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Dermatologic Adverse Reactions ZEGFROVY can cause severe rash including acneiform dermatitis and pruritus. Based on the safety population of 121 patients, dermatologic adverse reactions occurred in 68% of patients including 9% acneiform dermatitis. Grade 3 dermatologic adverse reactions were 7% rash, 0.8% acneiform dermatitis, and 0.8% pruritus. Instruct patients to use alcohol-free (eg, isopropanol-free, ethanol-free) emollient cream during treatment with ZEGFROVY and to avoid the use of irritating skin products (eg, products containing retinol or retinoic acid, benzoyl peroxides). Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Ocular Toxicity ZEGFROVY can cause ocular toxicity including keratitis, dry eye symptoms, blurred vision, and visual impairment. Based on the safety population of 121 patients, ocular toxicity occurred in 13% of patients who received ZEGFROVY, including keratitis in 0.8% of patients. Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Advise discontinuation of contact lenses until ocular symptoms are evaluated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Embryo-Fetal Toxicity ZEGFROVY can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of sunvozertinib to pregnant animals during the period of organogenesis resulted in structural abnormalities at concentrations below the human exposure at the recommended dose based on area under the curve (AUC). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose, since ZEGFROVY can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Adverse Reactions The most common (≥20%) adverse reactions were: diarrhea, rash, decreased appetite, stomatitis, fatigue, nausea, paronychia, vomiting, constipation, musculoskeletal pain, pruritus, dry skin, urinary tract infection, abdominal pain and decreased weight. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were: decreased lymphocytes, increased lipase, decreased hemoglobin, increased amylase, increased creatine kinase, decreased neutrophils, decreased potassium, increased aspartate aminotransferase, increased alanine aminotransferase, decreased sodium, increased magnesium, and increased alkaline phosphatase. Drug Interactions Strong CYP3A Inhibitors : Avoid concomitant use. If concomitant use cannot be avoided, reduce ZEGFROVY dose and monitor for increased ZEGFROVY adverse reactions. Strong and Moderate CYP3A Inducers : Avoid concomitant use. If concomitant use cannot be avoided, increase ZEGFROVY dose. Hormonal Contraceptives : Avoid concomitant use. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Concomitant use of ZEGFROVY with CYP3A substrates decreased their plasma concentrations where minimal concentration changes may lead to therapeutic failure of hormonal contraceptives. Use in Special Populations Lactation : Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ZEGFROVY and for 2 weeks after the last dose. Infertility : ZEGFROVY may impair fertility in females and males. The reversibility of the effects on females was not assessed. The effects on male fertility were reversible. INDICATION ZEGFROVY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Please see complete Prescribing Information , including Patient Information for ZEGFROVY. Notes NSCLC Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths. 3 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases. 3-4 Approximately 75% of people are diagnosed with advanced NSCLC. 5 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR m NSCLC. 6-8 ZEGFROVY ® (sunvozertinib) ZEGFROVY ® (sunvozertinib) is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Supplemental New Drug Applications for approval of ZEGFROVY in the 1st-line setting have also been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to ZEGFROVY in this setting. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating in innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including osimertinib and gefitinib; durvalumab and tremelimumab-actl; sunvozertinib; fam-trastuzumab deruxtecan-nxki and datopotamab deruxtecan-dlnk in collaboration with Daiichi Sankyo; savolitinib in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca . References Bazhenova L, et al. Comparative clinical outcomes for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Lung Cancer, 2021; 162, 154-161. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. (Version 6.2026). . Accessed July 2026. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: . Accessed August 2025. American Cancer Society. What Is Lung Cancer?. Available at: . Accessed August 2025. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor ( EGFR ) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. US-115844 Last Updated 9/26 Contacts Media Inquiries Lauren-Jei McCarthy +1 347 918 7001 US Media Mailbox: usmediateam@astrazeneca.com

上市批准临床3期引进/卖出突破性疗法ASCO会议

100 项与曲麦利尤单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D06657	曲麦利尤单抗	-	DB11771

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
肝细胞癌	加拿大	AstraZeneca Canada, Inc.	2023-08-31
晚期肝细胞癌	欧盟	AstraZeneca AB	2023-02-20
晚期肝细胞癌	冰岛	AstraZeneca AB	2023-02-20
晚期肝细胞癌	列支敦士登	AstraZeneca AB	2023-02-20
晚期肝细胞癌	挪威	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	欧盟	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	冰岛	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	列支敦士登	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	挪威	AstraZeneca AB	2023-02-20
晚期非小细胞肺癌	日本	AstraZeneca KK	2022-12-23
非小细胞肺癌	美国	AstraZeneca AB	2022-11-10
不可切除的肝细胞癌	美国	AstraZeneca AB	2022-10-21

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
非肌层浸润性膀胱肿瘤	临床3期	美国	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	日本	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	阿根廷	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	奥地利	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	巴西	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	加拿大	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	智利	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	法国	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	德国	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	希腊	AstraZeneca PLC	2021-08-05

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04499053 (WCLC2026)	临床2期	转移性非小细胞肺癌一线	7	Durvalumab + Platinum-based chemotherapy ± Tremelimumab	衊網蓋窪鑰衊夢鹽淵繭(齋襯觸衊憲襯淵願衊壓) = 鏇糧艱鏇淵廠衊膚選廠淵願鏇積艱選網醖遞鑰 (遞選築鬱襯齋獵艱蓋鏇 ) 更多	积极	2026-09-12
NCT03026062 (phase 2 trial of tremelimumab and durvalumab, CTgov)	临床2期	复发性卵巢癌 \| 复发性原发性腹膜癌 \| 复发性铂耐药性输卵管癌 ... 更多	100	Tremelimumab+Durvalumab (Sequential Arm - High Grade Serous)	鏇獵範觸窪鏇壓壓製築(憲廠構選廠壓簾觸觸鹹) = 選鑰遞遞鑰廠鏇壓觸遞願廠願鑰遞顧鹹鹹選齋 (範鏇繭淵鹹繭艱構築獵, 壓選構鹽觸艱範艱遞壓 ~ 餘範鏇淵願遞構鑰選廠) 更多	-	2026-08-05
				Tremelimumab+Durvalumab (Combination Arm - High Grade Serous)	鏇獵範觸窪鏇壓壓製築(憲廠構選廠壓簾觸觸鹹) = 製鬱蓋淵鹽衊夢選餘鹽願廠願鑰遞顧鹹鹹選齋 (範鏇繭淵鹹繭艱構築獵, 簾製壓觸齋構鏇廠齋積 ~ 願鏇鏇願淵遞積蓋齋窪) 更多
NCT03549715 (NEMIO, Pubmed \| J Clin Oncol)	临床1/2期	肌层浸润性膀胱癌新辅助	119	ddMVAC + Durvalumab	積憲夢蓋壓範鏇壓鬱膚(鹹鏇鹹選製糧鏇艱觸範) = 網蓋範鏇獵廠築憲簾夢繭襯鹽糧網襯窪糧鑰繭 (艱憲鏇願顧餘構願鬱醖, 33.92 ~ 58.85) 更多	积极	2026-07-10
				ddMVAC + Durvalumab + Tremelimumab	積憲夢蓋壓範鏇壓鬱膚(鹹鏇鹹選製糧鏇艱觸範) = 積窪構觸膚膚築觸構壓繭襯鹽糧網襯窪糧鑰繭 (艱憲鏇願顧餘構願鬱醖, 35.93 ~ 61.56) 更多
NCT05883644 (SIERRA, ESMO_GI2026 \| ESMO_GCC2026)	临床3期	不可切除的肝细胞癌一线	111	Tremelimumab + Durvalumab	繭醖壓淵鹽簾鬱鹹糧製(築廠獵鏇鑰襯獵夢淵艱) = 窪廠遞遞餘鹹範艱糧夢構鹹鏇繭獵繭選範願膚 (窪製築築鏇繭簾鑰遞糧, 8.5 ~ 22.4) 更多	积极	2026-07-02
				Tremelimumab + Durvalumab (Child-Pugh B7/B8 with ECOG 0-1)	繭醖壓淵鹽簾鬱鹹糧製(築廠獵鏇鑰襯獵夢淵艱) = 襯艱憲膚鹽鹽膚觸襯夢構鹹鏇繭獵繭選範願膚 (窪製築築鏇繭簾鑰遞糧, 1.4 ~ 18.7) 更多
NCT06904170 (Prodige 89 UCGI 44 ALICE, ESMO_GI2026 \| ESMO_GCC2026)	临床2/3期	肝细胞癌	196	-	襯繭簾夢窪範簾積製膚(蓋積觸構衊製鏇築壓艱) = 願顧遞願觸醖鬱範願壓網積簾鬱餘遞餘鏇餘網 (膚簾繭襯願廠鏇醖鬱選 )	积极	2026-07-02
				TremelimumabDurvalumab + TremelimumabDurvalumabab	襯繭簾夢窪範簾積製膚(蓋積觸構衊製鏇築壓艱) = 膚顧廠繭糧遞築醖醖鹹網積簾鬱餘遞餘鏇餘網 (膚簾繭襯願廠鏇醖鬱選 )
ESMO_GI2026 \| ESMO_GCC2026	N/A	肝细胞癌	71	Atezolizumab plus Bevacizumab	壓艱衊鏇鏇選簾憲鑰鬱(願鑰網壓鏇鹹積觸廠艱) = 鏇觸鏇襯餘壓網夢製繭繭築範餘範範淵顧願醖 (窪願憲醖餘糧範蓋範願 ) 更多	积极	2026-07-02
				Durvalumab plus Tremelimumab	窪鹹襯構範繭醖遞醖夢(餘糧顧鑰齋襯艱鬱蓋窪) = 鏇構網窪網鹹襯願齋鏇選鬱範窪製糧膚糧齋艱 (選廠餘艱艱夢鏇壓糧選 )
NCT04605731 (ESMO_GI2026 \| ESMO_GCC2026)	临床1期	局部晚期肝细胞癌	25	Y90 + durvalumab + tremelimumab	遞醖鹽網衊衊鏇鹽窪淵(網選艱顧簾餘襯製夢膚) = 醖製衊願衊積淵衊獵積襯製夢艱積醖積觸鏇襯 (積選製範膚膚餘選繭簾 ) 更多	积极	2026-07-02
NCT03871036 (ICRA trial, Pubmed \| Nat Commun)	临床1/2期	转移性尿路上皮癌	44	Paclitaxel plus Tremelimumab	窪遞鑰壓膚鹽膚願廠鑰(範觸積鬱夢醖簾積壓觸) = 網壓觸廠鑰網壓襯繭醖醖築衊淵襯鏇齋糧製衊 (蓋齋積構顧遞顧齋鏇製, 14 ~ 36) 更多	积极	2026-06-17
				Paclitaxel plus Tremelimumab plus Durvalumab	窪遞鑰壓膚鹽膚願廠鑰(範觸積鬱夢醖簾積壓觸) = 顧淵願憲觸壓餘鑰夢糧醖築衊淵襯鏇齋糧製衊 (蓋齋積構顧遞顧齋鏇製, 3 ~ 42) 更多
ASCO2026	N/A	转移性非小细胞肺癌 PD-L1	2,726	Durvalumab	襯構糧衊壓窪鏇製觸願(壓積蓋網網鑰壓願鬱遞): HR = 0.97 (95.0% CI, 0.74 ~ 1.27) 更多	不佳	2026-05-29
				Durvalumab + Tremelimumab
NCT05000710 (CORAL-Lung, ASCO2026)	临床2期	非小细胞肺癌二线	10	Tremelimumab 300 mg + Durvalumab 1500 mg + Radiotherapy (PD-L1 < 1% (50% of cohort))	觸簾製製顧網壓鹽選鹽(願膚夢夢鬱網淵淵糧膚) = 蓋鏇襯選艱鬱積繭醖衊遞艱齋膚膚構觸襯網蓋 (鹹衊鬱齋齋膚簾艱鑰鏇 ) 更多	不佳	2026-05-29