A Randomized Phase II Trial of Induction Cemiplimab Plus Chemotherapy With or Without Fianlimab in Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

开始日期2027-02-07

申办/合作机构

The University of Chicago

NCT07179315

/ Not yet recruiting临床2期IIT

A Randomized Phase II Trial of Cemiplimab With or Without Fianlimab in Patients With Detectable Minimal-residual Disease After Definitive Treatment for Human Papillomavirus Positive HPV(+) Head and Neck Cancer.

The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer who have detectable minimal-residual disease after definitive treatment. The main question(s) it aims to answer are:
* Does combining cemiplimab with fianlimab provide better results in preventing cancer recurrence than cemiplimab alone?
* Is the combination treatment safe and well-tolerated by patients? Researchers will compare the group receiving cemiplimab alone to the group receiving the combination of cemiplimab and fianlimab to see if the combination leads to improved treatment outcomes, such as better disease control and longer survival.
Participants will:
* Receive either cemiplimab alone or a combination of cemiplimab and fianlimab.
* Attend regular follow-up visits for monitoring of treatment efficacy and side effects.
* Undergo assessments to measure disease progression and response to treatment.

开始日期2026-12-01

申办/合作机构

The University of Chicago

NCT07281417

/ Recruiting临床2期IIT

Neoadjuvant Chemotherapy With or Without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study

This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.

开始日期2026-11-24

申办/合作机构

National Cancer Institute

100 项与塞普利单抗相关的临床结果

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100 项与塞普利单抗相关的转化医学

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100 项与塞普利单抗相关的专利（医药）

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481

项与塞普利单抗相关的文献（医药）

2026-05-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Efficacy of immune checkpoint inhibitors in the first line therapy of non-squamous non-small cell lung cancer: A systematic review and network meta-analysis

Review

作者: Mironenko, Olga ; Fedyanin, Mikhail ; Zhukov, Nikolai ; Sapozhnikov, Kirill ; Sableva, Natalia ; Tolkacheva, Daria ; Moiseenko, Fedor ; Lazarev, Andrei

AIM:

By 2026, several PD-1/PD-L1 antibodies were approved by FDA, EMA and non-EU Eastern European countries for the first-line therapy in advanced non-squamous non-small cell lung cancer (nsNSCLC) without EGFR mutations or ALK alterations. This study aimed to compare overall (OS) and progression-free (PFS) survival among anti-PD-1/PD-L1-containing regimens and to evaluate the immunotherapy effect modification due to PD-L1 expression.

METHODS:

A systematic search in MEDLINE and Embase on December 23, 2025 identified 15 Phase III randomized clinical trials involving adults with advanced nsNSCLC treated with therapies containing prespecified anti-PD-1/PD-L1 agents. Bayesian multilevel network meta-regressions with M-splines were estimated for OS and PFS, incorporating covariates for PD-L1 expression (TPS <1% versus ≥1%) and its interaction with the treatment class (anti-PD-1/PD-L1-based regimens versus chemotherapy ± bevacizumab).

RESULTS:

Regardless of PD-L1 expression, treatments with the highest probability of being the best (SUCRA) by OS are prolgolimab + chemotherapy, pembrolizumab + chemotherapy and cemiplimab + chemotherapy (SUCRA 0.80-0.94), by PFS nivolumab + bevacizumab + chemotherapy and atezolizumab + bevacizumab + chemotherapy (SUCRA 0.91-0.96). The hazard ratio for the interaction between PD-L1-negative status and anti-PD-1/PD-L1-containing therapy was 1.09 (95% CrI, 0.95-1.25) for OS and 1.41 (95% CrI, 1.16-1.71) for PFS.

CONCLUSION:

For advanced nsNSCLC patients, irrespective of PD-L1 expression, prolgolimab, pembrolizumab or cemiplimab, each combined with chemotherapy, are most efficacious by OS; nivolumab or atezolizumab combined with bevacizumab and chemotherapy demonstrate the highest PFS. PD-L1 expression does not modify the effect of examined immunotherapy options on OS, though the opposite is true for PFS.

2026-03-01·Immuno-oncology technology

Adjuvant anti-PD-1 therapy in high-risk cutaneous squamous-cell carcinoma: post hoc insights from the C-POST and KEYNOTE-630 studies

Article

作者: Cavalieri, S ; Alfieri, S ; Colombo, E ; Nuzzolese, I ; Bergamini, C ; Licitra, L ; Ottini, A ; Lombardi Stocchetti, B

Background:

Cutaneous squamous-cell carcinoma (cSCC) is cured with surgery with or without radiotherapy in most cases, but patients with high-risk features remain prone to recurrence. Until recently, no systemic adjuvant therapy was available. Recently, two phase III trials assessed post-operative anti-programmed cell death protein 1 (PD-1): C-POST (cemiplimab), which met its primary endpoint, and KEYNOTE-630 (pembrolizumab), which did not.

Methods:

We compared the eligibility criteria and risk definitions of both trials. Published disease-free survival (DFS) curves were digitized, and individual patient data (IPD) were reconstructed with validated algorithms. DFS was analyzed using Kaplan-Meier estimates, log-rank tests, Cox models, and restricted mean survival time. Subgroup analyses considered nodal high-risk patients in the two studies. Hazard ratios (HRs) informed a meta-analysis with the generic inverse variance method.

Results:

The placebo arms showed no DFS difference. Although no direct comparisons can be made across trials and in spite of the different eligibility criteria of the two studies, cemiplimab achieved superior DFS versus pembrolizumab. Pooling experimental arms confirmed a DFS benefit with PD-1 therapy [HR 0.53, 95% confidence interval (CI) 0.40-0.71]. Cemiplimab (HR 0.36) and pembrolizumab (HR 0.44) consistently reduced recurrence risk in nodal high-risk patients, yielding a combined HR of 0.40 (95% CI 0.26-0.62) with no heterogeneity.

Conclusion:

Adjuvant PD-1 blockade significantly improves DFS in high-risk cSCC. With the caveats of indirect comparisons and the pending full publication of one of the two trials, these post hoc findings are hypothesis generating and may help inform the selection of high-risk patients deserving adjuvant therapy.

2026-03-01·International Journal of Clinical Oncology

Real-world safety and efficacy of immune checkpoint inhibitors in Japanese patients with persistent, recurrent, or metastatic cervical cancer: a multicenter prospective and retrospective study

Article

作者: Hirasawa, Takeshi ; Watanabe, Reiko ; Miyagi, Etsuko ; Kato, Kazuyoshi ; Suzuki, Nao ; Kuji, Shiho ; Kamiya, Natsuko ; Machida, Hiroko ; Koike, Junki ; Kitami, Kazuhisa

OBJECTIVE:

To evaluate the real-world safety and efficacy of immune checkpoint inhibitors (ICIs) in Japanese patients with persistent, recurrent, or metastatic cervical cancer.

METHODS:

In this multicenter observational study at four Japanese institutions, 100 patients with recurrent, persistent, or advanced cervical cancer received pembrolizumab or cemiplimab. Primary endpoints were objective response rate (ORR) and the incidence of immune-mediated adverse events (imAEs) and grade 3-5 AEs. Secondary endpoints were progression-free survival (PFS) and overall survival (OS). Logistic and Cox regression were used to explore prognostic factors.

RESULTS:

Eighteen patients (18%) achieved complete response and 44 (44%) partial response, yielding an ORR of 62.0% and a disease control rate of 77.0%. Median PFS and OS were 10.4 and 22.0 months, respectively. ORR was 74.0% in the first-line setting and 29.6% in the second-line setting. Among patients who met KEYNOTE-826 eligibility criteria, ORR was 82.9% and median PFS 16.1 months. Cemiplimab, which was mainly used as off-label retreatment in frail or previously ICI-exposed patients, showed limited activity (ORR 5.6%). ImAEs occurred in 45.0% of patients, with grade 3-5 events in 19.0% and six treatment-related deaths. Poor performance status and recurrent disease were associated with lower response and shorter PFS, whereas PD-L1 tumor proportion score ≥ 50% and grade 3-5 imAEs were associated with longer PFS.

CONCLUSION:

In this real-world cohort, ICIs, particularly pembrolizumab, demonstrated substantial antitumor activity with acceptable toxicity in Japanese patients with advanced cervical cancer, especially when used as first-line therapy and in patients fulfilling KEYNOTE-826 eligibility criteria.

898

项与塞普利单抗相关的新闻（医药）

2026-03-26

·BioSpace

Dupixent® (dupilumab) Approved in Japan as the First Targeted Medicine to Treat Adults with Bullous Pemphigoid (BP)

Approval in moderate-to-severe patients was based on pivotal trial results showing over four times more Dupixent patients experienced sustained disease remission through Week 36 compared with placebo BP is a chronic, relapsing skin disease with underlying type 2 inflammation characterized by intense itch alongside painful blisters and other lesions BP is the seventh approved indication for Dupixent in Japan March 24, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Dupixent® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP). The approval in Japan is based on data from the pivotal LIBERTY-BP-ADEPT Phase 2/3 trial, which evaluated Dupixent in adults with moderate-to-severe BP. Patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) added to standard-of-care oral corticosteroids (OCS). During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained. For the primary endpoint, more than four times as many patients on Dupixent experienced sustained disease remission compared to placebo (18% vs. 4%; p=0.0250) at Week 36 in the companies’ core dataset used for the regulatory submission in Japan. Treatment-related adverse events (AEs) occurred in 26% of Dupixent patients and 15% of placebo patients. The treatment-related AE most commonly reported with Dupixent was conjunctivitis (4%). In addition to BP, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD). BP is a rare skin disease that primarily affects elderly patients, and is characterized by intense itch, painful blisters and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system. ADEPT was a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP for a 52-week treatment period. After randomization, patients received Dupixent or placebo every two weeks after an initial loading dose, along with OCS treatment. During treatment, OCS taper was initiated after patients experienced two weeks of sustained control of disease activity. OCS tapering could start between four to six weeks after randomization and was continued if disease control was maintained, with the intent of completion by Week 16. After OCS tapering, patients were only treated with Dupixent or placebo for the rest of the trial (rescue treatment could be used if required). The primary endpoint evaluated the proportion of patients achieving sustained disease remission at Week 36. Sustained disease remission was defined as complete clinical remission with completion of OCS taper by Week 16 without relapse after completion of the OCS taper and no rescue therapy use during the 36-week treatment period. Relapse was defined as appearance of ≥3 new lesions a month or ≥1 large lesion or urticarial plaque (>10 cm in diameter) that did not heal within a week. Rescue therapy could include treatment with high-potency topical corticosteroids, OCS (including increase of OCS dose during the taper or re-initiation of OCS after completion of the OCS taper) or systemic non-steroidal immunosuppressive medications or immunomodulating biologics. Dupixent is now available in Japan as a 300 mg pre-filled syringe or pre-filled pen for adults with bullous pemphigoid. Dupixent is intended for injection under the skin (subcutaneous injection) and is given every two weeks after an initial loading dose. It can be given in a clinic or at home by self-administration after training by a healthcare professional. Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis (EoE), prurigo nodularis, CSU, COPD, BP and allergic fungal rhinosinusitis (AFRS) in different age populations. More than 1,400,000 patients are being treated with Dupixent globally.1 Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, Board co-Chair, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), vkeeza ® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. The content above comes from the network. if any infringement, please contact us to modify.

临床结果上市批准

2026-03-25

·国际干细胞与免疫细胞研究

不打针！全球首款国研吸入式mRNA疫苗来了！2026五大疫苗井喷，3年生存率暴涨23%

点击蓝字关注我们肺癌作为“癌王”，发病率与死亡率长期高居榜首。尽管靶向药、免疫治疗日新月异，但仍有大批患者在耐药或治疗失效后陷入无药可医的绝境。如今，一款国研创新疫苗BMD006的问世，为无数患者带来破局之光！作为全球首款吸入式mRNA肿瘤相关抗原干粉疫苗，它凭借无创给药、局部强效免疫及优异安全性等核心优势，入选2026中国十大癌症疫苗，专为晚期肺癌及实体瘤肺转移患者设计，有望重塑肺部肿瘤治疗格局。更令人振奋的是，除BMD006外，多款肺癌疫苗同样蓄势待发，肺癌患者的治疗新选择正不断涌现！ ▲截图源自“wcg” BMD006：全球首款吸入式mRNA癌症疫苗 BMD006是全球首款吸入式mRNA肿瘤相关抗原干粉疫苗，依托原创黏膜递送技术MucoRD®与免疫增强平台ETP®打造，专为晚期肺癌、实体瘤肺转移患者设计。 PART 01 核心优势突出 1、无创给药，像雾化一样吸入：无需打针、无需输液，通过吸入方式直接将mRNA疫苗送达肺部，无创便捷、全身刺激小，患者耐受性更高。 2、局部精准，形成肺部免疫“热区”：避免传统疫苗全身扩散、病灶浓度低的短板，在肺部原位激活强效免疫，精准杀伤肿瘤细胞，并建立免疫记忆，降低复发风险。 3、现货即用，无需个体化定制：干粉剂型稳定、无需严苛冷链，可及性更高，更适合大规模临床应用。 4、广谱适用，联用免疫疗效翻倍：覆盖MUC1、NY-ESO-1等多靶点，对非小细胞肺癌、小细胞肺癌，以及乳腺癌、结直肠癌等实体瘤肺转移均有潜在获益。与PD-1抑制剂联用可将“冷肿瘤”转为“热肿瘤”，实现1+1＞2协同杀瘤，同时降低全身不良反应，破解耐药难题。 PART 02 BMD006吸入式疫苗上市在即！国内多中心启动免费临床招募好消息是，目前我国正在开展针对BMD006吸入式mRNA癌症疫苗的临床研究，小细胞肺癌，非小细胞肺癌患者均可申请！项目名称一项评估吸入型mRNA肿瘤相关抗原干粉疫苗BMD006，在晚期肺癌或实体瘤肺转移患者中的安全性、耐受性、药代动力学特征及有效性的I期临床研究。入排标准（部分） 1）经组织学或细胞学确诊为晚期肺癌(驱动基因阴性或驱动基因阳性但靶向治疗失败或标准治疗后进展)。 2）有症状的中枢神经系统转移排除。无症状脑转移或经过脑转移病灶治疗后症状稳定≥2周的患者，符合下列所有标准，可参与本项研究:肺部有可测量的病灶;首次试验产品治疗前14天停止激素治疗。 3）排除：患有慢性阻塞性肺疾病、哮喘或对花粉、粉尘过敏者;有间质性肺病史(例如，特发性肺纤维化或机化性肺炎)。申请流程想申请抗癌新药临床试验的患者，需将近期病理报告、基因检测报告等资料汇总后，提交至国际干细胞与免疫细胞研究医学部，进行初步评估。我们的专家将为您全面分析解读检测报告，预计一个工作日内电话联系推荐用药方案，并匹配适合患者入组的临床试验项目。符合条件患者可免费使用疫苗、免费检查、专家全程随访。注：国际干细胞与免疫细胞研究作为国内权威的肿瘤患者服务平台，我们承诺对所有受试者的个人信息保密，并保证在整个过程中，遵循国家临床研究相关的法律法规。 2026值得期待五大肺癌疫苗肺癌疫苗作为免疫治疗的重要方向，正为晚期患者带来全新治疗选择。以下五大已展现临床获益的肺癌疫苗，覆盖不同靶点与适用人群，为患者提供前沿治疗参考。 PART 01 XP001疫苗：靶向KRAS G12V突变，终末期肺癌病灶显著消退 KRAS G12V突变是肺癌、胰腺癌治疗的难点，在非小细胞肺癌中占KRAS突变的20%，传统靶向药无法结合该位点，PD-1单药疗效有限，患者标准治疗失败后常无药可用。 XP001是我国自主研发的单靶点mRNA治疗性疫苗，也是全球首个针对KRAS G12V的单一固定靶点mRNA疫苗，突破了个性化疫苗制备周期长的瓶颈。它直接锁定KRAS G12V公共突变位点，无需复杂生物信息预测，制备时间从数月缩短至数周，可快速投入临床使用。该疫苗通过mRNA编码特异性抗原，引导免疫系统精准攻击突变癌细胞，与PD-1抑制剂联用能激活耗竭免疫细胞，形成协同抗肿瘤效应。 2024年6月《Cell Research》刊发的研究证实：XP001联合帕博利珠单抗，让2名终末期实体瘤患者实现肿瘤缩小。其中一位69岁晚期非小细胞肺癌患者，经3个周期联合治疗后，右肺病灶基本消失，左肺及纵隔淋巴结病灶明显消退（详见下图），达到部分缓解（PR），仅出现可控的发热、注射部位疼痛等轻微不良反应。 ▲图源“Cell Research”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除好消息是，目前XP001的开放多中心Ⅰ期临床试验正在国内招募，符合条件的患者可将病历提交至国际干细胞与免疫细胞研究医学部，评估入组资格。 PART 02 Vx-001疫苗：全球首创TERT靶向疫苗，肺癌中位总生存期延长超21个月 Vx-001是全球首个采用“优化隐蔽肽”策略的肺癌疫苗，靶向端粒酶逆转录酶（TERT）抗原，可诱导特异性CD8⁺细胞毒性T细胞，直接关联晚期非小细胞肺癌患者的生存期改善。《英国癌症杂志》发表的Ⅱ期临床试验（NCT01935154），纳入221例HLA-A*0201阳性、TERT表达阳性的Ⅳ期非小细胞肺癌患者。结果显示：Vx-001组中位总生存期（OS）达14.3个月，优于安慰剂组的11.3个月（HR=0.96，p=0.86，详见下图a），33.7%的患者疾病控制超6个月，高于对照组的25.7%。 ▲图源“Br J Cancer”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除好消息是，目前Vx-001注射液已启动临床招募，适用于HLA-A*0201阳性、TERT表达阳性且肿瘤浸润淋巴细胞阴性的晚期实体瘤/非小细胞肺癌患者。符合条件的患者可将病历提交至国际干细胞与免疫细胞研究医学部，进行评估。 PART 03 BNT116疫苗：多抗原mRNA疫苗，肺癌初见疗效 BNT116由BioNTech研发，采用与新冠疫苗同源的mRNA技术，编码6种非小细胞肺癌常见共有抗原，可精准触发机体抗肿瘤免疫反应，识别并杀灭癌细胞，同时降低复发风险，且不损伤健康细胞。该疫苗Ⅰ期LuCa-MERIT-1研究（NCT05142189），探索BNT116单药或联合cemiplimab治疗晚期不可切除/转移性非小细胞肺癌的疗效。首批数据显示：经多线治疗的晚期患者，该疗法展现出积极的临床活性，且安全性整体可控。 PART 04 mRNA疫苗联合免疫治疗：肺癌3年生存率提升超23% 2025年MD安德森癌症中心的研究发表于《Nature》，并在欧洲肿瘤内科学会（ESMO）大会公布核心数据：mRNA疫苗可致敏肿瘤，与免疫检查点抑制剂（ICI）联用产生强效协同作用。其中晚期非小细胞肺癌队列的表现尤为突出，数据显示：180例接种患者的中位生存期（OS）达37.33个月，3年总生存（OS）率为55.7%；704例未接种患者分别为中位OS仅为20.6个月，3年OS率仅为30.8%。可见，疫苗接种组生存率提升超23%，提示mRNA新冠疫苗可致敏肿瘤，与免疫疗法产生协同抗肿瘤效应。 ▲图源“Nature”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 PART 05 WT1-DC联合化疗：肺癌原发灶骤缩70%，全身转移灶消退，PFS超577天 WT1是肺癌高表达的广谱肿瘤抗原，WT1-DC疫苗通过负载患者自身树突状细胞，激活特异性抗肿瘤免疫，联合化疗可显著提升疗效。《Cureus》曾报道过一个典型案例：一位69岁Ⅳ期肺鳞癌伴双侧肾上腺、肝、骨广泛转移患者，一线化疗后肿瘤复发，启动WT1-DC疫苗联合多西他赛、雷莫芦单抗治疗。结果显示：无进展生存期（PFS）超577天，肺部原发灶缩小超70%，全身转移灶显著消退；肿瘤标志物大幅下降，患者体力状态良好，可正常生活。治疗期间仅出现轻微发热，免疫指标持续改善，证实该疫苗能优化免疫状态，延长化疗获益时间。 ▼WT1-DC疫苗治疗前后胸部CT图像对比 ▲图源“Cureus”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 ▼WT1-DC疫苗治疗前后全身PET-CT对比 ▲图源“Cureus”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除小编寄语曾经，晚期肺癌几乎等同于“无药可治、痛苦挣扎”，我们也曾羡慕海外前沿疗法，期盼一款真正属于中国人的自主抗癌突破。如今，癌症疫苗历经数十年深耕，已展现出巨大治疗潜力，而国研吸入式mRNA癌症疫苗BMD006的问世，更是正式打破了这一困局！它无需注射、直击肺部病灶，副作用小、靶向性强，不仅填补了全球吸入式mRNA肿瘤疫苗的空白，更开启了中国肺癌治疗的全新篇章。未来，癌症疫苗还可与手术、放化疗、免疫治疗联合应用，构建多元化综合治疗体系，为患者带来更长生存期与更高生活质量。医学进步的终极意义，是让每一个生命都被温柔守护；中国创新药的崛起，正是为了让国内肿瘤患者不再远途求药、不再被高价药物所困。愿每一位肺部肿瘤患者，都能在国研创新的守护下远离病痛、重获新生；愿每一个家庭，都能重拾团圆与安康！若您对现有治疗方案不满意，或希望了解更多肺癌新药、新技术资讯，可扫描文末二维码，提交治疗经历、病理报告及出院小结至国际干细胞与免疫细胞研究医学部，进行初步评估或了解详细的临床入排标准。参考资料 [1]Wang X,et al.Combination therapy of KRAS G12V mRNA vaccine and pembrolizumab: clinical benefit in patients with advanced solid tumors[J]. Cell Research, 2024, 34(9): 661-664. https://www.nature.com/articles/s41422-024-00990-9 [2]Gridelli C,et al.Vx-001-201 trial team. Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial. Br J Cancer. 2020 May;122(10):1461-1466. https://pmc.ncbi.nlm.nih.gov/articles/PMC7217860/ [3]Grippin A J,et al.SARS-CoV-2 mRNA vaccines sensitize tumours to immune checkpoint blockade[J]. Nature, 2025: 1-10. https://www.nature.com/articles/s41586-025-09655-y [4]Nagai H,et al.WT1 Dendritic Cell Vaccine Therapy Improves Immune Profile and Prolongs Progression-Free Survival in End-Stage Lung Cancer[J].Cureus,2023,15(10). https://www.cureus.com/articles/193305-wt1-dendritic-cell-vaccine-therapy-improves-immune-profile-and-prolongs-progression-free-survival-in-end-stage-lung-cancer#!/ 往期推荐 RECOMMEND 速存！2026肺癌速查清单：73款获批药+7大抗癌新疗法，控病率直超87% 国研Vx-001疫苗锁定肺癌靶心：特定人群总生存提升近2倍【吸入式疫苗免费招募】吸入型mRNA疫苗 BMD006终于启动临床，现急招肺癌患者！本文为“国际干细胞与免疫细胞研究”原创，转载需授权干细胞与免疫细胞研究入群免费领取抗癌细胞资讯｜新技术｜新药研发｜权威专家资料求分享求收藏求点击求在看

疫苗信使RNA临床1期免疫疗法

2026-03-23

·PRNewswire

BioLineRx Reports 2025 Financial Results and Provides Corporate Update

- On track to initiate Phase 1/2a clinical trial of GLIX1 for treatment of glioblastoma (GBM) by end of this month - - GLIX1 is positioned to potentially address unmet needs for novel and more effective cancer treatments by targeting DNA damage response mechanisms - - Management to host conference call today, March 23, at 8:30 am EDT - TEL AVIV, Israel, March 23, 2026 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its audited financial results for the year ended December 31, 2025, and provided a corporate update. "Since our last quarterly update, we have been working diligently to move forward with a Phase 1/2a first-in-human clinical trial of GLIX1 in glioblastoma, and I am pleased to report that we expect to initiate the study by the end of this month, with the commencement of patient enrollment shortly thereafter," stated Philip Serlin, Chief Executive Officer of BioLineRx. "GLIX1, the lead asset that we acquired through our collaboration with Hemispherian, is a unique molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models, excellent blood-brain-barrier penetration and a favorable safety profile in toxicology studies. We are eager to establish the safety, recommended dose and proof-of-concept in order to advance this promising candidate through an efficient development pathway. "In parallel, we continue to conduct pre-clinical activities in support of further development of GLIX1 in additional cancer indications with high unmet needs, and, separately, we are also conducting studies to further investigate and affirm the potential synergistic effect of GLIX1 in combination with PARP inhibitors, as we work to maximize the value of the GLIX1 opportunity. "In metastatic pancreatic cancer, enrollment has accelerated in the ongoing CheMo4METPANC Phase 2b clinical trial of motixafortide, which is being led by Columbia University and supported by both Regeneron and BioLineRx, and we continue to anticipate that a prespecified interim/futility analysis will read out in 2026. We believe PDAC represents another opportunity to introduce a much-needed new treatment option to patients suffering from a very challenging tumor type, while creating sustained value for our company," Mr. Serlin concluded. Corporate Updates Announced that it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering GLIX1 for cancers in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold, estimated to be 90% of all cancers. Patent preserves BioLineRx's ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types. Patent further broadens and strengthens GLIX1's patent protection until 2040, with a possible patent-term extension of up to five years. Financial Updates With $20.9 million on its balance sheet as of December 31, 2025, BioLineRx is maintaining its cash runway guidance into the first half of 2027. Clinical Updates GLIX1 On track to initiate a Phase 1/2a clinical trial of GLIX1 in glioblastoma by the end of the month. Three renowned academic centers are planned to participate in this clinical trial: Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, NYU Langone Health, led by Dr. Alexandra M. Miller and Moffit Cancer Center, led by Dr. Patrick Grogan. The Phase 1 part of the trial is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the Phase 1 part of the trial are anticipated in H1 2027. The Phase 2a expansion part of the trial is planned to include various population cohorts, including GBM (newly diagnosed and/or recurrent), as well as additional cancers with/without standard of care (e.g., PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for rapid and effective advanced clinical development. Pre-clinical activities in support of clinical development for GLIX1 in additional cancer indications are ongoing. Motixafortide Pancreatic Ductal Adenocarcinoma (mPDAC) Enrollment has accelerated in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel). A prespecified interim/futility analysis is planned when 40% of progression-free survival (PFS) events are observed, which the Company continues to anticipate will occur in 2026. Sickle Cell Disease (SCD) & Gene Therapy Announced that a poster featuring final results from a Phase 1 clinical trial (NCT05618301) evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD) was presented at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition in December. A second SCD study, sponsored by St. Jude Children's Research Hospital, continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ HSCs for gene therapies for patients with SCD (NCT06442761). APHEXDA Performance Update For the full-year 2025, APHEXDA sales were $6.7 million, which provided royalty revenue to the Company of $1.2 million. Financial Results for the Year ended December 31, 2025 Revenues for the year ended December 31, 2025 were $1.2 million reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which primarily reflect a portion of the up-front payment received by the Company under the Gloria License Agreement and a milestone payment achieved under the Gloria License Agreement, which collectively amounted to $15.0 million, as well as the up-front payment received under the Ayrmid License Agreement and $6.0 million of net revenues from product sales of APHEXDA in the United States. Cost of revenues for the year ended December 31, 2025 were $0.2 million, compared to cost of revenues of $9.3 million for the year ended December 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects the amortization of intangible assets, sub-license fees on the up-front payment received for the Ayrmid License Agreement, sub-license fees accrued on a milestone payment recorded under the Gloria License Agreement, as well as royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales. Research and development expenses for the year ended December 31, 2025 were $8.1 million, a decrease of $1.1 million, or 11.5%, compared to $9.2 million for the year ended December 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, offset by expenses related to initiation of the GLIX1 project. There were no sales and marketing expenses for the year ended December 31, 2025, compared to $23.6 million for the year ended December 31, 2024. The decrease resulted from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid license agreement. General and administrative expenses for the year ended December 31, 2025 were $3.1 million, a decrease of $3.2 million, or 50.3%, compared to $6.3 million for the year ended December 31, 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, and a decrease in a number of general and administrative expenses. Non-operating income (expenses) for the years ended December 31, 2025 and 2024 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, as a result of changes in its share price, offset by warrant offering expenses. Net financial income for the year ended December 31, 2025 was $0.2 million, compared to net financial expenses of $7.3 million for the year ended December 31, 2024. Net financial income for 2025 relates to investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the appreciation of the NIS against the U.S. dollar during the period, partially offset by interest paid on loans. Net financial expenses for 2024 primarily relate to interest paid on loans, which increased in 2024 due to a one-time $4.0 million charge to interest expense in connection with the November 2024 amendment to loan agreement with BlackRock, partially offset by investment income earned on bank deposits. Net loss for the year ended December 31, 2025 was $2.0 million, compared to $9.2 million for the year ended December 31, 2024. As of December 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $20.9 million, sufficient to fund operations, as currently planned, into the first half of 2027. A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at and posted on the Company's investor relations website at . The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected]. Conference Call and Webcast Information To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 25, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally. About BioLineRx BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's lead development asset is GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial is expected to initiate in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS. The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and developed by Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in solid tumors, including metastatic pancreatic cancer (PDAC), and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University. Learn more about who we are, what we do, and how we do it at , or on LinkedIn.  Forward Looking Statement Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the expectations with regard to clinical trials of motixafortide and GLIX1, expected timing of clinical readouts, the expected cash runway, and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of GLIX1 and motixafortide including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance GLIX1 and motixafortide into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for GLIX1 and motixafortide will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for GLIX1 and motixafortide and the timing of other regulatory filings and approvals; whether access to GLIX1 and motixafortide is achieved in a commercially viable manner and whether GLIX1 and motixafortide receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel, as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection that BioLineRx's is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its need for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; statements as to the impact of the political and security situation in Israel on BioLineRx's business which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2026. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. Contacts: United States Irina Koffler LifeSci Advisors, LLC [email protected] Israel Moran Meir LifeSci Advisors, LLC [email protected] Logo - SOURCE BioLineRx Ltd. 21% more press release views with Request a Demo

临床1期临床2期引进/卖出上市批准ASH会议

100 项与塞普利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	塞普利单抗	L01XC33	DB14707

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
子宫颈转移癌	欧盟	Regeneron Pharmaceuticals, Inc.	2023-05-17
子宫颈转移癌	冰岛	Regeneron Pharmaceuticals, Inc.	2023-05-17
子宫颈转移癌	列支敦士登	Regeneron Pharmaceuticals, Inc.	2023-05-17
子宫颈转移癌	挪威	Regeneron Pharmaceuticals, Inc.	2023-05-17
晚期宫颈癌	日本	Regeneron Pharmaceuticals, Inc.	2022-12-23
复发性宫颈癌	日本	Regeneron Pharmaceuticals, Inc.	2022-12-23
宫颈癌	加拿大	Sanofi-Aventis Canada, Inc.	2022-03-25
晚期皮肤鳞状细胞癌	欧盟	Regeneron Pharmaceuticals, Inc.	2019-06-28
晚期皮肤鳞状细胞癌	冰岛	Regeneron Pharmaceuticals, Inc.	2019-06-28
晚期皮肤鳞状细胞癌	列支敦士登	Regeneron Pharmaceuticals, Inc.	2019-06-28
晚期皮肤鳞状细胞癌	挪威	Regeneron Pharmaceuticals, Inc.	2019-06-28
基底细胞癌	欧盟	Regeneron Pharmaceuticals, Inc.	2019-06-28
基底细胞癌	冰岛	Regeneron Pharmaceuticals, Inc.	2019-06-28
基底细胞癌	列支敦士登	Regeneron Pharmaceuticals, Inc.	2019-06-28
基底细胞癌	挪威	Regeneron Pharmaceuticals, Inc.	2019-06-28
局部晚期非小细胞肺癌	欧盟	Regeneron Pharmaceuticals, Inc.	2019-06-28
局部晚期非小细胞肺癌	冰岛	Regeneron Pharmaceuticals, Inc.	2019-06-28
局部晚期非小细胞肺癌	列支敦士登	Regeneron Pharmaceuticals, Inc.	2019-06-28
局部晚期非小细胞肺癌	挪威	Regeneron Pharmaceuticals, Inc.	2019-06-28
转移性基底细胞癌	欧盟	Regeneron Pharmaceuticals, Inc.	2019-06-28

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
非小细胞肺癌IIIA期	临床3期	奥地利	Regeneron Pharmaceuticals, Inc.	2026-01-12
非小细胞肺癌IIIA期	临床3期	爱沙尼亚	Regeneron Pharmaceuticals, Inc.	2026-01-12
非小细胞肺癌IIIA期	临床3期	法国	Regeneron Pharmaceuticals, Inc.	2026-01-12
非小细胞肺癌IIIA期	临床3期	德国	Regeneron Pharmaceuticals, Inc.	2026-01-12
非小细胞肺癌IIIA期	临床3期	爱尔兰	Regeneron Pharmaceuticals, Inc.	2026-01-12
非小细胞肺癌IIIA期	临床3期	意大利	Regeneron Pharmaceuticals, Inc.	2026-01-12
非小细胞肺癌IIIA期	临床3期	新加坡	Regeneron Pharmaceuticals, Inc.	2026-01-12
非小细胞肺癌IIIA期	临床3期	西班牙	Regeneron Pharmaceuticals, Inc.	2026-01-12
非小细胞肺癌IIIA期	临床3期	瑞士	Regeneron Pharmaceuticals, Inc.	2026-01-12
复发性非小细胞肺癌	临床3期	美国	Regeneron Pharmaceuticals, Inc.	2025-05-22

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临床结果

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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


AACR2026	临床2期	晚期头颈部鳞状细胞癌一线	42	Weekly carboplatin+paclitaxel+cemiplimab	憲鬱製選醖願壓窪膚獵(鏇壓蓋鹹膚壓襯鏇顧鬱) = 簾餘齋顧糧鹽衊鑰願鹽繭餘廠簾夢淵窪網淵廠 (鑰醖鹽夢蓋獵選簾顧齋, 12.6 ~ 23.9) 更多	积极	2026-04-20
EMPOWERCERVICAL 1 (ESGO2026)	临床2期	复发性宫颈癌 HPV infection \| PD-L1 expression	12	Cemiplimab	壓簾願願繭膚齋夢窪壓(夢簾糧網艱襯製積選構) = 構選顧製顧蓋壓獵顧壓鑰廠餘壓衊繭艱衊餘夢 (繭鹽醖網膚醖鏇膚鹹廠 ) 更多	积极	2026-02-28
NCT04913220 (Pegasus Skin, CTgov)	临床1/2期	黑色素瘤 \| 转移性黑色素瘤 \| 皮肤鳞状细胞癌	46	Pegenzileukin+Cemiplimab (Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab)	繭糧艱積鑰襯鹽餘醖餘 = 壓繭鹹繭觸觸選醖糧膚簾鬱構壓築夢網餘淵鑰 (顧廠鏇願襯衊齋積憲蓋, 範壓願醖壓憲鏇糧淵築 ~ 鑰鏇觸膚觸齋窪壓鏇簾) 更多	-	2026-02-04
NCT04913220 (Pegasus Skin, CTgov)	临床1/2期	黑色素瘤 \| 转移性黑色素瘤 \| 皮肤鳞状细胞癌	46	Pegenzileukin+Cemiplimab (Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab)	繭糧艱積鑰襯鹽餘醖餘 = 鏇壓膚艱壓製遞構簾醖簾鬱構壓築夢網餘淵鑰 (顧廠鏇願襯衊齋積憲蓋, 觸鏇鬱鬱範願鬱鏇鏇壓 ~ 艱構鹽顧膚製觸窪艱選) 更多	-	2026-02-04
NCT04243616 (CemiHALT, SABCS2025)	临床2期	新辅助 PD-L1 \| PD-L2	36	Cemiplimab + NACT (TNBC)	鑰構艱壓網憲鬱襯齋醖(餘窪餘糧淵廠壓淵齋簾) = 獵壓繭膚築襯淵壓窪獵膚簾襯艱顧醖繭襯鏇鬱 (範鹽簾繭醖範糧廠夢鑰 ) 更多	积极	2025-12-10
NCT04243616 (CemiHALT, SABCS2025)	临床2期	新辅助 PD-L1 \| PD-L2	36	Cemiplimab + NACT (ER+/HER2-negative)	網範鹽網夢繭願蓋觸獵(範鑰齋範鏇鏇顧糧醖艱) = 襯衊窪餘願糧糧鏇艱餘糧鏇窪淵觸繭鑰襯網淵 (蓋鬱窪壓選齋積遞繭願 ) 更多	积极	2025-12-10
NCT04916002 (CTgov)	临床2期	口咽部鳞状细胞癌 \| 基底细胞癌 \| 转移性肿瘤 ... 更多	77	CMP-001+Cemiplimab (Cohort A1: CMP-001+Cemiplimab for CSCC)	醖鏇繭齋範膚鹹鑰鏇鬱 = 蓋築蓋構製簾顧糧鹽齋壓窪構選繭鬱廠遞構網 (窪衊壓壓繭遞願鏇網製, 壓範築築築鬱獵壓簾鏇 ~ 鏇壓範鏇築選窪製窪選) 更多	-	2025-12-05
NCT04916002 (CTgov)	临床2期	口咽部鳞状细胞癌 \| 基底细胞癌 \| 转移性肿瘤 ... 更多	77	CMP-001+Cemiplimab (Cohort A2: CMP-001+Cemiplimab for CSCC)	醖鏇繭齋範膚鹹鑰鏇鬱 = 鑰鹹餘積範鏇繭糧蓋鹽壓窪構選繭鬱廠遞構網 (窪衊壓壓繭遞願鏇網製, 簾築觸網糧艱廠齋願築 ~ 製繭築鹽艱遞衊鏇遞願) 更多	-	2025-12-05
NCT04315701 (NeoPOWER, SITC2025)	临床2期	皮肤鳞状细胞癌复发新辅助	35	Cemiplimab 350mg IV	網鏇壓遞顧醖淵餘醖鬱(壓壓夢範積簾獵餘築膚) = 膚觸壓艱窪衊鹹醖廠顧壓築鑰構廠網蓋鑰鑰構 (醖構觸蓋觸窪齋遞獵夢 ) 更多	积极	2025-11-05
NCT04428671 (Winship4851, SITC2025)	临床2期	皮肤鳞状细胞癌辅助	14	Neoadjuvant and adjuvant cemiplimab	獵願選壓壓構範鬱積窪(遞壓遞憲壓壓齋築願蓋) = 衊廠選廠糧膚夢襯觸範淵夢獵觸衊網範蓋憲獵 (淵範襯鬱齋顧糧膚構醖 ) 更多	积极	2025-11-05
NCT05208944 (THIO-101, SITC2025)	临床2期	-	48	THIO + Cemiplimab	顧遞窪淵積蓋淵鬱願鬱(衊廠艱鹹鏇獵鬱膚簾齋) = 築製齋窪艱構獵選壓繭憲觸壓艱選襯遞遞襯築 (醖窪壓鬱壓鏇鬱夢範艱 )	积极	2025-11-05
NCT03836105 (CASE, ESMO2025)	临床4期	皮肤鳞状细胞癌	254	Cemiplimab (immunosuppressed)	餘構獵窪繭顧製鹽鏇餘(製積顧夢淵衊範鹽獵鏇) = 2/9 had rejection episodes leading to treatment-related allograft loss 顧選壓範獵觸窪築糧糧 (鑰窪夢鹽築繭蓋簾糧衊 ) 更多	积极	2025-10-17
NCT03836105 (CASE, ESMO2025)	临床4期	皮肤鳞状细胞癌	254	Cemiplimab 350 mg (non-immunosuppressed)		积极	2025-10-17
NCT05864144 (ESMO2025)	临床1期	晚期恶性实体瘤	43	Cemiplimab (350 mg)Solnerstotug (3 or 15 mg/kg) + Cemiplimab (350 mg)Solnerstotug (3 mg)	選襯膚憲醖鏇襯選夢蓋(構壓觸壓糧鹹遞鹹鏇範) = Most frequent AEs include fatigue (n=10), hypomagnesaemia and nausea (n=8 each), vomiting (n=6) and dyspnoea and dehydration (n=5 each). 鬱選淵淵壓築淵廠襯鹹 (築糧範願鏇齋築鹽蓋積 )	积极	2025-10-17