预约演示

更新于：2026-06-23

Nivolumab

纳武利尤单抗

更新于：2026-06-23

概要

基本信息

药物类型

单克隆抗体

别名

Nivolumab (Genetical Recombination)、Nivolumab (genetical recombination) (JAN)、Nivolumab (USAN/INN)

+ [17]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤免疫系统疾病消化系统疾病+ [13]

在研适应症

微卫星高度不稳定性直肠癌PD-L1阳性非小细胞肺癌转移性肝细胞癌+ [463]

非在研适应症

异戊酸血症获得性免疫缺陷综合征急性双系白血病+ [148]

原研机构

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

在研机构

Bristol Myers Squibb Co.

National Cancer Institute

The University of Texas MD Anderson Cancer Center

+ [24]

非在研机构

AbbVie, Inc.

Nektar Therapeutics

Bolt Biotherapeutics, Inc.

+ [17]

权益机构

Nektar Therapeutics

NeoImmuneTech, Inc.

Vedanta Biosciences, Inc.

+ [19]

最高研发阶段批准上市

首次获批日期

日本 (2014-07-04),

食管癌黑色素瘤

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、附条件批准 (中国)、孤儿药 (日本)、优先审评 (澳大利亚)、突破性疗法 (中国)、优先审评 (美国)、优先审评 (中国)

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结构/序列

Sequence Code 93681H

来源: *****

Sequence Code 93684L

来源: *****

关联

2,007

项与纳武利尤单抗相关的临床试验

NCT07176975

/ Not yet recruiting临床1期

Phase I Open-label, Dose Escalation and Expansion Trial of BI 1831169 in Combination With an Anti-PD1 mAb in Japanese Patients With Advanced/Metastatic Solid Tumours

This study is open to Japanese adults with different types of advanced cancer (solid tumors). People can join the study if their cancer has spread, and previous treatments were not successful or no treatments exist.
The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people can tolerate when taken together with an anti-PD1 antibody. The anti-PD1 antibody is already used to treat different cancers. Participants receive BI 1831169 together with an anti-PD1 antibody, which is given as an infusion into a vein for up to 1 year.
Participants visit the study site regularly. The number of site visits vary based on the study part and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.

开始日期2027-08-03

申办/合作机构

Boehringer Ingelheim GmbH

NCT07572123

/ Not yet recruiting临床2/3期IIT

A Two Cohort Randomized Study for Patients With High Risk (Phase II) and Standard Risk (Phase III) Classical Hodgkin Lymphoma in First Relapse

This phase II trial compares the impact of brentuximab vedotin and nivolumab after radiation to standard of care high dose chemotherapy (HDT)-autologous stem cell transplant (ASCT) in standard-risk patients with classic Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). In addition, the phase III trial will compare the effect of pembrolizumab after HDT-ASCT to standard of care HDT-ASCT alone in high-risk patients with relapsed or refractory classic Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. An ASCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving HDT before an ASCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Radiation therapy (RT) uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving brentuximab vedotin and nivolumab after radiation may be safe, tolerable and more effective than standard of care HDT-ASCT in treating patients with standard risk relapsed or refractory classic Hodgkin lymphoma. In addition, giving pembrolizumab after standard of care HDT-ASCT may be safe and tolerable and more effective than HDT-ASCT alone in treating high-risk patients with relapsed or refractory classic Hodgkin lymphoma.

开始日期2026-12-04

申办/合作机构

National Cancer Institute

NCT07551583

/ Not yet recruiting临床2期IIT

A Phase 2 Single Arm Study To Evaluate Safety And Preliminary Efficacy Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With Newly Diagnosed Early-Stage Non-Bulky Classical Hodgkin Lymphoma

The goal of this clinical research study is to learn if nivolumab plus AVD (doxorubicin, vinblastine, and dacarbazine) can help to control newly diagnosed early-stage non-bulky cHL in pediatric, adolescent, and young adult patients.
The safety of this drug combination will also be studied.

开始日期2026-10-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与纳武利尤单抗相关的临床结果

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100 项与纳武利尤单抗相关的转化医学

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100 项与纳武利尤单抗相关的专利（医药）

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10,127

项与纳武利尤单抗相关的文献（医药）

2026-12-31·CNS oncology

Tailored management of a melanoma patient with bleeding brain metastases and deep vein thrombosis with thrombectomy

Article

作者: Ceccarelli, Corrado ; Pastina, Ilaria ; Del Roscio, Davide ; Viterbo, Antonella ; De Angelis, Filippo ; Pieraccini, Massimo ; Arezzini, Luca

CASE PRESENTATION:

We describe a 62-year-old man with disseminated melanoma (initially staged pT2aN0M0, AJCC stage IB, 8th edition AJCC) who developed multiple brain metastases with hemorrhagic transformation, pulmonary embolism, retrobulbar progression with eyeball herniation, and deep vein thrombosis (DVT). After cerebral edema improved with corticosteroid tapering and the patient became asymptomatic, he started combination immunotherapy with ipilimumab (3 mg/kg q3w × 4) and nivolumab (1 mg/kg q3w × 4). Despite initial benefit, progression led to radiotherapy for retrobulbar lesion and subsequent targeted therapy with encorafenib (450 mg daily) and binimetinib (45 mg twice daily). Shortly after, the patient developed symptomatic left-leg DVT extending to the femoral vein with segmental pulmonary embolism. Given the contraindication to full anticoagulation, mechanical thrombectomy with the Indigo Aspiration System was performed, followed by prophylactic LMWH at reduced therapeutic dose (enoxaparin 1 mg/kg once daily due to recent thrombectomy and hemorrhagic risk from bleeding brain metastases). During targeted therapy, the patient experienced partial regression of brain, liver, and peritoneal metastases, although intracranial hemorrhage recurred later.

CONCLUSIONS:

This case highlights the value of a multidisciplinary, tailored approach integrating immunotherapy, radiotherapy, targeted therapy, and mechanical thrombectomy with no DVT recurrence observed following thrombectomy at 6-month follow-up.

2026-12-31·PLATELETS

Immune thrombocytopenia triggered by dostarlimab in a patient with endometrial carcinoma: first reported case

Article

作者: Pazmiño-Zambrano, M. Belén ; García-Jaén, Pablo ; González-Porras, José Ramón ; Bastida, José María ; Fernández-Sánchez, Adolfo ; Reguera-Puertas, Pablo ; Puerta-Vázquez, Carlos

Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for various malignancies, but they are associated with a range of immunerelated adverse events, including rare hematological complications. Immune thrombocytopenia (ITP) has been reported with other antiPD1 agents such as nivolumab and pembrolizumab, but to date, no cases have been described with dostarlimab. We report the first case of ITP in a patient receiving dostarlimab for relapsed endometrial carcinoma. A 55yearold woman developed severe thrombocytopenia (3 × 10⁹/L) accompanied by rectal bleeding, resulting in a lifethreatening condition. Secondary causes were excluded, and bone marrow findings supported a diagnosis of ITP. Initial treatment with highdose corticosteroids and intravenous immunoglobulin achieved only a partial response, while sustained platelet recovery was obtained with the addition of romiplostim. The patient remained on dostarlimab following hematological recovery without further episodes of ITP. This case highlights a potentially lifethreatening adverse effect of a widely used immunotherapy and underscores the importance of early recognition and timely escalation of treatment in ICIinduced ITP.

2026-09-01·Value in Health Regional Issues

Cost Savings in Oncology Chemotherapy: The Role of Vial Sharing in Centralized Preparation

Article

作者: Jalil, Mariam Abdel ; El-Dahiyat, Faris ; Almomani, Alaa ; Ballout, Mohammad ; Abu-Farha, Rana K ; Allan, Aya ; Hammour, Khawla Abu

OBJECTIVES:

The objective of this study was to find out how much money can be saved by introducing a vial sharing program in a Jordanian tertiary hospital's centralized intravenous admixture service.

METHODS:

From March 2023 to September 2025, 1662 prescriptions for 24 intravenous anticancer medications were part of this quasi-experimental study. Efficiency of a centralized vial share program and a conventional dispersed preparation technique were compared. Time efficiency, drug waste minimization, and total cost saving (JD) were some of the outcomes that were measured.

RESULTS:

A total of 309 patients were enrolled in the study and followed for 28 months and had 1662 prescription orders for 24 chemotherapy drugs. Median age was 58 years, and most patients were females (54.7%). The most common diagnoses were lymphoma (10.0%), breast cancer (9.1%), and acute myeloid leukemia (6.8%). Most patients (99%) had insurance. Doxorubicin (291 prescriptions, 17.5%), vincristine (234 prescriptions, 14.1%), and rituximab (210 prescriptions, 12.6%) were the highest prescribed medications. Implementation of a vial-sharing system resulted in cost savings of 39.6%, amounting to JD 254 743.28 (USD 359 188.02). Nivolumab caused most cost savings per prescription, followed by trastuzumab, whereas vincristine and fluorouracil saved very minimal amounts per prescription. Based on total savings, Rituximab led the list with JD 83 211.31 (USD 117 327.94).

CONCLUSIONS:

Vial sharing as part of a centralized preparation model has significantly decreased the cost and drug wastage in oncology care. It provides a viable method to increase resource efficiency in cancer care, especially within institutions that have limited healthcare budgets.

5,236

项与纳武利尤单抗相关的新闻（医药）

23 小时之前

·微信

2026 ESMO妇科癌症大会丨强化免疫治疗在局部晚期宫颈癌患者中是否有一席之地？

点击蓝字关注我们免疫治疗正在改善局部晚期宫颈癌（LACC）的结局，带来持久缓解和长期生存，尤其在免疫活化即“热”肿瘤患者中更为突出。诱导免疫治疗可通过远隔效应与放化疗协同作用，实现对全身疾病的控制。在2026年6月17日至19日于哥本哈根召开的ESMO妇科癌症大会上，COLIBRI-1研究公布的最终生存数据及免疫亚组探索性分析表明，诱导免疫治疗有助于在局部晚期宫颈癌中激发强烈的免疫应答（摘要27O）。此外，ATOMICC试验也报告了令人鼓舞的结果（摘要26O）。 COLIBRI研究长期生存结局与免疫亚组分析：局部晚期宫颈癌放化疗（RT-CT）前后诱导纳武利尤单抗联合伊匹木单抗及免疫维持治疗（ICB）此前，III期KEYNOTE-A18试验已证实，在局部晚期宫颈癌患者中将免疫治疗加入放化疗可带来获益。该研究显示，帕博利珠单抗联合放化疗可显著改善生存结局，因此已获批用于更高风险的III–IVA期患者（Lancet. 2024;403:1341–1350; Lancet. 2024;404:1321–1332）。 II期COLIBRI-1研究的既往数据提示，局部晚期宫颈癌的诱导免疫治疗能够“启动”肿瘤，从而提高对标准放化疗的应答（Nat Commun. 2026;17:922）。 COLIBRI-1研究纳入40例FIGO 2018分期为IB3–IVA期的局部晚期宫颈癌患者，给予纳武利尤单抗联合伊匹木单抗诱导治疗，继以标准放化疗及6个月纳武利尤单抗维持治疗。根据基线免疫特征（包括转录组“热”状态和CD8+/FOXP3+比值）进行了探索性亚组分析。共40例患者接受治疗，其中95%为鳞状细胞癌，93%的患者经SP263检测显示PD-L1表达≥1。中位随访40.3个月后，3年无进展生存（PFS）率和总生存（OS）率分别为83%和90%。在FIGO I–II期局部晚期宫颈癌患者中，3年时无死亡事件发生（OS率100%），第2年至第4年PFS率为93%。在FIGO III–IV期疾病患者中，3年OS率和PFS率分别为85%和77%。诱导免疫治疗后出现免疫反应（“热”评分）的患者，其生存优于持续性“冷-冷”肿瘤患者。免疫亚组分析提示，基线时为免疫活化肿瘤的患者PFS和OS均更优，而基线为免疫冷肿瘤特征的患者生存事件更多。关于无进展生存，基线即为“热”肿瘤的患者3年PFS率达到100%，免疫检查点阻断（ICB）后转为“热”肿瘤者为95%；而基线为“冷”肿瘤的患者PFS率为76%，ICB后仍为“冷”肿瘤者仅60%。关于总生存，无论是基线“热”肿瘤还是ICB后“热”肿瘤，3年OS率均为100%；基线“冷”肿瘤患者OS率为86%，ICB后仍为“冷”肿瘤者则为73%。 40例受试者中未观察到新的安全性信号。新辅助治疗期间，1例患者（2.5%）报告了可能与治疗相关的3–4级不良事件；放化疗期间为12例（30.0%），纳武利尤单抗维持治疗期间为8例（20.0%）。图. II期COLIBRI-1研究中按基线和免疫检查点阻断后免疫特征（“热”/“冷”）划分的无进展生存期（2026年ESMO妇科癌症大会，摘要27O）本最终分析表明，在局部晚期宫颈癌中，诱导及维持免疫检查点阻断（ICB）联合放化疗可带来持久的长期生存。探索性免疫亚组分析支持，基线免疫活化状态可能识别出最有可能从基于免疫治疗的强化策略中获益的患者。意大利米兰Humanitas医院San Pio X分院的Domenica Lorusso医生在评论这些COLIBRI-1研究数据时指出：“免疫亚组分析清楚显示，免疫活化肿瘤患者的应答更优，而40个月随访时较高的OS率和PFS率提示许多患者已获得治愈。当前数据表明，在这项小型研究中，免疫治疗的远期获益并未被显著毒性所抵消。” 高危局部晚期宫颈癌患者放化疗（CRT）后多塔利单抗维持治疗：GEICO 78-C/ATOMICC 随机II期试验此次大会还报告了另一项II期试验（ATOMICC）中期分析的鼓舞人心的结果，这项正在进行的开放标签、随机II期试验，旨在研究在标准同步放化疗后达到完全缓解（CR）/部分缓解（PR）的高危局部晚期宫颈癌（FIGO 2009定义）患者中，多塔利单抗维持治疗的疗效。患者被随机分配至观察组或多塔利单抗最长2年治疗组（摘要26O）。ATOMICC试验设计时（2018年），放化疗是局部晚期宫颈癌的标准治疗，联合免疫治疗的影响尚不明确。在2019年8月至2023年6月期间随机分组的134例患者中，诊断时FIGO 2009分期为IB–IIB期/III期/IVA期者分别占58%/37%/5%，69%存在盆腔淋巴结阳性，28%存在腹主动脉旁淋巴结阳性，69%达到完全缓解。患者接受了当前标准放化疗，79%接受了三维高剂量率临床靶体积近距离放疗。顺铂中位用药时长为4.3周（IQR 4.1–5.1）。多塔利单抗中位治疗时间为24.7个月（IQR 8.4–25.1）。至数据截止日期（2025年9月17日；中位随访3.4年[95% CI 3.0–3.8]），所有患者均已停止多塔利单抗治疗（56%完成2年治疗，18%因疾病进展停药，13%因治疗相关毒性停药）。多塔利单抗中位治疗时间为24.7个月（IQR 8.4–25.1）。在134例高危疾病患者中，中位随访40.6个月时，多塔利单抗维持治疗组的3年PFS率为77%（观察组为67%）。最终分析所需的74例患者中，已有34例（46%）发生PFS事件；PFS获益在数值上倾向于多塔利单抗组，但未达到统计学显著性（HR=0.64；95%CI: 0.31–1.31）。多塔利单抗组与观察组的3年总生存率相似，分别为86%和88%，OS风险比为0.94（95% CI: 0.34–2.58），未显示生存获益。多塔利单抗组的≥3级不良事件最常见的是腹泻（5%）和乏力（3%）。在安全性方面，多塔利单抗组≥3级治疗相关不良事件（TRAEs）发生率为18%，而观察组为0%。多塔利单抗组有1例患者死于十二指肠穿孔，但判断与治疗无关。 Lorusso医生指出：“虽然中期分析时两组的PFS差异不显著，但中期分析中出现了提示辅助免疫治疗在此情境下具有活性的信号，看到更长期监测的更新数据将会很有意义。” 虽然当前证据表明，并非所有局部晚期宫颈癌患者都需要强化免疫治疗，但部分患者可能并不需要长期维持免疫治疗。Lorusso医生补充道：“COLIBRI-1研究数据显示，I–II期患者在12个月时达到100%的OS率，并维持至3年，提示这些预后良好的患者可能无需2年维持治疗，甚至仅接受放化疗可能就足够了。” 未来需要进一步研究来探索局部晚期宫颈癌中免疫治疗联合放化疗的最佳组合。正在进行的II期COLIBRI-2试验（比较诱导及维持纳武利尤单抗联合抗LAG-3药物瑞拉利单抗vs纳武利尤单抗在FIGO IIB–IVA期局部晚期宫颈癌患者中的疗效，NCT06715241）将提供更多洞见。参考文献（上下滑动可查看） 1. Joly Lobbedez F, et al. Long-term survival outcomes and immune subgroup analyses in the COLIBRI study: Induction nivolumab plus ipilimumab with immunotherapy maintenance (ICB) prior to and following chemoradiation (RT-CT) in locally advanced cervical cancer (LACC). ESMO Gynaecological Cancers 2026 - Abstract 27O 2. Oaknin A, et al. Maintenance dostarlimab after chemoradiation (CRT) for patients (pts) with high-risk locally advanced cervical cancer (LACC): GEICO 78-C/ATOMICC randomised phase 2 trial. ESMO Gynaecological Cancers 2026 - Abstract 26O （来源：《肿瘤瞭望》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。

临床3期免疫疗法临床结果临床失败临床2期

2026-06-22

·国际干细胞与免疫细胞研究

75%控病率+60%两年无复发！2026 DC疫苗交出重磅答卷，横扫肺癌/胃癌/肝癌/脑瘤等

点击蓝字关注我们树突状细胞（DC）是人体功能最强的抗原呈递细胞，也是重要的免疫“哨兵”，在抗肿瘤免疫应答中居于核心地位，能够激活全身免疫、精准识别并清除癌细胞。依托这一机制研发的新抗原个性化DC疫苗，已成为肿瘤免疫治疗领域极具潜力的前沿方向。目前，全球多项临床研究均已证实：新抗原DC疫苗安全性良好、临床应用可行，在多种实体瘤中表现出稳定的抗肿瘤作用，也为晚期肿瘤患者及术后防复发人群开辟了全新治疗思路。为帮助大家了解前沿抗癌新方案、树立治疗信心，下面我们就系统梳理新抗原DC疫苗在实体瘤领域的最新临床研究进展与技术突破！晚期肺癌多线失败后，这款DC疫苗让转移灶“消退”，疾病控制率高达75% 一项针对晚期肺癌的单臂试点研究（NCT02956551），旨在研究个性化新肽脉冲树突状细胞疫苗（Neo-DCVac）的安全性和有效性。该研究纳入了12例多线标准治疗失败的复发性晚期肺癌患者，每位患者均接受了自体树突状细胞（DC）疫苗，该疫苗以12-30种新肽进行脉冲处理，该研究取得了令人鼓舞的结果。研究数据显示：客观缓解率（ORR）达25%，疾病控制率（DCR）高达75%（详见下图d）；中位无进展生存期（PFS）5.5个月（95%CI：1.9-9.2，详见下图b），中位总生存期（OS）7.9个月（95%CI：5.9-10.0，详见下图c）。12例患者中，有6例（50%）靶病灶出现缩小。 ▲图源“Signal Transduct Target Ther”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除研究中有两例典型患者表现尤为突出。第一例为15号广泛期小细胞肺癌男性患者，该患者多线常规治疗失败后，接受Neo-DCVac疫苗干预。完成5剂疫苗治疗后，病情达到稳定（SD），靶病灶较基线最大缩小15%，疾病稳定时长接近一年。另一例极具临床参考价值的是17号广泛转移性肺腺癌男性患者，转移累及骨骼、盆腔、肾上腺及下腔静脉淋巴结。患者在含纳武利尤单抗（PD-1抑制剂）的三线方案治疗失败后，入组接受Neo-DCVac疫苗治疗（图5a）。完成5剂治疗后，转移性淋巴结近乎消退，肾上腺、盆腔转移灶也持续缩小，整体靶病灶缩小幅度达29%（图5b）。免疫检测结果显示患者接种疫苗后的外周血单个核细胞（PBMC），对两种突变新抗原肽的特异性应答，显著强于野生型肽段，充分印证了这款个性化DC疫苗在抗肿瘤中的确切作用。 ▲图源“Signal Transduct Target Ther”，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 13例患者全部存活！肝癌术后DC疫苗防复发效果显著，2年无复发率达60% 2024年ASCO大会报道了一项肝细胞癌术后辅助治疗试点试验（NCT04147078），该试验旨在评估个性化新抗原肽脉冲自体树突状细胞疫苗（Neo-DCVac-02）在局部晚期实体瘤术后患者中的安全性与有效性。研究纳入13例肝细胞癌（HCC）术后患者，结果证实，Neo-DCVac-02安全性良好且耐受性佳，能显著延迟患者肝癌复发：1年无复发生存率达84.6%，2年无复发生存率为60%，且所有患者均存活。进一步分析显示，免疫反应较强患者的中位无复发生存期（尚未达到）显著长于免疫反应较弱患者（17.6个月，P=0.003）。综上，Neo-DCVac-02不仅安全耐受，还能诱导持久的抗原特异性淋巴细胞免疫反应，这种免疫应答可能是延迟肝细胞癌术后复发的关键。全球首例！DC疫苗联合PD-1抑制剂，助胃癌患者实现病灶完全消退国际权威《Nature》子刊刊发重磅病例研究，报道了Neo-MoDC疫苗治疗晚期胃癌的突破性案例。这也是全球已知首例经Neo-MoDC联合PD-1治疗后，肿瘤实现完全消退且长期维持的胃癌病例，具有里程碑意义。该患者确诊为晚期（IV期，Bormann III型）转移性胃癌，既往接受过D2根治性远端胃切除术、FOLFOX治疗等，但病情仍然进展，且已出现腹膜及淋巴结转移。此时临床已无其他适合的治疗方案可选，加之其符合入组标准，抱着最后一丝希望，该患者参加了Neo-MoDC临床试验（NCT03185429）。入组后接受Neo-MoDC联合免疫检查点抑制剂（PD-1）治疗。结果显示：该患者在首轮纳武单抗治疗后5天，血清肿瘤标志物CA125水平从596U/ml，迅速下降至64U/ml，这也意味着该患者肿瘤进展得到控制！更为惊喜的是，2周后患者恶性腹水症状也消失。初次接种疫苗后的第231天，PET显示该患者右侧卵巢病灶近乎完全消退。联合治疗第389天，CT显示患者卵巢种植转移完全消失（详见图3）。幸运的是，截至2021年10月复查CT显示，完全消退持续25个月之久！ ▼该患者治疗期间目标肿瘤病变的代表性图像 ▲图源“NPJ”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除注：黄色箭头代表目标肿瘤病变；蓝色箭头代表肿瘤病变完全消退。打破二十年治疗僵局DC疫苗Ⅲ期临床显著延长胶质母细胞瘤患者生存期，一年生存率高达54.1% 过去数十年研究证实，负载肿瘤裂解物的树突状细胞（DC）疗法，用于胶质母细胞瘤（GBM）治疗，整体安全性可控、毒性耐受良好。《转化医学杂志》公布了自体树突状细胞疫苗DCVax®-L治疗初诊胶质母细胞瘤的大型Ⅲ期临床试验（NCT00045968）首批生存数据。该研究共纳入331例胶质母细胞瘤患者，采用负载自体肿瘤裂解物的DC疫苗DCVax-L，联合标准治疗药物替莫唑胺开展干预，并将新诊断的胶质母细胞瘤（nGBM）、复发性胶质母细胞瘤（rGBM）患者，与同期接受常规标准治疗的匹配外部队列进行对照分析。结果显示：接受DCVax-L治疗的新诊断的胶质母细胞瘤（nGBM）患者的中位总生存期（OS）为19.3个月，而同期接受标准治疗（SOC）的匹配外部对照组患者的中位OS为16.5个月（详见下图A）。DCVax-L使nGBM队列（n=232）的4年生存率提高至15.7%，显著高于对照组的9.9%。 ▲图源“JAMA Oncol”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除在复发性胶质母细胞瘤（rGBM）队列（n= 64）中，与对照组相比，DCVax-L组的中位总生存期（mOS）显著延长，分别为13.2个月（95% CI，9.7-16.8个月） vs 7.8个月（95% CI，7.2-8.2个月，详见下图）。 ▲图源“JAMA Oncol”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除总之，这项试验是近20年来，首个成功延长初诊胶质母细胞瘤患者总生存期的大型 Ⅲ 期临床研究，为胶质母细胞瘤的治疗开辟了全新方向与希望。小编寄语癌症疫苗历经数十载的发展，逐渐从实验室转向临床研究阶段。值得欣慰的是，不断有DC、mRN等新款疫苗涌现，一次次地突破技术壁垒，在癌症的预防、治疗领域不断寻求新的突破，小编也期望随着癌症疫苗的不断优化，未来可以创造出更多的抗癌奇迹，让更多的高危人群及癌症患者获益！想寻求癌症疫苗等国内外抗癌新技术帮助的病友，可扫文末二维码，将治疗经历、近期病理报告等，提交至国际干细胞与免疫细胞研究医学部，进行初步评估。参考资料 [1]Ding Z,et al.Personalized neoantigen pulsed dendritic cell vaccine for advanced lung cancer. Signal Transduct Target Ther. 2021 Jan 20;6(1):26. https://pmc.ncbi.nlm.nih.gov/articles/PMC7817684/ [2]Wu Q,et al.A pilot trial of personalized neoantigen pulsed autologous dendritic cell vaccine as adjuvant treatment in hepatocellular carcinoma[J]. 2024. https://ascopubs.org/doi/abs/10.1200/JCO.2024.42.16_suppl.e16264 [3]Guo Z,et al.Durable complete response to neoantigen-loaded dendritic-cell vaccine following anti-PD-1 therapy in metastatic gastric cancer. NPJ Precis Oncol. 2022 Jun 3;6(1):34. https://pmc.ncbi.nlm.nih.gov/articles/PMC9166775/ [4]Liau LM,et al.Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma: A Phase 3 Prospective Externally Controlled Cohort Trial. JAMA Oncol. 2023 Jan 1;9(1):112-121. https://pmc.ncbi.nlm.nih.gov/articles/PMC9673026/ 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

2026-06-22

·动脉网

Biond Biologics任命 Giovanni Selvaggi医学博士为首席医疗官（“CMO”）Biond Biologics Appoints Giovanni Selvaggi, M.D., as Chief Medical Officer ("CMO")

Dr. Selvaggi, a veteran immuno-oncology executive brings more than 30 years of oncology experience and a proven track record of advancing global clinical programs, with novel cancer therapies to registration, strengthening Biond's efforts to advance the clinical development of BND-67 and BND-22 塞尔瓦吉博士是一位经验丰富的免疫肿瘤学高管，拥有超过30年的肿瘤学经验，并在推动全球临床项目以及新型癌症疗法直至注册上市方面有着卓越的业绩记录，从而加强了Biond公司推进BND-67和BND-22临床开发工作的努力。MISGAV, Israel 以色列，米斯加夫, ，June 22, 2026 2026年6月22日/PRNewswire/ -- /美通社/ --Biond Biologics Ltd. ('Biond' or the 'Company'), Biond Biologics有限公司（“Biond”或“公司”），a private clinical-stage biopharmaceutical company developing first-in-class immunotherapies for cancer and immune-mediated diseases, today announced the appointment of Giovanni Selvaggi, M.D. CMO. 一家专注于开发针对癌症和免疫介导疾病的首创类免疫疗法的私有临床阶段生物制药公司，今日宣布任命Giovanni Selvaggi医学博士为首席医疗官（CMO）。Dr.Selvaggi is a physician-scientist and oncology drug development executive with extensive experience spanning academic medicine, global pharmaceutical companies, and biotechnology organizations. Over the course of his career, he has led the clinical development of multiple oncology programs from early-stage research through regulatory submissions, including immuno-oncology therapies, targeted therapies, cancer vaccines, and oncolytic viruses.. 塞尔瓦吉博士是一位医师科学家，也是肿瘤药物开发领域的高管，在学术医学、全球制药公司和生物技术组织方面拥有广泛经验。在他的职业生涯中，他领导了多个肿瘤项目从早期研究到监管申报的临床开发工作，涵盖免疫肿瘤疗法、靶向疗法、癌症疫苗以及溶瘤病毒等领域。Dr. Selvaggi most recently served as CMO of Xcovery Holdings, where he led the clinical development and regulatory strategy for ensartinib, including its global Phase 3 program and regulatory interactions with the U.S. Food and Drug Administration. He also held senior leadership positions at Bristol Myers Squibb, where he led immuno-oncology clinical development programs in small cell lung cancer, mesothelioma, and non-small cell lung cancer, contributing to the regulatory filing of nivolumab in small cell lung cancer.. 塞尔瓦吉博士最近担任 Xcovery Holdings 的首席医学官，领导了恩沙替尼的临床开发和监管策略，包括其全球 III 期临床试验项目以及与美国食品药品监督管理局的监管沟通。他还曾在百时美施贵宝公司担任高级领导职务，领导小细胞肺癌、间皮瘤和非小细胞肺癌的免疫肿瘤学临床开发项目，并推动了纳武利尤单抗在小细胞肺癌适应症的监管申报。Earlier in his career, Dr.Selvaggi held senior development roles at Novartis Oncology, GlaxoSmithKline, Oncolytics Biotech, and Imugene. He is a board-certified pulmonologist and thoracic oncology specialist who spent more than a decade treating patients and conducting clinical research in lung cancer and mesothelioma at the University of Turin and San Luigi Hospital in Italy.. 在职业生涯早期，塞尔瓦吉博士曾在诺华肿瘤、葛兰素史克、Oncolytics Biotech 和 Imugene 担任高级开发职务。他是一名获得董事会认证的肺科医生和胸部肿瘤专家，在意大利都灵大学和圣路易吉医院花了十多年时间治疗患者，并进行肺癌和间皮瘤的临床研究。'We are delighted to welcome Giovanni to Biond at a transformative stage in the Company's growth,' said Tehila Ben Moshe, Ph.D., Co-Founder and Chief Executive Officer of Biond Biologics. 'Biond now has two highly differentiated clinical-stage immunotherapy programs, including BND-22, currently advancing in Phase 2 studies, and BND-67, which recently entered a first-in-human study to evaluate BND-67. “在公司发展的转型阶段，我们很高兴欢迎Giovanni加入Biond。”Biond Biologics的联合创始人兼首席执行官Tehila Ben Moshe博士表示。“Biond现在拥有两个高度差异化的临床阶段免疫治疗项目，包括正在推进二期研究的BND-22，以及最近进入首次人体试验以评估其安全性和有效性的BND-67。”Giovanni brings a unique combination of deep oncology expertise, immuno-oncology leadership, and hands-on experience advancing innovative therapies from early clinical development through regulatory filings. We believe his clinical leadership and experience will further strengthen our ability to execute our clinical strategy and unlock the full potential of our first-in-class pipeline.'. 乔瓦尼带来了深厚的肿瘤学专业知识、免疫肿瘤学领导力以及推动创新疗法从早期临床开发到监管申报的实战经验的独特组合。我们相信，他的临床领导力和经验将进一步增强我们执行临床战略的能力，并充分释放我们首创产品管线的全部潜力。'I am excited to join Biond at a crucial development stage and contribute to the advancement of its innovative immunotherapy portfolio,' said Giovanni Selvaggi, M.D. 'Biond has built a compelling pipeline based on novel biological insights and differentiated mechanisms of action. BND-67 represents a particularly exciting opportunity to unlock the full potential of T-cell immunity through a completely new approach to restoring physiological CD28 signaling. “我很兴奋能在Biond的关键发展阶段加入公司，并为其创新免疫治疗产品线的推进贡献力量，”Giovanni Selvaggi博士表示。“Biond基于新颖的生物学见解和差异化的作用机制，构建了令人瞩目的产品管线。BND-67代表了一个特别令人振奋的机会，通过一种全新的恢复生理性CD28信号传导的方法，释放T细胞免疫的全部潜力。”I look forward to working with the talented team at Biond to improve outcomes for patients with cancer.'. 我期待与 Biond 才华横溢的团队携手合作，改善癌症患者的治疗结局。About Biond Biologics 关于 Biond BiologicsBiond Biologics is a private, clinical-stage biotechnology company developing first-in-class immunotherapies targeting novel pathways across both the innate and adaptive immune systems. The company's pipeline includes clinical-stage programs in oncology, alongside a growing portfolio of discovery and preclinical programs in immune-mediated diseases.. Biond Biologics 是一家私营的临床阶段生物技术公司，致力于开发针对先天性和适应性免疫系统中新型通路的首创类免疫疗法。公司的产品管线包括肿瘤领域的临床阶段项目，以及不断增长的免疫介导疾病发现与临床前项目组合。Biond's clinical pipeline includes BND-22, a first-in-class antibody that acts as a multi-cell checkpoint inhibitor targeting the ILT2 receptor advancing in a phase 2 study. BND-22 enhances the anti-tumor activity of both innate and adaptive immune cells by blocking the interaction between ILT2 and HLA-G, for the treatment of solid tumors.. Biond 的临床管线包括 BND-22，这是一种首创的抗体，作为针对 ILT2 受体的多细胞检查点抑制剂，目前正处于 II 期临床研究阶段。BND-22 通过阻断 ILT2 与 HLA-G 之间的相互作用，增强先天性和适应性免疫细胞的抗肿瘤活性，用于治疗实体瘤。In addition, Biond is developing BND-67, a next-generation immunotherapy and a first-in-class asset targeting CD28 shedding, a novel immune evasion mechanism with the potential to redefine T-cell modulation in cancer. Given the central role of CD28 in T-cell activation, BND-67 introduces a fundamentally new approach to restoring immune responsiveness. 此外，Biond 正在开发 BND-67，这是一种新一代免疫疗法，也是首款靶向 CD28 脱落的同类首创资产。CD28 脱落是一种新型的免疫逃逸机制，有望重新定义癌症中的 T 细胞调节。鉴于 CD28 在 T 细胞活化中的核心作用，BND-67 引入了一种从根本上全新的方法，以恢复免疫应答能力。By preserving CD28 signaling, it enhances effector T-cell activity while selectively inhibiting regulatory T-cell function, driving a potent and sustained anti-tumor response. The program is IND-ready, with a Phase 1 trial planned for Q2 2026. 通过保留CD28信号传导，该方案在增强效应T细胞活性的同时选择性抑制调节性T细胞功能，从而驱动强效且持久的抗肿瘤反应。该项目已具备提交新药临床试验申请（IND）的条件，计划于2026年第二季度开展I期临床试验。Biond was founded in 2016, by Tehila Ben Moshe, Ph.D., Ori Shilo, and a team of accomplished scientists and drug developers from the Israel biopharmaceutical industry. Biond 由 Tehila Ben Moshe 博士、Ori Shilo 以及来自以色列生物制药行业的一批杰出科学家和药物研发专家于 2016 年共同创立。www.biondbio.com www.biondbio.com. 。Company contact: 公司联系人：Tal Sines 塔尔·西内斯VP of Business Development 业务发展副总裁Biond Biologics Ltd. 比昂德生物有限公司+972-4 884 4337 +972-4 884 4337[emailprotected] [email protected]SOURCE Biond Biologics Ltd. 来源：Biond Biologics有限公司21 二十一% %more press release views with 更多新闻稿浏览量，通过Request a Demo 申请演示

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适应症	国家/地区	公司	日期
微卫星高度不稳定性直肠癌	日本	Ono Pharmaceutical Co., Ltd.	2025-08-25
PD-L1阳性非小细胞肺癌	中国	Bristol-Myers Squibb Pharma EEIG	2025-07-22
转移性肝细胞癌	澳大利亚	Bristol-Myers Squibb Australia Pty Ltd.	2025-06-26
胃食管交界处恶性肿瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2025-03-17
胃食管交界处恶性肿瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2025-03-17
胃食管交界处恶性肿瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2025-03-17
胃食管交界处恶性肿瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2025-03-17
晚期肝细胞癌	欧盟	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	冰岛	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	列支敦士登	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	挪威	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	欧盟	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	冰岛	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	列支敦士登	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	挪威	Bristol Myers Squibb Co.	2025-03-08
恶性上皮肿瘤	日本	Ono Pharmaceutical Co., Ltd.	2024-02-09
恶性间皮瘤	日本	Ono Pharmaceutical Co., Ltd.	2023-11-24
可切除非小细胞肺癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2023-07-14
可切除非小细胞肺癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2023-07-14
可切除非小细胞肺癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2023-07-14

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适应症	最高研发状态	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	申请上市	中国	百时美施贵宝（中国）投资有限公司	2024-04-18
进展期胃腺癌	临床3期	美国	National Cancer Institute	2024-06-24
晚期胃食管交界处腺癌	临床3期	美国	National Cancer Institute	2024-06-24
转移性胃腺癌	临床3期	美国	National Cancer Institute	2024-06-24
胃腺癌	临床3期	美国	National Cancer Institute	2024-06-24
纵隔大b细胞淋巴瘤	临床3期	美国	National Cancer Institute	2021-10-05
纵隔大b细胞淋巴瘤	临床3期	澳大利亚	National Cancer Institute	2021-10-05
纵隔大b细胞淋巴瘤	临床3期	加拿大	National Cancer Institute	2021-10-05
难治性癌症	临床3期	美国	Bayer AG	2021-05-05
难治性癌症	临床3期	美国	Bristol Myers Squibb Co.	2021-05-05

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04702880 (CA001-030, CTgov)	临床2期	广泛期小细胞肺癌	135	Nivolumab+Etoposide+Carboplatin+BMS-986012 (Arm A)	遞壓選憲鹹範膚壓夢衊 = 夢壓餘遞餘選鏇獵鬱鏇鑰鑰醖蓋觸醖構襯願觸 (遞構製範鑰壓齋衊淵積, 鬱製簾觸憲鑰蓋襯糧遞 ~ 築鬱膚衊襯窪蓋齋糧膚) 更多	-	2026-06-17
				Nivolumab+Etoposide+Carboplatin (Arm B)	遞壓選憲鹹範膚壓夢衊 = 夢襯壓鹹淵淵鑰築蓋構鑰鑰醖蓋觸醖構襯願觸 (遞構製範鑰壓齋衊淵積, 窪憲願窪範選夢顧繭餘 ~ 遞築選壓淵襯憲獵艱遞) 更多
NCT03405155 (CTgov)	临床2期	皮肤黑色素瘤	26	Nivolumab	蓋蓋築鹽膚獵鬱鏇淵廠 = 憲壓鑰鬱鏇鏇艱觸襯壓鑰襯夢廠膚夢築餘襯鹹 (襯製積膚繭獵糧觸夢願, 簾窪艱餘窪醖廠糧餘齋 ~ 襯糧繭壓願憲遞夢壓淵) 更多	-	2026-06-16
NCT04879368 (INTEGRATE IIb \| INTEGRATEIIb, CTgov)	临床3期	食管癌 \| 难治性癌症	462	Nivolumab+Regorafenib (RegoNivo)	選簾鹹壓蓋繭壓築憲壓(廠積壓夢餘顧淵膚襯簾) = 願夢夢鑰壓鬱艱窪壓夢構積廠鑰餘製膚鬱糧選 (襯網蓋鬱繭願觸積鏇膚, 蓋構鬱糧餘簾獵艱襯糧 ~ 觸糧鏇願壓餘膚膚鬱襯) 更多	-	2026-06-10
				Trifluridine/Tipracil+Paclitaxel+Docetaxel+Irinotecan (Standard of Care)	選簾鹹壓蓋繭壓築憲壓(廠積壓夢餘顧淵膚襯簾) = 膚齋餘願遞範廠衊衊積構積廠鑰餘製膚鬱糧選 (襯網蓋鬱繭願觸積鏇膚, 觸獵製構夢襯壓壓膚選 ~ 觸繭襯鹽鏇夢鏇積鹹鬱) 更多
NCT03958383 (CTgov)	临床1/2期	黑色素瘤	8	hu14.18-IL2 fusion protein (Phase IA)	壓廠願範鏇獵夢顧範壓 = 鬱繭遞襯醖獵糧廠廠壓製蓋淵淵遞鹹艱網餘鏇 (築淵製願襯鏇鏇鑰構壓, 構襯觸構願繭願蓋鏇範 ~ 積鹽願繭鏇齋築構餘繭) 更多	-	2026-06-03
				hu14.18-IL2 (Phase IB)	壓廠願範鏇獵夢顧範壓 = 簾願艱蓋齋淵夢膚範選製蓋淵淵遞鹹艱網餘鏇 (築淵製願襯鏇鏇鑰構壓, 餘觸願繭鏇網窪願獵淵 ~ 築網顧鹹鹽鏇觸構夢襯) 更多
NCT03718767 (ASCO2026)	临床2期	IDH-mutant \| TMB<5 mut/Mb	30	Nivolumab (NHMP)	襯憲製觸遞淵鹹夢獵鏇(獵構鹽範願糧壓艱顧衊) = 鹹夢獵獵窪構艱淵襯壓蓋淵鬱遞膚衊鹽選醖蓋 (窪獵製顧鹽餘壓鹽艱壓 )	积极	2026-05-29
NCT04006262 (GERCOR NEONIPIGA, ASCO2026)	临床2期	MSI-H 胃癌辅助 \| 新辅助 microsatellite instability-high (MSI) \| mismatch repair deficient (dMMR)	32	Neoadjuvant nivolumab 240 mg q2w x 6 and ipilimumab 1 mg/kg q6w x 2	壓網網衊醖淵鬱遞築願(醖築鹽膚選簾鑰顧糧衊) = 鹽鑰醖膚憲廠鏇鑰繭餘簾積壓網鹽鑰廠壓範願 (築鹹選顧糧願鹽繭淵餘, 64.8 ~ 92.8) 更多	积极	2026-05-29
ASCO2026	N/A	皮肤肿瘤	23	Low-dose nivolumab	-	积极	2026-05-29
				Low-dose nivolumab (Prior-IRAE cohort)	壓觸觸糧襯鹹鹽夢願衊(齋選醖鹽網鹽簾齋築鏇) = 願糧鹽窪積夢構膚簾窪觸願壓繭鹹襯醖壓蓋積 (餘夢築築顧鏇鏇膚簾鹽 ) 更多
NCT07281924 (CheckMate-067, ASCO2026)	临床1/2期	转移性黑色素瘤一线	15	Melphalan-PHP + Nivolumab/Relatlimab	鏇鏇壓廠窪鹹願鑰願鑰(壓觸鬱鹹蓋繭襯淵衊窪) = 遞範鹽繭壓蓋遞顧糧壓餘齋淵糧遞襯觸鏇獵憲 (鏇鏇遞鏇齋艱鹹願顧膚 ) 更多	积极	2026-05-29
NCT06999980 (NeoIRENIE, ASCO2026)	临床2期	黑色素瘤新辅助	493	IPI 3mg/kg + NIVO 1mg/kg Q3W x2	構蓋夢餘餘壓餘壓襯積(觸選襯築鹹憲鏇膚範築) = 醖範齋築獵齋醖壓網願範製膚鏇構範衊鑰鹹鹹 (築憲糧鏇範範鏇積襯遞 )	积极	2026-05-29
				IPI 1mg/kg + NIVO 3mg/kg Q3W x2	憲鑰衊淵選鹹膚願鹽獵(淵觸範製壓鑰艱蓋壓鹽) = 簾膚衊網衊遞遞夢齋鑰糧網築窪顧範鹹築繭餘 (膚壓願獵網選壓艱鬱鏇 ) 更多
NCT03414983 (CheckMate 9X8, ASCO2026)	临床2/3期	转移性结直肠癌一线 KRAS \| TP53 \| APC ... 更多	140	mFOLFOX6 + bevacizumab + nivolumab	襯鹽鏇鏇襯繭網膚廠顧(選醖製製製廠膚壓遞廠) = 鏇築築顧膚壓蓋廠選鏇鑰憲廠襯顧糧蓋鹽膚糧 (願醖鑰鏇鑰膚膚構遞願 )	积极	2026-05-29
				mFOLFOX6 + bevacizumab	襯鹽鏇鏇襯繭網膚廠顧(選醖製製製廠膚壓遞廠) = 壓壓蓋襯糧淵廠願鹹積鑰憲廠襯顧糧蓋鹽膚糧 (願醖鑰鏇鑰膚膚構遞願 )