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更新于：2026-07-07

Durvalumab

度伐利尤单抗

更新于：2026-07-07

概要

基本信息

药物类型

单克隆抗体

别名

Durvalumab (Genetical Recombination)、Durvalumab (genetical recombination) (JAN)、Durvalumab (USAN/INN)

+ [10]

靶点

PDL1

作用方式

抑制剂

作用机制

PDL1抑制剂(程序性死亡配体1抑制剂)

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [11]

在研适应症

非肌层浸润性膀胱肿瘤胃癌早期胃癌+ [183]

非在研适应症

急性髓性白血病肺腺癌前列腺腺癌+ [87]

原研机构

在研机构

+ [17]

非在研机构

Fred Hutchinson Cancer Research Center

AVEO Pharmaceuticals, Inc.

MedPacto, Inc.

+ [7]

权益机构

MedImmune Pharma BV

Ultimovacs ASAVall d'Hebron Institut d'Oncologia

+ [14]

最高研发阶段批准上市

首次获批日期

美国 (2017-05-01),

尿路上皮癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、优先审评 (美国)

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结构/序列

Sequence Code 10069506H

来源: *****

Sequence Code 13384675L

来源: *****

关联

923

项与度伐利尤单抗相关的临床试验

NCT07639528

/ Not yet recruiting临床2期IIT

Phase II, Open Label, Non-Randomized, Study of Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC)

This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and/or targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.

开始日期2027-12-10

申办/合作机构

Northwestern University

[+1]

NCT07637513

/ Not yet recruiting临床3期

Phase III Trial of Consolidation Tarlatamab + Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer (LS-SCLC)

Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.
Tarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer.
Image testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed.
The purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).

开始日期2027-01-01

申办/合作机构

Amgen, Inc.

NCT07247786

/ Not yet recruiting临床2期

Phase II Randomized Clinical Trial for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant (FMT) in Stage II-III Non-small Cell Lung Cancer (NSCLC) Patients, Using Immune Checkpoint Inhibitors (ICI) Responders as Donors.

This is a randomized, phase II, multi-centre clinical trial.
Sample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients)
Population: Patients with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer
In the Experimental arm, patients will receive Fecal Microbiota Transplant. Once done, the patient will start neoadjuvant treatment with Durvalumab + Chemotherapy .
In the Control arm, patients will receive neoadjuvant treatment with Durvalumab + Chemotherapy.
After neoadjuvant/induction treatment every patient will be evaluated to decide if the patient is a candidate for surgery or not. Patients that are R0 after surgery will receive Adjuvant treatment with Durvalumab.
The primary objective is to evaluate the pathological Complete Response (pCR) rate.
The total trial duration will be 6.5 years approximately.

开始日期2026-09-15

申办/合作机构

Fundacion GECP

100 项与度伐利尤单抗相关的临床结果

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100 项与度伐利尤单抗相关的转化医学

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100 项与度伐利尤单抗相关的专利（医药）

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2,341

项与度伐利尤单抗相关的文献（医药）

2026-10-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Systematic development and optimization of a cIEF method for the charge variants analysis of moderately basic to basic monoclonal antibodies using the Analytical Quality by Design strategy

Article

作者: Orlandini, Serena ; Massolini, Gabriella ; Furlanetto, Sandra ; Pasquini, Benedetta ; Luciani, Francesca ; Floris, Lucrezia ; Gotti, Roberto

This study proposes a Capillary IsoElectric Focusing Analytical Procedure Platform for the charge heterogeneity characterization of monoclonal antibodies. The Analytical Quality by Design approach was implemented to define a robust Method Operable Design Region using Infliximab as the primary model compound. The Analytical Target Profile consisted in a robust Analytical Procedure Platform able to measure the monoclonal antibody isoforms pI values with a bias lower than 4%. Risk Management tools were used to evaluate and control the risk of Analytical Target Profile failure. Risk Analysis identified several potential Critical Procedure Parameters, including urea and methyl cellulose concentrations, cathodic/anodic stabilizer levels, carrier ampholytes composition. The carrier ampholytes composition was optimized utilizing a mixture design. A Scheffé mixture model allowed the selection of experiments, and the Partial Least Squares regression provided high predictive power models for the three defined responses, i.e. the calibration biases at the bracketing markers of Infliximab (pI 9.5 and pI 7.0) and the overall fit of the pI vs. migration time relationship. Within the Method Operable Design Region, the optimized conditions were achieved using as the specific carrier ampholyte a blend constituted of 1.5% at pH 3-10, 1.5% at pH 5-8, and 2.0% at pH 8-10.5. The validation results demonstrated the robustness of the Analytical Procedure Platform, with a bias in pI measurement lower than 0.3% for the markers bracketing the Infliximab isoforms. In addition, the method was validated for linearity, trueness and precision as degree of repeatability in the quantification of the charge variants of Infliximab. Under the same optimized experimental conditions, the method was applied to successfully profile Bevacizumab, Daratumumab, Trastuzumab and Durvalumab. By including molecules exhibiting a broader range of physicochemical properties compared to the Infliximab model, the study confirms the versatility of the proposed Capillary IsoElectric Focusing method for moderately basic to basic antibodies. This work provides a refined, regulatory-compliant conventional electrokinetic methodology for biopharmaceutical quality control.

2026-08-01·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Mixture cure model analysis of event-free survival in the NIAGARA Trial: Quantifying the cure fraction benefit of perioperative durvalumab in muscle-invasive bladder cancer

Article

作者: Masuda, Hitoshi ; Chen, Wei ; Hirakawa, Akihiro ; Fujii, Yasuhisa ; Yajima, Shugo ; Yoshida, Soichiro ; Fukushima, Hiroshi ; Sato, Hiroyuki ; Tanaka, Hajime

INTRODUCTION:

The NIAGARA trial demonstrated improved event-free survival (EFS) with perioperative durvalumab plus gemcitabine-cisplatin (GC) vs. GC alone in muscle-invasive bladder cancer (MIBC). This analysis applied mixture cure models to explore whether this EFS benefit may reflect an increase in the proportion of patients achieving long-term event-free status, complementing standard hazard ratio analyses.

METHODS:

Reconstructed individual patient data (rIPD) were derived from published Kaplan-Meier curves. Parametric mixture cure models (Weibull, log-logistic, and log-normal) were fitted separately by treatment arm, with model selection based on the Akaike Information Criterion (AIC). Cure regression models decomposed treatment effects into cure and latency components. Sensitivity analyses assessed robustness to reconstruction uncertainty and follow-up duration.

RESULTS:

The rIPD reproduced the published trial results with reasonable concordance (hazard ratio 0.68 vs. reported 0.68). The log-normal model provided the best fit. The estimated cure fraction (π) was 41% (95% confidence interval [CI]: 32%-48%) for the control arm and 60% (95% CI: 55%-65%) for the durvalumab arm, yielding a model-based difference (Δπ) of +19 percentage points (pp) (95% CI: +10 to +29). Akaike weights favored a cure-effect-only model (71%) over a combined cure-plus-latency model (29%), with a latency-only model receiving negligible support (<1%). Perturbation sensitivity analyses indicated that these bootstrap intervals underestimate total uncertainty, with individual-run estimates spanning negative values at plausible reconstruction noise levels.

CONCLUSIONS:

In this exploratory analysis of reconstructed individual patient data, perioperative durvalumab was associated with an estimated +19 pp higher cure fraction (95% CI: +10 to +29); cure regression assigned an Akaike weight of 71% to a pure cure fraction mechanism vs. 29% to a combined cure-plus-latency mechanism. These estimates depend on the reconstructed dataset and on the assumption that the EFS curves have plateaued within the observed follow-up; perturbation sensitivity analyses indicated that at plausible reconstruction noise (SD ≥ 0.5 months) the range of individual-run estimates spans negative values.

2026-08-01·LUNG CANCER

Development of a clinical prediction model using digital device data for interstitial lung disease in patients with unresectable stage III non-small cell lung cancer treated with durvalumab

Article

作者: Sato, Yoshinori ; Kenmotsu, Hirotsugu ; Yamamoto, Nobuyuki ; Koto, Ryo ; Kitagawa, Hiroshi ; Iwao, Chikako ; Ikeda, Satoshi ; Ogi, Mizue ; Hirai, Takehiro

BACKGROUND:

Early detection of interstitial lung disease including radiation pneumonitis (ILD/RP) is crucial in consolidative durvalumab therapy after chemoradiotherapy (CRT) in unresectable stage III non-small cell lung cancer. We conducted a multicenter, noninterventional pilot study to develop clinical prediction models for grade ≥2 ILD/RP following durvalumab treatment by using machine learning algorithms on continuously collected automatic measurements from a wearable device and cough-counting smartphone application, as well as electronic medical record data.

METHODS:

The primary objective of this prospective observational study was to develop a clinical prediction model for grade ≥2 ILD/RP. Eight machine learning algorithms were applied to develop the prediction model. After performing 4-fold cross-validation, the prediction performance was evaluated using the area under the receiver operating characteristic curve (ROC-AUC).

RESULTS:

Of the 145 registered patients, 123 were analyzed. The median age was 68.0 years (range: 39-85), and 79.7% were male. Grade ≥2 ILD/RP occurred in 46 patients. The XGBoost model outperformed the other seven models for the primary objective, with an ROC-AUC of 0.789 (95% confidence interval [CI]: 0.724-0.854). Heart rate showed the highest SHapley Additive exPlanations value for grade ≥2 ILD/RP. The model using patient background and wearable device data (excluding cough app) showed accuracy comparable with the model using all data sources, with an ROC-AUC of 0.794 (95% CI: 0.730-0.859).

CONCLUSIONS:

These findings support the feasibility and acceptability of developing a clinical prediction model for grade ≥2 ILD/RP in patients undergoing durvalumab treatment after CRT.

2,996

项与度伐利尤单抗相关的新闻（医药）

2026-07-07

·Biotech前瞻

维恩妥尤单抗围手术期适应症在华申报：Nectin-4 ADC开始争夺膀胱癌治愈阶段

点击蓝字关注我们本期看点引言 7月6日，国家药监局药品审评中心受理了安斯泰来注射用维恩妥尤单抗的新适应症上市申请，受理号为JXSS2600058。此次申报拟将维恩妥尤单抗联合帕博利珠单抗前移至肌层浸润性膀胱癌（MIBC）围手术期治疗，并覆盖适合及不适合接受顺铂化疗的患者。这并不是一次常规的适应症扩展。维恩妥尤单抗最初用于晚期尿路上皮癌后线治疗，随后联合帕博利珠单抗进入晚期一线，如今进一步进入具有治愈意图的围手术期阶段。Nectin-4 ADC的定位也由晚期治疗药物，逐步转向贯穿尿路上皮癌不同疾病阶段的核心方案。 01 两项Ⅲ期研究，覆盖不同顺铂适用人群为了更直观地理解 Zoldonrasib 联合方案所带来肌层浸润性膀胱癌约占膀胱癌的四分之一至三成，根治性膀胱切除术是主要治疗手段。对于能够耐受顺铂的患者，顺铂新辅助化疗长期以来是标准治疗；但约半数患者受肾功能、听力、神经病变或其他合并症影响，不能接受顺铂，过去通常只能直接接受手术。即使完成手术，仍有相当比例患者出现复发。维恩妥尤单抗联合帕博利珠单抗分别通过KEYNOTE-905/EV-303和KEYNOTE-B15/EV-304两项Ⅲ期研究，回答了顺铂不适合与顺铂适合患者的围手术期治疗问题。 EV-303共纳入344例用于主要疗效分析的患者。与直接接受根治性膀胱切除术联合盆腔淋巴结清扫、术后观察相比，围手术期维恩妥尤单抗联合帕博利珠单抗将EFS事件风险降低60%，死亡风险降低50%，并将pCR率由8.6%提高至57.1%。基于该研究，美国FDA已于2025年11月批准这一方案用于不适合接受顺铂的MIBC患者。 EV-304则纳入808例适合接受顺铂的患者，将维恩妥尤单抗联合帕博利珠单抗与吉西他滨联合顺铂直接比较。结果显示，联合方案将EFS事件风险降低47%，死亡风险降低35%，并将pCR率由32.5%提高至55.8%。这意味着在能够接受顺铂的患者中，非铂类ADC联合免疫方案也首次在生存终点上超越传统新辅助化疗。两项研究共同形成了较完整的证据链：对于顺铂不适合患者，联合方案较单纯手术显著改善生存；对于顺铂适合患者，联合方案又进一步优于长期标准的新辅助顺铂化疗。此次在华申报的核心意义，正在于有望弱化顺铂适用性对围手术期治疗选择的限制。无铂优效不等于治疗负担更低 EV-304证明了无铂方案可以优于含顺铂化疗，但这并不意味着治疗更简单或毒性更低。该研究中，维恩妥尤单抗联合帕博利珠单抗组≥3级治疗期间不良事件发生率为75.7%，对照组为67.2%。传统化疗的不良反应主要集中于骨髓抑制、恶心呕吐和肾毒性；ADC联合免疫治疗则需要重点关注皮肤反应、周围神经病变、高血糖、免疫相关不良事件和间质性肺病。此外，EV-304试验组不仅接受4个周期的新辅助治疗，术后还需继续完成维恩妥尤单抗及帕博利珠单抗辅助治疗，整体治疗时间明显长于4周期新辅助化疗。因此，临床价值不能只看pCR率，还需要综合考虑手术完成率、治疗中断、长期神经毒性、患者依从性和医疗成本。对于围手术期患者而言，治疗目标不是短期缩小肿瘤，而是在不影响根治性手术的基础上减少复发并延长生存。未来中国临床实践中的关键问题，也将从能否使用这一方案，转向哪些患者最适合、如何管理较长疗程以及如何处理术前和术后毒性。 02 Padcev正在成为膀胱癌联合治疗的重要基础药物维恩妥尤单抗由安斯泰来与Seagen共同开发。辉瑞于2023年完成对Seagen的收购，目前该产品由安斯泰来和辉瑞共同推进，帕博利珠单抗则来自默沙东。从后线单药、晚期一线联合，再到MIBC围手术期治疗，维恩妥尤单抗的前移路径已经较为清晰。此前，其单药用于既往接受铂类化疗和PD-1/PD-L1治疗的晚期尿路上皮癌，以及联合帕博利珠单抗用于局部晚期或转移性尿路上皮癌的一线治疗，均已在中国获批。更值得关注的是，选择维恩妥尤单抗作为联合对象的并不只有默沙东。阿斯利康开展的Ⅲ期VOLGA研究显示，在不适合或拒绝顺铂的MIBC患者中，度伐利尤单抗联合新辅助维恩妥尤单抗同样显著改善EFS和OS。两家跨国药企选择不同的免疫检查点抑制剂，却共同采用Nectin-4 ADC，说明维恩妥尤单抗正在成为膀胱癌免疫联合方案中的重要基础药物。 03 国产Nectin-4 ADC已进入关键临床阶段国内进展较快的产品主要包括迈威生物9MW2821和恒瑞医药SHR-A2102。迈威生物9MW2821已在尿路上皮癌、宫颈癌及三阴性乳腺癌等多个瘤种推进临床开发，目前共有4项关键Ⅲ期研究开展。公司计划于2026年对尿路上皮癌单药、联合治疗及宫颈癌单药Ⅲ期研究进行期中分析。其联合特瑞普利单抗围手术期治疗MIBC的Ⅱ期研究已报告初步结果，但目前完成根治性膀胱切除术的患者仅6例，其中4例达到pCR，样本量仍不足以进行成熟判断。恒瑞医药SHR-A2102采用拓扑异构酶Ⅰ抑制剂载荷，与维恩妥尤单抗使用的MMAE载荷不同。其联合阿得贝利单抗用于MIBC围手术期治疗的Ⅱ/Ⅲ期研究中，截至数据截止时共纳入37例患者，27例完成根治性膀胱切除术，pCR率为48.1%，且未有患者因治疗相关不良事件失去手术机会。该研究计划继续进入Ⅲ期阶段。这些进展表明，国产产品已经开始沿着晚期单药、晚期一线联合和围手术期治疗的路径推进。但目前多数数据仍来自早期、小样本或单臂研究，不能直接与EV-303和EV-304进行横向比较。 04 总结与展望维恩妥尤单抗围手术期适应症在华申报，意味着中国MIBC治疗可能迎来一次重要前移：Nectin-4 ADC联合免疫治疗不再局限于晚期患者，而是开始进入以减少复发和提高治愈机会为目标的治疗阶段。 EV-303和EV-304分别覆盖顺铂不适合及适合患者，并均取得EFS、OS和pCR改善，使维恩妥尤单抗联合帕博利珠单抗具备覆盖更广泛MIBC患者的证据基础。但无铂并不等于低毒，较长治疗周期、皮肤毒性、周围神经病变和治疗完成率仍需要在真实临床中持续评估。对于国产Nectin-4 ADC而言，机会依然存在，但竞争目标已经改变。未来需要追赶的不是Padcev某一项单药缓解率，而是其已经建立的围手术期生存证据、免疫联合能力和全疾病阶段开发体系。 Nectin-4 ADC的竞争，已经从药物活性比较进入治疗路径竞争。谁能进入更早期患者、提供更稳定的长期获益，并建立可持续的联合方案，谁才可能获得下一阶段的临床和商业价值。 ★

2026-07-07

·BioSpace

AIM ImmunoTech Announces Release of New CEO Corner Segment Highlighting Growing Momentum Across Pancreatic Cancer Program

CEO Thomas Equels discusses recent clinical progress, upcoming milestones and the Company's commitment to advancing Ampligen® for patients with pancreatic cancer Access it here OCALA, Fla., July 07, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the release of its latest CEO Corner segment, featuring Chief Executive Officer Thomas Equels discussing the Company's continued momentum in pancreatic cancer and the significant clinical, strategic and operational milestones positioning Ampligen® for its next stage of development. In the segment, Mr. Equels highlights the urgent unmet need facing patients with pancreatic cancer, reviews recent progress across the Company's DURIPANC Phase 2 clinical program evaluating Ampligen® (rintatolimod) in combination with AstraZeneca's Imfinzi® (durvalumab), and discusses why AIM believes it is entering one of the most catalyst-rich periods in the Company's history. Topics discussed include the successful completion of patient enrollment and dosing in the DURIPANC study, encouraging interim clinical observations, continued favorable safety findings, ongoing Phase 3 planning activities, the Company's strategic collaboration with AstraZeneca and Erasmus Medical Center, expansion of AIM's intellectual property portfolio and the broader potential of Ampligen to help overcome resistance in immunologically "cold" tumors. The latest CEO Corner segment is now available on the Company's website here . About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials. For more information, please visit aimimmuno.com and connect with the Company on X , LinkedIn , and Facebook . Cautionary Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor created by those sections. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For all forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “believes,” “expects,” “intends,” “may,” “will,” “plans,” “potential,” “anticipates,” “projects,” or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, but the absence of these words does not mean that a statement is not forward-looking. Any forward-looking statements set forth in this press release speak only as of the date hereof. These forward-looking statements are based upon the Company’s current expectations, estimates, assumptions, and beliefs concerning future events and conditions, which are subject to change. Such forward-looking statements may include statements relating to: the timing of evaluation of the DURIPANC study’s primary endpoint; the anticipated survival outcomes, quality-of-life measures, and the safety pro subjects and the expected timing thereof; the Company’s Phase 3 clinical trial planning efforts; the potential advancement of Ampligen toward pivotal-stage development; the timing of commencement, enrollment, completion, and results of clinical trials; IP expansion and regulatory progress; and timing for receiving government approvals, if at all. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof, except as required by applicable law. The Company is in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders, and disclosures in the Company’s reports filed with the U.S. Securities and Exchange Commission (the “SEC”), on its website, and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen ® will be effective in the treatment of these conditions. Results obtained in preclinical studies do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen ® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data, and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, lack of adequate funding, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data. No assurance can be given that the findings in preliminary studies will prove true or that such studies will yield favorable results, or that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website, and in its press releases. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks. For a detailed discussion of risk factors that could cause actual results to differ materially from those described in the forward-looking statements, please review the “Risk Factors” section in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC. The forward-looking statements in this press release should be read in conjunction with such filings. These filings are available at and The information found on the Company’s website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com

临床2期临床3期免疫疗法

2026-07-06

·医学界肿瘤前沿

免疫“踩油门”与ADC“精准制导”：ES-SCLC迎来双重创新驱动时代｜ 2026 CSCO BOC

*仅供医学专业人士阅读参考 TCE全面接棒、ADC多点开花整理 | NIENIE 2026年7月3-4日，由中国临床肿瘤学会（CSCO）与北京市希思科临床肿瘤学研究基金会联合主办的"2026年中国临床肿瘤学年度新进展学术研讨会（BOC）暨Best of CSCO 2026 China"在内蒙古呼和浩特落幕。会上，解放军总医院汪进良教授带来了《SCLC新型免疫与抗体偶联药物新进展》的重磅报告。报告聚焦于临床可落地的循证数据，梳理了广泛期小细胞肺癌（ES-SCLC）现存的治疗瓶颈，重点解读了新型免疫与抗体偶联药物（ADC）的新进展，为SCLC临床分层用药、新药临床转化提供了权威参考，本文特此整理核心内容，以飨读者。一线免疫化疗已成标准，多重临床痛点亟待新药破局汪进良教授首先梳理了ES-SCLC治疗体系，明确了PD-（L）1抑制剂+化疗是当前全球公认的一线标准方案。多项长期随访III期数据证实，免疫联合方案长期生存优势显著：替雷利珠单抗联合化疗4年总生存（OS）率为18.9%，度伐利尤单抗联合化疗4年OS率为14.3%，阿替利珠单抗联合化疗4 年OS率为13%，斯鲁利单抗联合化疗4年OS率为21.9%，而传统单纯化疗4年OS率仅7.2%。此外，目前多款免疫联合化疗方案已在国内获批适应症并纳入医保目录，显著提升了患者用药可及性。图1：多项免疫研究数据然而，即便一线免疫化疗改善了总体生存，临床实践中仍存在三大核心短板：其一，绝大多数患者经一线铂类±免疫治疗后进展，后线有效治疗选择稀缺；其二，大型III期研究基线数据显示，约44%的患者初诊即合并脑转移，传统方案对颅内病灶控制效果有限；其三，肿瘤易发生免疫耐药，常规免疫药物疗效受限。在此背景下，DLL3-TCE、多靶点ADC成为领域研发的核心突破口。打破“免疫刹车”天花板：TCE开辟杀瘤新路径汪进良教授形象地比喻了PD-（L）1抑制剂与TCE 药物的机制差异：PD-（L）1抑制剂属于免疫“松刹车”，可解除对T细胞免疫功能的抑制，恢复T细胞的抗肿瘤功能；而TCE则为免疫“踩油门”，可直接激活T细胞杀伤肿瘤细胞，且不依赖肿瘤自身抗原递呈，因此能够有效克服临床常见的免疫耐药。当前全球DLL3-TCE研发管线已步入成熟阶段，多款核心药物进入临床关键开发期，其中以全线布局的塔拉妥单抗、新一代差异化管线ZG006、Obrixtamig为代表，形成了梯度化、全覆盖的创新治疗体系。图2：目前SCLC领域TCE药物研发现状塔拉妥单抗：覆盖后线、二线、一线治疗场景 ≥3 线人群：疗效与安全性获得验证全球II期DeLLphi-301研究纳入多线治疗失败的复发SCLC患者，数据显示，确认的客观缓解率（ORR）达40%，中位缓解持续时间（DoR）为9.7个月，43%的缓解患者仍在持续缓解中；中位无进展生存期（mPFS）为4.3个月，mOS为15.2个月，1年OS率为57%。且无论患者DLL3表达高低，均能观察到明确肿瘤退缩。图3：DeLLphi-301研究结果聚焦中国人群的多中心II 期DeLLphi-307研究共入组 31例 ES-SCLC患者，71%接受过三线治疗。研究确认的ORR为39%，中位至缓解时间为1.3个月，中位PFS为2.9个月，中位OS尚未达到；安全性整体可控，细胞因子释放综合征（CRS）多为1-2级，全程未出现免疫效应细胞相关神经毒性综合征（ICANS）。图4：DeLLphi-307研究数据二线III期DeLLphi-304 ：全身、颅内双重生存获益 DeLLphi-304为全球、多中心、随机对照III期研究，共纳入509例一线免疫化疗进展的患者，1：1随机分配至塔拉妥单抗组或化疗组，71%的患者既往接受过PD-（L）1治疗，44%基线合并脑转移，研究主要终点为OS。图5：DeLLphi-304研究设计在全身抗肿瘤疗效层面，塔拉妥单抗组确认的ORR为35%，显著高于化疗组的 20%；两组中位DoR为6.9个月 vs 5.5个月，12个月持续缓解率为41% vs 13%；核心终点mOS为13.6个月 vs 8.3个月，HR=0.60，所有预设亚组均观察到一致的生存获益。脑转移亚组事后分析成为亮点：塔拉妥单抗可降低46%的颅内进展或死亡风险，颅内PFS为6.5个月 vs 4.2个月；颅内CR率为14.9%，远高于化疗组5.4%。分层分析证实，无论基线是否合并脑转移，患者均可获得显著OS获益。图6：DeLLphi-304研究结果一线联合探索数据亮眼，有望改写初治患者维持方案在联合治疗探索中，塔拉妥单抗联合PD-（L）1抑制剂用于一线诱导及维持治疗的中期数据（DeLLphi-303研究）显示，12个月OS率高达80.6%，中位OS尚未达到；单药一线维持方案mOS可达25.3个月，大幅突破传统免疫化疗生存上限，为初治患者提供免化疗长期维持新思路。目前，配套的III期确证试验正在稳步推进。图7：塔拉妥单抗在不同治疗线数人群中的研究新一代DLL3-TCE管线蓬勃发展，多款药物进入III期注册阶段 ZG006：作为国内自主研发的三特异性TCE，ZG006通过优化Fc段结构延长了药物半衰期。后线II期研究中，10mg与30mg剂量组确认的ORR分别为 53.3%、56.7%；10mg组mPFS为7.03 个月，15个月OS 率为61.2%。治疗相关不良反应以发热、CRS为主，3 级以上不良事件发生率为30%，安全性可控。图8：ZG006研究疗效与安全性数据 Obrixtamig：作为一款IgG样双特异性TCE，后线联合免疫治疗数据显示，其1080μg/kg高剂量组ORR为58%，DCR率为83%，中位PFS为10.0个月；CRS发生率为78%，ICANS发生率为13%。DAREON-8研究中，Obrixtamig 联合卡铂、依托泊苷、阿替利珠单抗，60mg剂量组ORR达76%，3例患者实现CR，6个月缓解持续率为81%。目前，全球III期 DAREON-Lung-1注册研究已开启入组。图9：Obrixtamig研究相关数据多靶点新型ADC迎来突破性进展除TCE外，汪教授会上还系统盘点了当前SCLC领域ADC研发管线，靶点涵盖了B7-H3、TROP2、SEZ6、EGFR×HER3、DLL3等，其中B7-H3靶点在研药物共7款，整体研发趋势清晰：初代DLL3 ADC因分子结构短板临床失利，经迭代优化的新一代DLL3 ADC以及靶向EGFR×HER3、SEZ6的ADC取得亮眼临床数据。 Rova-T：初代 DLL3 ADC存在先天缺陷，关键III期研究失利作为最早进入临床的DLL3靶向ADC，Rova-T受限于DAR值较低、连接子稳定性差、毒素毒性大三大短板，血液、皮肤相关不良反应突出。二线TAHOE、一线维持MERU研究均证实其疗效不及标准方案，最终全球研发终止。图10：TAHOE、MERU研究数据 ZL-1310：新一代优化型DLL3 ADC，颅内病灶控制优势突出作为新一代优化型DLL3 ADC，ZL-1310完成了分子结构的全面升级。I 期剂量探索确定了1.6mg/kg 为最优给药剂量，单药确认的ORR为57%，DCR率高达100%。针对41例基线脑转移患者的亚组分析显示，颅内ORR为53.7%，7 例患者实现颅内CR，既往未接受脑部放疗的人群颅内缓解率可达60%，全程无严重神经毒性、颅内出血事件发生。 Iza-bren（BL-B01D1）：国产EGFR×HER3双特异性ADC，一线联合免疫缓解率可观 Iza-bren是一款国产EGFR×HER3双特异性ADC，可同步靶向SCLC高表达的EGFR和HER3抗原。后线单药治疗确认的ORR为44.8%；在II期探索性研究中，联合斯鲁利单抗一线治疗初治的ES-SCLC，2.5mg/kg组确认的ORR为77.5%，2.75mg/kg78.4%，整体人群DCR为94.8%。综合疗效与安全性，2.5mg/kg已被确定为III期注册研究推荐剂量。图11：Iza-bren研究数据 ABBV-706（SEZ6 ADC）：后线单药ORR高达 82%，联合免疫拓展获益人群在1.8mg/kg剂量下，该药物单药二线治疗复发难治的SCLC，ORR高达82%，中位DoR为6.6个月；中位随访16.4个月，mPFS为6.8个月，mOS为14.3个月。其联合PD-L1抑制剂budigalimab的探索性方案显示ORR为54.5%，临床获益率为81.8%，为多重耐药的后线患者提供了全新的治疗选择。图12：ABBV-706联合方案疗效 SCLC迈入精准免疫新时代，多类新药重塑全线治疗格局汪进良教授在报告结尾指出，SCLC领域发展经历了3个阶段：长达三十年的单纯化疗时代、2018年后免疫联合化疗确立一线标准的时代，以及未来TCE与ADC创新药物并行的精准治疗时代。图13：SCLC领域发展阶段从药物发展趋势来看，DLL3-TCE已形成完整临床证据链：塔拉妥单抗顺利拿下二线、后线两大适应症，一线联合方案生存潜力突出；ZG006、Obrixtamig等新一代TCE进入III期确证阶段，针对脑转移、免疫耐药人群具备独特临床价值，有望完整覆盖全线治疗需求。ADC赛道方面，靶点多元化布局成效逐步显现：DLL3 ADC经分子迭代弥补了初代药物的短板，ZL-1310在颅内抗肿瘤方面优势明显；EGFR×HER3及SEZ6等新靶点ADC实现了高ORR，有效填补了传统治疗后的空白。未来，TCE与ADC药物将与 PD-（L）1 抑制剂、化疗开展多样化联合探索，根据初治、免疫耐药、合并脑转移等不同患者特征分层施治，有望彻底打破ES-SCLC长期生存瓶颈，为患者带来长期生存新希望。责任编辑：静秋 *医学界力求其发表内容专业、可靠，但不对内容的准确性做出承诺；请相关各方在采用或以此作为决策依据时另行核查。更多医疗资讯，点击“阅读原文”查看

100 项与度伐利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10808	度伐利尤单抗	L01XC28	DB11714

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
非肌层浸润性膀胱肿瘤	美国	AstraZeneca UK Ltd.	2026-05-28
胃癌	欧盟	AstraZeneca AB	2026-03-16
胃癌	冰岛	AstraZeneca AB	2026-03-16
胃癌	列支敦士登	AstraZeneca AB	2026-03-16
胃癌	挪威	AstraZeneca AB	2026-03-16
早期胃癌	美国	AstraZeneca PLC	2025-11-25
胃食管交界处腺癌	美国	AstraZeneca UK Ltd.	2025-11-25
胃食管交界处癌	美国	AstraZeneca PLC	2025-11-25
局部晚期胃癌	美国	AstraZeneca PLC	2025-11-25
不可切除的非小细胞肺癌	中国	AstraZeneca UK Ltd.	2025-11-18
肌层浸润性膀胱癌	美国	AstraZeneca UK Ltd.	2025-03-28
子宫癌	日本	阿斯利康制药有限公司	2024-11-22
晚期子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	挪威	AstraZeneca AB	2024-08-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
ALK阳性非小细胞肺癌	申请上市	中国	AstraZeneca AB	2025-02-21
EGFR突变的非小细胞肺癌	申请上市	中国	AstraZeneca UK Ltd.	2025-02-21
卵巢上皮癌	申请上市	中国	AstraZeneca UK Ltd.	2024-08-16
错配修复功能正常的微卫星稳定型结肠癌	临床3期	西班牙	AstraZeneca PLC	2024-12-30
PD-L1阳性三阴性乳腺癌	临床3期	美国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	中国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	日本	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	阿根廷	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	澳大利亚	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	巴西	AstraZeneca PLC	2023-11-23

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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


NCT03691714 (P397, CTgov)	临床2期	复发性头颈癌 \| 转移性头颈部鳞状细胞癌 \| 转移性肿瘤	35	Cetuximab+Durvalumab	廠顧鏇範夢醖鬱齋選膚 = 網廠構觸糧糧憲構憲夢構憲窪築鏇簾鑰選構範 (鏇觸窪廠襯蓋憲淵鹹繭, 鹹壓製淵廠繭壓淵繭遞 ~ 築夢範繭蓋衊顧醖窪廠) 更多	-	2026-06-01
ASCO2026	N/A	PD-L1阳性非小细胞肺癌 PD-L1 positive \| PD-L1 negative	340	Durvalumab (PD-L1 positive)	膚繭餘醖顧網糧願鑰網(鑰壓遞膚蓋願願構廠顧) = 鑰餘遞蓋襯觸憲艱窪艱窪觸顧糧醖網憲顧壓鹹 (顧糧憲鑰鹹壓獵鹽醖範, 29.8 ~ 47.3) 更多	积极	2026-05-29
				Durvalumab (PD-L1 negative)	膚繭餘醖顧網糧願鑰網(鑰壓遞膚蓋願願構廠顧) = 網艱網顧膚範鬱繭憲鬱窪觸顧糧醖網憲顧壓鹹 (顧糧憲鑰鹹壓獵鹽醖範, 21.6 ~ 39.7) 更多
ASCO2026	N/A	广泛期小细胞肺癌一线	2,182	Platinum-etoposide plus durvalumab	糧憲餘網鹽範鏇範夢膚(網顧夢鏇繭築築願蓋鬱) = 蓋襯積齋艱製鑰艱夢鹹積鏇艱餘鑰壓憲遞鹹觸 (膚觸遞餘鑰襯壓顧顧憲 ) 更多	积极	2026-05-29
				Platinum-etoposide alone	糧憲餘網鹽範鏇範夢膚(網顧夢鏇繭築築願蓋鬱) = 簾壓獵觸廠築製淵觸觸積鏇艱餘鑰壓憲遞鹹觸 (膚觸遞餘鑰襯壓顧顧憲 ) 更多
NCT05903092 (MOZART, ASCO2026)	临床2期	广泛期小细胞肺癌一线	30	Monalizumab + Durvalumab + Platinum-based Chemotherapy	夢餘蓋鹽簾壓糧襯積獵(網艱襯蓋衊齋鹽餘築鹹) = 觸鏇餘積憲製鏇繭繭艱顧獵齋選鹹廠衊網鹽衊 (窪範艱壓壓齋膚衊網蓋 ) 更多	不佳	2026-05-29
NCT03410615 (CCTG HN.9, ASCO2026)	临床2期	口咽部鳞状细胞癌 HPV+	129	cisplatin + cisplatinapy (PD-L1 unselected + HPV-positive locally advanced oropharyngeal squamous cell carcinoma)	憲築鑰壓範夢壓鬱獵鏇(夢願鹹網衊觸餘觸觸積) = 顧顧築夢壓襯鏇獵製醖窪鹽顧製築築網願廠鹽 (夢願遞衊襯夢壓構壓憲 ) 更多	不佳	2026-05-29
				durvalumab + durvalumabpy (PD-L1 unselected + HPV-positive locally advanced oropharyngeal squamous cell carcinoma)	憲築鑰壓範夢壓鬱獵鏇(夢願鹹網衊觸餘觸觸積) = 網選鹽繭獵鏇齋顧餘觸窪鹽顧製築築網願廠鹽 (夢願遞衊襯夢壓構壓憲 ) 更多
ASCO2026	N/A	广泛期小细胞肺癌一线	138	platinum-etoposide + Atezolizumab	齋鏇夢膚蓋範積遞鹹鑰(獵糧鏇鏇艱鬱夢積願艱) = 製觸鏇鹽顧鹽顧繭獵鬱鹽憲鏇膚製鹹顧網膚襯 (築窪壓獵襯襯鬱簾鏇艱 ) 更多	不佳	2026-05-29
				platinum-etoposide + Durvalumab	齋鏇夢膚蓋範積遞鹹鑰(獵糧鏇鏇艱鬱夢積願艱) = 觸鏇積鹽鑰襯構衊膚壓鹽憲鏇膚製鹹顧網膚襯 (築窪壓獵襯襯鬱簾鏇艱 ) 更多
NCT06464068 (DURVASCC, ASCO2026)	临床2期	广泛期小细胞肺癌一线	20	Durvalumab 1500 mg + Carboplatin AUC5-6 or Cisplatin 75-80 mg/m2 + Etoposide 80-100 mg/m2	鏇簾鏇淵艱觸壓願膚壓(鏇築憲壓觸範膚壓膚製) = 繭膚醖齋鬱糧繭鹽積齋鬱齋壓製獵願繭選襯廠 (鹽夢築糧鑰構觸鹽獵構 ) 更多	积极	2026-05-29
NCT04159974 (RICE, ASCO2026)	临床2期	食管腺癌辅助 \| 新辅助	56	Neoadjuvant durvalumab + chemoradiotherapy (CROSS)	鏇夢獵網簾襯壓艱艱壓(糧鑰簾鬱範簾鬱糧簾夢) = 獵夢網網襯製鏇廠網鬱廠壓蓋窪遞遞願積醖網 (糧選遞範網窪範選繭鹹 ) 更多	积极	2026-05-29
				Neoadjuvant durvalumab + chemoradiotherapy (CROSS)	糧夢壓選夢衊繭築襯醖(鬱鹹齋簾範膚構齋夢膚) = 選網鬱遞願餘遞獵衊觸醖繭積選膚憲壓築壓憲 (壓夢膚蓋遞夢選繭積鹹 ) 更多
ASCO2026	N/A	胃癌	327	Durvalumab	壓築憲襯憲壓醖獵遞觸(艱襯鹹鹽蓋構觸壓衊壓) = 憲膚願觸鹽艱鑰鑰製積觸觸廠鏇壓選膚膚範積 (膚憲醖鏇憲積構餘壓鬱 ) 更多	积极	2026-05-29
				Pembrolizumab	壓築憲襯憲壓醖獵遞觸(艱襯鹹鹽蓋構觸壓衊壓) = 憲鑰遞醖膚廠製選鏇衊觸觸廠鏇壓選膚膚範積 (膚憲醖鏇憲積構餘壓鬱 ) 更多
ASCO2026	N/A	广泛期小细胞肺癌一线 \| 维持	2,063	Atezolizumab + platinum-based chemotherapy	選餘繭簾齋衊醖齋繭鹽(築鑰觸鬱夢遞膚築製餘) = 獵獵鹽鹽醖衊鏇鏇繭衊廠淵鹹夢積夢鏇觸網壓 (襯憲淵選簾獵窪糧網繭, 7.9 ~ 9.5)	非劣	2026-05-29
				Durvalumab + platinum-based chemotherapy	選餘繭簾齋衊醖齋繭鹽(築鑰觸鬱夢遞膚築製餘) = 鏇夢繭顧淵範獵願襯齋廠淵鹹夢積夢鏇觸網壓 (襯憲淵選簾獵窪糧網繭, 8.2 ~ 9.3)