This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.

开始日期2025-05-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT06683755

/ Not yet recruiting临床1/2期IIT

Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)

To determine the recommended Phase IIa dose (RP2D) of the triplet combination.
To determine the safety and efficacy of the combination at the RP2D.

开始日期2025-05-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT06794775

/ Not yet recruiting临床3期IIT

SWE-NEO: Swedish NeoAdjuvant Trial Comparing Anti-PD-1 Monotherapy to Combined Anti-CTLA-4/anti-PD-1 Blockade in Resectable Stage III Melanoma

At present two studies (SWOG S1801 and NADINA) have demonstrated superiority when using neoadjuvant treatment compared to adjuvant treatment only, but no studies have compared PD-1 monotherapy (SWOG 1801 regimen) to the PD-1/CTLA-4 combination (NADINA regimen) therapy. The SWE-NEO study aims to compare these two regimens, where the PD-1/CTLA-4 combination is potentially more effective, but also associated with more side effects.

开始日期2025-04-15

申办/合作机构

Karolinska University Hospital

100 项与伊匹木单抗相关的临床结果

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100 项与伊匹木单抗相关的转化医学

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100 项与伊匹木单抗相关的专利（医药）

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5,429

项与伊匹木单抗相关的文献（医药）

2025-12-31·mAbs

Engineered ipilimumab variants that bind human and mouse CTLA-4

Article

作者: Barman, Ishita ; Lee, Peter S. ; Diong, SJ ; Bee, Christine ; Rajpal, Arvind ; Kumar, Anusha ; West, Sean ; Strop, Pavel ; Robison, Brett ; Chau, Bryant ; Chang, Olin ; Korman, Alan J. ; Moon, Thomas M.

Testing of candidate monoclonal antibody therapeutics in preclinical models is an essential step in drug development. Identification of antibody therapeutic candidates that bind their human targets and cross-react to mouse orthologs is often challenging, especially for targets with low sequence homology. In such cases, surrogate antibodies that bind mouse orthologs must be used. The antibody 9D9, which binds mouse CTLA-4, is a commonly used surrogate for CTLA-4 checkpoint blockade studies in mouse cancer models. In this work, we reveal that 9D9 has significant biophysical dissimilarities to therapeutic CTLA-4 antibodies. The 9D9-mCTLA4 complex crystal structure was determined and shows that the surrogate antibody binds an epitope distinct from ipilimumab and tremelimumab. In addition, while ipilimumab has pH-independent binding to hCTLA-4, 9D9 loses binding to mCTLA-4 at physiologically relevant acidic pH ranges. We used phage and yeast display to engineer ipilimumab to bind mouse CTLA-4 with single-digit nM affinity from an initial state with no apparent binding. The engineered variants showed pH-independent and cross-reactive binding to both mouse and human CTLA-4. Crystal structures of a variant in complex with both mouse and human CTLA-4 confirmed that it targets an equivalent epitope as ipilimumab. These cross-reactive ipilimumab variants may facilitate improved translatability and future mechanism-of-action studies for anti-CTLA-4 targeting in murine models.

2025-12-31·OncoImmunology

Circulating cytokine associations with clinical outcomes in melanoma patients treated with combination nivolumab plus ipilimumab

Article

作者: Baginska, Joanna ; Rodig, Scott J. ; Hodi, F. Stephen ; Severgnini, Mariano ; Chen, Jiajia ; Brennick, Ryan ; Manuszak, Claire ; Weirather, Jason L. ; Manos, Michael ; Ranasinghe, Srinika ; Liu, David ; Huang, Amy Y. ; Holovatska, Marta ; Hathaway, Emma ; Nazzaro, Matthew ; Giobbie-Hurder, Anita ; Tarantino, Giuseppe ; Russell, Janice D. ; Pfaff, Kathleen L.

Nivolumab plus ipilimumab (aCTLA-4/aPD-1) combination therapy has significantly improved clinical outcomes in patients with metastatic melanoma, with 50%-60% of patients responding to treatment, but predictors of response are poorly characterized. We hypothesized that circulating cytokines and peripheral white blood cells may predict response to therapy and evaluated 15 cytokines and complete blood counts (CBC with differentials) from 89 patients with advanced melanoma treated with combination therapy from three points in time: pre-treatment, one month and approximately three months after starting therapy. Clinical endpoints evaluated included durable clinical benefit (DCB), progression-free survival (PFS), and overall survival (OS). A parsimonious predictive model was developed to identify cytokines predictors of response to combination therapy. In this study, we found that pre-treatment, patients with DCB had higher IL-23, lower CXCL6, and lower IL-10 levels. Lower NLR one month after starting therapy predicted better PFS and OS, primarily driven by an increase in absolute lymphocytes. A multivariate model demonstrated that baseline CXCL6, IL-10, IL-23 were independent predictors of therapy response, and the combined model has reached an area under the curve (AUC) of 0.79 in prediction of response to combination therapy. Our study identified baseline CXCL6, IL-23, and IL-10 as predictors of response to aCTLA4/aPD1 combination therapy among patients with metastatic melanoma. This study also provides a framework for identifying patients who are likely to respond to combination ICB, as well as a subset of patients with high risk of developing resistance and are thus in need of alternative therapeutic options, such as clinical trials.

2025-12-31·OncoImmunology

Plasma protein dynamics during ipilimumab treatment in metastatic melanoma: associations with tumor response, adverse events and survival

Article

作者: Kyte, Jon Amund ; Lereim, Ragnhild Reehorst ; Dunn, Claire ; Chauhan, Sudhir Kumar ; Straume, Oddbjørn ; Aamdal, Elin ; Guren, Tormod Kyrre

The immune checkpoint inhibitor ipilimumab provides long term survival in some metastatic melanoma patients, but the majority has no benefit, and may experience serious side effects. Here, we investigated the dynamics of plasma cytokine concentrations and their potential utility for predicting treatment response, adverse events and overall survival (OS) in patients with metastatic melanoma undergoing ipilimumab monotherapy. A cohort of 148 patients was examined, with plasma samples collected prior to treatment initiation and at the end of the first and second treatment cycles. Concentrations of 48 plasma proteins were measured using a multiplex immunoassay. The results revealed a general increase in cytokine levels following the first ipilimumab dose, consistent with immune activation. Patients not responding to treatment exhibited significantly elevated baseline levels of G-CSF, IL-2RA, MIP-1a, and SCF, compared to tumor responders (p < 0.05). Furthermore, high levels of IL-2RA, IFNγ, PDGF-bb and MIG were linked to inferior OS, while high concentrations of MIF and RANTES were associated with improved OS (p < 0.05). A multivariate model containing CRP, LDH, ECOG, IL-2RA and PDGF-bb identified a subgroup of patients with poor OS. Patients who experienced severe immune-related adverse events within three months of treatment initiation had higher baseline concentrations of several cytokines, indicating a potential association between preexisting inflammation and adverse events. These findings indicate that the first dose of ipilimumab induces a systemic response with increased levels of circulating cytokines and suggest candidate biomarkers for clinical response, immune-mediated toxicity and survival. Further studies in independent patient cohorts are required to confirm the findings.

1,621

项与伊匹木单抗相关的新闻（医药）

2025-02-14

·ioncology

ASCO GU国际视野丨MD安德森癌症中心：肾癌或膀胱癌患者是否应接受免疫辅助治疗？

编者按：肾癌和尿路上皮癌均为常见的泌尿系统恶性肿瘤，具有较强的免疫原性，理论上为免疫检查点抑制剂的应用提供了潜在治疗优势；然而值得注意的是，多项免疫治疗的III期随机对照临床试验（RCT）的研究结果未能改善肾癌和尿路上皮癌的总生存获益。临床实践过程中，免疫辅助治疗应如何选择？在近期举行的ASCO GU大会上，全球排名前列的MD安德森癌症中心的多位泌尿肿瘤专家进行了分享。本刊特别总结，以飨读者。亮点抢先看： KEYNOTE-564试验是针对透明细胞肾细胞癌（RCC）的首个取得阳性结果的3期临床研究，该试验结果表明帕博利珠单抗辅助治疗可改善无病生存（DFS）和总生存（OS）。在尿路上皮癌（UC）中，CheckMate-274和AMBASSADOR两项研究发现，纳武利尤单抗和帕博利珠单抗等免疫辅助治疗可改善DFS（相比于安慰剂）；目前仍在等待两项研究的最终OS分析（AMBASSADOR的双重主要终点和CheckMate-274的次要终点）。必须仔细权衡免疫治疗相关毒性及其对未来转移性疾病治疗方案的潜在影响，尤其是手术切除过程中发现的高危患者，应与患者共同决定治疗策略，平衡风险获益和患者选择，未来也需要探索更具预测性的生物标志物和精准的治疗策略。基于关键的KEYNOTE-564试验，帕博利珠单抗辅助治疗方案获批上市，重塑了RCC临床实践。相比之下，局部肌层浸润性尿路上皮癌的治疗长期以来依赖于新辅助治疗和基于顺铂的辅助治疗；基于AMBASSADOR研究（帕博利珠单抗辅助治疗）和CheckMate-274研究（纳武利尤单抗辅助治疗），免疫方案也取得了一定进展。美国MD安德森癌症中心专家通过2例患者分享了相关治疗策略。病例数据病例1：一名52岁男性接受了左肾根治性切除术，病理学显示10.5 cm ccRCC肿瘤（Fuhrman分级IV级），伴有肉瘤样去分化、侵犯肾静脉和坏死。切除的3个淋巴结病理分析无恶性肿瘤。病例2：一名62岁女性患有肌层浸润性膀胱癌，接受了4个周期剂量密集的MVAC（甲氨蝶呤、长春花碱、阿霉素、顺铂）治疗，随后进行了根治性膀胱切除术和双侧盆腔淋巴结清扫术。病理学分析为ypT3N1，22个淋巴结中存在1个受累。 ASSURE列线图将第一位ccRCC患者归为高危类别，估计的3年DFS率为32%，早期进展风险为46.5%。对于第二位UC患者，国际膀胱癌Nomogram联盟模型估计的5年DFS率为28%。两位患者都面临显著的复发风险，并符合免疫辅助治疗相关研究的入组标准。 ccRCC治疗策略对于第一位患者，相关专家讨论了帕博利珠单抗改善DFS和OS的证据、肉瘤样特征对疾病的影响、酪氨酸激酶抑制剂治疗转移性RCC伴有肉瘤样特征的不良结局，以及免疫联合治疗在这些患者的作用。如果进行监测而非帕博利珠单抗治疗，专家还讨论患者复发后考虑使用纳武利尤单抗联合伊匹木单抗的治疗策略（因为CheckMate-214研究经过8年以上的随访，已证明该方案具有持久疗效；对肉瘤样特征患者的亚组分析，纳武利尤单抗联合伊匹木单抗治疗的5年随访的客观缓解率（ORR）接近61%，完全缓解率达23%，中位PFS为26.5个月，中位OS为48.6个月。对于这位ccRCC患者而言，目前开始免疫治疗可能会影响未来接受免疫治疗的机会。虽然目前并无研究直接分析前期抗PD-1单药和抗PD-1单抗联合抗CTLA-4单抗的疗效，但几项临床试验中的数据表明，抗PD-1单抗耐药后联合伊匹木单抗的反应率较低。因此，在与患者进行全面的共同决策讨论后，进行仔细监测并在复发时保留纳武利尤单抗联合伊匹木单抗的治疗策略也具有一定合理性。此外，在KEYNOTE-564的4年DFS分析中，安慰剂组中56%的患者仍无复发，这引发了人们的担忧：即普遍接受辅助治疗时，超过一半的患者可能会面临潜在的帕博利珠单抗毒性，却无明确获益。专家既往经验显示，在具有肉瘤样等不良特征的患者中，肾切除术后4~6周早期开始帕博利珠单抗辅助治疗，最初可能未检测到4期疾病，而随后3至4个月内可能发展为明显的转移性疾病。这凸显了采取更谨慎治疗方案的必要性，例如等到肾切除术后3个月再进行影像学复查，以准确评估疾病进展。理想情况下，在肾切除术后的不同时间点分析生物标志物并采用先进的成像技术能够较传统CT和MRI更早地发现复发，从而降低不恰当早期辅助治疗的风险。膀胱癌治疗策略对于上述的膀胱癌病例，患者对顺铂产生耐药性，表明其快速复发的风险很高，可能高于前面提到的国际膀胱癌Nomogram联盟模型的预测。首先，循环肿瘤DNA是监测膀胱切除术后残留病灶的预后工具，目前正在辅助试验中分析升阶和降阶治疗策略。其次，辅助免疫治疗的讨论应考虑其在转移性疾病中的价值。例如，KEYNOTE-052和LEAP-011研究事后分析的长期随访数据（中位数为56.3个月）表明，在体质虚弱、不适合或拒绝铂类化疗的人群（即东部肿瘤协作组体能状态2、年龄80岁或以上，或肾功能不全）中，使用帕博利珠单抗单药治疗的ORR为25%~33%。在获得客观缓解的患者中，约12%~34%的患者在48个月内维持缓解，占整个研究人群的不到15%。在KEYNOTE-361研究中，帕博利珠单抗单药治疗在18个月时的PFS率较低（19%）。第三，也需要讨论患者复发的后续治疗策略。既往的免疫辅助治疗对维恩妥尤单抗联合帕博利珠单抗（目前转移性UC的首选一线治疗方案）的影响仍不清楚。在2025年ASCO GU大会上，UNITE联盟的报告显示，对于43名既往接受免疫治疗的患者，维恩妥尤单抗联合帕博利珠单抗的ORR为48%（95%CI 33%~66%），中位PFS为6.9个月，中位OS为15.4个月。这些结果与UNITE既往的维恩妥尤单抗结果一致，研究结果显示304名患者的ORR为52%，mPFS为6.8个月，mOS为14.4个月。然而，这些结果明显低于维恩妥尤单抗联合帕博利珠单抗一线治疗的疗效，EV-302临床研究的ORR为67.7%，mPFS为12.5个月。此外，EV-103研究的5年随访发现，在45名患者中，47%的客观缓解患者（ORR 73%）在5年时没有疾病进展。而如果患者在免疫辅助治疗后进展迅速，则需要考虑其他治疗方案，如维恩妥尤单抗单药治疗，用于存在FGFR2/3改变的厄达替尼，或用于HER2阳性（免疫组织化学检测为3+）的德曲妥珠单抗（T-DXd）等。在CheckMate-274研究中，OS是次要终点，而在AMBASSADOR研究中，OS和DFS是意向治疗人群中的双重主要终点。CheckMate-274研究的中期OS分析尚未达到预先设定的显著性阈值，仍需要等待最终分析。而AMBASSADOR研究的中位随访期为44.8个月，但帕博利珠单抗辅助治疗1年并无OS获益，其原因可能是患者早期退出研究，而接受了纳武利尤单抗治疗。由于患者退出率增加，可能会因信息审查而导致试验解释出现偏差。总之，临床上仍需权衡是否提供前期免疫治疗，也需要仔细监测大多数局部疾病患者，并保留最有效但可能存在毒副作用的（微）转移性疾病治疗方案。未来，更好的疗法、风险分层模型、预测性生物标志物（例如，UC中的循环肿瘤DNA和RCC中的KIM-1）和多阶段治疗策略可以实现更精确、个性化和适应性更强的治疗决策。在这些创新实现之前，免疫辅助治疗的决定应该由医患共同决定，并仔细考虑每位患者的潜在获益、风险和个人需求。参考文献上下滑动查看更多内容 [1] Choueiri TK, Tomczak P, Park SH, et al; KEYNOTE-564 Investigators. Overall survival with adjuvant pembrolizumab in renal-cell carcinoma. N Engl J Med. 2024;390(15):1359-1371. [2] Correa AF, Jegede OA, Haas NB, et al. Predicting disease recurrence, early progression, and overall survival following surgical resection for high-risk localized and locally advanced renal cell carcinoma. Eur Urol. 2021;80(1):20-31. [3] Vickers AJ, Cronin AM, Kattan MW, et al; International Bladder Cancer Nomogram Consortium. Clinical benefits of a multivariate prediction model for bladder cancer: a decision analytic approach. Cancer. 2009;115(23):5460-5469. [4] Pal SK, Uzzo R, Karam JA, et al. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022;400(10358):1103-1116. [5] Motzer RJ, Russo P, Grünwald V, et al. Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial. Lancet. 2023;401(10379):821-832. [6] Allaf ME, Kim SE, Master V, et al. Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143): an open-label, randomised, phase 3 study. Lancet Oncol. 2024;25(8):1038-1052. [7] Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384(22):2102-2114. [8] Bellmunt J, Hussain M, Gschwend JE, et al; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(4):525-537. [9] Apolo AB, Ballman KV, Sonpavde G, et al. Adjuvant pembrolizumab versus observation in muscle-invasive urothelial carcinoma. N Engl J Med. Published online September 15, 2024. [10] Powles T, Catto JWF, Galsky MD, et al; NIAGARA Investigators. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med. 2024;391(19):1773-1786. [11] Golshayan AR, George S, Heng DY, et al. Metastatic sarcomatoid renal cell carcinoma treated with vascular endothelial growth factor-targeted therapy. J Clin Oncol. 2009;27(2):235-241. [12] Tannir NM, Albigès L, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 8-year follow-up results of efficacy and safety from the phase III CheckMate 214 trial. Ann Oncol. 2024;35(11):1026-1038. [13] Rini BI, Signoretti S, Choueiri TK, et al. Long-term outcomes with nivolumab plus ipilimumab versus sunitinib in first-line treatment of patients with advanced sarcomatoid renal cell carcinoma. J Immunother Cancer. 2022;10(12):e005445. [14] Yang Y, Mori SV, Li M, et al. Salvage nivolumab and ipilimumab after prior anti-PD-1/PD-L1 therapy in metastatic renal cell carcinoma: a meta-analysis. Cancer Med. 2022;11(7):1669-1677. [15] Brown JR, Sonpavde GP, Calaway A, Barata PC. Circulating tumor DNA to assess minimal residual disease: versatile, but how valuable? Eur Urol. 2024;86(4):312-314. [16] Vuky J, Balar AV, Castellano D, et al. Long-term outcomes in KEYNOTE-052: phase II study investigating first-line pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. J Clin Oncol. 2020;38(23):2658-2666. [17] Matsubara N, de Wit R, Balar AV, et al. Pembrolizumab with or without lenvatinib as first-line therapy for patients with advanced urothelial carcinoma (LEAP-011): a phase 3, randomized, double-blind trial. Eur Urol. 2024;85(3):229-238. [18] O’Donnell PH, Loriot Y, Csoszi T, et al. Efficacy and safety of pembrolizumab in patients with advanced urothelial carcinoma deemed potentially ineligible for platinum-containing chemotherapy: post hoc analysis of KEYNOTE-052 and LEAP-011. Cancer. Published online October 28, 2024. [19] Powles T, Csőszi T, Özgüroğlu M, et al; KEYNOTE-361 Investigators. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(7):931-945. [20] Koshkin VS, Henderson N, James M, et al. Efficacy of enfortumab vedotin in advanced urothelial cancer: analysis from the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study. Cancer. 2022;128(6):1194-1205. [21] Powles T, Valderrama BP, Gupta S, et al; EV-302 Trial Investigators. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med. 2024;390(10):875-888. [22] Rosenberg JE, Petrylak DP, Flaig T, et al. 1968P - Study EV-103 dose escalation/cohort A (DE/A): 5y follow-up of first-line (1L) enfortumab vedotin (EV) + pembrolizumab (P) in cisplatin (CIS)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC). Ann Oncol. 2024;35(suppl 2):S1139-S1140. [23] Klaassen Z. Extended follow-up from CheckMate 274 including the first report of overall survival outcomes. URO Today. Accessed December 12, 2024. https://www.urotoday.com/conference-highlights/eau-2024/eau-2024-bladder-cancer/150967-eau-2024-extended-follow-up-from-checkmate-274-including-the-first-report-of-overall-survival-outcomes.html Matthew T. Campbell 德克萨斯大学MD安德森癌症中心泌尿生殖医学肿瘤学系的副教授兼副医学主任 Mohammad Jad Moussa 德克萨斯大学MD安德森癌症中心泌尿生殖医学肿瘤学系的博士后研究员 Pavlos Msaouel 德克萨斯大学MD德森癌症中心泌尿生殖医学肿瘤学系和转化分子病理学系的助理教授 Nizar M. Tannir 德克萨斯大学MD安德森癌症中心泌尿生殖医学肿瘤学系的教授 Omar Alhalabi 德克萨斯大学MD安德森癌症中心泌尿生殖医学肿瘤学系的助理教授（来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床结果临床3期免疫疗法

2025-02-14

·ioncology

新锐视界丨邓艳红教授团队两项结直肠癌研究入选ASCO GI，吕晓双博士倾情解读

点上方蓝字“肿瘤瞭望消化时讯”关注我们，然后点右上角“…”菜单，选择“设为星标” ASCO GI 2025微专辑扫描二维码可查看更多内容编者按 2025年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI 2025）已顺利闭幕。在本次盛会上，中山大学附属第六医院的邓艳红教授团队有两项关于结直肠癌的研究成功入选壁报摘要环节。为了向读者呈现这两项研究的精髓，《肿瘤瞭望消化时讯》的记者进行了详尽的整理，并在大会现场特邀邓艳红教授团队的吕晓双博士对这两项研究进行了专业解读，以期为读者带来有价值的洞见与启示。邓艳红教授教授、主任医师、博士生导师，博士后合作导师中山大学附属第六医院副院长，肿瘤科主任，高质量发展办公室主任，GCP 主任中山大学医学院肿瘤教研室主任中国结直肠癌诊疗规范（国家卫健委）专家组成员中国抗癌协会整合肿瘤专委会副主任委员中国抗癌协会肿瘤精准治疗专业委员会常委中国抗癌协会肿瘤支持与营养治疗专业委员会常委 CSCO 结直肠专家委员会常委广东省医学会肿瘤学分会副主任委员广东省研究型医院学会秘书长广东省研究型医院学会肿瘤内科专委会主任委员以第一/通讯作者在J Clin Oncol (3篇），Cancer Cell，Lancet Gastroenterol & Hepatol，Lancet Oncology， Clin Cancer Res等高水平期刊发表论文70余篇吕晓双博士医学博士，毕业于清华大学八年制中山大学附属第六医院临床博士后在站，合作导师邓艳红教授主要研究方向为抗HER2靶向治疗相关耐药机制摘要号：278 01 背景成纤维细胞生长因子受体（FGFR）变异已被确认为多种恶性肿瘤，诸如膀胱癌和胆管癌的治疗靶点。结直肠癌（CRC）在遗传层面以TP53、KRAS和BRAF等核心基因的突变为主要特征。然而，关于FGFR变异等较为罕见的遗传学改变的作用，目前尚不清楚。针对FGFR抑制剂在结直肠癌中的临床试验结果也显示出有限的疗效。本研究致力于通过基因测序结直肠癌患者的肿瘤组织，来深入探究FGFR的变异情况，并进一步分析这些变异与临床预后之间的潜在关联，探索FGFR1作为结直肠癌预后潜在生物标志物和治疗靶点的可能性。 02 方法本回顾性分析纳入了2014年~2024年期间在中山大学附属第六医院接受治疗的Ⅰ-Ⅳ期结直肠癌患者的组织样本。采用下一代测序（NGS）技术评估FGFR的基因组改变。采用Cox回归分析和Kaplan-Meier曲线分析无病生存期（DFS）和无进展生存期（PFS）。利用cBioPortal和癌症基因组图谱（TCGA）数据库的数据进一步验证了FGFR改变对预后的影响。 03 结果在本研究队列中，有7.9%的患者存在FGFR变异，其中最常见的是FGFR1扩增（1.6%）。FGFR与经典CRC基因如KRAS、BRAF、NRAS和PIK3CA之间未发现共发生或互斥现象。 Kaplan-Meier生存分析和Cox回归分析显示，在Ⅰ-Ⅲ期患者中，FGFR变异是DFS较差的独立预测因子（中位DFS：13个月 vs. 45个月，HR=2.58，P=0.0002）；在Ⅳ期患者中，FGFR变异是PFS较差的独立预测因子（中位PFS：14个月 vs. 19个月，HR=2.17，P=0.0011）。在FGFR变异中，FGFR1扩增与不良预后（包括更短的DFS和PFS）的相关性最强。FGFR1的免疫组化（IHC）染色结果与基因扩增结果一致，进一步支持了其作为潜在生物标志物的可能性。 04 结论本研究描绘了结直肠癌中FGFR变异的基因组特征，并强调了FGFR1扩增作为FGFR变异型结直肠癌主要类型的预后意义。这些发现为理解FGFR改变在结直肠癌中的作用提供了新的见解，并支持进一步探索FGFR1作为结直肠癌预后潜在生物标志物和治疗靶点的可能性。摘要号：203 BRAF V600E突变型转移性结直肠癌的靶向治疗联合局部干预的真实疗效：一项单中心回顾性研究 01 背景携带BRAF V600E突变的转移性结直肠癌（mCRC）患者，尤其是微卫星稳定（MSS）型肿瘤患者，预后较差。该亚组患者对化疗的反应有限，尤其是二线或后续治疗。当前研究日益关注靶向疗法与局部治疗的结合，但真实世界证据仍然匮乏，尤其是来自亚洲队列的证据。本研究利用真实世界数据，评估了新型治疗组合（包括三联和双靶向疗法）联合局部治疗在这一高危患者群体中的影响。 02 方法本回顾性研究纳入了2014年4月~5月期间在中山大学附属第六医院接受治疗的MSS型BRAF V600E突变mCRC患者。接受靶向治疗的患者被分为三组：三联组（BRAF、EGFR和MEK抑制剂，包括达拉非尼、西妥昔单抗和曲美替尼）、双联组（BRAF和EGFR抑制剂，包括达拉非尼和西妥昔单抗或Encorafenib和西妥昔单抗）和双联靶向-化疗组（BRAF和EGFR抑制剂联合化疗，包括Vemurafenib、伊立替康和西妥昔单抗）。主要终点为PFS。次要终点包括总生存期（OS）和客观缓解率（ORR）。 03 结果在239例入组患者中，58例接受靶向治疗，68例接受常规化疗作为二线治疗。其中，63.5%的患者接受了局部治疗，包括原发肿瘤切除术、转移瘤切除术、肿瘤细胞减灭术加腹腔热灌注化疗（CRS+HIPEC）和肝脏消融术。与常规化疗相比，靶向治疗显著延长了中位无进展生存期（mPFS）（5.5个月 vs. 4.2个月；HR=0.44；95%CI：0.29~0.68；P<0.001）。两组的OS无显著差异（12.7个月 vs. 12.1个月；HR=0.80；95%CI：0.50~1.25；P=0.330）。在三联组中，ORR、mPFS和中位总生存期（mOS）分别为21%、5.8个月和18.0个月，与其他靶向治疗组相比显示出疗效增强的趋势，尽管无统计学意义。接受靶向治疗（n=35）或化疗（n=45）联合局部治疗的患者，与未接受局部治疗的患者相比，OS显著延长（mOS：22.3个月 vs. 9.2个月；HR=0.19；95%CI：0.09~0.42；P<0.001 和 14.3个月 vs. 10.9个月；HR=0.53；95%CI：0.29~0.98；P=0.042）。 04 结论针对BRAF V600E突变型mCRC的最佳治疗方案仍在研究中。本研究表明，将靶向疗法与选择性局部治疗相结合，可显著延长这一具有挑战性亚组患者的生存期，值得进行进一步前瞻性评估。研究者说吕晓双博士 2025年ASCO GI大会，作为消化道肿瘤研究领域的国际巅峰盛会，汇聚了全球顶尖学者，共同研讨诊疗技术的最新前沿。在此次大会上，中国学者大放异彩，共有29项关于结直肠癌的研究被甄选进行口头报告及壁报展示，内容广泛覆盖从靶向疗法到免疫联合疗法的创新探索。我们团队的两项研究成果同样被大会采纳，这不仅是国际学术界对中国临床研究的高度认可，更为后续的临床转化应用奠定了坚实的基础。我们团队的两项研究各具特色。其中一项深入探索了FGFR在结直肠癌中的变异图谱，并分析了其与治疗预后的相关性。研究发现，FGFR在结直肠癌中的变异以FGFR1扩增为主，这种扩增是影响结直肠癌预后的关键因素之一，导致患者术后DFS和PFS表现不佳。另一项研究则聚焦于BRAF V600E突变的转移性结直肠癌患者，通过真实世界研究探讨了靶向治疗结合局部干预的疗效。研究结果显示，与传统的化疗相比，该联合疗法在PFS和OS方面均展现出更优的表现。尽管在靶向治疗的亚组分析中，三联治疗组未达到统计学意义上的显著改善，但仍呈现出获益的趋势。除了我们团队的研究成果外，我还特别关注了大会中关于结直肠癌的临床研究口头报告。其中包括Breakwater研究针对一线BRAF V600E突变结直肠癌的疗效结果，以及CheckMate 8HW研究中双免疗法（纳武利尤单抗联合依匹木单抗）与单免疗法（纳武利尤单抗单药）在治疗MSI-H/dMMR mCRC的初步对比结果。在专题讨论方面，我尤为感兴趣的是MSS型结直肠癌的免疫治疗，特别是新辅助免疫治疗的前景。同时，我也关注了靶向治疗领域的最新进展，特别是CLDN18.2靶点的相关研究，包括单抗、双抗及ADC药物等。此外，全消化道肿瘤中的新型靶免治疗也备受瞩目，如CAR-T治疗、T细胞双特异性抗体、各类疫苗以及ADC类药物等，这些新型疗法为消化道肿瘤的治疗带来了新的希望。（来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议CSCO会议

2025-02-14

·PipelineReview

Bristol Myers Squibb Provides Update on Phase 3 RELATIVITY-098 Trial

PRINCETON, NJ, USA I February 13, 2025 I Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 RELATIVITY-098 trial evaluating Opdualag™ (nivolumab and relatlimab-rmbw) for the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS). The safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab. “We are disappointed in the outcome of the RELATIVITY-098 trial and that LAG-3 inhibition in the adjuvant setting did not lead to the same improved efficacy outcomes seen in advanced melanoma,” said Jeffrey Walch, M.D., Ph.D., vice president, Opdualag global program lead, Bristol Myers Squibb. “Patients whose tumors are completely resected before treatment may not have sufficient antitumor T cells in place for Opdualag to have its maximal effect. However, Opdualag remains a standard of care in the first-line treatment of unresectable or metastatic melanoma, and we continue to explore its potential across tumor types, including in non-small cell lung cancer.” In adjuvant melanoma, Opdivo ® (nivolumab) remains a standard of care for adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. Moreover, Opdivo Qvantig TM (nivolumab + hyaluronidase-nvhy), was recently approved in the U.S. as a subcutaneous option for the adjuvant treatment of adult patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. BMS thanks the patients, families and investigators for their contributions to this important clinical trial. About RELATIVITY-098 RELATIVITY-098 is a randomized Phase 3, double-blind study evaluating adjuvant immunotherapy with Opdualag, the fixed-dose combination of nivolumab and relatlimab, compared to Opdivo monotherapy after complete resection of stage III-IV melanoma. The primary endpoint of the trial is recurrence-free survival (RFS). Secondary endpoints include overall survival (OS), distant metastasis-free survival (DMFS), and safety. About Opdualag Opdualag (nivolumab and relatlimab-rmbw) is a first-in-class, fixed-dose, dual immunotherapy combination of the programmed death-1 (PD-1) inhibitor nivolumab and the lymphocyte activation gene 3 (LAG-3) blocking antibody relatlimab. With its approval by the FDA in 2022, Opdualag became the first LAG-3-blocking antibody containing combination to receive regulatory approval anywhere in the world. About LAG-3 Lymphocyte-activation gene 3 (LAG-3) is a molecule found on the surface of several immune cell types including CD4+ and CD8+ T cells, regulatory T cells (Tregs), and natural killer (NK) cells. LAG-3 inhibits the function of T cells and reduces the activation and growth of the cell on which it is found. This T-cell dysfunction allows tumors to avoid attack from the immune system and grow unchecked. Preclinical studies indicate that inhibition of LAG-3 may promote an anti-tumor response. Targeting both LAG-3 and PD-1 in combination may be a key strategy to help restore T cell activity, improving anti-tumor response in certain cancers that is greater than the effects of PD-1 monotherapy. Bristol Myers Squibb is evaluating relatlimab in clinical trials in combination with other agents in a variety of tumor types. About Melanoma Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanomas can be mostly treatable when caught in very early stages; however, survival rates can decrease as the disease progresses. INDICATION Opdualag™ (nivolumab and relatlimab-rmbw) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. NDICATIONS OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO® (nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO® as adjuvant treatment after surgery. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Please see U.S. Full Prescribing Information for OPDIVO and YERVOY . INDICATIONS OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC), following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with cabozantinib, is indicated for the first- line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic melanoma. OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for treatment of unresectable or metastatic melanoma. OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the adjuvant treatment of adult patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors >/=4 cm or node positive) non- small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO QVANTIG as monotherapy in the adjuvant setting after surgical resection. OPDIVO QVANTIG ™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO QVANTIG. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO QVANTIG™ (nivolumab and hyaluronidase) in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. OPDIVO QVANTIG™ (nivolumab and hyaluronidase) as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO QVANTIG™ (nivolumab and hyaluronidase) in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Please see U.S. Full Prescribing Information for OPDIVO QVANTIG . Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research programs uniquely position the company to approach cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , X , YouTube , Facebook and Instagram . SOURCE: Bristol Myers Squibb

临床3期上市批准免疫疗法临床结果加速审批

100 项与伊匹木单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04603	伊匹木单抗	L01XC11	DB06186

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
错配修复缺陷或微高卫星不稳定性结肠癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2025-01-13
错配修复缺陷或微高卫星不稳定性结肠癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2025-01-13
错配修复缺陷或微高卫星不稳定性结肠癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2025-01-13
错配修复缺陷或微高卫星不稳定性结肠癌	挪威	Bristol-Myers Squibb Pharma EEIG	2025-01-13
不能切除的食管鳞状细胞癌	美国	Bristol Myers Squibb Co.	2022-05-27
食管癌	日本	Bristol-Myers Squibb KK	2022-05-26
间皮瘤	日本	Ono Pharmaceutical Co., Ltd.	2021-05-27
间皮瘤	日本	Bristol-Myers Squibb KK	2021-05-27
肝细胞癌	美国	Bristol Myers Squibb Co.	2020-03-10
结直肠癌	美国	Bristol Myers Squibb Co.	2018-04-16
晚期肾细胞癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2011-07-13
晚期肾细胞癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2011-07-13
晚期肾细胞癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2011-07-13
晚期肾细胞癌	挪威	Bristol-Myers Squibb Pharma EEIG	2011-07-13
转移性结直肠癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2011-07-13
转移性结直肠癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2011-07-13
转移性结直肠癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2011-07-13
转移性结直肠癌	挪威	Bristol-Myers Squibb Pharma EEIG	2011-07-13
转移性食管鳞状细胞癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2011-07-13
转移性食管鳞状细胞癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2011-07-13

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
不可切除的肝细胞癌	申请上市	欧盟	Bristol-Myers Squibb Pharma EEIG	2025-01-30
晚期肝细胞癌	申请上市	中国	Bristol-Myers Squibb Pharma EEIG	2024-07-13
膀胱癌	临床3期	美国	Ono Pharmaceutical Co., Ltd.	2022-01-30
膀胱癌	临床3期	美国	中美上海施贵宝制药有限公司	2022-01-30
HER2阴性胃癌	临床3期	日本	Ono Pharmaceutical Co., Ltd.	2021-11-05
HER2阴性胃癌	临床3期	韩国	Ono Pharmaceutical Co., Ltd.	2021-11-05
HER2阴性胃癌	临床3期	中国台湾	Ono Pharmaceutical Co., Ltd.	2021-11-05
胶质母细胞瘤	临床3期	美国	National Cancer Institute	2020-09-01
神经胶质肉瘤	临床3期	美国	National Cancer Institute	2020-09-01
局部晚期非小细胞肺癌	临床3期	美国	Bristol Myers Squibb Co.	2019-10-08

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临床结果

适应症

分期

评价

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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


NCT02488759 (CheckMate 358, Pubmed \| J Clin Oncol)	临床1/2期	转移性Merkel细胞癌	-	Nivolumab	選顧醖膚壓鹽願鏇遞鹽(蓋鹹製衊鏇醖壓鹽繭齋) = 網廠醖積遞壓鏇願範鏇憲齋構築膚夢構構夢選 (襯艱鹹鹹醖齋醖鏇積夢, 38.7 ~ 78.9) 更多	不佳	2025-01-31
				Nivolumab + Ipilimumab	選顧醖膚壓鹽願鏇遞鹽(蓋鹹製衊鏇醖壓鹽繭齋) = 構齋願選獵鏇願蓋觸鏇憲齋構築膚夢構構夢選 (襯艱鹹鹹醖齋醖鏇積夢, 42.1 ~ 73) 更多
NCT05014776 (CTgov)	临床2期	转移性胰腺腺癌 \| 转移性胰腺癌	17	CRS-207+ipilimumab+pembrolizumab+Tadalafil	壓鬱窪壓簾鬱蓋鏇壓齋(淵艱淵鑰築膚鹽選淵觸) = 淵餘築齋夢淵衊範遞廠憲網顧醖夢膚觸顧襯願 (鹹襯簾齋鏇獵觸網襯淵, 觸衊鏇鹽窪夢製簾鹹蓋 ~ 積鹽衊鹹衊鹽窪艱鹽蓋) 更多	-	2025-01-30
NCT04008030 (CheckMate 8HW, ASCO_GI2025) 人工标引	临床3期	错配修复缺陷或微卫星高度不稳定性结直肠癌二线 \| 一线 MSI-High \| Deficient DNA Mismatch Repair (dMMR)	703	Nivolumab + ipilimumab	遞繭鑰壓獵繭醖選艱築(膚網廠齋鑰艱構範餘築) = 遞襯鏇構廠製廠衊鹹衊製鏇選鹽衊願壓淵蓋遞 (範構積積憲鏇夢餘網鏇, 53.8 ~ NE) 达到更多	优效	2025-01-27
				Nivolumab	遞繭鑰壓獵繭醖選艱築(膚網廠齋鑰艱構範餘築) = 願構鬱獵衊築艱艱願糧製鏇選鹽衊願壓淵蓋遞 (範構積積憲鏇夢餘網鏇, 22.1 ~ NE) 达到更多
NCT04039607 (CheckMate 9DW, ASCO_GI2025 \| Company_Website) 人工标引	临床3期	不可切除的肝细胞癌一线	668	Nivolumab + Ipilimumab	觸齋鏇顧觸艱糧蓋鏇夢(積窪膚衊繭鬱積築齋範) = 夢襯鏇積顧鑰襯鑰構憲鑰遞觸淵積醖夢積繭築 (膚積齋衊齋膚鹽遞構襯, 31 ~ 42) 更多	积极	2025-01-23
				Lenvatinib/sorafenib	觸齋鏇顧觸艱糧蓋鏇夢(積窪膚衊繭鬱積築齋範) = 網夢繭衊網遞廠範齋餘鑰遞觸淵積醖夢積繭築 (膚積齋衊齋膚鹽遞構襯, 10 ~ 17) 更多
NCT02693535 (TAPUR, ASCO_GI2025) 人工标引	临床2期	胰腺癌 BRCA2 Mutation \| BRCA1 Mutation	32	Nivolumab plus ipilimumab	齋艱廠壓網窪膚鏇艱襯(壓餘構廠艱廠醖願襯鏇) = 襯選鏇壓鏇遞獵鹹選鏇積繭壓艱膚餘餘夢艱鹽 (淵選觸衊壓鹽簾窪願廠, 18 ~ 100) 更多	积极	2025-01-23
NCT03262779 (CTgov)	临床2期	晚期非小细胞肺癌	20	ipilimumab+nivolumab (Combination Nivolumab and Ipilimumab - Primary)	廠壓繭願鑰觸糧醖鑰鬱(壓願窪夢簾選壓衊襯鹽) = 鏇鬱淵鹽淵遞衊顧艱夢膚遞壓夢窪觸艱顧壓遞 (鏇製鑰蓋衊鹽鬱夢顧遞, 廠範積鬱構鏇齋選鬱鏇 ~ 鏇顧選窪願選網衊範願) 更多	-	2025-01-09
				ipilimumab+nivolumab (Combination Nivolumab and Ipilimumab - Acquired)	廠壓繭願鑰觸糧醖鑰鬱(蓋觸選齋膚壓顧繭艱齋) = 顧窪獵顧顧築範襯構願糧窪選窪壓淵繭鏇製蓋 (觸艱膚蓋積獵製網構製, 獵願淵觸膚構襯壓鏇獵 ~ 範鑰簾鬱廠積醖憲淵繭) 更多
NCT02890329 (CTgov)	临床1期	复发性急性髓细胞白血病 \| 继发性骨髓增生异常综合征 \| 难治性骨髓增生异常综合征 ... 更多	54	ipilimumab+Decitabine (Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 0)	觸網鹹鏇醖糧鹹糧繭窪(壓鬱鏇夢願鑰鹽獵鏇蓋) = 鏇鏇積蓋觸餘淵艱壓簾窪構願壓憲鬱蓋顧鬱餘 (鑰鑰夢簾構衊鹽顧齋鬱, 獵憲構淵膚顧艱醖鑰夢 ~ 鬱繭艱窪選範觸淵網顧) 更多	-	2025-01-07
				ipilimumab+Decitabine (Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 0)	觸網鹹鏇醖糧鹹糧繭窪(壓鬱鏇夢願鑰鹽獵鏇蓋) = 鹽糧築製淵襯糧糧築夢窪構願壓憲鬱蓋顧鬱餘 (鑰鑰夢簾構衊鹽顧齋鬱, 鹹願糧製夢廠顧齋襯餘 ~ 醖艱構夢鬱築願醖窪鏇) 更多
NCT03138512 (CheckMate 914, CTgov)	临床3期	肾细胞癌	1,641	Nivo (Treatment Part A: Nivo + Ipi)	蓋襯鑰齋鹽襯醖鏇顧繭(顧糧鬱齋糧構築醖齋範) = 衊繭積網餘醖淵憲鹹襯夢鏇鹽築鹽憲衊顧網醖 (淵餘遞簾鹹獵衊窪構鑰, 衊積艱壓壓膚築憲遞壓 ~ 顧鏇遞鬱繭蓋築積膚製) 更多	-	2024-12-18
				Placebo+ipilimumab+nivolumab (Treatment Part A: Placebo)	蓋襯鑰齋鹽襯醖鏇顧繭(顧糧鬱齋糧構築醖齋範) = 網鹽廠鬱餘範蓋鹽壓夢夢鏇鹽築鹽憲衊顧網醖 (淵餘遞簾鹹獵衊窪構鑰, 鬱廠選鏇構顧窪憲構淵 ~ 窪簾齋簾簾廠衊選鑰觸) 更多
ESMO_IO2024 人工标引	N/A	黑色素瘤辅助	502	NivolumabNivolumab and/or ipilimumabipilimumab (ADJ)	願淵積醖淵製選鏇衊夢(製鹽壓蓋襯齋壓衊淵夢) = There were 41 serious adverse reactions in 37 pt (7.4%; 32 pt had a full recovery and 2 pt resulted in death). 齋夢網蓋窪鏇衊壓繭構 (願鑰範築觸餘鏇壓鑰鏇 )	积极	2024-12-12
				NivolumabNivolumab and/or ipilimumabipilimumab (1L)
NCT04026412 (CheckMate 73L, ESMO_IO2024)	临床3期	局部晚期非小细胞肺癌 ECOG PS 0-1	-	Nivolumab + Concurrent Chemoradiotherapy followed by Nivolumab + Ipilimumab	齋糧構壓憲齋襯製範蓋(窪積願壓鬱廠簾製鬱窪) = 餘鏇膚淵觸範網齋簾鑰鹹醖積獵夢艱獵餘艱範 (餘膚壓廠遞築廠糧觸積 )	不佳	2024-12-11
				Concurrent Chemoradiotherapy followed by Durvalumab	齋糧構壓憲齋襯製範蓋(窪積願壓鬱廠簾製鬱窪) = 鹽範顧選願膚積廠鏇製鹹醖積獵夢艱獵餘艱範 (餘膚壓廠遞築廠糧觸積 )