预约演示
更新于：2026-07-07
Domvanalimab
更新于：2026-07-07
概要
基本信息
药物类型 单克隆抗体 |
别名 AB-154 |
靶点 |
作用方式 抑制剂 |
作用机制 TIGIT抑制剂(T细胞免疫球蛋白ITIM结构域抑制剂) |
在研适应症 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评孤儿药 (欧盟) |
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结构/序列
Sequence Code 22751923L
来源: *****
Sequence Code 631427673H
来源: *****
关联
27
项与 Domvanalimab 相关的临床试验NCT07337447
PRODIGE 113 (FFCD 2314) - REWENEC 01 STUDY Randomized Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin. Phase II Comparative Randomized Study - Multicentric
Background Neuroendocrine carcinomas (NECs) of gastro-entero-pancreatic (GEP) or unknown (UK) origin are rare and highly aggressive diseases. The recommended first-line (L1) treatment is platinum-etoposide combination therapy, which has a progression-free survival (PFS) of only 4-9 months and a median overall survival (OS) of approximately 12 months. All patients experience relapse, often rapidly after this first line of chemotherapy. The standard second-line (L2) chemotherapies recommended by ESMO, ENETS, and NCCN, FOLFIRI and FOLFOX, have modest efficacy with a PFS of 3 months and a median OS of 6 months. The BEVANEC study (PHRCK 2014, NCT02820857) reported no benefit of FOLFIRI + bevacizumab compared to FOLFIRI in a randomized phase II study that enrolled 150 patients in 26 centers over a period of 5 years in France.
To date, the most promising efficacy data for this highly aggressive cancer come from clinical trials of immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 checkpoint. For example, in France, the non-comparative phase II NIPINEC trial (NCT03591731) randomized patients to receive nivolumab +/- ipilimumab in L2/3 and achieved its primary evaluation criterion (ORR-8 weeks>10%). Other trials in Europe and worldwide have also reported efficacy data in the context of single-arm studies.
Scientific Questions and Unmet Needs:
1. New therapeutic options/perspectives are necessary for patients with GEP/UK NECs given the limited overall survival.
2. Approximately 50% of patients experienced early progression under immunotherapy in the NIPINEC trial and other trials, which may be explained by the absence of chemotherapy combined with immunotherapy and/or the existence of resistance mechanisms.
3. In the GEP/UK NEC indication, the design of these immunotherapy trials has been non-comparative single-arm studies because the realization of randomized comparative trials is considered very difficult for these very rare cancers (incidence <5/million).
Rationale for the REWENEC-01 Trial The DURIGAST PRODIGE 59 study, conducted by the FFCD, demonstrated the feasibility and safety of the FOLFIRI + double immune checkpoint inhibitor (anti-PD-1 and anti-CTLA4) combination, as well as for the combination Folfox-Domvanalimab-Zimberelimab (anti-PD-1 and anti-TIGIT). In a translational study of the immune phenotype in patients with NECs treated with the anti-PD1 pembrolizumab, an increase in TIGIT expression was observed after pembrolizumab treatment and higher TIGIT expression on T cells in the blood of patients with high Ki67 expression in their tumors. These data suggest that TIGIT is a potential complementary therapeutic target to PD-1/PD-L1 checkpoint inhibition in GEP/UK NECs. Domvanalimab has been developed as an anti-TIGIT monoclonal antibody and zimberelimab as an anti-PD-1.
Design and primary objective of the REWNEC-01 Trial The REWENEC-01 trial is a comparative phase II trial that will randomize GEP/UK NEC patients between an experimental arm FOLFIRI+Zimberelimab + Domvanalimab and a control arm FOLFIRI in L2. The FOLFIRI arm will be a "hybrid" synthetic control arm composed of patients from historical/external data from the FOLFIRI arm of BEVANEC and French retrospective studies RBNEC and CEPD, mixed with patients recruited prospectively during the trial and randomized to the control arm. The randomization ratio for patients included prospectively during the trial will be 4:1 (4 patients assigned to FOLFIRI+Zimberelimab + Domvanalimab for 1 patient assigned to FOLFIRI). The randomization algorithm will take into account "external" patients assigned progressively to the control arm to obtain a 1:1 ratio between the trial arms, with balanced distributions of stratification factors between the two arms.
With 77 patients to be included, this strategy will provide statistical power equivalent to that of a trial including 122 patients, sufficient to demonstrate an advantage in overall survival rate at 12 months from 32% to 50%.
The hypotheses related to efficacy criteria are formulated a priori, as recommended by the FDA guidance document on trials with synthetic/external control arms. The proof of concept has been reported at ESMO 2023. The primary judgment criterion will be the overall survival rate at 12 months because it is a strong and significant criterion for translating the clinical benefit of the Chemotherapy + Zimberelimab + Domvanalimab combination. The design with a hybrid synthetic control arm allows for the consideration of a randomized comparative study in a cancer as rare as neuroendocrine carcinoma.
To date, the most promising efficacy data for this highly aggressive cancer come from clinical trials of immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 checkpoint. For example, in France, the non-comparative phase II NIPINEC trial (NCT03591731) randomized patients to receive nivolumab +/- ipilimumab in L2/3 and achieved its primary evaluation criterion (ORR-8 weeks>10%). Other trials in Europe and worldwide have also reported efficacy data in the context of single-arm studies.
Scientific Questions and Unmet Needs:
1. New therapeutic options/perspectives are necessary for patients with GEP/UK NECs given the limited overall survival.
2. Approximately 50% of patients experienced early progression under immunotherapy in the NIPINEC trial and other trials, which may be explained by the absence of chemotherapy combined with immunotherapy and/or the existence of resistance mechanisms.
3. In the GEP/UK NEC indication, the design of these immunotherapy trials has been non-comparative single-arm studies because the realization of randomized comparative trials is considered very difficult for these very rare cancers (incidence <5/million).
Rationale for the REWENEC-01 Trial The DURIGAST PRODIGE 59 study, conducted by the FFCD, demonstrated the feasibility and safety of the FOLFIRI + double immune checkpoint inhibitor (anti-PD-1 and anti-CTLA4) combination, as well as for the combination Folfox-Domvanalimab-Zimberelimab (anti-PD-1 and anti-TIGIT). In a translational study of the immune phenotype in patients with NECs treated with the anti-PD1 pembrolizumab, an increase in TIGIT expression was observed after pembrolizumab treatment and higher TIGIT expression on T cells in the blood of patients with high Ki67 expression in their tumors. These data suggest that TIGIT is a potential complementary therapeutic target to PD-1/PD-L1 checkpoint inhibition in GEP/UK NECs. Domvanalimab has been developed as an anti-TIGIT monoclonal antibody and zimberelimab as an anti-PD-1.
Design and primary objective of the REWNEC-01 Trial The REWENEC-01 trial is a comparative phase II trial that will randomize GEP/UK NEC patients between an experimental arm FOLFIRI+Zimberelimab + Domvanalimab and a control arm FOLFIRI in L2. The FOLFIRI arm will be a "hybrid" synthetic control arm composed of patients from historical/external data from the FOLFIRI arm of BEVANEC and French retrospective studies RBNEC and CEPD, mixed with patients recruited prospectively during the trial and randomized to the control arm. The randomization ratio for patients included prospectively during the trial will be 4:1 (4 patients assigned to FOLFIRI+Zimberelimab + Domvanalimab for 1 patient assigned to FOLFIRI). The randomization algorithm will take into account "external" patients assigned progressively to the control arm to obtain a 1:1 ratio between the trial arms, with balanced distributions of stratification factors between the two arms.
With 77 patients to be included, this strategy will provide statistical power equivalent to that of a trial including 122 patients, sufficient to demonstrate an advantage in overall survival rate at 12 months from 32% to 50%.
The hypotheses related to efficacy criteria are formulated a priori, as recommended by the FDA guidance document on trials with synthetic/external control arms. The proof of concept has been reported at ESMO 2023. The primary judgment criterion will be the overall survival rate at 12 months because it is a strong and significant criterion for translating the clinical benefit of the Chemotherapy + Zimberelimab + Domvanalimab combination. The design with a hybrid synthetic control arm allows for the consideration of a randomized comparative study in a cancer as rare as neuroendocrine carcinoma.
开始日期2026-04-01 |
申办/合作机构 |
NCT07134556
A Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as First-line Therapy for PD-L1 Positive Advanced Triple-negative Breast Cancer
The ADJUNCT is a single-arm, phase II clinical trial to evaluate the safety and efficacy of the combination of zimberelimab, domvanalimab and sacituzumab govitecan as first-line therapy for patients with PD-L1 positive advanced or metastatic triple-negative breast cancer.
开始日期2026-04-01 |
NCT07283848
A Single-Arm, Phase II Study of Perioperative Zimberelimab + Domvanalimab and Neoadjuvant Chemotherapy in Locally Advanced, Resectable, Gastroesophageal Adenocarcinoma
The purpose of the study is to understand whether study drugs domvanalimab and zimberelimab are safe and effective in combination with standard chemotherapy for patients with operable cancer of the esophagus, stomach, or gastroesophageal junction (where the stomach meets the esophagus).
All participants will receive the study treatment. Participants will receive chemotherapy and two immune therapies drugs (domvanalimab and zimberelimab) for up to 4 months before surgery. After surgery and at least a 4 week recovery, participants will receive domvanalimab and zimberelimab for up to 8 months. After completion of the study treatment, participants will be followed for up to 5 years per standard of care.
All participants will receive the study treatment. Participants will receive chemotherapy and two immune therapies drugs (domvanalimab and zimberelimab) for up to 4 months before surgery. After surgery and at least a 4 week recovery, participants will receive domvanalimab and zimberelimab for up to 8 months. After completion of the study treatment, participants will be followed for up to 5 years per standard of care.
开始日期2026-02-01 |
申办/合作机构 |
100 项与 Domvanalimab 相关的临床结果
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100 项与 Domvanalimab 相关的转化医学
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100 项与 Domvanalimab 相关的专利（医药）
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4
项与 Domvanalimab 相关的文献（医药）2026-05-01·LUNG CANCER
Domvanalimab combined with zimberelimab as first-line treatment in patients with PD-L1–high, advanced non-small cell lung cancer: Results from the randomized phase 2 ARC-10 study, Part 1
Article
作者: Bermingham, Candy ; Graham, Julie R ; Runglodvatana, Yotsawaj ; Naidoo, Jarushka ; Dang, Thao ; Juengsamarn, Jitlada ; Johnson, Melissa L ; Fong, Chin Heng ; How, Soon Hin ; Patel, Deepa ; Han, Sasha ; Marina, Neyssa ; Peters, Solange ; Li, Jacky Yu-Chung ; Ho, Gwo Fuang
INTRODUCTION:
TIGIT and PD-1 trigger distinct but interconnected immunosuppressive pathways. We investigated first-line domvanalimab (Fc-silent anti-TIGIT) plus zimberelimab (anti-PD-1) in PD-L1-high (≥50%), stage IIIB-IV NSCLC.
MATERIALS AND METHODS:
This phase 2, multicenter, randomized, open-label study (ARC-10, Part 1) randomized (2:2:1) patients to intravenous domvanalimab 15 mg/kg plus zimberelimab 360 mg (DZ), zimberelimab 360 mg (Z), or platinum-doublet chemotherapy every 3 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), confirmed objective response rate (ORR), and safety.
RESULTS:
Of 98 randomized patients, 95 received treatment (DZ, n = 38; Z, n = 40; chemotherapy, n = 17). As of May 17, 2024, median follow-up was 24.5 months; 22patients remained on first-line treatment (DZ, n = 11; Z, n = 10; chemotherapy, n = 1). Median (95% CI) PFS was 11.5 (4.0-26.2) months for DZ, 6.2 (2.5-12.3) months for Z, and 9.6 (2.6-16.4) months for chemotherapy. Median (95% CI) OS was not reached (13.7-not evaluable [NE]) for DZ, 24.4(7.8-NE) months for Z, and 11.9(2.7-NE) months for chemotherapy. DZ vs Z hazard ratio (95% CI) was 0.69 (0.40-1.18) for PFS and 0.64 (0.32-1.25) for OS. ORR (95% CI) was 44.7% (28.6-61.7) for DZ, 35.0% (20.6-51.7) for Z, and 35.3% (14.2-61.7) for chemotherapy. Grade ≥ 3 treatment-related adverse events (AEs) were lower for DZ (21.1%) and Z (15.0%) vs chemotherapy (47.1%). Immune-mediated AEs were similar between DZ (23.7%) and Z (20.0%). Infusion-related reactions were low (0%-7.9% across arms).
CONCLUSIONS:
Adding Fc-silent anti-TIGIT (domvanalimab) to anti-PD-1 (zimberelimab) led to encouraging efficacy and showed no new safety concerns in patients with previously untreated stage IIIB-IV NSCLC.
2026-01-01·Nature Reviews Clinical Oncology
Domvanalimab plus zimberelimab shows promise in upper-tract cancers
Article
作者: Peter Sidaway
2024-05-01·Clinical lung cancer
STAR-121: A Phase III Randomized Study of Domvanalimab and Zimberelimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Untreated Metastatic Non–Small Cell Lung Cancer With No Actionable Gene Alterations
Article
作者: Saad Mohammad ; Xinwei Yu ; Melissa Johnson ; Jhanelle E. Gray ; Delvys Rodriguez-Abreu ; Xueying Chen ; Jongseok Kim ; Trever Todd ; Martin Reck ; Joaquim Bosch-Barrera ; Myung-Ju Ahn
INTRODUCTION:
Dual inhibition with a T-cell immunoreceptor with immunoglobulin and ITIM domains plus programmed death (ligand)-1 (PD[L]-1) inhibitors, with or without chemotherapy, is an emerging therapeutic strategy in metastatic non-small cell lung cancer (mNSCLC). The STAR-121 (NCT05502237) phase III, global, randomized, open-label study will investigate first-line domvanalimab (anti-TIGIT) and zimberelimab (anti-PD-1) plus chemotherapy versus pembrolizumab plus chemotherapy in mNSCLC with no actionable gene alterations.
PARTICIPANTS AND METHODS:
Approximately 720 participants (≥18 years old) with untreated mNSCLC and no EGFR and ALK mutations will be randomized into 3 groups (A, B, or C) in a 4:4:1 ratio and stratified by baseline PD-L1 expression (tumor cells <50% vs. ≥50%), histology (squamous vs. nonsquamous), and geographic region (East Asia vs. non-East Asia). Group A will receive domvanalimab 1200 mg plus zimberelimab 360 mg plus platinum-doublet chemotherapy (PT), group B will receive pembrolizumab 200 mg plus PT, and group C will receive zimberelimab 360 mg plus PT, every 3 weeks. Treatment will be administered until disease progression or intolerable toxicity. Dual primary endpoints are progression-free survival (by blinded independent central review [BICR]) and overall survival for group A versus B. Key secondary endpoints comprise overall response rate (by BICR), safety, and quality of life. Exploratory endpoints include efficacy and safety between groups A and C, pharmacokinetics, patient-reported outcomes, and biomarkers.
CONCLUSION:
Enrollment in the STAR-121 study commenced on October 12, 2022, and is currently ongoing with completion planned by September 2024. The study completion is expected by December 2027.
262
项与 Domvanalimab 相关的新闻（医药）2026-07-02
·动脉网
The non-small cell lung cancer market is experiencing robust growth, driven by the increasing incidence of lung cancer and continuous advancements in precision medicine. The introduction of targeted therapies, immune checkpoint inhibitors, and biomarker-driven treatment approaches has significantly improved patient outcomes and expanded treatment options. 非小细胞肺癌市场正经历强劲增长，这得益于肺癌发病率的不断上升以及精准医疗的持续进步。靶向疗法、免疫检查点抑制剂和基于生物标志物的治疗方法的引入，显著改善了患者预后并扩大了治疗选择。Additionally, the expected launch of emerging therapies such as BMS-986504 + Pembrolizumab (BMS), Iza-bren (izalontamab brengitecan) (SystImmune and Bristol Myers Squibb), Neladalkib (NVL-655) (Nuvalent), PF-08046054 (SGN-PDL1V) (Pfizer), and others will further propel the market growth.. 此外，BMS-986504联合帕博利珠单抗（百时美施贵宝）、Iza-bren（izalontamab brengitecan）（SystImmune与百时美施贵宝）、Neladalkib（NVL-655）（Nuvalent）、PF-08046054（SGN-PDL1V）（辉瑞）等新兴疗法的预期上市，将进一步推动市场增长。LAS VEGAS 拉斯维加斯, ，July 2, 2026 2026年7月2日/PRNewswire/ -- Recently published Non-small Cell Lung Cancer Market Insights report includes a comprehensive understanding of current treatment practices, non-small cell lung cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].. /美通社/ -- 最近发布的《非小细胞肺癌市场洞察》报告包括对当前治疗实践、非小细胞肺癌新兴药物、各疗法市场份额以及2022年至2036年当前和预测市场规模的全面理解，按主要市场（美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本）进行细分。Non-small Cell Lung Cancer Market Summary 非小细胞肺癌市场概览The market size for non-small cell lung cancer was found to be 非小细胞肺癌的市场规模被发现为USD 33 billion 330亿美元in the 7MM in 2025. 在2025年的7毫米口径中。The total market size of EGFR-mutated NSCLC in the US was nearly 美国EGFR突变非小细胞肺癌（NSCLC）的总体市场规模接近USD 3.8 billion 38亿美元in 2025. EGFR is one of the profitable biomarker segments, with blockbuster therapies such as TAGRISSO. TAGRISSO is now the dominant EGFR inhibitor. 2025年。EGFR是盈利的生物标志物细分领域之一，拥有TAGRISSO等重磅疗法。TAGRISSO目前是主导的EGFR抑制剂。The total market size of ALK-mutated NSCLC in the US was nearly 美国ALK突变型非小细胞肺癌（NSCLC）的总体市场规模接近USD 1.28 billion 12.8亿美元in 2025. In the adjuvant setting, ALECENSA has become the first approved ALK inhibitor following surgical resection, expanding treatment duration and increasing the addressable early-stage population. 2025年。在辅助治疗领域，ALECENSA已成为首个在手术切除后获批的ALK抑制剂，延长了治疗持续时间，并扩大了可治疗的早期患者人群。In 2025, the 7MM had approximately 2025年，7MM大约有539,000 539,000incident cases of NSCLC. These are expected to rise due to the growing incident population and advancements in diagnostic capabilities during the forecast period (2026−2036). 非小细胞肺癌（NSCLC）的新发病例。在预测期（2026−2036年）内，由于新发患者人群的增长以及诊断技术的进步，预计这些病例数将上升。Leading non-small cell lung cancer pharmaceutical companies, such as 领先的非小细胞肺癌制药公司，例如SystImmune, Bristol Myers Squibb, Nuvalent, AbbVie, Revolution Medicines, GSK, Compugen, BioNTech, Candel Therapeutics, OncoC4, BioNTech, Incyte, Macrogenics, Iovance Biotherapeutics, Hoffmann-La Roche, Genentech, Regeneron Pharmaceuticals, Kelun-Biotech, Immutep, Moderna Therapeutics, BeyondSpring, Cullinan Oncology, Eli Lilly and Company, OSE Immuno-therapeutics, Pfizer, ImmunityBio, Jiangsu HengRui Medicine, AstraZeneca, Arcus Biosciences, Gilead Sciences, Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals), ArriVent BioPharma, Shanghai Allist Pharmaceuticals, Innovent Biologics, Takeda Pharmaceutical, Apollomics, Avistone Biotechnology,. SystImmune、百时美施贵宝、Nuvalent、艾伯维、Revolution Medicines、葛兰素史克、Compugen、BioNTech、Candel Therapeutics、OncoC4、BioNTech、Incyte、MacroGenics、Iovance Biotherapeutics、霍夫曼-拉罗氏、基因泰克、再生元制药、科伦博泰、Immutep、Moderna Therapeutics、BeyondSpring、Cullinan Oncology、礼来公司、OSE Immuno-therapeutics、辉瑞、ImmunityBio、江苏恒瑞医药、阿斯利康、Arcus Biosciences、吉利德科学、默沙东、大冢制药（Taiho 和 Astex Pharmaceuticals）、ArriVent BioPharma、上海艾力斯医药、信达生物、武田制药、Apollomics、Avistone Biotechnology。and others, are developing new non-small cell lung cancer treatment drugs that can be available in the non-small cell lung cancer market in the coming years. 以及其他公司，正在开发新的非小细胞肺癌治疗药物，这些药物有望在未来几年内上市。The promising non-small cell lung cancer therapies in clinical trials include 临床试验中颇具前景的非小细胞肺癌疗法包括Iza-bren (izalontamab brengitecan), BMS-986504 + Pembrolizumab, Neladalkib (NVL-655), PF-08046054 (SGN-PDL1V), Telisotuzumab adizutecan, Temab-A (ABBV-400), Daraxonrasib (RMC-6236), ZEJULA (niraparib), Rilvegostomig (AZD2936), Pumitamig (BNT327/PM8002), CAN-2409 (aglatimagene besadenovec), Gotistobart (BNT316, ONC-392), ZYNYZ (retifanlimab-dlwr, INCMGA00012), LN-145, Divarasib (GDC-6036), Fianlimab (REGN3767), Sacituzumab tirumotecan (MK-2870/SKB264), Eftilagimod alpha, Intismeran autogene (mRNA-4157/V940), Plinabulin, Zipalertinib, Olomorasib, Ceralasertib, TEDOPI, Sigvotatug vedotin, ANKTIVA, Pyrotinib, Volrustomig, TRODELVY (sacituzumab govitecan), Domvanalimab + Combination Therapies, OPDUALAG (nivolumab and relatlimab), Calderasib (MK-1084), Firmonertinib, IBI363, Vebreltinib (APL-101), . 伊扎布伦（izalontamab brengitecan）、BMS-986504 + 帕博利珠单抗、内拉达尔基布（NVL-655）、PF-08046054（SGN-PDL1V）、泰利索珠单抗 adizutecan、Temab-A（ABBV-400）、达拉雄拉西布（RMC-6236）、ZEJULA（尼拉帕利）、瑞尔维戈斯托米格（AZD2936）、普米塔米格（BNT327/PM8002）、CAN-2409（aglatimagene besadenovec）、戈蒂斯托巴特（BNT316，ONC-392）、ZYNYZ（retifanlimab-dlwr，INCMGA00012）、LN-145、迪瓦拉西布（GDC-6036）、菲安利马单抗（REGN3767）、萨西妥珠单抗 tirumotecan（MK-2870/SKB264）、依夫替拉吉莫德α、英蒂斯美兰自基因（mRNA-4157/V940）、普利纳布林、齐帕替尼、奥洛莫拉西布、塞拉拉瑟替布、TEDOPI、西格沃塔图格维多汀、ANKTIVA、吡咯替尼、沃尔鲁斯托米格、TRODELVY（萨西妥珠单抗戈维替康）、多姆瓦那利马单抗 + 联合疗法、OPDUALAG（纳武利尤单抗和瑞拉利马单抗）、卡尔德拉西布（MK-1084）、菲尔莫奈替尼、IBI363、韦布替尼（APL-101）and others. 以及其他。Discover bispecific antibody treatments for EGFR-mutated non-small cell lung cancer @ 探索针对EGFR突变非小细胞肺癌的双特异性抗体疗法 @https://www.delveinsight.com/report-store/non-small-cell-lung-cancer-nsclc-market https://www.delveinsight.com/report-store/non-small-cell-lung-cancer-nsclc-marketKey Factors Driving the Growth of the Non-small Cell Lung Cancer Market 推动非小细胞肺癌市场增长的关键因素Rising NSCLC Incidence: 非小细胞肺癌发病率上升：Non-small cell lung cancer continues to represent a significant healthcare burden in the United States, although its incidence is showing signs of stabilization. This trend reflects the impact of sustained tobacco control efforts, which have contributed to a gradual decline in overall lung cancer rates, while broader adoption of low-dose CT screening and increased incidental detection through routine imaging have led to more diagnoses at earlier stages. 非小细胞肺癌在美国仍然构成重大的医疗负担，尽管其发病率已显现出稳定迹象。这一趋势反映了持续烟草控制措施的影响，这些措施促使整体肺癌发病率逐渐下降；同时，低剂量CT筛查的广泛普及以及常规影像学检查中偶然发现病例的增加，使得更多患者能够在早期阶段获得诊断。In 2025, the US recorded approximately 203,000 incident NSCLC cases, a figure projected to increase modestly to around 205,000 cases by 2036.. 2025年，美国记录的新发非小细胞肺癌（NSCLC）病例约为203,000例，预计到2036年将小幅增至约205,000例。Rising Opportunities in EGFR NSCLC Therapies: EGFR非小细胞肺癌治疗领域日益增长的机遇：In EGFR-mutated NSCLC, where Tagrisso continues to dominate the market, Rybrevant is steadily strengthening its position. The J&J therapy has expanded into the broader first-line EGFR-mutated NSCLC setting through its combination with the oral EGFR-TKI Lazcluze. Additionally, the company is pursuing the launch of a subcutaneous (SC) formulation of Rybrevant to further enhance patient convenience and treatment accessibility.. 在泰瑞沙持续主导市场的EGFR突变非小细胞肺癌领域，Rybrevant的市场地位正稳步增强。通过与口服EGFR-TKI药物Lazcluze联用，强生公司的该疗法已拓展至更广泛的一线EGFR突变非小细胞肺癌治疗场景。此外，该公司正推动Rybrevant皮下注射制剂的上市，以进一步提升患者便利性和治疗可及性。The Untapped Potential of Front-Line NSCLC Treatment: 一线非小细胞肺癌治疗的未开发潜力：Front-line NSCLC represents a large market, currently only being dominated by anti-PD1 drugs and anti-PD-1 + CTx combination, leaving a significant opportunity for therapy beyond anti-PD1 to deliver higher clinical benefit. 一线非小细胞肺癌（NSCLC）市场庞大，目前主要由抗PD-1药物及抗PD-1联合化疗（CTx）方案主导，这为超越抗PD-1的疗法提供了显著机会，以带来更高的临床获益。Robust NSCLC Clinical Trial Activities: 稳健的非小细胞肺癌临床试验活动：The NSCLC clinical trial landscape is robust with various candidates in late stage of development, including 非小细胞肺癌（NSCLC）临床试验格局强劲，有多种候选药物处于后期开发阶段，包括BMS-986504 + Pembrolizumab BMS-986504 + 帕博利珠单抗(BMS), （电池管理系统）Iza-bren (izalontamab brengitecan) 伊扎布伦（伊扎仑塔单抗布伦吉特康）(SystImmune and Bristol Myers Squibb), （SystImmune 和百时美施贵宝）Neladalkib (NVL-655) 奈拉达尔克布（NVL-655）(Nuvalent), （Nuvalent），PF-08046054 (SGN-PDL1V) PF-08046054（SGN-PDL1V）(Pfizer), （辉瑞）Telisotuzumab adizutecan, Temab-A (ABBV-400) 替利索珠单抗阿迪苏特康，Temab-A（ABBV-400）(AbbVie), （艾伯维）Daraxonrasib (RMC-6236) 达拉索拉西布（RMC-6236）(Revolution Medicines), (革命药物公司),ZEJULA (niraparib) 则杰拉（尼拉帕利）(GSK), （葛兰素史克）Rilvegostomig (AZD2936) Rilvegostomig（AZD2936）(AstraZeneca/Compugen), （阿斯利康/Compugen）Pumitamig (BNT327/PM8002) 普米塔米格（BNT327/PM8002）(BioNTech/BMS), （BioNTech/百时美施贵宝）CAN-2409 (aglatimagene besadenovec) CAN-2409（阿格拉蒂马基因贝萨多诺韦克）(Candel Therapeutics), and other. （Candel Therapeutics）及其他。Sadaf Javed, Functional Head, Forecasting at DelveInsight, said that the total market size of KRAS-mutated NSCLC in the US was nearly USD 2.23 billion in 2025. The most frequent KRAS variant in NSCLC is G12C. KRAS-mutated NSCLC represents a rapidly evolving and highly competitive market across 1L and 2L+ settings, driven by the shift from first-generation monotherapies to next-generation, combination-based strategies. DelveInsight 预测功能主管 Sadaf Javed 表示，2025 年美国 KRAS 突变非小细胞肺癌（NSCLC）的总体市场规模接近 22.3 亿美元。NSCLC 中最常见的 KRAS 变异是 G12C。KRAS 突变 NSCLC 市场在一线治疗和二线及以上治疗领域均呈现出快速演变和高度竞争的态势，这一趋势由从第一代单药疗法向新一代联合治疗策略的转变所驱动。In the 2L+ settings, approved agents such as LUMAKRAS (2021) and KRAZATI (2023) established the KRAS G12C class, with KRAZATI demonstrating slightly stronger competitive positioning.. 在二线及以上治疗（2L+）中，已获批的药物如LUMAKRAS（2021年）和KRAZATI（2023年）确立了KRAS G12C抑制剂这一类别，其中KRAZATI展现出略强的竞争优势。Non-small Cell Lung Cancer Market Analysis 非小细胞肺癌市场分析Real-world treatment patterns in non-small cell lung cancer have evolved considerably, with a clear transition from conventional systemic therapies to targeted treatments and immunotherapies, which now represent the primary drivers of therapeutic advancement. 非小细胞肺癌的真实世界治疗模式已发生显著演变，明显从传统全身性治疗转向靶向治疗和免疫治疗，后者如今已成为推动治疗进步的主要动力。However, a substantial proportion of NSCLC patients remain ineligible for targeted therapies due to the absence of actionable mutations. In these patients, PD-L1–directed therapies play a central role, with 然而，由于缺乏可靶向的突变，相当大比例的非小细胞肺癌（NSCLC）患者仍然无法接受靶向治疗。在这些患者中，针对PD-L1的治疗发挥着核心作用，Merck's KEYTRUDA 默沙东的KEYTRUDA, particularly in combination with platinum-based chemotherapy, continuing to serve as the standard first-line treatment irrespective of PD-L1 expression levels. ，尤其是与铂类化疗联合使用时，无论PD-L1表达水平如何，继续作为标准的一线治疗方案。A major challenge in the immunotherapy landscape is the development of acquired resistance to PD-1/PD-L1 inhibitors. As resistance emerges, many patients lose the clinical benefit of these agents and are often left with chemotherapy, which may offer limited efficacy and considerable toxicity. 免疫治疗领域面临的一个主要挑战是获得性耐药对PD-1/PD-L1抑制剂的发展。随着耐药性的出现，许多患者失去了这些药物的临床获益，往往只能接受化疗，而化疗可能疗效有限且毒性较大。This significant unmet need has prompted extensive research into novel therapeutic agents and combination regimens for patients with advanced NSCLC who have progressed following immunotherapy. 这一显著未满足的临床需求促使人们开展广泛研究，探索用于免疫治疗后进展的晚期非小细胞肺癌患者的新型治疗药物及联合方案。Among molecularly defined NSCLC subtypes, EGFR exon 20 insertion mutations have attracted significant attention in recent years, resulting in an increasingly competitive treatment landscape. 在分子定义的非小细胞肺癌（NSCLC）亚型中，EGFR 20号外显子插入突变近年来引起了广泛关注，导致治疗格局的竞争日益激烈。Beyond these alterations, uncommon EGFR mutations, including 除这些改变外，罕见的EGFR突变，包括G719X, S768I, and PACC variants G719X、S768I 和 PACC 变异, are emerging as important areas of clinical development and represent the next frontier for targeted therapies in EGFR-mutated NSCLC. ，正成为临床开发的重要领域，并代表了EGFR突变非小细胞肺癌靶向治疗的下一个前沿。In ALK-positive NSCLC, 在ALK阳性的非小细胞肺癌中，ALECENSA and ALUNBRIG 艾乐替尼和阿来替尼have become the preferred first-line tyrosine kinase inhibitors (TKIs), with ALECENSA maintaining a dominant position due to its broader clinical adoption. Before the introduction of these next-generation agents, 已成为首选的一线酪氨酸激酶抑制剂（TKI），其中阿来替尼凭借更广泛的临床应用而占据主导地位。在这些下一代药物问世之前，XALKORI 克唑替尼was the primary treatment option for ALK-rearranged disease. 是ALK重排疾病的主要治疗选择。KRAS-mutated NSCLC has also witnessed substantial progress, particularly for the KRAS G12C subtype, which represents the most common KRAS alteration in NSCLC. As multiple therapies now target this mutation, the G12C segment is becoming increasingly crowded and competitive. KRAS突变的非小细胞肺癌（NSCLC）也取得了显著进展，尤其是KRAS G12C亚型，这是NSCLC中最常见的KRAS变异。随着多种疗法现在针对这一突变，G12C领域正变得越来越拥挤和竞争激烈。Future growth opportunities are expected to arise from expanding treatment options in relapsed/refractory settings and advancing KRAS-targeted therapies into first-line treatment. 未来的增长机会预计将来自在复发/难治性环境中扩大治疗选择，以及将KRAS靶向疗法推进至一线治疗。The treatment landscape for rare NSCLC biomarkers remains less well-defined due to the low prevalence of these alterations and the limited availability of late-stage clinical evidence. 由于这些罕见非小细胞肺癌（NSCLC）生物标志物的发生率较低，且晚期临床证据有限，其治疗格局仍不够明确。Nevertheless, significant advancements have been achieved for rare molecular subsets such as ROS1 rearrangements, HER2 mutations, RET fusions, and NTRK gene fusions, leading to improved therapeutic options for these patient populations. 然而，在ROS1重排、HER2突变、RET融合和NTRK基因融合等罕见分子亚型方面已取得显著进展，从而为这些患者群体提供了更优的治疗选择。Despite remarkable progress in precision oncology and immunotherapy, early-stage NSCLC (Stages I–III) continues to represent a significant area of unmet need. Surgical resection followed by adjuvant platinum-based chemotherapy remains the standard of care but provides only modest survival benefits while exposing patients to substantial toxicity.. 尽管在精准肿瘤学和免疫治疗方面取得了显著进展，但早期非小细胞肺癌（I–III期）仍然代表着一个存在巨大未满足需求的重要领域。手术切除后辅以含铂辅助化疗仍是标准治疗方案，但其带来的生存获益有限，同时使患者面临显著的毒性反应。Although immunotherapeutic approaches, including PD-1/PD-L1 inhibitors and neoadjuvant chemo-immunotherapy regimens, have demonstrated encouraging improvements in event-free survival and pathological response rates, their integration into routine clinical practice is still evolving, with challenges related to accessibility, patient selection, and treatment personalization.. 尽管包括PD-1/PD-L1抑制剂和新辅助化疗免疫联合方案在内的免疫治疗方法，在无事件生存期和病理缓解率方面显示出令人鼓舞的改善，但其在常规临床实践中的整合仍在不断发展中，并面临与可及性、患者选择和治疗个体化相关的挑战。The dynamics of the NSCLC market are anticipated to change in the coming years owing to the improvement in the rise in healthcare spending across the world. Some of the key players in the pipeline include 预计未来几年，随着全球医疗保健支出的增加，非小细胞肺癌（NSCLC）市场的动态将发生变化。研发管线中的一些主要参与者包括Bristol Myers Squibb, SystImmune, Nuvalent, Pfizer, AbbVie, Revolution Medicines, GSK, AstraZeneca, Compugen, BioNTech, Candel Therapeutics, OncoC4, Incyte, Macrogenics, Iovance Biotherapeutics, Hoffmann-La Roche, Genentech, Regeneron Pharmaceuticals 百时美施贵宝、SystImmune、Nuvalent、辉瑞、艾伯维、Revolution Medicines、葛兰素史克、阿斯利康、Compugen、BioNTech、Candel Therapeutics、OncoC4、Incyte、MacroGenics、Iovance Biotherapeutics、罗氏、基因泰克、再生元制药, and others are involved in developing drugs for NSCLC. ，其他机构也参与了非小细胞肺癌（NSCLC）药物的研发。Non-small Cell Lung Cancer Competitive Landscape 非小细胞肺癌竞争格局Some of the NSCLC drugs under late stage of development include 处于后期开发阶段的非小细胞肺癌药物包括BMS-986504 + Pembrolizumab BMS-986504 + 帕博利珠单抗(BMS), （电池管理系统）Iza-bren (izalontamab brengitecan) 伊扎布伦（伊扎仑塔单抗布伦吉替康）(SystImmune and Bristol Myers Squibb), （SystImmune 和百时美施贵宝）Neladalkib (NVL-655) 奈拉达尔克（NVL-655）(Nuvalent), (Nuvalent),PF-08046054 (SGN-PDL1V) PF-08046054（SGN-PDL1V）(Pfizer), （辉瑞）Telisotuzumab adizutecan, Temab-A (ABBV-400) 泰利索妥珠单抗阿迪祖替康，Temab-A（ABBV-400）(AbbVie), （艾伯维）Daraxonrasib (RMC-6236) 达拉松拉西布（RMC-6236）(Revolution Medicines), （革命医药公司）ZEJULA (niraparib) 泽杰拉（尼拉帕利）(GSK), （葛兰素史克）Rilvegostomig (AZD2936) Rilvegostomig（AZD2936）(AstraZeneca/Compugen), （阿斯利康/Compugen）Pumitamig (BNT327/PM8002) 普米塔米格（BNT327/PM8002）(BioNTech/BMS), （BioNTech/百时美施贵宝）CAN-2409 (aglatimagene besadenovec) CAN-2409（阿格拉蒂马基因贝萨多诺韦克）(Candel Therapeutics), （Candel Therapeutics），Gotistobart (BNT316, ONC-392) 戈替斯托巴特（BNT316，ONC-392）(OncoC4/BioNTech), （OncoC4/百欧恩泰）ZYNYZ (retifanlimab-dlwr, INCMGA00012) ZYNYZ（retifanlimab-dlwr，INCMGA00012）(Incyte/Macrogenics), （Incyte/Macrogenics），LN-145 LN-145(Iovance Biotherapeutics), （Iovance Biotherapeutics）Divarasib (GDC-6036) 迪瓦拉西布（GDC-6036）(Hoffmann-La Roche/Genentech), （霍夫曼-拉罗氏/基因泰克）Fianlimab (REGN3767) 菲安利单抗（REGN3767）(Regeneron Pharmaceuticals), （再生元制药公司）Sacituzumab tirumotecan (MK-2870/SKB264) 萨西妥珠单抗替鲁特康（MK-2870/SKB264）(Merck and Kelun-Biotech), （默克和科伦博泰）Eftilagimod alpha 依夫替莫德α(Immutep), (Immutep)Intismeran autogene (mRNA-4157/ V940) Intismeran autogene（mRNA-4157/V940）(Moderna Therapeutics and Merck), （莫德纳治疗公司和默克公司）Plinabulin 普利纳布林(BeyondSpring), （BeyondSpring），Zipalertinib 齐帕雷替尼(Cullinan Oncology/Taiho Pharma), （Cullinan Oncology/大正制药）Olomorasib 奥洛莫拉西布(Eli Lilly and Company), （礼来公司）Ceralasertib 塞拉拉斯替布(AstraZeneca), （阿斯利康），TEDOPI OSE TEDOPI OSE(Immuno-therapeutics), （免疫治疗药物）Sigvotatug vedotin 西格沃塔图格·韦多廷(Pfizer), （辉瑞）ANKTIVA 安科蒂瓦(ImmunityBio), （ImmunityBio）Pyrotinib 吡咯替尼(Jiangsu HengRui Medicine), （江苏恒瑞医药）Volrustomig 沃尔鲁斯托米格(AstraZeneca), （阿斯利康）TRODELVY (sacituzumab govitecan) 特罗德尔维（戈沙妥珠单抗）(Gilead Sciences), （吉利德科学公司）Domvanalimab + Combination Therapies 多姆瓦那利单抗 + 联合疗法(Arcus Biosciences/Gilead Sciences), （Arcus Biosciences/吉利德科学）OPDUALAG (nivolumab and relatlimab) OPDUALAG（纳武利尤单抗和瑞拉利珠单抗）(Bristol Myers Squibb), （百时美施贵宝）Calderasib (MK-1084) 卡尔德拉西布（MK-1084）[Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals)], [默克、大冢制药（Taiho 和 Astex Pharmaceuticals）]，Firmonertinib 非莫替尼(ArriVent BioPharma/Shanghai Allist Pharmaceuticals), （ArriVent BioPharma/上海艾力斯医药）IBI363 IBI363(Innovent Biologics and Takeda Pharmaceutical), （信达生物和武田制药），Vebreltinib (APL-101) 韦布替尼（APL-101）(Apollomics and Avistone Biotechnology), and others. （阿波罗米克斯和艾维斯通生物技术）等。Immutep's Eftilagimod alpha Immutep 公司的 Eftilagimod alphais a recombinant soluble protein composed of a dimeric form of LAG-3 that has been engineered to circulate freely rather than remain attached to the cell surface. As a first-in-class activator of antigen-presenting cells (APCs), it enhances immune system activity and has demonstrated the ability to generate durable immune responses in cancer patients. 是一种重组可溶性蛋白，由经工程化改造的二聚体LAG-3组成，使其能够在体内自由循环，而非锚定在细胞表面。作为首创的抗原呈递细胞（APC）激活剂，它能够增强免疫系统活性，并已在癌症患者中展现出诱导持久免疫反应的能力。The therapy can be administered at lower doses as an adjuvant to cancer vaccines or at higher doses to achieve broader systemic activation of APCs.. 该疗法可以作为癌症疫苗的辅助治疗以较低剂量给药，或以较高剂量给药以实现对抗原呈递细胞（APCs）更广泛的全身激活。Nuvalent's Neladalkib Nuvalent公司的Neladalkibis an advanced, brain-penetrant ALK inhibitor with high selectivity, developed to effectively target ALK resistance mutations while minimizing central nervous system toxicities associated with TRK inhibition. Created by Nuvalent for the treatment of ALK-driven malignancies, the therapy is designed to address resistance mechanisms and offer improved tolerability. 是一种先进的、能够穿透血脑屏障的ALK抑制剂，具有高选择性，旨在有效靶向ALK耐药突变，同时最大限度地减少与TRK抑制相关的中枢神经系统毒性。该疗法由Nuvalent公司开发，用于治疗ALK驱动的恶性肿瘤，旨在应对耐药机制并提供更好的耐受性。It is currently undergoing clinical investigation.. 目前正在接受临床研究。Revolution Medicines' Daraxonrasib (RMC-6236) Revolution Medicines 公司的 Daraxonrasib（RMC-6236）is an orally administered, multi-selective inhibitor that directly targets the active RAS(ON) state, enabling broad applicability across cancers driven by RAS mutations. By preventing activated RAS proteins from interacting with downstream signaling effectors, it disrupts key pathways responsible for tumor growth and survival. 是一种口服的多选择性抑制剂，直接靶向活性RAS（ON）状态，从而在由RAS突变驱动的多种癌症中具有广泛的适用性。通过阻止活化的RAS蛋白与下游信号效应因子相互作用，它破坏了负责肿瘤生长和存活的关键通路。The drug is active against several oncogenic RAS variants, including G12X, G13X, and Q61X mutations, which are frequently observed in cancers such as non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC).. 该药物对多种致癌性RAS变异体具有活性，包括在非小细胞肺癌（NSCLC）、胰腺导管腺癌（PDAC）和结直肠癌（CRC）等癌症中常见的G12X、G13X和Q61X突变。Iovance Biotherapeutics' LN-145 Iovance Biotherapeutics 公司的 LN-145is an autologous tumor-infiltrating lymphocyte (TIL) therapy that harnesses a patient's own immune cells to combat cancer. The treatment is produced by isolating T cells from a patient's tumor tissue and expanding them outside the body before reinfusion. A related product, LN-145-S1, is manufactured through an enhanced process that selectively enriches a specific subset of T cells, potentially improving therapeutic activity.. 是一种自体肿瘤浸润淋巴细胞（TIL）疗法，利用患者自身的免疫细胞来对抗癌症。该治疗方案通过从患者的肿瘤组织中分离T细胞，在体外进行扩增后再回输到患者体内。一款相关产品LN-145-S1则通过一种增强工艺生产，该工艺可选择性地富集特定亚群的T细胞，从而可能提高治疗活性。The anticipated launch of these emerging therapies are poised to transform the non-small cell lung cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the non-small cell lung cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.. 这些新兴疗法的预期上市将在未来几年内改变非小细胞肺癌市场的格局。随着这些前沿疗法不断成熟并获得监管批准，预计它们将重塑非小细胞肺癌市场格局，提供新的治疗标准，并为医疗创新和经济增长带来机遇。Discover more about non-small cell lung cancer PD-L1 inhibitors competitors 2026 @ 深入了解2026年非小细胞肺癌PD-L1抑制剂竞争格局 @Non-small Cell Lung Cancer Therapeutics Market 非小细胞肺癌治疗药物市场Recent Developments in the Non-small Cell Lung Cancer Market 非小细胞肺癌市场的最新进展In 在June 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 2026年6月，四川科伦博泰生物医药股份有限公司announced the online publication of translational research findings in the international journal Cancer Cell, highlighting the use of sacituzumab tirumotecan in combination with osimertinib as a first-line therapy for patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). 宣布在国际期刊《癌症细胞》（Cancer Cell）在线发表转化研究成果，重点介绍了萨西妥珠单抗替鲁特康联合奥希替尼作为晚期EGFR突变非小细胞肺癌（NSCLC）患者的一线治疗方案。In 在June 2026, MAIA Biotechnology 2026年6月，MAIA生物技术公司announced the activation of Winship Cancer Institute of Emory University as the third U.S. site in its Phase 2 THIO-101 expansion trial. The study is enrolling patients to assess ateganosine as a third-line therapy for non-small cell lung cancer (NSCLC). 宣布启动埃默里大学温希普癌症研究所作为其THIO-101二期扩展试验的第三个美国站点。该研究正在招募患者，以评估阿替加诺辛作为非小细胞肺癌（NSCLC）三线疗法的疗效。In 在May 2026, Bristol Myers Squibb (BMS) and its partner BioNTech 2026年5月，百时美施贵宝（BMS）及其合作伙伴BioNTechunveiled interim Phase II findings from the global Phase II/III ROSETTA Lung-02 trial (NCT06712316) at ASCO 2026, evaluating the PD-L1/VEGF bispecific antibody pumitamig in combination with chemotherapy as a first-line treatment for patients with previously untreated non-small cell lung cancer (NSCLC).. 在2026年美国临床肿瘤学会（ASCO）年会上，公布了全球II/III期ROSETTA Lung-02试验（NCT06712316）的II期中期结果，该研究评估了PD-L1/VEGF双特异性抗体pumitamig联合化疗作为既往未经治疗的非小细胞肺癌（NSCLC）患者一线治疗的疗效。In 在May 2026, Nuvation Bio 2026年5月，Nuvation Bioentered into a strategic collaboration with Thermo Fisher Scientific for the U.S.-based manufacturing of ibtrozi, an investigational drug targeting ROS1-positive non-small cell lung cancer (NSCLC). 与赛默飞世尔科技达成战略合作，在美国本土生产靶向ROS1阳性非小细胞肺癌（NSCLC）的在研药物ibtrozi。In 在May 2026, Innovent Biologics, Inc. 2026年5月，信达生物制药公司reported preliminary findings from a proof-of-concept (PoC) clinical study evaluating its first-in-class global PD-1/IL-2α-biased bispecific fusion protein, IBI363 (Takeda R&D code: TAK-928), in combination with chemotherapy for the first-line treatment of advanced non-small cell lung cancer (NSCLC). 报告了一项概念验证（PoC）临床研究的初步结果，该研究评估了其首创的全球性PD-1/IL-2α偏向性双特异性融合蛋白IBI363（武田研发代码：TAK-928）联合化疗用于晚期非小细胞肺癌（NSCLC）一线治疗的疗效。The results were presented at the 2026 ASCO Annual Meeting.. 这些结果在2026年美国临床肿瘤学会（ASCO）年会上进行了展示。In 在May 2026, Dizal 2026年5月，Dizalshared findings from two non-small cell lung cancer (NSCLC) studies at the 2026 ASCO Annual Meeting. One study highlighted the investigational fourth-generation EGFR tyrosine kinase inhibitor (TKI), DZD6008, in previously treated NSCLC patients harboring EGFR C797X mutations after disease progression on third-generation EGFR TKIs, with results presented during an oral session. 在2026年美国临床肿瘤学会（ASCO）年会上分享了两项非小细胞肺癌（NSCLC）研究的结果。其中一项研究重点介绍了 investigational 第四代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）DZD6008，用于既往接受过治疗、且在第三代EGFR TKI治疗后出现疾病进展并携带EGFR C797X突变的NSCLC患者，相关结果在口头报告环节公布。The second study reported outcomes of golidocitinib, a selective JAK1 inhibitor, used in combination with an anti-PD-1 antibody as a first-line therapy for patients with PD-L1-positive advanced NSCLC lacking driver mutations.. 第二项研究报告了选择性JAK1抑制剂戈利昔替尼联合抗PD-1抗体作为一线疗法，用于缺乏驱动基因突变的PD-L1阳性晚期非小细胞肺癌（NSCLC）患者的治疗结果。What is Non-small Cell Lung Cancer? 什么是非小细胞肺癌？Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases. It is a heterogeneous group of malignancies that originate from the epithelial cells of the lung and includes several histological subtypes, primarily adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. 非小细胞肺癌（NSCLC）是最常见的肺癌类型，约占所有肺癌病例的85%。它是一组起源于肺上皮细胞的异质性恶性肿瘤，包括多种组织学亚型，主要为腺癌、鳞状细胞癌和大细胞癌。NSCLC typically grows and spreads more slowly than small cell lung cancer (SCLC), although disease progression can vary depending on the tumor subtype and molecular characteristics. Major risk factors include tobacco smoking, exposure to environmental carcinogens such as radon and asbestos, air pollution, and certain genetic predispositions. 非小细胞肺癌（NSCLC）的生长和扩散速度通常慢于小细胞肺癌（SCLC），尽管疾病进展可能因肿瘤亚型和分子特征而异。主要风险因素包括吸烟、接触氡和石棉等环境致癌物、空气污染以及某些遗传易感性。Advances in molecular diagnostics have identified key genetic alterations, including mutations in EGFR, ALK, ROS1, KRAS, and other oncogenic drivers, enabling the development of targeted therapies and immunotherapies that have significantly improved treatment outcomes for patients with advanced disease.. 分子诊断技术的进步已识别出关键的基因改变，包括EGFR、ALK、ROS1、KRAS及其他致癌驱动基因的突变，从而推动了靶向治疗和免疫治疗的发展，显著改善了晚期疾病患者的治疗结局。Non-small Cell Lung Cancer Epidemiology Segmentation 非小细胞肺癌流行病学细分The non-small cell lung cancer epidemiology section provides insights into the historical and current non-small cell lung cancer patient pool and forecasted trends for the leading markets. Among the 7MM, the US accounted for the highest incident cases of NSCLC in 2025. This was followed by Japan, whereas the least number of cases were accounted by Spain.. 非小细胞肺癌流行病学部分提供了对主要市场历史及当前非小细胞肺癌患者群体规模以及预测趋势的洞察。在七大主要市场（7MM）中，美国在2025年记录的非小细胞肺癌新发病例数最多，其次是日本，而西班牙的新发病例数最少。The non-small cell lung cancer treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into: 非小细胞肺癌治疗市场报告提供了2022年至2036年研究期间主要市场的流行病学分析，细分如下：Total Incident Cases of NSCLC 非小细胞肺癌总发病病例数Gender-specific Cases of NSCLC 非小细胞肺癌的性别特异性病例Age-specific Cases of NSCLC 非小细胞肺癌的年龄特异性病例Total Incident Cases of NSCLC by Histology 按组织学分类的非小细胞肺癌总发病病例数Total Incident Cases of NSCLC by Stage 按分期划分的非小细胞肺癌总发病病例数Total Incident Cases of NSCLC by Genetic Mutations/Biomarkers 按基因突变/生物标志物分类的非小细胞肺癌（NSCLC）总发病病例数Patient Seeking Treatment for NSCLC 寻求非小细胞肺癌治疗的患者Line-wise Treated Cases of Metastatic NSCLC 按治疗线数划分的转移性非小细胞肺癌病例Non-small Cell Lung Cancer Market Report Metrics 非小细胞肺癌市场报告指标Details 详细信息Study Period 学习阶段2022–2036 2022–2036Coverage 覆盖范围7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. 7国集团（美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本）。Non-small Cell Lung Cancer Market CAGR 非小细胞肺癌市场复合年增长率6.6% 6.6%Non-small Cell Lung Cancer Market Size in 2025 2025年非小细胞肺癌市场规模USD 33 Billion 330亿美元Key Non-small Cell Lung Cancer Companies 关键非小细胞肺癌公司SystImmune, Bristol Myers Squibb, Nuvalent, AbbVie, Revolution Medicines, GSK, Compugen, BioNTech, Candel Therapeutics, OncoC4, BioNTech, Incyte, Macrogenics, Iovance Biotherapeutics, Hoffmann-La Roche, Genentech, Regeneron Pharmaceuticals, Kelun-Biotech, Immutep, Moderna Therapeutics, BeyondSpring, Cullinan Oncology, Eli Lilly and Company, OSE Immuno-therapeutics, Pfizer, ImmunityBio, Jiangsu HengRui Medicine, AstraZeneca, Arcus Biosciences, Gilead Sciences, Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals), ArriVent BioPharma, Shanghai Allist Pharmaceuticals, Innovent Biologics, Takeda Pharmaceutical, Apollomics, Avistone Biotechnology, Boehringer Ingelheim, Hansoh Pharma, Dizal (Jiangsu) Pharmaceutical, Johnson & Johnson Innovative Medicine (Janssen), and others. SystImmune、百时美施贵宝、Nuvalent、艾伯维、Revolution Medicines、葛兰素史克、Compugen、BioNTech、Candel Therapeutics、OncoC4、BioNTech、Incyte、MacroGenics、Iovance Biotherapeutics、霍夫曼-拉罗氏、基因泰克、再生元制药、科伦博泰、Immutep、Moderna Therapeutics、BeyondSpring、Cullinan Oncology、礼来公司、OSE Immuno-therapeutics、辉瑞、ImmunityBio、江苏恒瑞医药、阿斯利康、Arcus Biosciences、吉利德科学、默克、大冢制药（Taiho 和 Astex Pharmaceuticals）、ArriVent BioPharma、上海艾力斯医药、信达生物、武田制药、Apollomics、Avistone Biotechnology、勃林格殷格翰、翰森制药、迪哲（江苏）医药、强生创新药（杨森）等。Key Non-small Cell Lung Cancer Therapies 关键非小细胞肺癌疗法Iza-bren (izalontamab brengitecan), BMS-986504 + Pembrolizumab, Neladalkib (NVL-655), PF-08046054 (SGN-PDL1V), Telisotuzumab adizutecan, Temab-A (ABBV-400), Daraxonrasib (RMC-6236), ZEJULA (niraparib), Rilvegostomig (AZD2936), Pumitamig (BNT327/PM8002), CAN-2409 (aglatimagene besadenovec), Gotistobart (BNT316, ONC-392), ZYNYZ (retifanlimab-dlwr, INCMGA00012), LN-145, Divarasib (GDC-6036), Fianlimab (REGN3767), Sacituzumab tirumotecan (MK-2870/SKB264), Eftilagimod alpha, Intismeran autogene (mRNA-4157/V940), Plinabulin, Zipalertinib, Olomorasib, Ceralasertib, TEDOPI, Sigvotatug vedotin, ANKTIVA, Pyrotinib, Volrustomig, TRODELVY (sacituzumab govitecan), Domvanalimab + Combination Therapies, OPDUALAG (nivolumab and relatlimab), Calderasib (MK-1084), Firmonertinib, IBI363, Vebreltinib (APL-101), TAGRISSO, GILOTRIF/GIOTRIF, VIZIMPRO, EXKIVITY, AUMSEQA, ZEGFROVY, RYBREVANT, DATROWAY, PORTRAZZA, KEYTRUDA, OPDIVO and others. 伊扎布伦（izalontamab brengitecan）、BMS-986504 + 帕博利珠单抗、奈拉达尔基布（NVL-655）、PF-08046054（SGN-PDL1V）、泰利索妥珠单抗 adizutecan、Temab-A（ABBV-400）、达拉雄拉西布（RMC-6236）、ZEJULA（尼拉帕利）、Rilvegostomig（AZD2936）、Pumitamig（BNT327/PM8002）、CAN-2409（aglatimagene besadenovec）、Gotistobart（BNT316，ONC-392）、ZYNYZ（retifanlimab-dlwr，INCMGA00012）、LN-145、Divarasib（GDC-6036）、Fianlimab（REGN3767）、Sacituzumab tirumotecan（MK-2870/SKB264）、eftilagimod alpha、Intismeran autogene（mRNA-4157/V940）、Plinabulin、Zipalertinib、Olomorasib、Ceralasertib、TEDOPI、Sigvotatug vedotin、ANKTIVA、Pyrotinib、Volrustomig、TRODELVY（sacituzumab govitecan）、Domvanalimab + 联合疗法、OPDUALAG（纳武利尤单抗和 relatlimab）、Calderasib（MK-1084）、Firmonertinib、IBI363、Vebreltinib（APL-101）、TAGRISSO、GILOTRIF/GIOTRIF、VIZIMPRO、EXKIVITY、AUMSEQA、ZEGFROVY、RYBREVANT、DATROWAY、PORTRAZZA、KEYTRUDA、OPDIVO 等。Scope of the 范围Non-small Cell Lung Cancer 非小细胞肺癌Market Report 市场报告Non-small Cell Lung Cancer Patient Population Forecast 非小细胞肺癌患者人群预测Non-small Cell Lung Cancer Therapeutics Market Size 非小细胞肺癌治疗药物市场规模Non-small Cell Lung Cancer Pipeline Analysis 非小细胞肺癌在研管线分析Non-small Cell Lung Cancer Market Size and Trends 非小细胞肺癌市场规模及趋势Non-small Cell Lung Cancer Market Opportunity 非小细胞肺癌市场机遇Non-small Cell Lung Cancer Market Unmet Needs 非小细胞肺癌市场未满足的需求KOL's Views on Non-small Cell Lung Cancer 关键意见领袖对非小细胞肺癌的观点Non-small Cell Lung Cancer Market Access and Reimbursement 非小细胞肺癌的市场准入与报销Download the report to understand the first-line treatment of advanced non-small cell lung cancer @ 下载报告以了解晚期非小细胞肺癌的一线治疗方案 @Non-small Cell Lung Cancer Pharmaceutical Company 非小细胞肺癌制药公司Table of Contents 目录1 1Non-small Cell Lung Cancer Market Key Insights 非小细胞肺癌市场关键洞察2 2Non-small Cell Lung Cancer Market Report Introduction 非小细胞肺癌市场报告简介3 3Key Highlights 核心亮点4 4Executive Summary 执行摘要5 5Key Events 关键事件6 6Epidemiology and Market Forecast Methodology of NSCLC 非小细胞肺癌的流行病学与市场预测方法学7 7NSCLC Market Overview at a Glance 非小细胞肺癌市场概览7.1 7.1Emerging Landscape Analysis in the 7MM (by Phase) 七大主要市场（按阶段划分）的新兴格局分析7.2 7.2Market Share of NSCLC by Biomarker (%) in the 7MM in 2025 2025年七国市场（7MM）中按生物标志物划分的非小细胞肺癌（NSCLC）市场份额（%）7.3 7.3Market Share of NSCLC by Biomarker (%) in the 7MM in 2036 2036年七大主要市场（7MM）中按生物标志物划分的非小细胞肺癌（NSCLC）市场份额（%）8 8Disease Background and Overview of NSCLC 疾病背景及非小细胞肺癌概述8.1 8.1Introduction 引言8.2 8.2Disease Biology: NSCLC 疾病生物学：非小细胞肺癌8.3 8.3Diagnosis 诊断9 9Current Treatment Practices: NSCLC 当前治疗实践：非小细胞肺癌9.1 9.1Treatment Algorithm 治疗算法9.2 9.2Treatment Guidelines and Recommendations for NSCLC 非小细胞肺癌的治疗指南与建议10 10Epidemiology and Patient Population 流行病学与患者人群10.1 10.1Key Findings 主要发现10.2 10.2Assumptions and Rationale 假设与理由10.3 10.3Total Incident Cases of NSCLC in the 7MM 7MM国家非小细胞肺癌（NSCLC）的总发病病例数10.4 10.4United States 美国10.4.1 10.4.1Total Incident Cases of NSCLC in the United States 美国非小细胞肺癌的总发病病例数10.4.2 10.4.2Gender-specific Cases of NSCLC in the United States 美国非小细胞肺癌的性别特异性病例10.4.3 10.4.3Age-specific Cases of NSCLC in the United States 美国非小细胞肺癌的年龄别病例数10.4.4 10.4.4Total Incident Cases of NSCLC by Histology in the United States 美国按组织学分类的非小细胞肺癌总发病病例数10.4.5 10.4.5Total Incident Cases of NSCLC by Stage in the United States 美国按分期统计的非小细胞肺癌总发病病例数10.4.6 10.4.6Total Cases of NSCLC by Genetic Mutations/Biomarkers in the United States 美国按基因突变/生物标志物划分的非小细胞肺癌病例总数10.4.7 10.4.7Patient Seeking Treatment for NSCLC in the United States 在美国寻求非小细胞肺癌治疗的患者10.4.8 10.4.8Line-wise Treated Cases of NSCLC in the United States 美国非小细胞肺癌按治疗线数统计的病例数10.5 10.5EU4 and the UK 欧盟4国与英国10.6 10.6Japan 日本11 十一Patient Journey 患者旅程12 12Key Endpoints in NSCLC 非小细胞肺癌的关键终点13 13Marketed NSCLC Therapies 已上市的非小细胞肺癌治疗药物13.1 13.1Competitive Landscape 竞争格局13.1.1 13.1.1Regulatory Approval History Across the 7MM 7MM国家的监管审批历史13.2 13.2EGFR Mutations EGFR突变13.2.1 13.2.1AUMSEQA (Aumolertinib): Jiangsu Hansoh Pharmaceutical AUMSEQA（阿美替尼）：江苏豪森药业13.2.1.1 13.2.1.1Product Description 产品描述13.2.1.2 13.2.1.2Regulatory Milestones 监管里程碑13.2.1.3 13.2.1.3Other Developmental Activity 其他发展性活动13.2.1.4 13.2.1.4Summary of Pivotal Clinical Trial 关键性临床试验总结13.2.2 13.2.2VIZIMPRO (Dacomitinib): Pfizer VIZIMPRO（达可替尼）：辉瑞13.2.3 13.2.3GILOTRIF/GIOTRIF (Afatinib maleate): Boehringer Ingelheim 吉洛特瑞夫/吉奥特瑞夫（马来酸阿法替尼）：勃林格殷格翰13.2.4 13.2.4TAGRISSO (Osimertinib): AstraZeneca 泰瑞沙（奥希替尼）：阿斯利康13.2.5 13.2.5PORTRAZZA (Necitumumab): Eli Lilly and Company PORTRAZZA（耐昔妥珠单抗）：礼来公司13.2.6 13.2.6RYBREVANT (Amivantamab) ± LAZCLUZE (Lazertinib): Johnson & Johnson Innovative Medicine/Yuhan Corporation RYBREVANT（埃万妥单抗）± LAZCLUZE（拉泽替尼）：强生创新医药/柳韩公司13.2.7 13.2.7ZEGFROVY (Sunvozertinib): Dizal Pharmaceutical ZEGFROVY（舒沃替尼）：迪哲医药13.2.8 13.2.8DATROWAY (Datopotamab Deruxtecan): Daiichi Sankyo/AstraZeneca DATROWAY（德曲妥珠单抗）：第一三共/阿斯利康13.3 13.3PD-1 Inhibitors PD-1抑制剂13.3.1 13.3.1OPDIVO (Nivolumab): Bristol Myers Squibb/Ono Pharmaceutical 欧狄沃（纳武利尤单抗）：百时美施贵宝/小野制药13.3.2 13.3.2KEYTRUDA (Pembrolizumab): Merck KEYTRUDA（帕博利珠单抗）：默克公司13.3.3 13.3.3LIBTAYO (Cemiplimab): Regeneron/Sanofi LIBTAYO（西米普利单抗）：再生元/赛诺菲13.3.4 13.3.4TEVIMBRA (Tislelizumab): BeiGene 替雷利珠单抗（TEVIMBRA）：百济神州13.3.5 13.3.5IMFINZI (Durvalumab) + IMJUDO (Tremelimumab): AstraZeneca IMFINZI（度伐利尤单抗）+ IMJUDO（曲美木单抗）：阿斯利康13.3.6 13.3.6CEJEMLY (Sugemalimab): CStone Pharmaceuticals CEJEMLY（舒格利单抗）：基石药业13.3.7 13.3.7IMFINZI (Durvalumab): AstraZeneca IMFINZI（度伐利尤单抗）：阿斯利康13.3.8 13.3.8TECENTRIQ (Atezolizumab): Genentech/Roche 泰圣奇（阿替利珠单抗）：基因泰克/罗氏13.4 13.4Other Mutations 其他突变13.4.1 13.4.1LORBRENA/LORVIQUA (Lorlatinib): Pfizer LORBRENA/LORVIQUA（洛拉替尼）：辉瑞13.4.2 13.4.2ENSACOVE (Ensartinib): Betta Pharmaceuticals/Xcovery 恩沙替尼（Ensartinib）：贝达药业/Xcovery13.4.3 13.4.3ALUNBRIG (Brigatinib): Takeda Pharmaceuticals ALUNBRIG（布格替尼）：武田制药13.4.4 13.4.4AUGTYRO (Repotrectinib): BMS AUGTYRO（瑞波替尼）：百时美施贵宝13.4.5 13.4.5ALECENSA (Alectinib): Roche/Chugai Pharmaceutical 艾乐替尼（Alectinib）：罗氏/中外制药13.4.6 13.4.6ROZLYTREK (Entrectinib): Roche (Genentech) 罗扎特雷克（恩曲替尼）：罗氏（基因泰克）13.4.7 13.4.7IBTROZI (Taletrectinib): Nuvation Bio IBTROZI（他雷替尼）：Nuvation Bio13.4.8 13.4.8GAVRETO (Pralsetinib): Blueprint Medicines/Rigel Pharmaceuticals GAVRETO（普拉替尼）：Blueprint Medicines/Rigel Pharmaceuticals13.4.9 13.4.9RETEVMO/RETSEVMO (Selpercatinib): Eli Lilly and Company RETEVMO/RETSEVMO（塞尔帕替尼）：礼来公司13.4.10 13.4.10TEPMETKO (Tepotinib): EMD Serono (Merck KGaA) TEPMETKO（特泊替尼）：EMD Serono（默克 KGaA）13.4.11 13.4.11HAIYITAN (Gumarontinib): Haihe Biopharma and Taiho Pharmaceutical 海益坦（古玛罗替尼）：海河生物制药与泰和制药13.4.12 13.4.12TABRECTA (Capmatinib): Novartis TABRECTA（卡马替尼）：诺华13.4.13 13.4.13LUMAKRAS/LUMYKRAS (Sotorasib): Amgen LUMAKRAS/LUMYKRAS（索托拉西布）：安进13.4.14 13.4.14KRAZATI (Adagrasib): BMS KRAZATI（阿达格拉西布）：百时美施贵宝13.4.15 13.4.15ENHERTU (Trastuzumab deruxtecan): Daiichi Sankyo /AstraZeneca ENHERTU（德曲妥珠单抗）：第一三共/阿斯利康13.4.16 13.4.16TAFINLAR (Dabrafenib) + MEKINIST (Trametinib): Novartis TAFINLAR（达拉非尼）+ MEKINIST（曲美替尼）：诺华13.4.17 13.4.17BRAFTOVI (Encorafenib) + MEKTOVI (Binimetinib): Pfizer/Pierre Fabre BRAFTOVI（康奈非尼）+ MEKTOVI（比美替尼）：辉瑞/皮埃尔法布雷13.4.18 13.4.18VITRAKVI (Larotrectinib): Bayer VITRAKVI（拉罗替尼）：拜耳13.4.19 13.4.19EMRELIS (Telisotuzumab vedotin-tllv): AbbVie EMRELIS（Telisotuzumab vedotin-tllv）：艾伯维13.4.20 13.4.20BIZENGRI (Zenocutuzumab): Merus and Partner Therapeutics BIZENGRI（泽诺库妥珠单抗）：Merus 与 Partner Therapeutics13.4.21 13.4.21HYRNUO (Sevabertinib): Bayer HYRNUO（塞瓦伯替尼）：拜耳13.4.22 13.4.22HERNEXEOS (Zongertinib): Boehringer Ingelheim HERNEXEOS（宗格替尼）：勃林格殷格翰14 十四Emerging NSCLC Therapies 新兴的非小细胞肺癌疗法14.1 14.1Competitive Landscape 竞争格局14.2 14.2Ateganosine: MAIA Biotechnology 阿替加诺辛：MAIA生物技术公司14.2.1 14.2.1Product Description 产品描述14.2.2 14.2.2Other Developmental Activities 其他发展活动14.2.3 14.2.3Clinical Development 临床开发14.2.3.1 14.2.3.1Clinical Trials Information 临床试验信息14.2.4 14.2.4Safety and Efficacy 安全性和有效性14.3 14.3BMS-986504 + Pembrolizumab: Bristol-Myers Squibb BMS-986504 + 帕博利珠单抗：百时美施贵宝14.4 14.4Iza-bren (izalontamab brengitecan): SystImmune and Bristol Myers Squibb 伊扎布伦（伊扎仑塔单抗布伦吉替康）：SystImmune 与百时美施贵宝14.5 14.5Neladalkib (NVL-655): Nuvalent 奈拉达克替尼（NVL-655）：Nuvalent公司14.6 14.6PF-08046054 (SGN-PDL1V): Pfizer PF-08046054（SGN-PDL1V）：辉瑞14.7 14.7Telisotuzumab adizutecan, Temab-A (ABBV-400): AbbVie Telisotuzumab adizutecan，Temab-A（ABBV-400）：艾伯维14.8 14.8Daraxonrasib (RMC-6236): Revolution Medicines 达拉松拉西布（RMC-6236）：Revolution Medicines公司14.9 14.9ZEJULA (niraparib): GlaxoSmithKline ZEJULA（尼拉帕利）：葛兰素史克14.10 14.10Rilvegostomig (AZD2936): AstraZeneca/Compugen Rilvegostomig（AZD2936）：阿斯利康/Compugen14.11 14.11Pumitamig (BNT327/PM8002): BioNTech/Bristol Myers Squibb 普米塔米格（BNT327/PM8002）：BioNTech/百时美施贵宝14.12 14.12CAN-2409 (aglatimagene besadenovec): Candel Therapeutics CAN-2409（阿格拉替马基因贝萨多诺韦克）：Candel Therapeutics14.13 14.13Gotistobart (BNT316): OncoC4/BioNTech 戈替斯托巴特（BNT316）：OncoC4/ BioNTech14.14 14.14ZYNYZ (retifanlimab-dlwr): Incyte/Macrogenics ZYNYZ（retifanlimab-dlwr）：Incyte/Macrogenics14.15 14.15LN-145: Iovance Biotherapeutics LN-145：Iovance Biotherapeutics14.16 14.16Divarasib (GDC-6036): Hoffmann-La Roche/Genentech Divarasib（GDC-6036）：霍夫曼-拉罗氏/基因泰克14.17 14.17Fianlimab (REGN3767): Regeneron Pharmaceuticals Fianlimab（REGN3767）：再生元制药公司14.18 14.18Sacituzumab Tirumotecan (MK-2870): Merck and Kelun-Biotech 萨西妥珠单抗替鲁替康（MK-2870）：默沙东与科伦博泰14.19 14.19Eftilagimod alpha (Efti, IMP321): Immutep 艾夫替拉莫德α（Efti，IMP321）：Immutep公司14.20 14.20Intismeran autogene (mRNA-4157/V940): Moderna Therapeutics and Merck Sharp & Dohme Intismeran autogene（mRNA-4157/V940）：莫德纳治疗公司与默沙东14.21 14.21Plinabulin: BeyondSpring 普利那布林：BeyondSpring14.22 14.22Zipalertinib (CLN-081): Cullinan Therapeutics and Taiho Pharma Zipalertinib (CLN-081)：Cullinan Therapeutics 与 Taiho Pharma14.24 14.24Olomorasib (LY3537982): Eli Lilly and Company 奥洛莫拉西布（LY3537982）：礼来公司14.25 14.25Ceralasertib (AZD6738): AstraZeneca Ceralasertib (AZD6738)：阿斯利康14.26 14.26TEDOPI (OSE2101): OSE Immunotherapeutics TEDOPI (OSE2101)：OSE免疫治疗公司14.27 14.27Sigvotatug Vedotin (PF08046047, SGN-B6A): Pfizer Sigvotatug Vedotin (PF08046047, SGN-B6A)：辉瑞14.28 14.28ANKTIVA (N-803, nogapendekin alfa inbakicept-pmln): ImmunityBio ANKTIVA（N-803，nogapendekin alfa inbakicept-pmln）：ImmunityBio14.29 14.29Pyrotinib: Jiangsu HengRui Medicine 吡咯替尼：江苏恒瑞医药14.30 14.30Volrustomig (MEDI5752): AstraZeneca Volrustomig（MEDI5752）：阿斯利康14.31 14.31TRODELVY (sacituzumab govitecan): Gilead Sciences 特罗达维（戈沙妥珠单抗）：吉利德科学14.32 14.32Domvanalimab + Combination Therapies: Arcus Biosciences and Gilead Sciences Domvanalimab联合疗法：Arcus Biosciences与Gilead Sciences14.33 14.33OPDUALAG (nivolumab and relatlimab): Bristol-Myers Squibb OPDUALAG（纳武利尤单抗和瑞拉利珠单抗）：百时美施贵宝14.34 14.34Calderasib (MK-1084): Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals) Calderasib（MK-1084）：默克、大冢制药（Taiho 和 Astex Pharmaceuticals）14.35 14.35Firmonertinib: ArriVent BioPharma and Shanghai Allist Pharmaceuticals 法米替尼：ArriVent BioPharma 和上海艾力斯医药14.36 14.36Livmoniplimab (ARGX-115): AbbVie 利夫莫尼普利单抗（ARGX-115）：艾伯维14.37 14.37IBI363: Innovent Biologics and Takeda Pharmaceutical IBI363：信达生物与武田制药14.38 14.38Ivonescimab (AK112): Akeso Bio and Summit Therapeutics 依沃西单抗（AK112）：康方生物与 Summit Therapeutics14.39 14.39Vebreltinib (APL-101): Apollomics and Avistone Biotechnology 韦布替尼（APL-101）：阿波罗生物制药与艾维斯通生物技术14.4 14.4Zidesamtinib (NVL-520): Nuvalent Zidesamtinib（NVL-520）：Nuvalent15 十五Phase II Emerging Drugs Under Development 研发中的二期新兴药物16 16NSCLC: 7MM Market Analysis 非小细胞肺癌：7MM市场分析报告16.1 16.1Key Findings 主要发现16.2 16.2Total Market Size of NSCLC by Country in the 7MM 七个主要市场（7MM）中各国非小细胞肺癌（NSCLC）的总体市场规模16.3 16.3Total Market Size of NSCLC by Biomarker in the 7MM 七大主要市场中按生物标志物划分的非小细胞肺癌总市场规模16.4 16.4Market Outlook of NSCLC 非小细胞肺癌市场展望16.4.1 16.4.17MM Market Dynamics Overview of NSCLC 7MM NSCLC市场动态概览16.4.1.1 16.4.1.1PD-L1 Expression PD-L1表达16.4.1.2 16.4.1.2EGFR Mutation EGFR突变16.4.1.3 16.4.1.3ALK Mutation ALK突变16.4.1.4 16.4.1.4KRAS Mutation KRAS突变16.4.1.5 16.4.1.5BRAF Mutation BRAF突变16.4.1.6 16.4.1.6MET 气象16.4.1.7 16.4.1.7Others Emerging Biomarkers 其他新兴生物标志物16.5 16.5Key Market Forecast Assumptions 关键市场预测假设16.5.1 16.5.1PD-L1 Expression PD-L1表达16.5.2 16.5.2EGFR NSCLC EGFR非小细胞肺癌16.5.3 16.5.3ALK NSCLC ALK阳性非小细胞肺癌16.5.4 16.5.4KRAS NSCLC KRAS非小细胞肺癌16.5.5 16.5.5ROS-1 NSCLC ROS-1 非小细胞肺癌16.5.6 16.5.6HER2 NSCLC HER2 非小细胞肺癌16.5.7 16.5.7BRAF NSCLC BRAF 非小细胞肺癌16.5.8 16.5.8C-Met NSCLC C-Met非小细胞肺癌16.5.9 16.5.9RET NSCLC RET 非小细胞肺癌16.5.10 16.5.10NTRK NSCLC NTRK 非小细胞肺癌16.5.11 16.5.11NRG1 Fusion NSCLC NRG1融合非小细胞肺癌16.6 16.6The United States NSCLC Market 美国非小细胞肺癌市场16.7 16.7EU4 and the UK NSCLC Market 欧盟四国与英国非小细胞肺癌市场16.8 16.8Japan NSCLC Market 日本非小细胞肺癌市场17 17Unmet Needs of NSCLC 非小细胞肺癌的未满足需求18 18SWOT Analysis of NSCLC 非小细胞肺癌的SWOT分析19 十九KOL Views of NSCLC 非小细胞肺癌领域的关键意见领袖观点20 二十Market Access and Reimbursement of NSCLC 非小细胞肺癌的市场准入与报销21 二十一Bibliography 参考文献22 二十二NSCLC Market Report Methodology 非小细胞肺癌市场报告方法论Related Reports 相关报告Non-small Cell Lung Cancer 非小细胞肺癌Clinical Trial Analysis 临床试验分析Non-small Cell Lung Cancer 非小细胞肺癌Pipeline Insight 管道洞察– –2026 2026年report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including 报告提供了关于管线格局、管线药物概况（包括临床和非临床阶段产品）以及关键非小细胞肺癌公司的全面见解，包括ArriVent BioPharma, iTeos Therapeutics, GSK, Incyte, Macrogenics, AstraZeneca, Hutchison MediPharma, Hoffmann-La Roche, Genentech, AnaptysBio, Shanghai Henlius Biotech, Otsuka Pharmaceutical, Bristol-Myers Squibb, OSE Immunotherapeutics, Arcus Biosciences, Gilead Sciences, Pfizer, Cullinan Oncology, Taiho Pharma, ImmunityBio, Jiangsu Hansoh Pharmaceutical, Daiichi Sankyo, Boehringer Ingelheim, Moderna Therapeutics, Merck Sharp & Dohme, Eli Lilly and Company, BeyondSpring, Immutep, Genmab, Imugene, Dizal Pharmaceutical, Regeneron Pharmaceuticals, AbbVie, Candel Therapeutics, . ArriVent BioPharma、iTeos Therapeutics、葛兰素史克（GSK）、Incyte、MacroGenics、阿斯利康、和记黄埔医药、罗氏（Hoffmann-La Roche）、基因泰克（Genentech）、AnaptysBio、上海复宏汉霖生物技术、大冢制药、百时美施贵宝、OSE Immunotherapeutics、Arcus Biosciences、吉利德科学、辉瑞、Cullinan Oncology、Taiho Pharma、ImmunityBio、江苏恒瑞医药、第一三共、勃林格殷格翰、Moderna Therapeutics、默沙东（Merck Sharp & Dohme）、礼来公司、BeyondSpring、Immutep、Genmab、Imugene、迪哲医药、再生元制药、艾伯维（AbbVie）、Candel Therapeutics。and others. 以及其他。EGFR NSCLC Market EGFR非小细胞肺癌市场EGFR NSCLC Market Insights, Epidemiology, and Market Forecast – 2036 EGFR非小细胞肺癌市场洞察、流行病学及市场预测（至2036年）report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key EGFR NSCLC companies, including 报告提供了对疾病的深入理解、历史和预测的流行病学，以及市场趋势、市场驱动因素、市场障碍和关键的EGFR非小细胞肺癌公司，包括AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hansoh Pharmaceutical, Johnson & Johnson Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Akeso Biopharma, Summit Therapeutics, 阿斯利康、勃林格殷格翰、礼来、翰森制药、强生创新药、辉瑞、Cullinan Oncology、大冢制药、ArriVent Biopharma、Black Diamond Therapeutics、第一三共、康方生物、Summit Therapeutics，and others. 以及其他。EGFR Inhibitors Market EGFR抑制剂市场EGFR Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 EGFR抑制剂市场规模、目标人群、竞争格局及市场预测——2036年report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key EGFR inhibitors companies, including 报告深入解析了市场趋势、市场驱动因素、市场壁垒以及关键的EGFR抑制剂企业，包括Cullinan Oncology, Taiho Pharma, ArriVent BioPharma, Akeso Biopharma, Summit Therapeutics, Pfizer, Daiichi Sankyo, AstraZeneca, Merck, Kelun-Biotech, CSPC Pharmaceutical, Shanghai JMT-Bio, Bristol-Myers Squibb, AbbVie, Lantern Pharma, Wayshine Biopharm, Teligene US, Genprex, J Ints Bio, Black Diamond Therapeutics, BlossomHill Therapeutics, Scorpion Therapeutics, Pierre Fabre, Antares Therapeutics, A2 Biotherapeutics, BioNTech, Dragonfly Therapeutics, Merus, DualityBio, ORIC Pharmaceuticals, BeOne Medicines (formerly BeiGene), Dizal Pharmaceutical, Jiangsu Hansoh Pharmaceutical, Boehringer Ingelheim, Pfizer, Johnson & Johnson Innovative Medicine, Yuhan Corporation, Eli Lilly and Company,. Cullinan Oncology、Taiho Pharma（大正制药）、ArriVent BioPharma（阿瑞云生物）、Akeso Biopharma（康方生物）、Summit Therapeutics、Pfizer（辉瑞）、Daiichi Sankyo（第一三共）、AstraZeneca（阿斯利康）、Merck（默克）、Kelun-Biotech（科伦博泰）、CSPC Pharmaceutical（石药集团）、Shanghai JMT-Bio（上海君实生物）、Bristol-Myers Squibb（百时美施贵宝）、AbbVie（艾伯维）、Lantern Pharma、Wayshine Biopharm（微芯生物）、Teligene US、Genprex、J Ints Bio、Black Diamond Therapeutics、BlossomHill Therapeutics、Scorpion Therapeutics、Pierre Fabre（皮尔法伯）、Antares Therapeutics、A2 Biotherapeutics、BioNTech（拜恩泰科）、Dragonfly Therapeutics、Merus、DualityBio（康诺亚）、ORIC Pharmaceuticals、BeOne Medicines（前身为百济神州）、Dizal Pharmaceutical（迪哲医药）、Jiangsu Hansoh Pharmaceutical（江苏恒瑞医药）、Boehringer Ingelheim（勃林格殷格翰）、Pfizer（辉瑞）、Johnson & Johnson Innovative Medicine（强生创新制药）、Yuhan Corporation（柳韩洋行）、Eli Lilly and Company（礼来公司）。and others. 以及其他。Antibody Drug Conjugates Market 抗体药物偶联物市场Antibody Drug Conjugates Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 抗体药物偶联物市场规模、目标人群、竞争格局及市场预测——2036年report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key ADCs companies, including 报告深入分析了市场趋势、市场驱动因素、市场壁垒以及关键的ADC公司，包括ImmunoGen, Daiichi Sankyo, AstraZeneca, Seagen, Sorrento Therapeutics, Inc., Mythic Therapeutics, Merck KGaA, NBE-Therapeutics AG, Gilead Sciences, Regeneron Pharmaceuticals, Kirilys Therapeutics Inc., Tanabe Research Laboratories USA Inc, Sutro Biopharma, Inc., OBI Pharma, Inc, MediLink Therapeutics (Suzhou) Co., Ltd., TORL Biotherapeutics, LLC, Ambrx, Inc.,. ImmunoGen、第一三共、阿斯利康、Seagen、Sorrento Therapeutics, Inc.、Mythic Therapeutics、默克（KGaA）、NBE-Therapeutics AG、吉利德科学、再生元制药、Kirilys Therapeutics Inc.、田边美国研究实验室有限公司、Sutro Biopharma, Inc.、OBI Pharma, Inc.、迈迪安龙药业（苏州）有限公司、TORL Biotherapeutics, LLC、Ambrx, Inc.。and others. 以及其他。About 关于DelveInsight DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platformPharmDelve. 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2026-06-30
·医悦汇
编者按
2026年欧洲肿瘤内科学会胃肠道肿瘤大会（ESMO Gastrointestinal Cancers Congress）将于7月1日至4日在德国慕尼黑国际会议中心（ICM）盛大召开。作为消化道肿瘤领域最具影响力的学术盛会之一，本次大会汇聚了全球顶尖的临床研究者、肿瘤学专家和医药研发人员，将集中展示从早期筛查、生物标志物驱动治疗到系统治疗创新的最新进展。
目前，大会官网已公布了除Late-Breaking Abstract（LBA）外的全部入选研究摘要。本文梳理了本次大会最具分量的口头报告（Proffered Paper和Rapid Oral）核心内容，涵盖结直肠癌、肝胆肿瘤、胃食管癌和胰腺癌四大领域的前沿突破。
结直肠癌：
围术期策略优化与精准治疗并进
ATOMIC研究：辅助治疗时长再审视
ATOMIC研究（摘要号：1O）针对Ⅲ期dMMR结肠癌患者，探索阿替利珠单抗联合mFOLFOX6辅助治疗的持续时间是否影响疗效。
结果显示，只有完成≥6个周期（约3个月）化疗的患者，联合阿替利珠单抗才能显著获益（3年DFS率88.2% vs 79.1%；aHR 0.46），而化疗周期不足的患者未观察到DFS改善。值得关注的是，阿替利珠单抗治疗超过12个周期未带来额外的DFS获益（84.0% vs 88.0%；aHR 0.81），提示免疫辅助治疗并非“越长越好”。该研究为临床决策提供了精准的时间窗口参考。
GALAXY研究：ctDNA-MRD精准指导肝转移术后治疗
GALAXY研究（摘要号：8O）是本次大会备受瞩目的焦点之一。研究纳入298例结直肠癌肝转移（CLM）切除术后的患者，采用个体化肿瘤知情检测评估术后ctDNA-MRD状态。
关键发现具有直接临床转化价值：
MRD阳性患者：接受辅助化疗较观察组显著改善OS（48个月OS率：65% vs 33%；HR 0.27）和DFS（48个月DFS率：38% vs 7%；HR 0.07）。
MRD阴性患者：辅助化疗无OS或DFS获益，长期预后良好（HR 0.54）。
ctDNA-MRD可精准筛选出能从辅助化疗中获益的患者，支持在直接手术的CLM患者中前瞻性验证ctDNA指导的辅助治疗策略。
TORCH-iTNT更新：免疫TNT在pMMR直肠癌中的疗效
中国学者章真教授团队报告的TORCH-iTNT研究（摘要号：295RO）评估了免疫治疗为基础的全程新辅助治疗（iTNT）在pMMR局部晚期直肠癌（LARC）中的疗效。
192例患者随机接受CAPOX+特瑞普利单抗（A组）或短程放疗后序贯CAPOX+特瑞普利单抗（B组）。结果显示，B组总体CR率显著优于A组（60.2% vs 37.3%），其中手术pCR率分别为43.4%和32.8%。这是首个比较两种iTNT方案在pMMR LARC中疗效的研究，为器官保留策略提供了新的证据。
其他亮点
KRAS G12C新药Calderasib：KANDLELIT-001研究（摘要号：6RO）报道了该药在KRAS G12C突变晚期CRC中的数据。
抗EGFR再挑战策略：5项RCT的个体患者数据分析（摘要号：4RO）为后线治疗提供了决策依据。
LBA3：中国学者宋章法教授报告的Ⅲ期研究，探索了改良短程放疗联合CAPOX及替雷利珠单抗在pMMR/MSS LARC中的应用。
肝胆肿瘤：
TACE+靶免OS折戟，FGFR2抑制剂交出亮眼答卷
EMERALD-1：PFS获益未能转化为OS改善
EMERALD-1研究（摘要号：183O）是肝胆肿瘤领域的重磅研究。该Ⅲ期研究此前已达到主要终点——度伐利尤单抗+贝伐珠单抗+TACE相比单纯TACE显著改善了不可切除HCC患者的PFS（15.0个月 vs 8.2个月；HR 0.77）。
然而，本次报告的最终OS分析令人意外：D+B+TACE组中位OS为29.9个月，而TACE组为33.3个月（HR 1.10；P=0.470），未能转化为生存获益。D+TACE组OS同样无改善（33.6个月 vs 33.3个月；HR 0.93）。
这一结果提示，在TACE基础上加用免疫+抗血管治疗虽能延缓疾病进展，但需警惕长期暴露于联合治疗可能增加毒性负担，反而抵消了PFS获益。安全性数据显示D+B+TACE组3/4级治疗相关不良事件发生率高达27.3%，而TACE组仅为7.5%。
EMERALD-3研究（摘要号：LBA2）将在本次大会报告曲麦利尤单抗+度伐利尤单抗±仑伐替尼联合TACE的肿瘤缓解分析。
PROACTIF：钇-90真实世界剂量-生存数据
PROACTIF研究（摘要号：184RO）纳入989例HCC患者，聚焦巨大肿瘤和门静脉血栓（PVT）这一难治人群。
关键发现：高剂量（≥400Gy）显著改善OS，且与肿瘤大小无关。Vp1-Vp2期PVT患者接受≥200Gy和≥400Gy时，mOS与无PVT患者相似。Vp3期PVT患者接受≥400Gy剂量时呈现类似趋势。
结论：对于巨大病灶或PVT患者，靶向≥400Gy的肿瘤剂量是实现生存获益的必要条件。
Fanregratinib：FGFR2融合ICC的ORR达42.5%
中国学者徐建明教授报告的Ⅱ期研究（摘要号：343RO）评估了泛FGFR抑制剂Fanregratinib在既往经治FGFR2融合/重排肝内胆管癌（ICC）中的疗效。
87例患者接受Fanregratinib 300mg每日一次（2周用药/1周停药方案），独立审查委员会评估的客观缓解率（ORR）达42.5%（37/87；95%CI 32.0%~53.6%），疾病控制率83.9%，中位PFS 6.9个月，中位OS 16.6个月。该研究达到预设的有效性界值，为FGFR2融合ICC患者提供了新的治疗选择。
胰腺癌：
KRAS G12D靶向联合方案带来突破曙光
胰腺癌领域有多项研究入选口头报告，其中最引人注目的是针对KRAS G12D这一难治靶点的联合策略。
Zoldonrasib + Daraxonrasib联合方案
摘要号341O报道了zoldonrasib（RMC-9805，G12D选择性抑制剂）联合daraxonrasib（RMC-6236，多靶点RAS抑制剂）在二线及以上KRAS G12D突变mPDAC中的I期数据。
60例患者接受联合治疗（中位随访12.2个月），初步疗效令人鼓舞：中位PFS和OS数据虽然尚未完全成熟，但已显示出超越现有化疗的潜力；安全性可控，≥3级TRAE主要为皮疹（12%）和贫血（10%）。
约40%的PDAC患者存在KRAS G12D突变，而目前尚无获批的靶向疗法。该联合方案已启动全球性Ⅱ期研究（RASolute 309），评估其在一线治疗中的疗效。
其他胰腺癌研究
Zoldonrasib联合化疗一线治疗（摘要号：340O）：同样值得关注。
CLDN18.2靶向药物佐妥昔单抗联合吉西他滨+白蛋白紫杉醇的Ⅱ期GLEAM研究（摘要号：342O）。
LBA4：TRIPP-FFX研究——磷-32微粒子瘤内植入联合FOLFIRINOX治疗局部晚期胰腺癌。
胃食管癌：
免疫联合、新靶点与生活质量并重
STAR-221：双免疫联合化疗挑战一线标准
摘要号493O报道了STAR-221 Ⅲ期研究——domvanalimab（抗TIGIT）+ zimberelimab（抗PD-1）+化疗对比纳武利尤单抗+化疗一线治疗HER2阴性晚期胃癌/胃食管结合部癌/食管腺癌。该研究有望重新定义一线治疗格局。
HERIZON-GEA-01：HER2阳性mGEA的HRQoL数据
摘要号494O和495RO分别报告了泽尼达妥单抗+化疗±替雷利珠单抗一线治疗HER2阳性晚期/转移性胃食管腺癌（mGEA）的健康相关生活质量（HRQoL）和缓解特征分析。在关注疗效的同时，患者生活质量的评估日益受到重视。
PD-L1检测方法学争议
摘要号496RO聚焦胃食管腺癌中PD-L1检测方法和评分方法的互换性问题（EORTC ASPIRE项目）。这一问题直接关系到免疫治疗患者的筛选和临床决策的一致性。
临床决策精准化：
生物标志物驱动治疗走向前台
2026年ESMO GI大会传递了消化道肿瘤领域的几个明确趋势：
精准分层指导治疗决策：ctDNA-MRD指导辅助化疗（GALAXY）、分子标志物筛选靶向人群（KRAS G12D，FGFR2，CLDN18.2），均体现了从“群体治疗”向“个体化治疗”的转变。
靶向KRAS的突破：从G12C到G12D，从单药到联合，RAS通路抑制在胰腺癌和结直肠癌中持续推进，有望填补巨大的未满足需求。
免疫治疗时机的精细化：ATOMIC研究表明“疗程不是越长越好”，提示未来需要建立基于biomarker的动态治疗时长策略。
局部治疗与系统治疗的整合：HCC领域TACE+靶免的OS折戟敲响警钟；而钇-90剂量优化和FGFR2抑制剂在胆管癌中的数据则提供了积极范例。
中国学者持续活跃：TORCH-iTNT（王雅琪）、Fanregratinib（徐建明）、LBA3（宋章法）等多项研究入选口头报告，体现了中国在消化道肿瘤临床研究领域的国际影响力。
随着LBA数据的陆续揭晓，ESMO GI 2026必将为消化道肿瘤的临床实践带来更多改变。我们拭目以待。
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编辑 | 佼娇
排版 | 粘洞
审核 | 晓娟 鹏哥
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2026-06-24
·药弈
一个靶点的兴衰，一部肿瘤免疫的缩影
2020年5月，罗氏公布CITYSCAPE研究数据——Tiragolumab联合阿替利珠单抗在PD-L1高表达NSCLC中，ORR达到惊人的66%，几乎是单药的3倍。整个行业为之沸腾，TIGIT被冠以"下一代PD-1"的光环。
然而仅仅五年后，从罗氏到默沙东，从百济到Arcus/吉利德，全球范围内已投入超过200亿美元研发费用，6款以上TIGIT单抗在III期临床中接连失利，数十个项目黯然终止。
TIGIT到底是一个怎样的靶点？为何从万众瞩目的"希望之星"跌落神坛？抗体工程的优化能否挽救这个靶点？双抗路线又能否柳暗花明？
这是一个关于靶点验证、资本狂热与科学理性的故事。一、靶点生物学：复杂的免疫调控网络1.1 TIGIT的结构与表达
TIGIT（T cell immunoreceptor with Ig and ITIM domains）是2009年由基因泰克首次发现的共抑制受体，属于免疫球蛋白超家族。其结构包括：
胞外段：一个免疫球蛋白可变（IgV）结构域，特征性的（V/I）（S/T）Q、AX₆G和T（F/Y）PX₁G亚基序，介导与配体的"锁-钥"反式相互作用。
跨膜区：单次跨膜结构。
胞内段：含有免疫受体酪氨酸抑制基序（ITIM）和Ig尾酪氨酸（ITT）样基序，是传递抑制信号的关键。
表达分布：TIGIT主要表达于活化的CD4⁺T细胞、CD8⁺T细胞、调节性T细胞（Treg）、自然杀伤（NK）细胞和滤泡辅助性T细胞。在肿瘤微环境中，TIGIT在耗竭性T细胞和肿瘤浸润Treg上高表达，与PD-1存在显著共表达（70%以上）。1.2 配体系统：三重结合的复杂性
TIGIT有三个已知配体，亲和力呈梯度分布：配体别名亲和力表达分布PVRCD155、Necl-5最高肿瘤细胞、树突状细胞、内皮细胞、成纤维细胞PVRL2CD112、Nectin-2中等抗原呈递细胞、单核细胞、部分肿瘤细胞PVRL3CD113、Nectin-3较低上皮细胞、部分肿瘤细胞
关键机制：TIGIT与共刺激受体CD226（DNAM-1）竞争性结合相同配体（尤其是CD155），但TIGIT的亲和力显著高于CD226。这构成了一个精细的调控平衡——当TIGIT高表达时，会"抢占"配体，抑制CD226介导的激活信号。
这种"竞争抑制"模式与PD-1/PD-L1的"直接抑制"模式有本质区别，也决定了TIGIT靶点的成药性逻辑与PD-1截然不同。1.3 三重免疫抑制机制
TIGIT通过三重机制发挥免疫抑制作用，比PD-1的调控网络更为复杂：
第一，直接抑制T细胞活化。TIGIT结合CD155后，通过胞内ITIM和ITT样基序招募SHIP-1磷酸酶，抑制PI3K-Akt和NF-κB信号通路，下调TCR信号，减少IFN-γ、TNF-α等效应细胞因子产生。
第二，间接增强Treg功能。TIGIT在Treg上高表达，与其免疫抑制功能正相关。TIGIT⁺Treg通过上调IL-10和Fgl2的分泌，增强对效应T细胞的抑制；同时TIGIT信号可稳定Foxp3表达，维持Treg的免疫抑制表型。
第三，通过树突状细胞介导免疫抑制。TIGIT与DC上的CD155结合后，反向信号诱导DC产生IL-10，同时下调IL-12分泌，削弱DC的抗原呈递能力，形成"肿瘤细胞→DC→T细胞"的多级免疫抑制链条。1.4 NK细胞调控：常被忽视的维度
TIGIT也是NK细胞的重要抑制性受体。阻断TIGIT可直接增强NK细胞的细胞毒性和细胞因子分泌。在免疫源性低的"冷肿瘤"中，NK细胞的作用可能比T细胞更关键——这也是TIGIT靶点区别于PD-1的重要特征之一。
然而，硬币的另一面是：TIGIT抗体的Fc功能可能导致NK细胞的"自相残杀"（fratricide）——当抗体结合NK细胞表面的TIGIT后，Fc段可能通过FcγR介导的机制引发NK细胞之间的相互杀伤。这一机制可能部分解释了部分临床研究中观察到的疗效矛盾。
TIGIT的生物学复杂性既是潜力也是陷阱。相比PD-1相对单一的T细胞抑制通路，TIGIT同时调控T细胞、NK细胞、Treg和DC四种免疫细胞。但这种多维度调控也意味着，简单的抗体阻断可能带来难以预测的净效应——激活与抑制并存，最终疗效取决于多种因素的动态平衡。二、靶点验证历程：从狂热到理性的十五年2.1 为什么TIGIT曾被称为"下一代PD-1"？
TIGIT赛道的兴起源于三个核心逻辑，每一个在当时看来都极具说服力：
第一，机制互补性。PD-1主要通过抑制TCR下游信号发挥作用，而TIGIT通过CD226通路调控，两者在耗竭T细胞上共表达，双重阻断理论上可产生协同效应。临床前模型中，联合阻断TIGIT和PD-1/PD-L1确实显示出优于单药的抗肿瘤活性。
第二，CITYSCAPE研究的爆炸性数据。2020年5月，罗氏公布II期CITYSCAPE研究结果：在PD-L1高表达（TPS≥50%）NSCLC亚组（约80例）中，Tiragolumab + 阿替利珠单抗对比安慰剂 + 阿替利珠单抗，ORR达到66% vs 24%，中位PFS为未达到 vs 4.1个月（HR=0.31）。
这一数据远超市场预期——PD-1单药在PD-L1高表达人群的ORR通常在30-40%。2021年1月，FDA授予该方案突破性疗法认定（BTD）。但需要注意的是，这只是小样本亚组分析，统计学效力有限。
第三，商业想象力。PD-1/PD-L1市场已达数百亿美元规模，如果TIGIT能在PD-1基础上再提升疗效，将成为新的"超级炸弹"。各大药企纷纷入场，巅峰时期全球有超过60个TIGIT项目在研。2.2 泡沫破裂：III期接连失利
然而，CITYSCAPE的惊艳表现并没有在III期延续。从2022年开始，TIGIT领域进入了"兵败如山倒"的模式：时间公司药物研究适应症结果2022.03罗氏TiragolumabSKYSCRAPER-02ES-SCLC一线未达PFS主要终点2022.05罗氏TiragolumabSKYSCRAPER-01NSCLC（PD-L1高）一线未达PFS共同终点2023.11默沙东VibostolimabKeyVibe-003NSCLC（PD-L1≥1%）一线未达PFS2024.05GSK/iTeosBelrestotug-NSCLC终止开发2024.12默沙东Vibostolimab-黑色素瘤等终止开发2025.04百济神州OciperlimabAdvanTIG-302NSCLC（PD-L1高）一线中期分析OS无望，终止2025.12Arcus/吉利德DomvanalimabSTAR-221胃/胃食管结合部癌一线未达OS主要终点2026.04Arcus/吉利德DomvanalimabSTAR-121 / EDGE-LungNSCLC一线因疗效不足终止
累计研发投入：据估计，全球药企在TIGIT靶点上已投入超过200亿美元，但至今尚无产品获批上市。这可能是肿瘤免疫领域最昂贵的一次"试错"。
TIGIT的兴衰轨迹完美诠释了创新药研发的"双相情感障碍"——从早期数据惊艳时的极度乐观，到III期失败后的极度悲观。客观来看，II期数据并非完全没有参考价值，但行业倾向于用最乐观的方式解读早期信号，并以此驱动大规模的资本投入和管线布局。当潮水退去，才发现大多数人都在裸泳。三、关键临床数据深度解析3.1 Tiragolumab（罗氏）：先驱的滑铁卢
作为TIGIT领域的先驱和标杆，罗氏Tiragolumab的临床数据最具代表性，也最值得深入分析。
SKYSCRAPER-01研究（NSCLC一线，PD-L1高表达）：
这是TIGIT领域最受关注的III期研究。入组534例PD-L1 TPS≥50%的IV期NSCLC患者，随机接受Tiragolumab + 阿替利珠单抗或安慰剂 + 阿替利珠单抗。主要终点为PFS和OS。
结果令人失望：
• 中期PFS未达到统计学显著性（HR≈0.85）
• 第二次中期OS（2023年8月）：联合组22.9个月 vs 单药组16.7个月（HR=0.81，95%CI 0.63-1.03），p=0.045（未达预设边界）
• 最终分析（2024年）：OS仍未达统计学意义
• ORR：联合组55.6% vs 对照组38.3%（有改善但未转化为生存获益）
这里有一个值得注意的矛盾：ORR和PFS有改善趋势，但OS未达统计学意义。这提示TIGIT抗体可能带来了早期缓解但未能持久——免疫细胞被短暂激活后迅速进入更深的耗竭状态，或者被抗体的Fc功能反向清除。
SKYSCRAPER-02研究（ES-SCLC一线）：
490例未经治疗的广泛期小细胞肺癌患者，方案为Tiragolumab + 阿替利珠单抗 + 化疗对比安慰剂 + 阿替利珠单抗 + 化疗。结果几乎是"完败"：
• 中位PFS：5.4个月 vs 5.6个月（HR≈1.0，几乎无差异）
• 中位OS：13.6个月 vs 13.6个月（完全相同）
• 中国队列事后分析显示一定生存趋势（OS 18.7 vs 13.5个月，HR=0.89），但无统计学意义
SCLC的全面失败进一步打击了市场信心——连PD-1已经证明有效的适应症，加上TIGIT都没有增益，这个靶点的价值到底在哪里？3.2 Vibostolimab（默沙东）：IgG1的另一种尝试
默沙东的Vibostolimab是一款全人源IgG1κ型抗TIGIT抗体，结合表位为TIGIT的CC'C''FG环区域，具有完整Fc功能，可介导ADCC/ADCP。
KeyVibe-003研究（NSCLC一线，PD-L1≥1%）：对比Vibostolimab + 帕博利珠单抗 vs 帕博利珠单抗单药，2023年11月公布未达到PFS主要终点。2024年底默沙东全面终止Vibostolimab的临床开发。
值得注意的是，Tiragolumab和Vibostolimab虽然都是IgG1型、都有完整Fc功能、结合表位也相似，但最终结局高度一致——均未能在III期证明生存获益。这说明失败不是某个药物的问题，而是靶点本身或开发策略的共性问题。3.3 Domvanalimab（Arcus/吉利德）：Fc沉默路线的尝试与失败
Domvanalimab是Arcus Biosciences开发的Fc沉默型TIGIT抗体，通过Fc区域突变（L234A/L235A/P329G）实现Fc沉默，理论上避免FcγR介导的免疫细胞耗竭和潜在毒性。
这款药物曾被视为TIGIT领域的"黑马"，因为它解决了业界对Fc功能的一大担忧——即Fc介导的效应T细胞和NK细胞清除。
ARC-7研究（NSCLC一线，PD-L1高表达）：
• II期随机研究，入组150例PD-L1 TPS≥50%的NSCLC
• 三组设计：zimberelimab（PD-1）单药、domvanalimab + zimberelimab、三药联合（+ etrumadenant）
• 结果（2022年公布）：ORR联合组41% vs 单药组27%；中位PFS联合组12.0个月 vs 单药组5.4个月（HR=0.55）
• 安全性亮眼：≥3级TRAEs 47% vs 58%（联合组反而更低）
ARC-10研究（NSCLC一线，PD-L1高表达）：
• II期随机，95例PD-L1 TPS≥50%患者
• 结果（2025年公布）：中位PFS联合组11.5个月 vs 单药组6.2个月（HR=0.69）；中位OS联合组未达到 vs 单药组24.4个月（HR=0.64）
EDGE-Gastric研究（胃癌/胃食管结合部癌一线）：
• II期多臂研究，domvanalimab + zimberelimab + FOLFOX化疗
• 结果（2025年10月更新）：确认ORR 54%（ITT人群），中位PFS约12个月，中位OS 26.7个月
• PD-L1高表达亚组ORR达67%，6个月PFS率93%
这些II期数据不可谓不亮眼——PFS HR 0.55、OS HR 0.64，放在任何靶点上都是值得推进的信号。于是Arcus/吉利德快速推进了多项III期研究。
然而，STAR-221研究（胃癌/胃食管结合部癌一线）在2025年12月公布的中期分析中，未达到OS主要终点。紧接着在2026年4月，Arcus宣布终止NSCLC领域的STAR-121和EDGE-Lung研究。
Domvanalimab的失败最令人唏嘘——它一度被认为是"最有可能成功的TIGIT单抗"，它的II期数据质量甚至优于当年罗氏的CITYSCAPE，但最终仍未能逃脱III期魔咒。
即使是Fc沉默设计，即使在II期看到了令人鼓舞的PFS和OS趋势（HR 0.64），在以PD-1+化疗为标准对照的III期试验中仍然失败。这提示TIGIT靶点的问题可能不只是Fc设计，而是更深层的机制问题——或者说，II期数据的可靠性本身就值得审视。3.4 国内产品：百济折戟， others跟进
欧司珀利单抗（百济神州）：
作为国内TIGIT管线的"标杆"，欧司珀利单抗曾被寄予厚望。诺华曾以3亿美元首付款引进其海外权益。它采用了相对少见的IgG4型设计。
AdvanTIG-302研究（III期，NSCLC一线，PD-L1高表达）是其关键试验——直接头对头对比帕博利珠单抗。这个设计本身就非常激进，反映了行业对TIGIT的过高预期。
2025年4月，百济宣布该研究中期分析显示OS无望，终止试验。详细数据显示：
• 中位OS：联合组约26个月 vs 帕博利珠单抗组约24个月（数值略有延长但无统计学意义）
• ≥3级不良反应：联合组显著高于对照组
也就是说，疗效提升有限，但毒性显著增加——这是最差的一种结果。
其他国内项目大多处于早期临床阶段：信达生物IBI939（IgG4型）、康方生物AK127（单抗）及AK130（TIGIT/TGF-β双抗）、君实生物JS009、恒瑞医药SHR-1706等。随着全球TIGIT热度退潮，这些项目的推进速度预计将放缓。四、技术路线差异：抗体设计的成败关联4.1 Fc功能之争：不是答案的核心矛盾
Fc功能是TIGIT领域争论最激烈的技术话题，也是各公司差异化布局的核心方向：Fc设计代表药物理论逻辑临床结局IgG1（完整Fc）Tiragolumab、VibostolimabADCC清除TIGIT⁺Treg，增强免疫III期失败IgG4Ociperlimab低ADCC，安全性优先III期失败Fc沉默突变Domvanalimab完全避免Fc介导的免疫细胞耗竭III期失败
一个值得注意的事实是：无论何种Fc设计，TIGIT单抗均未能在III期证明OS获益。这提示Fc功能可能不是TIGIT靶点的核心矛盾——更深层的机制问题（如生物标志物缺失、通路冗余）尚未解决。不同Fc设计可能在特定亚组中存在差异，但在未经选择的人群中影响有限。4.2 双特异性抗体：最后的希望？
在单抗全线受挫的背景下，PD-1/TIGIT双抗成为TIGIT领域仅存的亮点。阿斯利康的Rilvegostomig（AZD2936）是其中进展最快的产品。
ARTEMIDE-01研究（I/II期）显示，在PD-L1 TPS≥50%的NSCLC一线治疗中，ORR达61.8%，中位PFS达12.3个月，化疗初治亚组PFS更是达到21.2个月。这组数据让人依稀看到了当年CITYSCAPE的影子。
目前阿斯利康正在推进多项III期研究，结果预计2026-2027年陆续读出。双抗究竟是机制上的真正突破，还是又一次"II期惊艳、III期翻车"的轮回，尚需时间检验。· · ·
（上篇完，下篇继续解读：适应症布局分析、竞争格局复盘、失败深层原因拆解、未来终局判断与行业启示）
主要参考来源
罗氏、默沙东、Arcus/吉利德、百济神州、阿斯利康等公司官方公告与临床数据公布；ASCO、ESMO、AACR、WCLC等国际学术会议公布数据
⚠️ 本账号所刊载内容仅供医学专业人士学术交流使用，不构成任何诊疗建议。医学问题请咨询专业医疗机构。药弈聚焦领域前沿，追踪新药管线，解读临床进展，拆解方案设计与审批逻辑
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 食管腺癌 | 临床3期 | 美国 | 2022-11-21 | |
| 食管腺癌 | 临床3期 | 日本 | 2022-11-21 | |
| 食管腺癌 | 临床3期 | 阿根廷 | 2022-11-21 | |
| 食管腺癌 | 临床3期 | 澳大利亚 | 2022-11-21 | |
| 食管腺癌 | 临床3期 | 比利时 | 2022-11-21 | |
| 食管腺癌 | 临床3期 | 巴西 | 2022-11-21 | |
| 食管腺癌 | 临床3期 | 加拿大 | 2022-11-21 | |
| 食管腺癌 | 临床3期 | 智利 | 2022-11-21 | |
| 食管腺癌 | 临床3期 | 法国 | 2022-11-21 | |
| 食管腺癌 | 临床3期 | 格鲁吉亚 | 2022-11-21 |
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临床结果
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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 |
|---|
临床2期 | 41 | 廠醖窪範憲鏇遞餘鏇鑰(構積觸選構鬱衊廠襯鏇) = 窪構鹽齋觸齋糧觸窪繭 獵網願簾觸構鹹淵築壓 (網遞糧遞鹹網範積鏇觸, 44.5 ~ 71.6) 更多 | 积极 | 2025-10-18 | |||
(PD-L1 positive) | 廠醖窪範憲鏇遞餘鏇鑰(構積觸選構鬱衊廠襯鏇) = 鹽簾製遞淵廠廠醖鹽鏇 獵網願簾觸構鹹淵築壓 (網遞糧遞鹹網範積鏇觸, 45.1 ~ 77.1) 更多 | ||||||
临床2期 | 41 | (PD-L1 Positive (TAP ≥1%)) | 鬱網簾窪範壓廠範夢構(窪窪鑰艱範膚壓遞範構) = 膚鬱構構夢鹽願選糧膚 鏇觸觸觸鏇醖糧鹽積糧 (夢醖遞醖艱範積糧壓遞, 45 ~ 77) 更多 | 积极 | 2025-10-17 | ||
(PD-L1 High (TAP ≥5%)) | 鬱網簾窪範壓廠範夢構(窪窪鑰艱範膚壓遞範構) = 製蓋壓憲鏇顧顧餘廠壓 鏇觸觸觸鏇醖糧鹽積糧 (夢醖遞醖艱範積糧壓遞, 45 ~ 87) 更多 | ||||||
临床2期 | 41 | 繭膚構顧顧獵願鹽願憲(鬱鹹鹹鬱窪廠鹽鬱鬱築) = 鑰窪憲鏇淵糧餘鹹鬱鑰 艱壓鏇遞廠遞製壓憲網 (獵願築顧鏇壓獵製蓋蓋, 45 ~ 72) 更多 | 积极 | 2025-10-12 | |||
(PD‐L1 Positive (TAP ≥ 1%)) | 繭膚構顧顧獵願鹽願憲(鬱鹹鹹鬱窪廠鹽鬱鬱築) = 鏇蓋遞齋鑰遞願廠艱艱 艱壓鏇遞廠遞製壓憲網 (獵願築顧鏇壓獵製蓋蓋, 45 ~ 77) 更多 | ||||||
临床2期 | 甲状腺未分化癌 BRAFV600 mutation | TIGIT expression | 24 | 顧觸蓋鑰艱築醖蓋遞鏇(鹽襯簾齋淵糧獵鑰壓廠) = 醖遞鬱膚艱獵廠觸範製 鑰齋衊鑰膚網製壓廠膚 (窪醖選顧範範範顧顧鹽 ) | 积极 | 2025-05-30 | ||
临床1期 | PD-L1阳性非小细胞肺癌 PD-L1 High Expression | 98 | 網簾夢淵襯範齋遞簾淵(衊鏇構鹹鹽範獵鏇襯膚) = 選襯積壓醖鏇壓壓餘選 醖醖夢餘壓願衊製淵鹽 (製選壓醖範壓衊簾窪淵, 13.7 ~ NE) 更多 | 积极 | 2024-11-05 | ||
網簾夢淵襯範齋遞簾淵(衊鏇構鹹鹽範獵鏇襯膚) = 鬱醖獵鑰鑰遞觸顧鑰壓 醖醖夢餘壓願衊製淵鹽 (製選壓醖範壓衊簾窪淵, 7.8 ~ NE) 更多 | |||||||
临床2期 | 29 | 願網鑰願簾齋獵膚襯夢(壓鏇網遞遞夢糧襯襯鹹) = Treatment-related adverse events (TRAE) defined as any adverse event that was at least possibly attributed to domvanalimab plus zimberelimab occurred in 16 patients (55.2%) and SAEs attributed to study treatment occurred in 2 patients (6.9%). TRAEs that were grade 3 or greater occurred in 3 patients (10.3%) 願壓夢齋夢簾網艱夢鹹 (壓鬱網選襯齋醖衊糧餘 ) | 积极 | 2024-11-05 | |||
临床2期 | 肝细胞癌 二线 | 三线 | 29 | 顧廠壓襯繭壓積膚製鏇(鏇選鹹積範糧淵鬱獵齋) = 獵願壓衊衊醖遞製觸膚 觸鬱醖廠積願襯鏇鹹淵 (範遞壓蓋齋鑰觸遞餘餘 ) 更多 | 积极 | 2024-11-05 | ||
临床2期 | 41 | 製構醖鹹網獵淵淵淵構(廠鹽構壓範簾艱遞觸淵) = 顧夢壓製構鬱鬱鹽鹽網 窪構廠鹽膚餘廠淵鹹選 (衊選夢膚遞觸鹽鬱網餘, 9.8 ~ 13.8) 更多 | 积极 | 2024-06-01 | |||
(PD-L1-high) | 製構醖鹹網獵淵淵淵構(廠鹽構壓範簾艱遞觸淵) = 積餘艱遞簾齋範遞網醖 窪構廠鹽膚餘廠淵鹹選 (衊選夢膚遞觸鹽鬱網餘, 11.3 ~ NE) 更多 | ||||||
临床2期 | 41 | 鹹繭襯網鏇糧糧獵構製(糧壓艱醖鏇積窪艱鏇鏇) = 鬱蓋廠選醖觸製鏇遞積 遞廠窪壓鹹願憲範糧顧 (淵淵憲顧憲觸衊襯齋積, 42 ~ 74) 更多 | 积极 | 2023-11-06 | |||
(PD-L1-high* (TAP ≥5%)) | 鹹繭襯網鏇糧糧獵構製(糧壓艱醖鏇積窪艱鏇鏇) = 鏇壓夢艱築願襯構製襯 遞廠窪壓鹹願憲範糧顧 (淵淵憲顧憲觸衊襯齋積, 52 ~ 96) 更多 | ||||||
临床2期 | 非小细胞肺癌 一线 | 150 | 鹹廠簾繭遞鏇鹽網遞壓(齋衊衊鑰鹽築艱鬱廠獵) = 鹽憲壓膚憲簾艱壓憲壓 繭網鹽窪襯顧膚廠獵醖 (餘鹹遞襯觸鑰壓觸蓋鏇, 17.9 ~ 44.6) 更多 | 积极 | 2023-06-03 | ||
鹹廠簾繭遞鏇鹽網遞壓(齋衊衊鑰鹽築艱鬱廠獵) = 願壓鹹顧選積積願艱顧 繭網鹽窪襯顧膚廠獵醖 (餘鹹遞襯觸鑰壓觸蓋鏇, 26.4 ~ 54.8) 更多 |
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