A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer.
The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.

开始日期2025-12-12

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT06833073

/ Recruiting临床2期

A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)

Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder.
The standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer.
The goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.

开始日期2025-03-11

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT06295809

/ Terminated临床2/3期

A Phase 2/3, Adaptive, Randomized, Open-label, Clinical Study to Evaluate Neoadjuvant and Adjuvant Intismeran Autogene (mRNA-4157) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care, and Pembrolizumab Monotherapy in Participants With Resectable Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (INTerpath-007)

This is a two-part (Phase 2/Phase 3) study of intismeran autogene, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms intismeran autogene plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of intismeran autogene in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that intismeran autogene plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to intismeran autogene plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.
As of Amendment 04, enrollment was stopped and there will be no Phase 3 expansion.

开始日期2024-04-18

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

100 项与 Intismeran Autogene 相关的临床结果

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100 项与 Intismeran Autogene 相关的转化医学

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100 项与 Intismeran Autogene 相关的专利（医药）

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项与 Intismeran Autogene 相关的文献（医药）

2026-05-01·Translational Oncology

Personalized and HPV cancer vaccines in head and neck squamous cell carcinoma: from concept to clinical implementation

Review

作者: Le Tourneau, Christophe ; Filippini, Daria Maria

Head and neck squamous cell carcinoma (HNSCC) remains a challenging malignancy, with limited survival improvements despite recent advances with immune checkpoint inhibitors (ICIs). Within this context, personalized neoantigen vaccines and HPV-targeted therapeutic vaccines are emerging as innovative strategies aimed at enhancing antitumor immunity. Personalized vaccines exploit tumor-specific mutational landscape to generate highly individualized T cell responses, demonstrating favorable safety profiles and durable immunogenicity in early-phase trials. Compounds such as TG4050, mRNA-4157, and PGV001 have shown early, hypothesis-generating signals of activity (from small early-phase studies), particularly in the adjuvant setting. HPV-targeted vaccines, including PDS0101, BNT113, and CUE-101, are being explored in HPV-positive HNSCC, mainly in combination with ICIs. While some early clinical activity has been observed, these signals should be interpreted cautiously given limited sample sizes, heterogeneous populations, and exploratory endpoints in many studies, and randomized trials such as ISA101b have failed to show survival benefits over ICIs alone. Overall, therapeutic vaccination appears safe and immunologically active, yet its efficacy is constrained by the immunosuppressive tumor microenvironment. The greatest clinical potential of therapeutic vaccination may lie in earlier disease stages, where the tumor burden is lower and immune modulation more feasible. Further clinical and translational research is needed to define the optimal integration of vaccine-based therapies into multimodal treatment paradigms for HNSCC.

2024-11-01·Cancer Discovery

T-cell Responses to Individualized Neoantigen Therapy mRNA-4157 (V940) Alone or in Combination with Pembrolizumab in the Phase 1 KEYNOTE-603 Study

Article

作者: Coder, Brandon ; Sun, Jing ; Chen, Xing ; Morrissey, Manju ; Weber, Jeffrey S. ; Gainor, Justin F. ; Hou, Peijie ; Feldman, Igor ; Aanur, Praveen ; Bauman, Julie E. ; Gerbereux, Lauren ; Clarke, Jeffrey M. ; Scott, Aaron J. ; Sehgal, Vasudha ; Daghestani, Hikmat N. ; Meehan, Robert ; Tasneem, Moomal ; Julian, Ricklie ; Kirtane, Kedar ; Srinivasan, Lakshmi ; Porichis, Filippos ; Pollard, Jack Russella ; Gutierrez, Martin ; Zheng, Wei ; Frederick, Joshua P. ; Burris, Howard A. ; Robert-Tissot, Celine ; Brown, Michelle ; Patel, Manish R. ; Geiger, Jessica L. ; Laino, Andressa

Abstract:

mRNA-4157 (V940) is an individualized neoantigen therapy targeting up to 34 patient-specific tumor neoantigens to induce T-cell responses and potentiate antitumor activity. We report mechanistic insights into the immunogenicity of mRNA-4157 via characterization of T-cell responses to neoantigens from the first-in-human, phase 1, KEYNOTE-603 study (NCT03313778) in patients with resected non–small cell lung cancer (Part A: 1-mg mRNA-4157, n = 4) or resected cutaneous melanoma (Part D: 1-mg mRNA-4157 + 200-mg pembrolizumab, n = 12). Safety, tolerability, and immunogenicity were assessed. All patients experienced ≥1 treatment-emergent adverse event; there were no grade 4/5 adverse events or dose-limiting toxicities. mRNA-4157 alone induced consistent de novo and strengthened preexisting T-cell responses to targeted neoantigens. Following combination therapy, sustained mRNA-4157-induced neoantigen-specific T-cell responses and expansion of cytotoxic CD8 and CD4 T cells were observed. These findings show the potential of a novel mRNA individualized neoantigen therapy approach in oncology.

Significance::

The safety and immunogenicity results from this phase 1 study of mRNA-4157 as adjuvant monotherapy or combination therapy with pembrolizumab show generation of de novo and enhancement of existing neoantigen-specific T-cell responses and provide mechanistic proof of concept to support further development of mRNA-4157 for patients with resected solid tumors.See related commentary by Berraondo et al., p. 2021

2024-02-01·Lancet (London, England)1区 · 医学

Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study

1区 · 医学

Article

作者: Manju Morrissey ; Thuy T Tran ; C Lance Cowey ; Peijie Hou ; George Ansstas ; Vasudha Sehgal ; Robert S Meehan ; Jennifer Segar ; Sajeve Thomas ; Jeffrey S Weber ; Theresa Medina ; Adnan Khattak ; Montaser Shaheen ; Michelle Brown ; Celine Robert-Tissot ; Geoffrey T Gibney ; Matteo S Carlino ; Victoria Atkinson ; Tarek Meniawy ; Kevin B Kim ; Jane A Healy ; Matthew H Taylor ; Igor Feldman ; Mo Huang ; Andrew Pecora ; Mark Faries ; Georgina V Long ; Meredith McKean ; Lili Zhu ; Ryan J Sullivan ; Jason J Luke ; Tal Zaks ; Elizabeth I Buchbinder ; Praveen Aanur

BACKGROUND:

Checkpoint inhibitors are standard adjuvant treatment for stage IIB-IV resected melanoma, but many patients recur. Our study aimed to evaluate whether mRNA-4157 (V940), a novel mRNA-based individualised neoantigen therapy, combined with pembrolizumab, improved recurrence-free survival and distant metastasis-free survival versus pembrolizumab monotherapy in resected high-risk melanoma.

METHODS:

We did an open-label, randomised, phase 2b, adjuvant study of mRNA-4157 plus pembrolizumab versus pembrolizumab monotherapy in patients, enrolled from sites in the USA and Australia, with completely resected high-risk cutaneous melanoma. Patients with completely resected melanoma (stage IIIB-IV) were assigned 2:1 to receive open-label mRNA-4157 plus pembrolizumab or pembrolizumab monotherapy. mRNA-4157 was administered intramuscularly (maximum nine doses) and pembrolizumab intravenously (maximum 18 doses) in 3-week cycles. The primary endpoint was recurrence-free survival in the intention-to-treat population. This ongoing trial is registered at ClinicalTrials.gov, NCT03897881.

FINDINGS:

From July 18, 2019, to Sept 30, 2021, 157 patients were assigned to mRNA-4157 plus pembrolizumab combination therapy (n=107) or pembrolizumab monotherapy (n=50); median follow-up was 23 months and 24 months, respectively. Recurrence-free survival was longer with combination versus monotherapy (hazard ratio [HR] for recurrence or death, 0·561 [95% CI 0·309-1·017]; two-sided p=0·053), with lower recurrence or death event rate (24 [22%] of 107 vs 20 [40%] of 50); 18-month recurrence-free survival was 79% (95% CI 69·0-85·6) versus 62% (46·9-74·3). Most treatment-related adverse events were grade 1-2. Grade ≥3 treatment-related adverse events occurred in 25% of patients in the combination group and 18% of patients in the monotherapy group, with no mRNA-4157-related grade 4-5 events. Immune-mediated adverse event frequency was similar for the combination (37 [36%]) and monotherapy (18 [36%]) groups.

INTERPRETATION:

Adjuvant mRNA-4157 plus pembrolizumab prolonged recurrence-free survival versus pembrolizumab monotherapy in patients with resected high-risk melanoma and showed a manageable safety profile. These results provide evidence that an mRNA-based individualised neoantigen therapy might be beneficial in the adjuvant setting.

FUNDING:

Moderna in collaboration with Merck Sharp & Dohme, a subsidiary of Merck & Co, Rahway, NJ, USA.

795

项与 Intismeran Autogene 相关的新闻（医药）

2026-07-03

·康和源免疫之家

癌症疫苗，距离“终结癌症”还有多远？5款值得期待癌症疫苗产品数据一览

长期以来，手术、化疗、放疗是抗癌的常见战争手段。但如今，我们这正在一个微妙的转折点上。科学家正试图通过“教育”免疫系统，让身体自己学会如何打赢这场仗。癌症疫苗，便是这一转变的突出表现。不同于预防宫颈癌的HPV疫苗或预防乙肝的疫苗，治疗性癌症疫苗是通过唤醒患者体内被抑制的肿瘤特异性T细胞，建立“活的”免疫记忆，实现长期的肿瘤控制甚至清除。不同技术路线实现这个目标的方式不同：mRNA疫苗把编码新抗原的mRNA送进体内，让细胞自己“打印”抗原；DC疫苗（树突状细胞疫苗）则在体外把抗原装载到最强的抗原呈递细胞上，再回输给患者；多肽疫苗直接注射合成的新生抗原肽段；病毒载体疫苗则用改造过的病毒作为“快递员”把抗原信息送进体内。技术路径各有优劣，但终极目标一致：把免疫系统的“识别精度”和“杀伤力度”同时拉满。如果您或家人正面临等实体瘤治疗的选择困境，希望深入了解个体化癌症疫苗（包括mRNA疫苗、多肽疫苗等）的最新全球临床试验进展、评估自身肿瘤的基因测序结果是否符合入组条件，请联系康和源免疫之家（400-880-3716）。今天，我们一起来了解几款值得期待的癌症疫苗究竟走到了哪一步、数据到底怎么样。 mRNA-4157 如果说癌症疫苗领域有一位“领头羊”，那我认为Moderna的mRNA-4157（现称intismeran autogene）是当之无愧的标杆级产品。 mRNA-4157（V940）是Moderna公司研发的一种基于信使RNA（mRNA）的新型研究性个体化新抗原疗法。它由编码多达34种新抗原的合成mRNA组成，根据患者肿瘤DNA序列的独特突变特征设计和生产。在2026年ASCO年会上，Moderna与默沙东联合公布了其个体化mRNA新抗原疫苗intismeran autogene（mRNA-4157）联合帕博利珠单抗，用于高危可切除黑色素瘤辅助治疗的5年长期随访数据。中位随访超过60个月后，与单独使用帕博利珠单抗相比，联合mRNA-4157治疗将患者的复发或死亡风险降低了49%，将远处转移或死亡风险降低了59%。更重要的是，这种获益在几乎所有亚组中均保持一致，包括不同疾病分期、PD-L1表达状态、BRAF突变状态的患者。尤其值得注意的是，在基线循环肿瘤DNA检测为阴性（即分子层面微小残留病灶水平极低）的患者中，联合治疗组的复发风险降低幅度高达76%，这强烈提示疫苗在清除微量残留病灶、预防复发方面具有巨大潜力。 Moderna副总裁兼肿瘤治疗领域开发负责人Kyle Holen博士表示“长达五年的随访数据突显了intismeran autogene联合KEYTRUDA方案为切除术后高危黑色素瘤患者带来持久获益的潜力。它们展现了mRNA技术在癌症治疗领域的潜力。” BNT122 BioNTech的BNT122（又名autogene cevumeran）是个性化mRNA癌症疫苗领域的另一个标杆。在纪念斯隆凯特琳癌症中心开展的1期试验中，16名接受手术、化疗及该疫苗联合免疫检查点抑制剂治疗的胰腺癌患者有8名患者对疫苗产生了免疫应答。令人振奋的是，这8名应答者中，有7人（87.5%）在术后4至6年依然存活。相比之下，8名未产生免疫应答的患者中，仅有2人（25%）存活，中位生存期为3.4年。 LK101 LK101注射液是立康生命自主研发的个体化肿瘤新生抗原mRNA-DC疫苗。2024年美国临床肿瘤学会（ASCO）大会上公布的数据显示，用于肝细胞癌（HCC）术后辅助治疗，LK101联合消融治疗组1年复发率仅为18.2%，显著低于单纯消融对照组的33.3%；2年复发率为36.4%，亦低于对照组的51.4%。更令人振奋的是，接种疫苗组所有患者均存活，5年生存率达到100%。目前LK101已在海南博鳌乐城国际医疗旅游先行区落地使用，覆盖肝癌、肺癌、胰腺癌等实体瘤。 iNeo-Vac-P01 iNeo-Vac-P01是根据患者自身肿瘤新生抗原定制生产的个体化多肽疫苗。2026年ASCO年会上，来自中国浙江大学医学院附属第二医院团队在ASCO上报告了iNeo-Vac-P01针对食管鳞状细胞癌的数据。在中位随访近30个月时，其3年无复发生存率超过70%，3年总生存率超过80%。这一数据显著优于国际III期研究CheckMate 577中纳武利尤单抗辅助治疗食管鳞癌患者36%的3年RFS率，也优于其他国内PD-1抑制剂围手术期疗法的数据。尤为重要的是，所有已报道的患者均未出现3级及以上疫苗相关不良反应，安全性卓越。 XP-004 XP-004是一款国产自主研发的个体化新抗原mRNA疫苗，针对的是化疗不耐受的可切除胰腺癌术后患者。 2026年ASCO年会上，上海交通大学医学院附属瑞金医院沈柏用教授团队公布了XP-004的I期临床数据。截至2026年1月，16例入组患者全部实现100%无复发；13例可评估免疫原性的患者免疫应答率100%；165个候选新抗原中53个成功激活了特异性T细胞。中位随访约10个月。不良反应以1-2级为主，≥3级不良事件发生率仅12.5%。虽然只是早期数据，样本量较小，但已充分证明该路线的临床价值。目前癌症疫苗最主要的应用场景是辅助治疗，清理残余的微量病灶，降低复发风险，或是与PD-1/PD-L1抑制剂联用，产生协同效应。除了少数几种（如用于前列腺癌的Provenge，以及古巴肺癌疫苗在特定地区的获批），前绝大多数癌症疫苗（包括mRNA-4157）尚未获得FDA或NMPA的正式上市批准。康和源免疫之家（400-880-3716）致力于为肿瘤患者提供专业的临床试验匹配与医学顾问服务。如果您或家人对个性化癌症疫苗、mRNA肿瘤治疗等前沿疗法有疑问，或者希望了解相关的临床试验信息和入组条件，欢迎致电咨询。我们的医学顾问团队将为您提供专业的病情评估与治疗建议。结语癌症疫苗不是神话，但正在成为现实。它不是“打了就不得癌”的魔药，但对于特定人群，它确实提供了前所未有的治疗选择。这场仗还远未打完，但我们已经从“硬碰硬”的消耗战，转向了“以智取胜”的精准战。当科学家教会免疫系统识别癌细胞的面孔，当疫苗在体内建立起“活的”警戒网络，抗癌便不再是医生与患者两个人的孤军奋战，而是整个人体免疫系统被重新武装后的集体觉醒。这条路，刚刚开始，但方向已清晰可见。如果您在阅读本文后仍有困惑，或需要帮助，可通过康和源免疫之家医学部（400-880-3716）获取专业指导。您可以通过添加以下微信方式联系我们。赵老师微信：15810815293 曹老师微信：17801183037 康和源免疫之家-癌症患者的生命希望桥梁康和源免疫之家作为肿瘤诊疗服务平台，始终秉持“以患者为中心”的理念。在肿瘤治疗领域，患者面临着巨大的身心压力和复杂的治疗选择，康和源免疫之家深知患者的需求和困境，致力于为患者提供全方位、个性化的服务。为了实现这一目标，该平台整合了中国、美国、欧洲、日本、韩国等全球顶尖肿瘤专家资源。这些专家拥有丰富的临床经验和先进的治疗理念，能够为患者提供专业的诊断和治疗建议。同时，平台还与知名药企、创新药物研发机构建立了深度合作关系，这使得患者能够及时了解到前沿的抗癌药物和治疗技术，为治疗提供更多的选择。国际专家会诊服务肿瘤治疗具有复杂性和个体差异性，不同患者的病情和身体状况各不相同，因此需要个性化的治疗方案。康和源免疫之家通过国际专家会诊服务，可协调中美欧日韩等多国权威肿瘤专家，针对癌症开展跨国联合诊疗。对于那些需要第二诊疗意见的患者来说，国际专家会诊可以提供不同的视角和建议，帮助患者更全面地了解自己的病情和治疗方案。而对于寻求海外先进治疗方案的患者，平台的专业团队能够帮助他们获取国际前沿治疗指南，为患者制定更加科学、合理的治疗计划。临床试验作为连接患者与创新疗法的纽带，康和源免疫之家与全球领先药企及研发机构保持战略合作，持续提供涉及PD-1/L1抑制剂、CAR-T细胞治疗、ADC药物等领域的临床试验项目。这些临床试验项目代表了当前癌症治疗的前沿进展和研究方向，为患者提供了接触新型抗癌药物和治疗技术的机会。康和源免疫之家团队会根据患者的病情阶段、基因检测结果和治疗史，精准匹配适合的临床试验机会。这不仅提高了患者参与临床试验的成功率，也确保了患者能够接受更加适合自己的治疗。在康和源免疫之家，每个生命都被视为值得更好的医疗选择，无论是寻求国际顶尖专家的诊疗建议，还是尝试突破性的临床试验，平台都将竭诚为患者提供专业、可靠的全方位支持。让我们携手，在抗击肿瘤的征程上走得更远。 END 如果您或您身边的人正在遭受癌症的困扰，不妨拨打咨询电话400-880-3716，登录官网 https://www.myimm.net/或关注微信公众号“康和源免疫之家”（头条、知乎、百度、搜狐等自媒体同名），了解更多关于临床试验和肿瘤诊疗服务的信息。 🌿抗癌，不仅是力量的抗争，更是精准的博弈。🌿 当亲人面对癌症，我们常问：“什么治疗方案更有效？会不会产生耐药？这种病会遗传给家人吗？”这些关乎生存与未来的关键问题，答案可能就藏在每个人的基因里。 🧬基因检测：为患者点亮精准治疗的“导航”，为家属揭开遗传风险的“谜底”。🧬 精准打击肿瘤，避免无效治疗肿瘤千差万别，用药也需“量体裁衣”。我们的基因检测能明确揭示肿瘤的基因突变靶点，就像为导弹装上“精确制导系统”，快速匹配更可能有效的靶向药物，避免在无效的化疗中消耗宝贵的生命与希望。评估遗传风险，为家人构筑健康防线部分癌症与遗传密切相关。通过基因检测，可以评估患者是否携带明确的遗传易感基因突变。这不仅解释了病因，更能为您的子女、兄弟姐妹等近亲提供至关重要的预警，让他们能及早干预，主动守护健康。 🔬康和源免疫之家，用基因图谱，守护您与家人的生命延续。🔬 我们提供的不仅是冰冷的报告，更是一份贯穿诊断、治疗与康复的“科学行动指南”。我们的医学专家将为您深度解读基因信息，在复杂的治疗选择中提供决策支持，并为整个家庭的健康风险管理提供专业建议。 📞一人检测，可能惠及全家。立即拨打400-880-3716，康和源免疫之家医学部，为您与家人的未来，提供一份科学的答案。让科学指引方向，让选择更有力量。扫描下方二维码，或者直接电话咨询康和源免疫之家医学部（400-880-3716），持续为您关注并分享癌症前沿消息。免责声明:文本参考来源于网络，版权归原作者所有。该文章仅供分享，如涉嫌侵犯您的著作权请联系我们删除，谢谢！

疫苗临床结果ASCO会议信使RNA临床1期

2026-07-03

·今日头条

2026上半年癌症疫苗杀疯了！10大突破，国研也上桌了

你爸妈体检报告上如果出现"结节"两个字，全家都要失眠三天。但2026年上半年，医学界发生了一件事，可能让"癌症"这两个字的恐怖程度，永久性地降一个档次。半年。10个突破。横扫十余个癌种。最狠的三个数——高危黑色素瘤复发或死亡风险降 49% ，胰腺癌4年生存率 87.5% ，现货型黑色素瘤客观缓解率 83% 。这不是实验室里的PPT。是发表在《自然》上的临床实锤。一、两个数，先看mRNA平台扛不扛住过去质疑mRNA癌症疫苗的人，最大的槽点是"短期数据好看，长期呢？" 2026年1月，Moderna加默沙东把mRNA-4157联合K药治高危黑色素瘤的 5年随访甩出来了。中位随访60个月，复发或死亡风险降低49%。2年时44%，3年时49%，5年还是49%。你可能会问：5年不衰减，很重要吗？太重要了。之前所有人都在质疑mRNA癌症疫苗——短期数据好看，长期呢？免疫力会不会三个月就掉？这次5年随访直接把这个问题按死了。疫苗诱导的免疫记忆有没有长期保护效应，这个问号终于变成了句号。同一条线，BioNTech的autogene cevumeran在胰腺癌上也交了卷。AACR年会上MSK团队公布的1期长期随访：16个胰腺癌术后患者，联合化疗加PD-1，4年生存率87.5%。胰腺癌什么概念？"癌王"。免疫治疗打到它身上，就像用滋水枪打坦克。冷肿瘤里的冷肿瘤，传统上PD-1在胰腺癌上的有效率不到5%。结果BioNTech这针下去，4年生存率87.5%。BioNTech自己看到数据的时候，估计都怀疑是不是算错了。这两个数摆在一起，mRNA平台在实体瘤辅助治疗这条路上，从"概念验证"走到"临床实锤"了。二、但这半年最值得品的，是国研终于上桌了这半年最值得品的，不是Moderna又发了篇《自然》，是国研终于上桌了。我专门去翻了翻AACR和ASCO这俩会的摘要。国研这波是真上桌了。 EVM16——北大肿瘤医院加复旦肿瘤联合，自研AI算法挑新抗原。沈琳的原话是"在多线治疗失败的患者中观察到了抗肿瘤信号"。翻译一下：都是别无选择的人才进I期，能从这档里抠出信号，说明激活能力真有。 XP-004——瑞金医院沈柏用的胰腺癌mRNA，ASCO上发的I期，免疫应答100%，近10个月零复发。样本小，随访没到24到36个月那个胰腺癌复发高峰，但早期数据已经够亮。 YKYY031——北大肿瘤医院牵的通用型mRNA，不走个体化定制那套慢流程，直接瞄KRAS、TP53、BRAF、PIK3CA、FBXW7这些公共高频突变。胃癌、肠癌、肝癌、胰腺癌、肺癌都在收。自主知识产权脂质加冻干工艺。还有个事得单说——2026年6月，国内首条AI加个性化靶点肿瘤疫苗生产线在北京亦庄开工，LK101在中美同步推临床。"实体瘤治疗性mRNA疫苗研发"项目进了"创新药物研发国家科技重大专项"。国研在癌症疫苗这条道上，过去是跟跑。现在EVM16、XP-004、YKYY031这三款能同时在国际会场被讨论，加上生产线和国家专项落地，算是第一次在牌桌上坐稳了一个位置。但得清醒——I期到III期到上市还长，Moderna那款都跑到III期了，我们最快的还在I/II期。追，但别飘。三、10个突破里，有一个最颠覆——北大让癌细胞"自曝身份" 10个突破里，我个人最想单拎出来讲的是北大的iVAC，1月8日发在《自然》主刊。陈鹏加席建忠团队的逻辑很野——不靠树突状细胞递抗原了，直接改造癌细胞，让癌细胞自己"自曝身份"。分子量才18kDa，小到能在致密实体瘤里穿梭。干两件事：拆刹车——降解癌细胞表面PD-L1；贴标签——把外源抗原呈到癌细胞表面。妙处在哪？肿瘤微环境里虽然缺肿瘤特异T细胞，但有大量"旁观者T细胞"——比如你小时候感染巨细胞病毒留下的记忆T细胞。癌细胞一旦被迫呈出巨细胞病毒抗原，这些沉睡的"老兵"就被唤醒了，从旁观变参战。传统免疫疗法两重困境：树突状细胞在瘤里不行；疫苗在淋巴结训出来的T细胞，跟瘤里实际抗原对不上。iVAC让癌细胞自己当抗原呈递细胞，从根上绕开这两关。目前还在推临床转化，模块化设计，未来能快速迭代个体化版本。这东西如果真跑通，就不是"又一个疫苗"了，是换了一条路。四、其他几条线也顺手记一下，但真正该想的，是三件事 Moderna的现货型mRNA-4359，数据更离谱。12个一线黑色素瘤患者，联合K药。2个完全缓解，8个部分缓解，客观缓解率83%。疾病控制率92%。12个人里11个有效。这已经不是"统计学显著"了，这是"你随便挑一个都有大概率有效"。不分PD-L1表达，适用面宽。 GNOS-PV01挑战胶质母细胞瘤——中位生存12到18个月那种狠角色，最多靶向40个新抗原，是迄今任何癌症疫苗抗原数两倍以上，把"冷"脑瘤焐热了。 TG4050在头颈部鳞癌术后辅助，OVM-200牛津的靶向survivin，菌源疫苗南通大学加南京大学加北大第一医院在试。技术路线百花齐放。真正该想的是三件事。第一，mRNA平台是真的成熟了。49%和87.5%这两个数，是这半年最硬的两条腿。Moderna八项II/III期在同步推，III期黑色素瘤已入组完成，下一步就是上市申请。第二，"个体化vs现货型"两条腿走路清楚了。个体化效果好但贵、慢、每人定制；现货型瞄公共高频突变，能规模化。两条线并行，才有普及可能。第三，国研这次是真的上桌了。但I期到III期掉下去的管线，历史上比跑出来的多。别上头。说到底，2026上半年这10个突破，不是"癌症被攻克了"的通告，是"癌症疫苗从PPT走到临床"的确认函。但别上头。新抗原预测准确率、肿瘤异质性、免疫逃逸，这三座山还在。I期到III期掉下去的管线，历史上比跑出来的多。有一点可以确定——这半年之后，再说"癌症疫苗是忽悠"，你得先解释那49%和87.5%是怎么来的。评论区聊聊——如果家里有人查出晚期癌症，标准治疗走到头了，医生会建议你去试临床试验。你会同意吗？还是觉得"试验就是拿人当小白鼠"？我猜大部分人选后者。但如果你知道这个试验用的是已经在《自然》上发表过数据的疫苗呢？

2026-07-02

·动脉网

到2036年，非小细胞肺癌市场在新兴靶向治疗和免疫疗法创新的推动下，预计将以6.6%的年均复合增长率强劲扩张 DelveInsightNon-Small Cell Lung Cancer Market Poised for Robust Expansion at a 6.6% CAGR Through 2036, Driven by Emerging Targeted and Immunotherapy Innovations

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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100 项与 Intismeran Autogene 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌Ⅰ期	临床3期	美国	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	加拿大	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	荷兰	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	中国台湾	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	土耳其	Merck Sharp & Dohme LLC	2026-05-04
可切除非小细胞肺癌	临床3期	美国	ModernaTX, Inc.	2024-10-21
可切除非小细胞肺癌	临床3期	美国	Merck Sharp & Dohme LLC	2024-10-21
可切除非小细胞肺癌	临床3期	日本	Merck Sharp & Dohme LLC	2024-10-21
可切除非小细胞肺癌	临床3期	日本	ModernaTX, Inc.	2024-10-21

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2026	临床1/2期	黑色素瘤辅助	7	Intismeran autogene + pembrolizumab	蓋簾醖獵醖鬱醖憲襯鑰(餘衊鬱鑰糧顧夢觸積顧) = 觸窪淵壓鹹遞選膚窪築糧憲繭艱鬱餘醖齋淵鑰 (夢獵範鏇鑰築鹽壓範夢 ) 更多	积极	2026-05-29
NCT03897881 (KEYNOTE-942, ASCO2026)	临床2期	黑色素瘤	157	intismeran + pembro	鏇糧鑰襯積襯選製鬱製(鬱積簾獵餘淵積衊憲壓) = 夢鬱醖選廠網鑰艱襯餘窪廠鏇觸夢鹹膚鬱簾築 (選鏇窪窪製獵顧餘齋夢, 56.3 ~ 78.3) 更多	积极	2026-05-29
				pembro	鏇糧鑰襯積襯選製鬱製(鬱積簾獵餘淵積衊憲壓) = 鬱艱廠襯積願遞選積願窪廠鏇觸夢鹹膚鬱簾築 (選鏇窪窪製獵顧餘齋夢, 33.3 ~ 63.0) 更多
NCT07221474 (INTerpath-013, ASCO2026)	临床2期	鳞状非小细胞肺癌一线	180	Pembrolizumab + carboplatin + (paclitaxel or nab-paclitaxel) + Intismeran autogene	淵築構醖齋築範艱構鑰(壓製製繭願鏇齋醖繭膚) = 淵膚鏇製築衊簾選淵襯廠衊鹽願鹽願衊構廠糧 (鹽齋範鹹淵衊範獵窪觸, 43 ~ 67)	积极	2026-05-29
				Pembrolizumab + carboplatin + (paclitaxel or nab-paclitaxel) + placebo	淵築構醖齋築範艱構鑰(壓製製繭願鏇齋醖繭膚) = 網廠齋構鹹壓繭壓網範廠衊鹽願鹽願衊構廠糧 (鹽齋範鹹淵衊範獵窪觸, 36 ~ 64)
NCT03897881 (KEYNOTE-942 \| mRNA-4157-P201, NEWS) 人工标引	临床2期	黑色素瘤	157	intismeran autogene + KEYTRUDA	獵衊窪糧築願繭製夢醖(構選襯齋鬱顧襯選齋淵): HR = 0.510 (95.0% CI, 0.294 ~ 0.887) 达到	积极	2026-01-20
				KEYTRUDA
NCT03313778 (KEYNOTE-603, Pubmed \| Cancer Discov) 人工标引	临床1期	可切除非小细胞肺癌 \| 皮肤黑色素瘤	16	mRNA-4157 (resected non-small cell lung cancer)	願範蓋範簾蓋獵憲餘壓(積膚淵齋顧獵範製衊醖) = All patients experienced ≥1 TEAE. 膚鑰壓蓋簾觸製鹹鬱艱 (鏇獵夢觸壓艱鹽糧獵鏇 ) 更多	积极	2024-11-01
				mRNA-4157 + pembrolizumab (resected cutaneous melanoma)
NCT03897881 (mRNA-4157-P201 (KEYNOTE-942), ESMO2024)	临床2期	黑色素瘤	16	mRNA-4157 + pembrolizumab	艱齋醖繭鹹獵網網憲醖(窪製醖顧艱鹽願積鏇顧) = 網憲淵蓋鬱鏇襯簾糧鬱餘願鏇衊簾艱襯糧壓餘 (範鬱顧蓋遞製願積糧衊 )	积极	2024-09-14
NCT03897881 (KEYNOTE-942, ASCO2024) 人工标引	临床2期	黑色素瘤	-	mRNA-4157 + pembrolizumab	鏇網壓獵鏇觸鏇壓廠夢(製鹹顧構淵選糧積壓鬱) = 糧積鑰繭淵醖製鹽構淵窪壓壓淵簾壓鑰顧醖鏇 (選醖鑰廠鬱餘積淵繭範 ) 更多	积极	2024-06-02
				Pembrolizumab	鏇網壓獵鏇觸鏇壓廠夢(製鹹顧構淵選糧積壓鬱) = 餘築淵鏇範淵獵構築餘窪壓壓淵簾壓鑰顧醖鏇 (選醖鑰廠鬱餘積淵繭範 ) 更多
NCT03313778 (mRNA-4157-P101/KEYNOTE-603, AACR2024) 人工标引	临床1期	头颈部鳞状细胞癌	22	mRNA-4157 (V940) individualized neoantigen therapy (INT) + pembrolizumab (pembro)	範壓憲積觸鹹艱蓋膚壓(窪鬱製鹹鏇鑰選選鏇願) = Most adverse events (AEs) related to INT were grade 1-2; most common were influenza-like illness, injection site pain, and pyrexia. 觸獵遞網齋壓鏇襯衊簾 (壓繭獵淵膚廠遞簾顧鑰 ) 更多	积极	2024-04-05
NCT03897881 (KEYNOTE-942, Pubmed \| Lancet) 人工标引	临床2期	黑色素瘤辅助	157	mRNA-4157 plus pembrolizumab	繭願獵壓顧構製積鏇廠(壓選積鑰獵淵餘鬱積築) = 膚糧獵築鑰築襯廠壓顧選遞憲願齋醖艱壓獵醖 (衊簾膚網襯製鏇製鹹窪, 69.0 ~ 85.6) 更多	积极	2024-01-18
				pembrolizumab monotherapy	繭願獵壓顧構製積鏇廠(壓選積鑰獵淵餘鬱積築) = 憲夢製範蓋積獵構艱繭選遞憲願齋醖艱壓獵醖 (衊簾膚網襯製鏇製鹹窪, 46.9 ~ 76.3) 更多
NCT03897881 (mRNA-4157-P201 \| KEYNOTE-942, Corporate Publications) 人工标引	临床2期	黑色素瘤	157	mRNA-4157 + KEYTRUDA	淵廠顧糧窪廠遞膚艱艱(鹽築廠醖壓築艱鏇網築) = mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 49% 糧積鹽構獵鹹衊網膚淵 (鑰膚夢願襯鹽齋淵廠製 ) 更多	积极	2023-12-14
				KEYTRUDA