GIANT is an open-label, multi-center, randomized, perioperative (neoadjuvant followed by adjuvant), phase 2 trial with a safety lead-in phase to investigate the feasibility, safety and tolerability, and establish the biological activity of nivolumab with or without relatlimab in patients with isocitrate dehydrogenase (IDH) wildtype newly diagnosed glioblastoma (ndGBM).

开始日期2025-06-01

申办/合作机构

Duke University

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

NCT05629546

/ Recruiting临床1期IIT

Phase I Study of Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors

This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogeneic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogeneic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.

开始日期2024-11-06

申办/合作机构

Washington University School of Medicine

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100 项与瑞拉利单抗相关的转化医学

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100 项与瑞拉利单抗相关的专利（医药）

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项与瑞拉利单抗相关的文献（医药）

2025-02-01·EUROPEAN JOURNAL OF CANCER

An update on access to novel treatment for metastatic melanoma in Europe — A 2024 survey of the European melanoma registry and the European association of dermato-oncology

Article

作者: Lallas, A ; Kessels, J I ; Saiag, P ; Mazilu, L ; Ascierto, P A ; Ocvirk, J ; Krajsova, I ; Gavrilova, I ; Kandolf, L ; Herceg, D ; Garbe, C ; Rutkowski, P ; Stojkovski, I ; Cicmil Sarić, N ; Schwarze, J K ; Haanen, J ; Marquez-Rodas, I ; Hauschild, A ; Jalovcic Suljevic, A ; Vieira, R ; Hoeller, C ; Bylaite-Bucinskiene, M ; Bastholt, L ; Kukushkina, M ; Mohr, P ; Weichenthal, M ; Lorigan, P ; Putnik, K ; Olah, J ; Mangana, J ; Samolyenko, I

Advances in cancer treatments have significantly improved their effectiveness, yet access to first-line therapies remains limited. A 2017 survey revealed that over 25 % of metastatic melanoma patients in Europe lacked access to recommended therapies. To address this, the European Association of Dermato-Oncology and the European Melanoma Registry conducted a follow-up study on the registration and reimbursement of first-line treatments.A web-based survey using LimeSurvey was distributed to melanoma experts across 27 European countries from February to April 2022 and updated from February to April 2024. The questionnaire covered the percentage of patients receiving recommended treatments, as well as treatment authorization and reimbursement dates for systemic and adjuvant therapies.There has been significant improvement in the registration and reimbursement of BRAFi/MEKi, anti-PD1, and anti-PD1/anti-CTLA4 therapies, increasing from 48 %, 63 %, and 37 % in 2017 to 96 %, 96 %, and 78 % in 2024, respectively. Despite these gains, restrictions persist. Anti-PD1/anti-CTLA4 combination immunotherapy is still not available without restrictions in 48 % of the surveyed countries. The nivolumab/relatlimab combination is licensed only for PDL-1-negative melanoma and reimbursed in seven countries of Europe. Tebentafusp is reimbursed in 15 countries and talimogene laherpervec in 5. In 2024, adjuvant treatments for stage III melanoma are reimbursed in 22 countries for dabrafenib/trametinib and 24 of 27 for anti-PD1 antibodies. Pembrolizumab and nivolumab are reimbursed in 15 and 8 countries, respectively, for stage IIB/IIC disease.While there have been improvements in the reimbursement of metastatic melanoma treatments in Europe, challenges and discrepancies remain. Further efforts at European and global levels are needed to harmonize and enhance access to cancer medicines.

2025-02-01·ESMO Open

Nivolumab combination therapies in patients with advanced gastric and gastroesophageal junction cancer: the phase II FRACTION gastric cancer study

Article

作者: He, A R ; Shankaran, V ; Ku, G ; von Moos, R ; Geva, R ; Greenawalt, D ; Gutierrez, M ; Sawyer, M B ; Yoon, H H ; Starr, J ; George, T J ; Denlinger, C S ; Lam, V K ; Di Bartolomeo, M ; Wang, Q ; Golan, T ; Elimova, E ; Lim, D ; Patel, A ; Aoyama, T ; Curigliano, G ; Fritsch, R ; Park, H ; Haag, G M ; Nagrial, A ; Lei, M ; Stein, S ; Kim, S S

BACKGROUND:

Nivolumab-based therapies are efficacious with acceptable safety in patients with gastric cancer (GC) and gastroesophageal junction cancer (GEJC). Novel nivolumab-based combination immunotherapies may offer enhanced efficacy in these indications. FRACTION-GC was a signal-seeking, randomized, open-label, phase II adaptive-design trial assessing efficacy and safety of nivolumab in combination with ipilimumab [cytotoxic T lymphocyte antigen-4 (CTLA-4) antibody], relatlimab (lymphocyte-activation gene 3 antibody), or IDO1i (BMS986205, an indoleamine-2,3-dioxygenase-1 inhibitor) in patients with unresectable, advanced/metastatic GC/GEJC.

PATIENTS AND METHODS:

Previously treated patients with GC/GEJC were randomized to receive nivolumab + ipilimumab, nivolumab + relatlimab, or nivolumab + IDO1i across two tracks: anti-programmed death-(ligand) 1/anti-CTLA-4-naïve (track 1) and -experienced (track 2). Primary endpoints were objective response rate (ORR) by investigator per RECIST v1.1, duration of response, and progression-free survival (PFS) rate at 24 weeks. Secondary endpoint was safety.

RESULTS:

Eighty-one patients in track 1 and 81 in track 2 received one combination therapy. With a median follow-up of 50.2 months, ORR [95% confidence interval (CI)] by investigator for nivolumab + ipilimumab, nivolumab + relatlimab, and nivolumab + IDO1i in track 1 was 4% (0.1% to 21.9%), 5% (0.1% to 24.9%), and 13% (4.4% to 28.1%), and for track 2 was 9% (1.1% to 28.0%), 6% (0.7% to 18.7%), and 0% (0% to 15.4%), respectively. PFS rate at 24 weeks (95% CI) was 24% (11% to 39%) for nivolumab + IDO1i track 1, 17% (16% to 32%) for nivolumab + relatlimab track 2, and not estimable for other treatment arms. Grade 3/4 treatment-related adverse events were reported in 22%, 5%, and 18% of patients receiving nivolumab + ipilimumab, nivolumab + relatlimab, and nivolumab + IDO1i in track 1 and in 35%, 11%, and 18% of patients in track 2, respectively. No treatment-related deaths were reported.

CONCLUSIONS:

While ORR did not meet prespecified expansion criteria in any treatment arm, the safety profile of the combinations was manageable. FRACTION-GC represents a novel adaptive protocol for testing multiple combination immunotherapies.

2025-02-01·Journal for ImmunoTherapy of Cancer

Effect of prior and first-line immunotherapy on baseline immune biomarkers and modulation of the tumor microenvironment in response to nivolumab and relatlimab combination therapy in patients with melanoma from RELATIVITY-020

Article

作者: Warad, Deepti ; Nyakas, Marta ; Marie Svane, Inge ; Djidel, Patrick ; Chiarion-Sileni, Vanna ; Grob, Jean Jacques ; Dummer, Reinhard ; Larkin, James ; Dolfi, Sonia ; Melero, Ignacio ; Peltola, Katriina ; Tang, Hao ; Gomez-Roca, Carlos Alberto ; Callahan, Margaret ; Reusser-Wolf, Diane ; Ascierto, Paolo A ; Muñoz-Couselo, Eva ; Garnett-Benson, Charlie ; Lipson, Evan J

Background:

Some patients with melanoma experience disease progression during immunotherapy (IO) and may benefit from novel combinations of immune checkpoint inhibitors (ICIs). We report results from exploratory biomarker analyses to characterize the responses of patients with advanced melanoma to treatment with nivolumab (anti-programmed cell death-1 (PD-1)) and relatlimab (anti-lymphocyte-activation gene 3 (LAG-3)) combination therapy in RELATIVITY-020 (NCT01968109).

Methods:

Tumor biopsies collected at baseline and ≤4 weeks after treatment initiation were evaluated for % LAG-3-positive and % CD8-positive immune cells and % programmed death-ligand 1 (PD-L1) expression on tumor cells. Baseline biomarker expression was compared among patients with IO-refractory melanoma based on last prior therapy and IO-resistance type, and between patients with IO-refractory and IO-naïve melanoma. Change in biomarker expression after treatment was evaluated in patients with IO-refractory and IO-naïve melanoma. Immune-related gene expression was compared among resistance groups and by the last prior treatment.

Results:

Among patients with IO-refractory melanoma (N=505), elevated baseline LAG-3, PD-L1, and CD8 expression (p≤0.01, p≤0.05, p≤0.001, respectively) was observed in patients whose last prior therapy was IO versus non-IO, and in those who responded (complete/partial per Response Evaluation Criteria in Solid Tumors V.1.1) to nivolumab and relatlimab combination therapy versus those who did not (stable/progressive disease). Inflammation-related gene expression was significantly higher (p<0.05) in patients with secondary versus primary resistance to prior IO treatment, and in those whose last prior therapy was IO versus non-IO. IO-refractory patients whose tumors responded to nivolumab and relatlimab combination therapy had higher inflammation-related gene expression than non-responders (p<0.05); proliferation and hypoxia-related gene expression were enriched in non-responders. During treatment with nivolumab and relatlimab combination therapy, LAG-3 expression increased significantly in patients with IO-refractory (p≤0.01) and IO-naïve melanoma (p≤0.001), and PD-L1 and CD8 increased significantly (p≤0.01 and p≤0.05, respectively) in patients with IO-naïve melanoma.

Conclusions:

Nivolumab and relatlimab combination therapy can modulate the tumor microenvironment in patients with both IO-refractory and IO-naïve melanoma. Further research is needed to identify patients who will most benefit from anti-LAG-3/PD-(L)1 agents, and to elucidate the mechanisms of action of, and resistance to, this combination therapy in patients with advanced melanoma.

Trial registration number:

NCT01968109.

141

项与瑞拉利单抗相关的新闻（医药）

2025-03-09

·蒲公英Ouryao

谁家抗癌药最畅销？2024全球肿瘤药企TOP3出炉

随着科技的飞速发展和人类对癌症认知的不断深入，2024年的全球制药肿瘤行业迎来了新一轮的洗牌。今天，就让我们一起揭晓2024年全球制药肿瘤行业排名TOP10，看看TOP3的企业是哪些？哪些产品又占据了前三甲？在肿瘤产品市场前三甲的激烈排位争夺战中，默沙东凭借史上最畅销的肿瘤药物K药强势卫冕。与此同时，BMS与罗氏之间的竞争态势愈发白热化。靠着实体瘤和血液瘤两大板块的多元扩张，两者的肿瘤业务收入都增长到了270亿美元量级，在肿瘤市场中形成了强有力的竞争格局，也为整个行业的发展注入了新的活力与变数。图 2024年全球制药巨头肿瘤业务排名TOP10 （来源：医药魔方） PART.01 2024年全球制药肿瘤业务TOP3企业 NO.3 罗氏凭借着实体瘤和血液瘤板块的双轮驱动增长，罗氏作为肿瘤霸主的辉煌再度闪耀，2024年其肿瘤业务收入达237.44亿瑞士法郎（约270.40亿美元），与BMS的肿瘤业绩已相差无几。 Tecentriq（阿替利珠单抗）和Perjeta（帕妥珠单抗）依然是罗氏实体瘤领域的两大拳头产品。在一众实体瘤产品中，治疗乳腺癌的HER2单抗复方制剂Phesgo（帕妥珠单抗曲妥珠单抗皮下注射制剂）的增长表现较为亮眼，同比增长62%至17.40亿瑞士法郎（约19.82亿美元）。此外，PI3Kα抑制剂Itovebi的获批也为罗氏的乳腺癌产品线注入了新的活力。在乳腺癌领域持续领跑的罗氏正通过外部创新巩固其优势。2024年9月，罗氏旗下基因泰克将以8.5亿美元的首付款收购锐格医药的下一代CDK抑制剂，这与罗氏现有的HER2、PI3K等靶向药物形成了更全面的产品矩阵。血液瘤领域，革新弥漫性大B细胞淋巴瘤（DLBCL）一线治疗的CD79b ADC药物Polivy展现不错的产品力，以11.21亿瑞士法郎（约12.77亿美元）的销售额跻身重磅炸弹行列。两款主打适应症差异化的CD3/CD20双抗Columvi和Lunsumio还在起量阶段。通用型CAR-T疗法的开发有望进一步强化罗氏在血液瘤领域的实力。2024年11月，罗氏以15亿美元收购了Poseida Therapeutics。罗氏认为，基于后者的技术平台打造的通用型CAR-T疗法有潜力成为各治疗领域的同类最佳产品。 NO.2 BMS BMS的肿瘤业务十分庞大，实体瘤与血液瘤两大板块齐头并进。Opdivo（纳武利尤单抗）仍是BMS在实体瘤领域的扛大旗者，2024年销售收入93.04亿美元，同比增长3%。 BMS始终跑在免疫联合赛道的前沿。Yervoy（伊匹木单抗）销售额稳健增长，O药+Y药的免疫双子星组合还于2024年在中国迎来了新适应症的全球首批，一线治疗MSI-H/dMMR结直肠癌患者。PD-1+LAG-3组合疗法Opdualag（纳武利尤单抗+瑞拉利单抗）离重磅炸弹只有一步之遥。新一代ROS1/NTRK抑制剂Augtyro（瑞普替尼）和全球第2款KRAS G12C抑制剂Krazati（阿达格拉西）初露头角，2024年的全球销售额分别为0.38亿美元和1.26亿美元。在后期实体瘤管线的储备中，抗岩藻糖GM1神经节苷脂（Fucosyl-GM1）单抗atigotatug（BMS-986012）承载了BMS进击小细胞肺癌的雄心，其与O药一线联合治疗广泛期小细胞肺癌的III期研究已推进至III期阶段。血液瘤领域，CD19 CAR-T疗法Breyanzi因产能扩大释放了销售潜力，翻倍增长至7.47亿美元。BCMA CAR-T疗法Abecma销售有所下滑，为4.06亿美元。全球首个红细胞成熟剂Reblozyl（罗特西普）全年销售额达17.73亿美元，高增长主要由一线骨髓增生异常综合征导致的贫血患者的需求驱动。Revlimid（来那度胺）和Pomalyst/Imnovid（泊马度胺）两代度胺类产品合计贡献93.18亿美元。未来BMS在血液瘤领域将重点攻坚多发性骨髓瘤，其精准布局的GPRC5D CAR-T疗法arlo-cel、两款分子胶iberdomide和mezigdomide均已推进至III期阶段。 NO.1 默沙东全球肿瘤免疫标杆产品Keytruda（帕博利珠单抗）再度展现“药王”的实力，2024年以18%的增长速度创收294.82亿美元，不仅贡献了默沙东全年总营收46%的份额，更助力其坐稳了肿瘤领域NO.1的位置。默沙东从晚期适应症的覆盖到早中期的前移探索，从单药到联合，以及皮下制剂的开发。就以早期肿瘤的治疗来说，K药是唯一在4项研究中显示出显著OS获益的肿瘤免疫疗法，并获得了9项适应症批准。其他肿瘤产品也均处于增长之中。全球首创HIF-2α抑制剂Welireg于2021年上市，如今似乎进入了快速放量阶段，2024年取得5.09亿美元的销售额，同比增长133%。Lynparza（奥拉帕利）和Lenvima（仑伐替尼）则分别带来了13.11亿美元和10.10亿美元的收入分成。基于现有的业务布局，默沙东认为在肿瘤领域还有250亿美元的潜在市场机会。要将这250亿美元的潜在价值转化为实际收益，ADC药物将打出关键组合拳。通过与第一三共和科伦博泰等ADC龙头企业的合作，默沙东快速收获了一系列管线，覆盖HER3、B7-H3、CDH6和TROP2诸多潜力靶点。其中，HER3-DXd已申报上市。 PART.02 2024年肿瘤产品销售额TOP3 No.3 / Opdivo（纳武利尤单抗） 2024年，BMS的Opdivo（纳武利尤单抗）销售收入93.04亿美元，加上来自小野制药的8.40亿美元，总销售额达到101.44亿美元。纳武利尤单抗目前已在包括美国、欧盟、日本和中国在内的超过65个国家和地区获得批准上市，涵盖12个瘤种，包括肺癌、头颈癌、胃癌、食管癌、肝癌、肾癌、结直肠癌、尿路上皮癌、黑色素瘤、霍奇金淋巴瘤、胸膜肿瘤、不明原发部位肿瘤。纳武利尤单抗的专利将于2028年到期，BMS正通过推出皮下制剂等方式延长产品生命周期。2024年12月28日，FDA批准了Opdivo皮下注射剂Opdivo Qvantig（nivolumab加透明质酸酶）上市，用于所有已批准的Opdivo适应症，意味着Opdivo成为全球首款获批上市的PD-1皮下制剂。 No.2 / Darzalex（达雷妥尤单抗）强生的达雷妥尤单抗（Darzalex）作为治疗多发性骨髓瘤的靶向CD38单抗，2024年全球销售额达116.70亿美元，同比增长19.8%，首次突破百亿美元大关。达雷妥尤单抗的组合物专利将于2026年3月到期，国内药企中，正大天晴、复宏汉霖、九源基因都有在研的生物类似药。 No.1 / Keytruda（帕博利珠单抗） 2023年的药王Keytruda（帕博利珠单抗）营收高达294.82亿美元，同比增长18%，其销售额约占默沙东全年总营收的46%，成功卫冕2024年的全球药王。2024其增长主要源于全球范围内对转移适应症的需求持续强劲，包括新增膀胱癌、子宫内膜癌适应症以及包括三阴性乳腺癌和非小细胞肺癌等在内的早期适应症。不过，K药的部分关键专利将在2028年到期，生物类似药的涌入和国产PD-1的“出海”都将蚕食其市场份额。 2024年全球制药肿瘤行业排名TOP10的出炉，不仅展现了各家药企在肿瘤领域的实力，也为未来肿瘤治疗的发展指明了方向。免疫治疗发展迅速，联合治疗方式因其显著疗效而逐渐成为研究热点。此外，部分药企借助AI技术辅助药物研发，加速了药物研发的速度，也提升了治疗方案的精准性。 END 参考来源：1、2024年全球制药巨头肿瘤业务排名TOP10 https://mp.weixin.qq.com/s/MKFoIGw04PieE5A8Jzn2bQ 2、谁是肿瘤药之王?2024年全球肿瘤药品TOP3https://mp.weixin.qq.com/s/BTaHwf13fUWJBhEaBedbSw 声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。

免疫疗法细胞疗法抗体药物偶联物并购

2025-03-06

·PRNewswire

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 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 BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight 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 platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准免疫疗法优先审批

2025-02-28

·生物探索

Nature Medicine | 三重免疫密钥破局"脑癌之王"：新疗法让患者17个月无复发

引言胶质母细胞瘤（Glioblastoma, GBM）始终是神经外科医生与肿瘤学家心头的一根刺。这种被称为“脑癌之王”的恶性肿瘤，患者确诊后的中位生存期仅14个月，五年存活率不足5%。更令人绝望的是，传统治疗“三板斧”——手术、放疗和化疗，在对抗MGMT启动子未甲基化（unmethylated MGMT promoter）这类高危亚型时几乎束手无策：即便接受全球标准的Stupp方案治疗，患者生存期也难以突破12个月。而曾被寄予厚望的免疫治疗，在GBM领域却屡屡折戟，PD-1单药临床试验全军覆没，甚至被贴上“免疫治疗黑洞”的标签。然而，2月27日《Nature Medicine》的一项突破性研究“Neoadjuvant triplet immune checkpoint blockade in newly diagnosed glioblastoma”，为这片黑暗撕开了一道光——手术前使用三种免疫检查点抑制剂（ICIs）的“新辅助三联疗法”，竟让一名56岁的晚期GBM患者实现17个月无复发存活！研究团队大胆颠覆传统治疗时序，在肿瘤原位完整时注射抗PD-1（Nivolumab）、抗CTLA-4（Ipilimumab）和抗LAG-3（Relatlimab），仅12天后手术切除的肿瘤中，杀伤性T细胞数量暴涨8倍，83%的癌细胞竟主动“举起白旗”表达免疫识别信号（MHC分子）。更惊人的是，原本被视为“免疫荒漠”的肿瘤微环境中，活化T细胞占比从5%飙升至44%，颗粒酶B（Granzyme B）的“杀伤风暴”席卷癌巢。这项研究不仅挑战了“血脑屏障阻隔大分子药物”的传统认知，更揭示了新辅助免疫治疗的独特优势：完整肿瘤释放的抗原如同“通缉令”，让免疫系统在手术前完成“敌我识别训练营”。而三药联动的协同效应，则像“三重加密钥匙”，同时解除T细胞的多重制动机制。目前，全球首个针对新诊断GBM的三联免疫治疗临床试验（GIANT, NCT06816927）已箭在弦上。这场医学奇迹是否预示着一场脑癌治疗的范式革命？答案或许就在不远的未来。在医学界，胶质母细胞瘤（Glioblastoma, GBM）被称为"脑癌之王"。这种恶性脑肿瘤患者的中位生存期仅有14个月，五年生存率不足5%。然而，27日《自然·医学》杂志的这项突破性研究，为这道医学难题撕开了一道希望之光——通过手术前使用三种免疫检查点抑制剂（Immune Checkpoint Inhibitors, ICIs），一名56岁的晚期GBM患者成功实现17个月无复发生存。这场医学奇迹背后，是对免疫系统的精妙操控，更是癌症治疗范式的革命性突破。脑癌之王的致命困局：当传统疗法集体失效胶质母细胞瘤：大脑中的"完美杀手" 胶质母细胞瘤的恐怖之处，在于它完美复刻了"癌细胞生存法则"。快速增殖：GBM细胞的分裂速度是正常脑细胞的10倍，确诊时肿瘤直径往往已超5厘米免疫逃逸：肿瘤微环境（Tumor Microenvironment, TME）中充斥着抑制性免疫细胞，如同为癌细胞打造"防弹衣" 血脑屏障庇护：传统化疗药物难以穿透这道天然屏障，90%的化疗方案宣告失效更令人绝望的是，约60%的GBM患者属于"MGMT启动子未甲基化"亚型——这意味着癌细胞能快速修复化疗药物造成的DNA损伤，使替莫唑胺（Temozolomide）等一线化疗药彻底失效。这类患者的中位生存期仅有10.6个月，比甲基化型患者短40%。免疫疗法的"滑铁卢" 当PD-1抑制剂在黑色素瘤、肺癌等领域大放异彩时，GBM却成为免疫治疗的"黑洞"。既往临床试验显示：术后使用PD-1单药（如纳武利尤单抗）的患者，生存期与安慰剂组无差异放疗联合PD-1治疗未能突破生存瓶颈复发患者中，仅有0.3%对免疫治疗产生响应问题根源直指GBM的三大免疫屏障： T细胞荒漠——肿瘤浸润淋巴细胞（Tumor-Infiltrating Lymphocytes, TILs）数量不足正常脑组织的1/100 免疫抑制微环境——巨噬细胞/小胶质细胞占比超80%，持续分泌TGF-β等抑制因子低肿瘤突变负荷（TMB）——平均仅2突变/Mb，远低于黑色素瘤的15突变/Mb 破局时刻：新辅助三联疗法的三重奏治疗时序的革命：为什么要在手术前用药？传统免疫治疗多在术后或复发后使用，但此时：手术创伤引发炎症风暴，破坏免疫稳态残留癌细胞已建立新的免疫抑制网络长期使用地塞米松等激素进一步压制免疫力新辅助治疗（Neoadjuvant Therapy）的颠覆性在于：保留完整肿瘤抗原：原位肿瘤释放大量新抗原，犹如为免疫系统绘制"通缉令" 突破血脑屏障：术前血供完整，药物更易渗透至肿瘤核心时间窗口优势：在放疗/化疗损伤免疫系统前激活T细胞三药联用的精妙协同研究团队选择了PD-1抑制剂（纳武利尤单抗）+CTLA-4抑制剂（伊匹木单抗）+LAG-3抑制剂（瑞拉利单抗）的黄金组合：动物实验显示：三药联合可使TILs数量提升300%，疗效是单药的5倍。这种协同效应在低TMB肿瘤中尤为显著。奇迹案例：56岁患者的治愈之路病情全记录患者男性，56岁，因癫痫发作就诊：基线特征：左颞叶IDH野生型、MGMT未甲基化GBM，RTK2分子亚型基因组图谱：EGFR扩增、PTEN纯合缺失、TERT启动子突变——三重高危因素治疗流程：确诊后第4天接受肿瘤活检第1天静脉注射三药联合疗法（纳武利尤单抗480mg+伊匹木单抗80mg+瑞拉利单抗160mg）第13天进行最大安全范围切除术后接受放疗（60Gy/30次）和个性化肽疫苗免疫系统的"震撼动员" 治疗前后肿瘤微环境对比：更惊人的是，颗粒酶B（GzmB）+细胞占比达91%——这意味着杀伤性T细胞已进入"战斗状态"。单细胞测序显示，治疗后T细胞受体（TCR）克隆多样性提升6倍，83.8%的肿瘤细胞表达MHC-I分子，为免疫识别铺平道路。机制揭秘：三重免疫激活的分子交响第一重：打破血脑屏障的"特洛伊木马" 传统观点认为，大分子抗体难以穿透完整血脑屏障。但该研究发现：术后肿瘤中检测到高浓度纳武利尤单抗，证实抗体成功渗透 T细胞表面的PD-1受体被药物完全占据（Occupancy Rate >95%）循环肿瘤细胞（CTCs）从16个/7.5ml血液降至0 这提示：活化的T细胞本身成为"药物载体"，通过主动迁移将抗体带入脑实质。第二重：改写肿瘤微环境的"生态革命" 多重荧光染色显示：巨噬细胞/小胶质细胞与肿瘤细胞的共定位减少70% 树突状细胞（DCs）数量增加4倍，抗原呈递能力提升 IFN-γ、CXCL9等趋化因子表达上调300% 此时的肿瘤微环境从"免疫沙漠"转变为"炎症热土"，为后续放疗/疫苗打下基础。第三重：系统免疫的"记忆形成" 外周血分析发现：循环T细胞中Ki-67+增殖群体从3%飙升至81% OX40、MHC-II等活化标志物表达提升10倍 TCR克隆多样性指数（Shannon Index）增加4倍这表明，新辅助治疗不仅激活局部免疫，更在全身建立长效免疫记忆，形成"抗癌预备队"。未来：GBM治疗的新纪元 GIANT临床试验启航基于该研究，全球首个新辅助三联免疫治疗试验（GIANT, NCT06816927）即将启动：入组标准：新诊断MGMT未甲基化GBM，KPS≥70 治疗方案：术前3周三药联合→最大切除→辅助放疗+个体化疫苗主要终点：24个月总生存率（OS）个体化治疗的四大方向生物标志物分层：通过TMB、PD-L1 CPS评分筛选优势人群给药时序优化：探索双周期新辅助治疗的增效潜力局部给药创新：瘤腔内缓释剂型提升药物浓度联合放疗增敏：利用免疫治疗的"远隔效应"清除微转移灶改写癌症治疗史的启示这项突破带给医学界的思考远超GBM本身：时机决定成败：在肿瘤原位激活免疫，比术后"亡羊补牢"更有效组合优于单药：多重免疫检查点的协同阻断能克服耐药脑部非免疫豁免区：合理设计下，系统免疫可穿透血脑屏障当56岁的患者术后第526天复查MRI，看到稳定的影像学表现时，这场抗癌战役已不仅是医学的胜利，更是对人类勇气的礼赞。免疫治疗的三重奏，正在谱写脑癌治疗的新乐章。或许在不远的未来，"脑癌之王"的称号，终将成为历史。参考文献 Long, G.V., Shklovskaya, E., Satgunaseelan, L. et al. Neoadjuvant triplet immune checkpoint blockade in newly diagnosed glioblastoma. Nat Med (2025). https://doi-org.libproxy1.nus.edu.sg/10.1038/s41591-025-03512-1 责编|探索君排版|探索君转载请注明来源于【生物探索】声明：本文仅用于分享，不代表平台立场，如涉及版权等问题，请尽快联系我们，我们第一时间更正，谢谢！ End 往期精选围观 Nature Medicine | 从CAR-T到CAR-M：实体瘤免疫治疗的下一步革命热文 Nature | 杜氏肌营养不良症治疗迎来基因补偿新突破：研究人员发现肌肉细胞的"自救基因开关" 热文 Nature | 胰腺癌的神经黑客行动：揭秘癌细胞如何“策反”神经元加速扩散热文 Nature Biotechnology | 借菌造药：噬菌体巧用大肠杆菌打造活体药物车间热文 Nature | 当癌细胞开始“抱团取暖”：破解肿瘤生存的致命同盟

免疫疗法

100 项与瑞拉利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11350	瑞拉利单抗	-	DB14851

研发状态

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
复发性非鳞状非小细胞肺癌	临床3期	美国	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	中国	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	日本	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	阿根廷	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	澳大利亚	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	奥地利	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	比利时	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	巴西	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	智利	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	哥伦比亚	Bristol Myers Squibb Co.	2024-10-07

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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


NCT04552223 (phase II study of nivolumab/relatlimab, CTgov)	临床2期	葡萄膜黑色素瘤	27	Nivolumab+Relatlimab	網簾廠醖積網鹽窪繭願(衊憲窪積範觸願築願醖) = 膚獵構遞顧選顧糧膚觸鬱鏇夢繭鹽選鏇夢遞鑰 (鑰淵醖鑰願蓋淵鹽鬱顧, 鏇襯窪鑰積憲醖襯膚醖 ~ 鹽構鹽齋窪鑰鏇憲餘範) 更多	-	2025-02-13
NCT03642067 (CTgov)	临床2期	微卫星稳定型结直肠癌 \| 大肠腺癌	59	Nivolumab+Relatlimab (Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer)	鏇鹹簾糧壓製艱顧繭醖(淵選襯糧鑰夢齋艱襯願) = 遞積衊憲網範顧膚願鏇製遞簾廠衊顧膚鬱膚鬱 (遞築繭膚壓醖餘壓醖窪, 遞鑰鏇製鑰衊糧鏇壓網 ~ 遞蓋襯壓窪簾鑰獵鹽願) 更多	-	2025-01-28
				Nivolumab+Relatlimab (Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer)	鏇鹹簾糧壓製艱顧繭醖(淵選襯糧鑰夢齋艱襯願) = 餘壓網構衊鏇膚製網簾製遞簾廠衊顧膚鬱膚鬱 (遞築繭膚壓醖餘壓醖窪, 蓋網製鹹獵簾餘壓積願 ~ 網淵糧齋廠鹹鑰構蓋齋) 更多
NEWS 人工标引	N/A	可切除非小细胞肺癌新辅助	-	纳武利尤单抗240 mg (PD-L1≥50%)	膚範襯獵鹹鹹鏇築艱醖(齋夢齋製積願廠選顧壓) = 憲築憲鏇艱鹽憲鏇襯鹹醖壓鏇壓蓋醖襯襯憲襯 (餘觸積構醖淵膚選構蓋 ) 更多	积极	2025-01-20
				纳武利尤单抗240 mg + Relatlimab 80 mg (PD-L1≥50%)	膚範襯獵鹹鹹鏇築艱醖(齋夢齋製積願廠選顧壓) = 鑰窪築簾艱願淵衊獵窪醖壓鏇壓蓋醖襯襯憲襯 (餘觸積構醖淵膚選構蓋 ) 更多
NCT04567615 (CTgov)	临床2期	晚期肝细胞癌	266	Nivolumab (Treatment A)	醖餘窪繭蓋網淵廠選襯(範膚窪鑰衊選憲願糧廠) = 顧獵蓋顧顧願願簾艱網壓積膚鹹膚鹽襯築簾蓋 (糧蓋觸築繭鏇餘鹽顧齋, 鑰壓構顧憲顧膚糧築憲 ~ 餘窪醖艱廠餘醖艱遞憲) 更多	-	2024-10-08
				Nivolumab (Treatment B)	醖餘窪繭蓋網淵廠選襯(範膚窪鑰衊選憲願糧廠) = 餘網網膚壓膚遞觸鏇襯壓積膚鹹膚鹽襯築簾蓋 (糧蓋觸築繭鏇餘鹽顧齋, 築鏇夢鑰繭範繭糧簾夢 ~ 糧觸齋鹹觸遞構醖鬱鹹) 更多
NCT03026140 (NICHE-3, Pubmed \| Nat Med) 人工标引	临床2期	错配修复缺陷或微卫星高度不稳定性结直肠癌新辅助 Deficient DNA Mismatch Repair (dMMR)	59	Nivolumab relatlimab	獵願鹹衊鏇壓鹹淵製夢(齋範壓衊願餘鬱製襯膚) = 網顧膚鏇繭憲壓鑰築遞繭選窪築壓憲鑰範鑰築 (選鏇鹹蓋夢淵鏇鏇淵簾, 81 ~ 97) 更多	积极	2024-09-15
NCT04552223 (ESMO2024) 人工标引	临床2期	葡萄膜黑色素瘤	26	Nivolumab 480 mg/relatlimab 160 mg	顧鑰遞顧糧窪範齋憲鬱(蓋醖顧蓋顧範膚築遞鑰) = 壓鹹簾鬱鬱襯獵網網鹽憲鹽壓憲觸夢糧築艱糧 (艱鬱製觸膚願窪壓積壓 ) 更多	不佳	2024-09-14
NCT03493932 (CTgov)	临床1期	胶质母细胞瘤	21	nivolumab+BMS-986016	鹹鬱獵糧選鹽夢網鹹壓(願網襯齋艱顧觸網膚糧) = 願窪繭觸積製膚糧齋鹹鹹醖膚製選蓋窪蓋鏇積 (壓繭襯製構蓋齋鬱網簾, 簾艱壓鑰獵壓選淵築鬱 ~ 鬱鏇獵構醖顧築憲膚艱)	-	2024-07-24
NCT03743766 (ASCO2024) 人工标引	临床2期	黑色素瘤一线 BRAF Mutation	43	Nivolumab	蓋鹹願顧壓範膚醖憲鑰(齋願夢鑰鹽齋鹽餘網積) = 糧製淵淵範鑰餘築鏇廠壓選廠範蓋積網膚構簾 (觸願壓鑰膚範憲淵廠鏇 ) 更多	积极	2024-05-24
				Relatlimab	蓋鹹願顧壓範膚醖憲鑰(齋願夢鑰鹽齋鹽餘網積) = 獵遞鬱構顧齋窪憲襯廠壓選廠範蓋積網膚構簾 (觸願壓鑰膚範憲淵廠鏇 ) 更多
NCT03642067 (ASCO2024) 人工标引	临床2期	微卫星稳定型结直肠癌 Microsatellite Stable (MSS)	59	Nivolumab/Relatlimab	憲範淵襯製壓範夢願鬱(構憲願衊觸壓鏇製顧夢) = 齋廠觸鑰窪選構願構網築鑰選淵範選獵夢窪衊 (鑰蓋壓獵窪繭簾齋築繭 ) 未达到更多	不佳	2024-05-24
				Nivolumab 480mg/Relatlimab 160mg	艱築衊積襯艱鑰選齋繭(餘願鏇壓憲憲鏇壓鹹窪) = 願構蓋積蓋壓窪餘鏇選製顧積壓範獵獵夢鹹夢 (簾廠鏇糧醖醖齋觸襯積 ) 更多
NCT03459222 (RELATIVITY-048, ASCO2024) 人工标引	临床1/2期	局部晚期黑色素瘤一线 PD-L1 Positive \| LAG3 Positive	46	Nivolumab 480 mg Q4W	願積簾願餘窪齋膚糧齋(齋築襯淵餘鏇願範鹹範) = 繭鹹齋遞鏇網醖鬱鏇淵積衊艱簾廠構窪糧觸遞 (製遞獵鹽糧繭積願選窪, 43.2–73.0) 更多	积极	2024-05-24