An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Budigalimab in Advanced or Metastatic Non-Squamous NSCLC with No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations (AndroMETa-Lung-536) - M24-536

开始日期2025-04-29

申办/合作机构

AbbVie Deutschland GmbH & Co. KG

NCT06772623

/ Recruiting临床1/2期

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) inhibitor (budigalimab) to adult participants to treat NSCLC.
ABBV-400 and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of ABBV-400 in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 4 treatment groups. Two groups will receive budigalimab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed. One group will receive the standard of care (SOC) pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 172 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with budigalimab or receive IV budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed, or IV SOC pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

开始日期2025-03-06

申办/合作机构

AbbVie, Inc.

NCT06632951

/ Active, not recruiting临床2期

A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma

Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.
Livmoniplimab is an investigational drug being developed for the treatment of mUC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at one of 2 different doses) in combination with budigalimab (another investigational drug), or either docetaxel, paclitaxel, or gemcitabine (based on investigator's choice). Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide.
In arm 1, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab. In arm 2, participants will receive IV infused livmoniplimab (dose B) in combination with IV infused budigalimab. In arm 3 (control), participants will receive the investigator's choice: IV infused or injected docetaxel; IV infused or injected paclitaxel; or IV infused gemcitabine. The estimated duration of the study is up to approximately 3.5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

开始日期2025-01-20

申办/合作机构

AbbVie, Inc.

100 项与布格利单抗相关的临床结果

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100 项与布格利单抗相关的转化医学

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100 项与布格利单抗相关的专利（医药）

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项与布格利单抗相关的文献（医药）

2022-10-01·Annals of oncology : official journal of the European Society for Medical Oncology

Circulating L-arginine predicts the survival of cancer patients treated with immune checkpoint inhibitors

Article

作者: Chaput, N ; Tselikas, L ; Le Loarer, F ; Besse, B ; Fontan, L ; Roubaud, G ; Peyraud, F ; Auzanneau, C ; Cabart, M ; Italiano, A ; Barlesi, F ; Cousin, S ; Danlos, F-X ; Bodet, D ; Soria, J-C ; Nafia, I ; Guégan, J-P ; Bessede, A ; Planchard, D ; Even, C ; Marabelle, A ; Khettab, M ; Chomy, F

BACKGROUND:

The discovery of immune checkpoint inhibitors (ICIs) has revolutionized the systemic approach to cancer treatment. Most patients receiving ICIs, however, do not derive benefits. Therefore, it is crucial to identify reliable predictive biomarkers of response to ICIs. One important pathway in regulating immune cell reactivity is L-arginine (ARG) metabolism, essential to T-cell activation. We therefore aimed to evaluate the association between baseline plasma ARG levels and the clinical benefit of ICIs.

PATIENTS AND METHODS:

The correlation between ARG levels and clinical ICI activity was assessed by analyzing plasma samples obtained before treatment onset in two independent cohorts of patients with advanced cancer included in two institutional molecular profiling programs (BIP, NCT02534649, n = 77; PREMIS, NCT03984318, n = 296) and from patients in a phase 1 first-in-human study of budigalimab monotherapy (NCT03000257). Additionally, the correlation between ARG levels and ICI efficacy in preclinical settings was evaluated using a syngeneic mouse model of colorectal cancer responsive to ICIs. Using matched peripheral blood mononuclear cell (PBMC) plasma samples, we analyzed the correlation between ARG levels and PBMC features through multiplexed flow cytometry analysis.

RESULTS:

In both discovery and validation cohorts, low ARG levels at baseline (<42 μM) were significantly and independently associated with a worse clinical benefit rate, progression-free survival, and overall survival. Moreover, at the preclinical level, the tumor rejection rate was significantly higher in mice with high baseline ARG levels than in those with low ARG levels (85.7% versus 23.8%; P = 0.004). Finally, PBMC immunophenotyping showed that low ARG levels were significantly associated with increased programmed death-ligand 1 expression in several immune cell subsets from the myeloid lineage.

CONCLUSIONS:

We demonstrate that baseline ARG levels predict ICI response. Plasma ARG quantification may therefore represent an attractive biomarker to tailor novel therapeutic regimens targeting the ARG pathway in combination with ICIs.

2022-04-01·Journal of immunotherapy (Hagerstown, Md. : 1997)4区 · 医学

Association of Baseline and Pharmacodynamic Biomarkers With Outcomes in Patients Treated With the PD-1 Inhibitor Budigalimab

4区 · 医学

Article

作者: Tribouley, Catherine ; McLaughlin, Robert Tyler ; Masica, David L. ; Sheridan, James ; Vosganian, Greg ; Englert, Stefan ; Turan, Tolga ; Guo, Claire ; Zhang, Chun ; Afar, Daniel ; Lambert, Stacie L. ; Fang, Yuni

Budigalimab, a novel anti–PD-1 monoclonal antibody, demonstrated efficacy and biomarker pharmacodynamics in patients with head and neck squamous cell carcinoma (HNSCC) or non–small cell lung cancer (NSCLC) consistent with those reported by other PD-1 inhibitors. Herein are presented additional outcomes of biomarker analyses from the phase 1 study of budigalimab monotherapy in patients with HNSCC and NSCLC (NCT03000257). PD-1 inhibitor naive patients with advanced HNSCC (n=41) or NSCLC (n=40) received budigalimab intravenously at 250 mg every 2 weeks (Q2W) or 500 mg Q4W until progression. Archival tumor specimens were evaluated by immunohistochemistry for CD8 and tumor PD-1 ligand 1 (PD-L1) expression, RNA, and whole-exome sequencing. Serum and whole blood samples were acquired at baseline and at select on-treatment time points. As of October 2019, best overall response of 15% in HNSCC and 18% in NSCLC was observed in all treated patients; both cohorts reported responses in PD-L1+ and PD-L1– tumors. Treatment with budigalimab was associated with increases in multiple soluble biomarkers including interferon gamma-induced chemokines. Expanded overall T-cell counts, total CD8 T-cell counts, and percentages of CD8+CD45RA–CD62L– effector memory T cells were observed at cycle 1, day 15 in responders. Univariate analysis demonstrated an association between prolonged progression-free survival and higher tumor mutational burden/neoantigen load, smaller tumor size, lower platelet-lymphocyte ratios, lower CCL23, lower colony-stimulating factor 1, and lower interleukin-6 levels at baseline. The biomarker analysis presented herein identified additional early pharmacodynamic biomarkers associated with anti–PD-1 activity and improved clinical responses to budigalimab in patients with advanced HNSCC and NSCLC.

2022-02-01·Cancer immunology, immunotherapy : CII2区 · 医学

First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma

2区 · 医学

Article

作者: Warburton, Lydia ; Englert, Stefan ; Shiah, Her-Shyong ; Gazzah, Anas ; Lin, Chia-Chi ; Parikh, Apurvasena ; Afar, Daniel E ; Cassier, Philippe A ; Moreno, Victor ; Gao, Bo ; Vosganian, Gregory ; Cervantes, Andrés ; Calvo, Emiliano ; Alanko, Tuomo ; Tanner, Minna ; Italiano, Antoine ; Lambert, Stacie ; Peltola, Katriina J ; Roda, Desamparados ; Tosi, Diego ; Millward, Michael

Abstract:

Background:

Budigalimab is a humanized, recombinant immunoglobulin G1 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We present the safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data from patients enrolled in the head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) expansion cohorts of the phase 1 first-in-human study of budigalimab monotherapy (NCT03000257; registered 15 December 2016).

Patients and methods:

Patients with recurrent/metastatic HNSCC or locally advanced/metastatic NSCLC naive to PD-1/PD-1-ligand inhibitors were enrolled; patients were not selected on the basis of oncogene driver mutations or PD-L1 status. Budigalimab was administered at 250 mg intravenously Q2W or 500 mg intravenously Q4W until disease progression/unacceptable toxicity. The primary endpoints were safety and PK; the secondary endpoint was efficacy. Exploratory endpoints included biomarker assessments.

Results:

In total, 81 patients were enrolled (HNSCC: N = 41 [PD-L1 positive: n = 19]; NSCLC: N = 40 [PD-L1 positive: n = 16]); median treatment duration was 72 days (range, 1–617) and 71 days (range, 1–490) for the HNSCC and NSCLC cohorts, respectively. The most frequent grade ≥ 3 treatment-emergent adverse event was anemia (HNSCC: n = 9, 22%; NSCLC: n = 5, 13%). Both dosing regimens had comparable drug exposure and increased interferon gamma-induced chemokines, monokine induced by gamma interferon, and interferon-gamma-inducible protein 10. Objective response rates were 13% (90% CI, 5.1–24.5) in the HNSCC cohort and 19% (90% CI, 9.2–32.6) in the NSCLC cohort. Median progression-free survival was 3.6 months (95% CI, 1.7–4.7) and 1.9 months (95% CI, 1.7–3.7) in the HNSCC and NSCLC cohorts.

Conclusions:

The safety, efficacy and biomarker profiles of budigalimab are similar to other PD-1 inhibitors. Development of budigalimab in combination with novel anticancer agents is ongoing.

项与布格利单抗相关的新闻（医药）

2025-08-03

·Biotech前瞻

艾伯维2025年H1财报与PD-(L)1×VEGF双抗战略分析

点击蓝字关注我们本期看点在全球生物医药市场竞争日趋激烈的大背景下，艾伯维（AbbVie）于2025年上半年交出了一份兼具转型与成长信号的财报—在阿达木单抗（Humira，修美乐）专利悬崖持续冲击之下，其新一代免疫与神经科学产品快速崛起，展示了稳健的接棒潜力。与此同时，公司也在加速肿瘤免疫板块的重构布局，尤其开始对“PD-(L)1×VEGF”这一备受关注的双特异性抗体赛道释放出浓厚兴趣。本文将聚焦艾伯维2025年H1财务表现、核心产品走向与管线动态，深度解析其为何押注这一潜在“下一代免疫主力疗法”赛道，并置于全球竞争格局中观察其战略意图。本期内容01艾伯维丨2025H1财报分析02创新药物研发管线进展03PD-(L)1×VEGF双抗布局04总结与展望【01 艾伯维丨2025H1财报分析】公司整体财务表现营收与净利（2025 H1）: 艾伯维2025年上半年（1-6月）总营收约287.66亿美元，同比增长7.4%；归属母公司净利润约22.24亿美元（2024年同期27.39亿美元）。摊薄后每股收益为1.24美元（去年同期1.53美元）。各业务板块表现: 2025 H1，免疫学（Immunology）业务收入约138.95亿美元，同比增长12.6%；神经科学（Neuroscience）收入约49.65亿美元，同比增长20.3%；肿瘤学（Oncology）收入约33.09亿美元，同比增长4.2%；医疗美容（Aesthetics）收入约23.81亿美元，同比下降9.8%。其中免疫学板块的Skyrizi（利生奇珠单抗，IL-23抑制剂）和Rinvoq（乌帕替尼，选择性JAK抑制剂）是主要增长动力，均实现高双位数增长。主要产品销售情况Humira（阿达木单抗）: 由于专利到期及生物类似药竞争，上半年销售额仅约23.01亿美元，同比下降54.7%，呈持续下滑态势。Skyrizi（利生奇珠单抗）: 2025年H1销售约78.48亿美元，同比增长65.8%，增长强劲。Rinvoq（乌帕替尼）: 2025年H1销售约37.46亿美元，同比增长48.5%。Skyrizi和Rinvoq合计收入已超过Humira，成为公司最大的驱动产品。Vraylar（卡利拉嗪，精神分裂药物）: 2025年H1销售约16.65亿美元，同比增长13.5%。Botox（肉毒毒素，治疗型与美容型）：截至2025年Q2，Botox治疗型（Botox Therapeutic）季度收入9.28亿美元，同比增长14.1%；Botox美容型（Botox Cosmetic）收入6.92亿美元，同比仅略降5.0%。由此推算2025年H1 Botox治疗型约17.94亿美元，Botox美容型约12.48亿美元。Botox全线产品表现稳健，治疗型需求持续上升。02 创新药物研发管线进展接下来，我们具体来看艾伯维肿瘤和免疫领域管线进展。ADC： 2024年5月，艾伯维的c-Met ADC “Teliso-V”获批（抗晚期非小细胞肺癌）。公司另一款FRα靶点ADC（Elahere，索米妥昔单抗）上半年销售3.38亿美元，同比增长75.5%，显示出快速增长势头。艾伯维还推进多款新ADC，如双靶PSMA/STEAP1 ADC （ABBV-969），已进入1期临床。免疫检查点与双抗：公司自研的PD-1抗体布格利单抗（Budigalimab）处于Ⅱ期试验阶段；CCR8靶向抗体ABBV-514在1期试验中显示可耗竭肿瘤内调节性T细胞，正在与Budigalimab联用进行多项实体瘤临床研究。Epkinly（艾可瑞妥单抗，CD3×CD20双抗）自2023年获批上市，今年H1销售1.21亿美元，同比增长92.1%。外部合作与收购：上半年AbbVie积极进行BD活动，截至7月已完成约10笔交易，其中包括1月与先声药业合作开发GPRC5D/BCMA/CD3三特异抗体SIM0500；7月斥资19亿美元收购Amunix的三特异性T细胞衔接器（CD3/BCMA/CD38三抗，ISB-2001）。这些交易表明AbbVie正扩充三抗、ADC和其他创新靶向药物管线。【03 PD-(L)1×VEGF双抗布局】艾伯维公开表态对PD-(L)1×VEGF双抗感兴趣：艾伯维首席科学官于2025年二季度业绩电话会议上表示，公司注意到PD-(L)1×VEGF双抗赛道的进展，并明确提到“这一类别正在陆续披露多项数据，我们对此领域很感兴趣并在关注”。尽管艾伯维未公布具体的PD-(L)1×VEGF候选药物，但该表态表明了其浓厚兴趣。截至目前，艾伯维并未公开任何PD-(L)1×VEGF双抗在研产品。艾伯维表示将关注将双抗与其现有ADC相结合的潜力，但尚无已知联合研发或许可合作公告。PD-(L)1×VEGF双抗集成了免疫检查点阻断和抗血管生成机制，被视为“下一代”肿瘤免疫基础治疗药物，具备成为千亿美元市场基石药物的潜力。艾伯维拥有多款肿瘤免疫和ADC产品（如Teliso-V、Elahere、Epkinly等）及PD-1单抗Budigalimab。公司认为，新双抗若与其ADC管线联合使用，可在多种适应症中发挥协同效应。例如，早期研究中Summit/辉瑞就计划将PD-1×VEGF双抗Ivonescimab与多种ADC联合测试。艾伯维布局PD-(L)1×VEGF的决策正是基于希望与其多元化抗肿瘤药物组合产生增效作用。行业趋势与竞争格局：目前全球已有多家公司研发PD-(L)1×VEGF双抗，并涌现大量大额交易。国际巨头，如默沙东、辉瑞等纷纷通过授权或并购等方式大力布局此领域。研究机构普遍认为，PD-(L)1×VEGF类双抗可能成为肿瘤免疫治疗的新主流方案。在此背景下，艾伯维加入该领域可补齐产品线空白，并抢占未来市场先机。04 总结与展望综上所述，艾伯维在2025年上半年展现出强劲的业务韧性与转型决心：Skyrizi 和 Rinvoq 持续高增长，带动免疫板块超越 Humira 成为新的业绩支柱；神经科学和ADC产品线同样表现亮眼。与此同时，公司在肿瘤免疫领域加速拓展布局，明确表达对PD-(L)1×VEGF双抗的战略兴趣，意在借此补强其免疫治疗矩阵、提升管线协同效益，并抢占下一轮肿瘤免疫主流治疗窗口。面对全球竞争者在该赛道的迅速推进，艾伯维的这一表态不仅释放出其研发战略的前瞻性信号，也预示着下一阶段大分子双抗布局或将迎来新的资本与创新热潮。 ★

财报抗体药物偶联物免疫疗法专利到期生物类似药

2025-05-27

·PRNewswire

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers. "The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs." An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase: Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO. Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC. "The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis." Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123: In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO. This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors. Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4 Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO. PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia. "Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited." Further information on AbbVie clinical trials is available at . Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here. Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp) Please see full Prescribing Information for IMBRUVICA® (ibrutinib) Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138. Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果ASCO会议临床1期抗体药物偶联物临床2期

2025-04-09

·VIP说

肿瘤免疫治疗策略2.0

# 本篇笔记仅基于公开资料和信息撰写、为个人观点、供学术交流所用、不构成任何建议 #我用了差不多一个月的时间，看了几十家代表公司的产品线、几千篇研报和点评、几万个注册临床试验，想要看清楚肿瘤免疫治疗棋局的现状和未来。这不符合我的本性，我是宁可去无人区探险，也不想投入毫厘铢锱不能差错的极致内卷中。但是，现实就是，现在和未来很长一段时间内，免疫检查点抑制剂都会是肿瘤治疗的基石，即使MNC们早就已经布局于免疫检查点抑制剂之外甚至肿瘤治疗之外，国内大多数药企还有一段国产替代的长路要走。既然不能提前退休，只能强忍着非常严重的内卷PTSD看棋局，这种不适感压制了我的段子手级别语言天赋，所以这篇笔记会写的非常......直白。我个人给免疫治疗策略1.0的定义，就是大家手里都有个PD-(L)1抑制剂产品。全球已经有32个/国内已经有24个PD-(L)1抑制剂产品上市。图片引用来自“IO笔记”。至于免疫治疗策略2.0，就是如何进一步迭代和升级。PD-(L)1抑制剂产品本身的迭代和升级，目前大家的策略非常一致，改良单抗本身没能创造出什么奇迹，就开发双抗/多抗和复方，以及皮下注射、口服小分子、ADC等新剂型。双抗/多抗和复方本质类似于联合给药方案，所以放到后面再说。开发皮下注射剂型看上去是个捷径，不过如果大家的目标是国际市场，可能会有专利侵权风险：阿斯利康7.5亿美元引进Alteogen透明质酸酶技术，后者深陷侵权风险口服小分子PD-(L)1抑制剂，我是没有“小药说药”那么关注，而且似乎已经冷却：靶向PD-1/PD-L1小分子药物的研究进展至于PD-(L)1 ADC，反正已经热闹起来：靶向PD-L1 ADC：辉瑞首次国内申报临床！复宏汉霖、映恩生物“勇攀高峰”此外，国内外很多家药企已经想开了，不搞什么伪创新药，帕博利珠单抗核心专利将于2028年到期，直接开发生物类似药。国内外我已经数出来10个帕博利珠单抗类似药在做注册临床试验了，还有3个纳武利尤单抗生物类似药。更广谱的迭代和升级策略，就是以PD-(L)1抑制剂产品为基石，开发各种联合给药方案。汇总信息还是医药魔方做得最漂亮（反正我下载了PPT）：PD-1/PD-L1抑制剂中美获批及全球注册性临床试验15年动态趋势医药魔方PPT中部分内容截图：类似的汇总信息报告和点评很多，都能让大家一眼看清楚肿瘤免疫治疗棋局已经内卷到什么地步，看完不但没有思路，反而更加焦虑了。所以我们还是采用最简单高效的fast follow的老办法，看看几十家代表公司的肿瘤免疫治疗产品线，看看follow谁家的具体策略最适合自家。1. 默沙东/默克帕博利珠单抗(PD-1单抗)，长期被群殴和围攻的药王，王冠太重。在肿瘤领域，默沙东/默克不断探索和拓展其各种联合给药方案，并且积极布局复方和皮下等新剂型，双抗等新产品，以求夯实其在肿瘤领域的领先地位。复方主要是MK-1308A(PD-1+CTLA-4，Pembrolizumab+Quavonlimab)，MK-7684A(PD-1+TIGHT，Pembrolizumab+Vibostolimab)，MK-4280A(PD-1+LAG-3，Pembrolizumab+favezelimab)，2024年12月宣布终止开发后两个，目前只有MK-1308A还在推进。皮下剂型MK-3475A的III期临床试验刚官宣成功。近年来，默沙东/默克的肿瘤产品线重点已经布局于免疫检查点抑制剂之外，但免疫检查点抑制剂还是肿瘤治疗的基石，肿瘤领域且没有禁忌症，什么新产品都尝试联联看，就像吃什么菜都要配一碗白米饭。看帕博利珠单抗适应症布局是一项极其艰巨的工作，我差不多用了半个月时间，剩下几十个产品用了剩下的半个月时间。太多了。不仅因为默沙东/默克财大气粗，有把握的III期试验开几百个，没把握的I-II期试验和IIT开几千个，更因为帕博利珠单抗是基石中的基石，米饭中的白米饭，其他药企开发联合给药方案也是首选帕博利珠单抗。即使默沙东/默克没有布局，其他药企也会填空，所有瘤种所有适应症，完全没有空缺。最后得去翻默沙东/默克官网的PPT，才能找出他家真正的主线。如果布局图里出现了个别空缺，那也是某些III期临床试验失败导致的，绝不是没人尝试过填空。比如大家都吃过瓜的LEAP系列。但是有三个瘤种，即著名的冷肿瘤们，卵巢癌、胰腺癌、前列腺癌，所有药企都是屡战屡败+屡败屡战。先驱栽坑里那是代价，后来者再盲目跳坑，我可能忍不住嘲笑了，如果不是颠覆性作用机制的新药，建议不要再尝试将免疫治疗用于这几个瘤种。2. BMS纳武利尤单抗(PD-1单抗)，没能问鼎药王，所以在此基础上早早开发出皮下注射剂型，与伊匹木单抗(Ipilimumab, CTLA-4)联合方案，与Relatlimab(LAG-3单抗)联合方案，甚至开发了复方OPDUALAG(Nivolumab+Relatlimab)，均已成功获批多个适应症。也曾在TIGHT、IDO等靶点药物联合方案上栽过跟头，最新产品是复方BMS-986489(PD-1+fucosyl-GM1, Nivolumab+BMS-986012)。近年来，BMS的肿瘤产品线重点也已经布局于免疫检查点抑制剂之外。但免疫检查点抑制剂还是肿瘤治疗的基石，主动或被动开发联合方案也非常多。3. 罗氏阿替利珠单抗(PD-L1单抗)，其实已经算差异化开发了，靶点从PD-1换成了PD-L1。阿替利珠单抗是早早成功开发了皮下注射剂型。之后开发双抗时换回PD-1单抗，包括Tobemstomig(RO7247669, PD-1/LAG-3)，Lomvastomig(PD-1/TIM-3, RO7121661)。罗氏在肿瘤免疫治疗方面不算成功，主要是因为阿替利珠单抗与Tiragolumab(TIGHT单抗)的联合方案投入太大，受伤太深。但是深挖一下新技术平台，还能翻出来PD1-IL2v，PDL1 LNA等产品。值得注意的是，阿替利珠单抗用于三阴性乳腺癌非常波折，各种姿势的III期临床试验失败和撤回适应症，鉴于特瑞普利单抗在同一适应症里取得过成功，咱们不能说三阴性乳腺癌不适合免疫治疗，但PD-1单抗似乎比PD-L1单抗强一些。肾癌、尿路上皮癌、头颈癌、宫颈癌里也有类似情况，建议谨慎选择PD-L1单抗。4. 阿斯利康度伐利尤单抗(PD-L1单抗)，早期策略和BMS类似，开发皮下注射剂型，还有和替西木单抗(Tremelimumab, CTLA-4)的联合给药方案。后来者的好处就是可以避开先驱们栽过的坑，适应症开发都比较顺利。现在已经不做复方了，直接换双抗，Volrustomig(PD-1/CTLA-4)，Sabestomig(PD-1/TIM-3)，Rilvegostomig (PD-1/TIGHT)。发起IO+ADC潮流的应该就是他家，而且他家明显艺高人胆大，最偏爱Rilvegostomig (PD-1/TIGHT)，这是要死磕TIGHT靶点的节奏。5. 辉瑞、吉列德、再生元、GSK、Incyte、BIOCAD可以说，辉瑞几乎错了肿瘤免疫治疗浪潮。Avelumab(PD-L1单抗)开发顺位非常靠后，所以从超级冷门小适应症下手—皮肤默克尔细胞癌，弯道超车获批上市后，目前仅在膀胱癌领域取得成功（联合阿昔替尼用于肾癌一线是基于PFS成功附条件获批，但是OS失败，现在很尴尬；用于非小细胞肺癌、头颈癌和胃癌都是全面失败）。后来一度想悄悄开发PD-1单抗皮下注射剂型Sasanlimab（未获批上市），最终还是抢跑PF-08046054(PD-1 ADC)。后来者后来到辉瑞这个地步，如果还不愿赌服输，就得这么另辟蹊径。但是Sasanlimab有点过，首个适应症居然选择联合BCG用于非肌层浸润性膀胱癌，之前帕博利珠单抗和纳武利尤单抗都挑战失败的适应症，全球均未有免疫检查点抑制剂类产品获批。吉列德也是后来者，但是通过收购Arcus获得了赛帕利单抗(Zimberelimab，PD-1单抗)，果然顺产没有顺手快。在国内，赛帕利单抗用于经典型霍奇金淋巴瘤和晚期宫颈癌已获批上市。但是他家的联合给药方案，目前以Domvanalimab(TIGHT单抗)为主，又是一个死磕TIGHT靶点的。再生元不算后来者，Cemiplimab(PD-1单抗)虽然不算先驱，但是通过小适应症—皮肤鳞状细胞癌和皮肤基底细胞癌，早早弯道超车获批上市。他家毕竟是资深肿瘤免疫疗法biotech，联合给药方案非常多，目前以联合Fianlimab(LAG-3单抗)为主。GSK不算后来者也不算先驱，多塔利单抗(Dostarlimab，PD-1单抗) 通过小适应症—dMMR/MSI-H子宫内膜癌，早早弯道超车获批上市，之后仅专注于子宫内膜癌、结直肠癌和头颈癌，坚定的反内卷思维，深得我心。Incyte真不容易，当初为了卡瑞利珠单抗和恒瑞分分合合，最后终于拥有了自己的Retifanlimab(PD-1单抗)。跟辉瑞类似，因为Retifanlimab开发顺位非常靠后，所以从超级冷门小适应症下手—皮肤默克尔细胞癌，弯道超车获批上市。后来居然又被再鼎引入中国继续开发，反正各种不容易。再看Incyte产品线，始终专注于肿瘤免疫疗法，口服PD-L1，PD-1/LAG-3双抗、PD-1/TGF-βRII双抗均有布局。Prolgolimab(PD-1单抗)由俄罗斯药企BIOCAD开发，获得俄罗斯卫生部批准上市，用于治疗转移性黑色素瘤。在两国总理的共同见证下，由上药集团引进入国内共同开发，上药集团不愧是一流国企，非常正确。值得一提的是，Prolgolimab都这么正确了也没有躺平，继续开发复方BCD-217(Prolgolimab+Nurulimab，PD-1+CTLA-4)，还开发了帕博利珠单抗生物类似药。6. 其他外企艾博维：Budigalimab(PD-1单抗)Budigalimab绝对算后来者，我个人高度怀疑艾博维是为了联合其他自家真爱的新产品才被迫开发了基石。到现在最高开发阶段II期临床试验。强生：Cetrelimab(PD-1单抗)也不知道这个产品是不是和辉瑞的Sasanlimab高度类似，首个适应症居然也选择非肌层浸润性膀胱癌，但联合了自家TAR-200，我个人觉得就是为了陪衬TAR-200。2025年1月15日，强生宣布递交TAR-200的上市申请，用于治疗卡介苗（BCG）不应答的高危非肌肉侵袭性膀胱癌（HR-NMIBC）伴原位癌（CIS）患者。此次递交通过实时肿瘤审评（RTOR）项目，允许FDA在完全申请正式递交之前就开始审评以加快进度。 TAR-200为一种膀胱内局部给药的新型递送系统，采用一种双重小片设计，材质为硅聚合物半透小管，吉西他滨在膀胱持续缓慢释放。BI：Ezabenlimab(PD-1单抗)反正我个人高度怀疑BI是为了联合其他自家真爱的新产品才被迫开发了基石。到现在最高开发阶段II期临床试验。安进：Zeluvalimab(PD-1单抗)在安进最新的产品线信息里已经找不到Zeluvalimab了，但是找到了纳武利尤单抗生物类似药，预期2025年获批上市。放弃死磕开发顺位过于滞后的伪创新药，拥抱生物类似药，拥抱效率和利润，毕竟肿瘤免疫治疗也不是安进公司的主线，顶多用来联合其他自家真爱的新产品。Agenus：Botensilimab(PD-1单抗)Agenus还算比较重视Botensilimab，但主要是为了配合新一代产品—Balstilimab(CTLA-4单抗)，声称可以将冷肿瘤转化为热肿瘤。首个适应症选择联合Balstilimab用于non-MSI-H结直肠癌。坚定的反内卷思维，深得我心。BioNTech：BNT327(PD-L1/VEGF双抗)等收购普米斯生物等biotechs，跳过肿瘤免疫治疗1.0时代，直接飞跃至2.0时代潮头，拥有各种最热门双抗和ADC，又是顺产哪有顺手快的成功案例和典型代表。不过最新的消息是BNT311(PD-L1/4-1BB双抗)退回Genmab，这不是一个好消息，真正成功的双抗也不多。BioNTech的策略虽然有抄袭AZ，但非常清晰明确，值得学习。先分析免疫检查点抑制剂单药或既往的联合给药方案，在全球范围内获批过哪些适应症，还有哪些细分人群中有未被满足的临床需求，既往放弃开发或开发失败适应症的困难在哪里。再分析或补充自家产品线里的产品，是否有新颖的作用机制可能攻克之前的困难。最后设计BNT327的临床开发计划：第一步，联合化疗去攻克确定性高、能快速实现高市场价值的适应症；第二步，联合各种新颖作用机制的新产品，填补之前未被满足的临床需求；第三步，探索更多、更新的联合给药方案和适应症。篇幅原因，写完外企部分已经快5000字了，改天再写国内企业部分。信息量过大，CPU干烧到头晕，所有重点点到即止，如有疏漏错误，请大家多包涵。# 本篇笔记仅基于公开资料和信息撰写、为个人观点、供学术交流所用、不构成任何建议 #

抗体药物偶联物免疫疗法生物类似药

100 项与布格利单抗相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性非鳞状非小细胞肺癌	临床3期	美国	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	日本	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	澳大利亚	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	比利时	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	智利	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	法国	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	以色列	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	荷兰	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	西班牙	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	中国台湾	AbbVie, Inc.	2024-04-10

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临床结果

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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


NCT05599984 (WCLC2025)	临床1期	广泛期小细胞肺癌三线 \| 二线	80	ABBV-706 (Relapsed/refractory SCLC + 1.8 mg/kg Q3W)	願鹹蓋網願獵簾選壓製(鏇願觸築簾襯齋衊構壓) = 鹹製齋淵壓膚選艱衊積簾艱鑰積淵鹹範鑰廠獵 (製築鬱鏇選齋簾顧積鹹 ) 更多	积极	2025-09-07
				ABBV-706 (Relapsed/refractory SCLC + 2.5 mg/kg Q3W)	願鹹蓋網願獵簾選壓製(鏇願觸築簾襯齋衊構壓) = 築範鑰鹹遞鹽繭觸艱獵簾艱鑰積淵鹹範鑰廠獵 (製築鬱鏇選齋簾顧積鹹 ) 更多
NCT03821935 (NCT03821935, Pubmed \| Front Oncol)	临床1期	晚期恶性实体瘤 GARP:TGF-ß1 complex	-	Livmoniplimab	範淵鑰糧選窪鑰夢窪遞(簾憲製廠淵積鑰襯餘齋) = 淵積遞壓壓鏇繭襯築窪顧蓋遞構鹹壓製顧廠選 (壓襯鬱餘鑰淵選選觸範 )	积极	2024-10-29
				Budigalimab	憲築蓋廠鑰醖範艱鹽鹽(鏇艱網蓋築構廠憲窪憲) = 網簾選餘艱壓簾鬱廠鬱遞製製蓋壓夢簾選壓膚 (構艱齋構製選壓鹽鏇窪 ) 更多
NCT03821935 (ASCO2024)	临床1期	实体瘤 \| 尿路上皮癌 TGF-β1 \| GARP:TGF-β1 complex	200	Livmoniplimab 1500 mg + Budigalimab 500 mg	醖淵淵獵糧餘蓋淵繭餘(選製醖廠選淵鑰齋築鹽) = 淵夢願繭襯築齋選築鏇鬱憲鑰製鹹齋鹹齋觸網 (遞夢膚糧餘繭繭鑰遞夢, 12.9 ~ 39.5) 更多	积极	2024-05-24
NCT03821935 (ASCO_GU2024) 人工标引	临床1期	尿路上皮癌	48	Livmoniplimab + budigalimab	繭壓遞鏇壓遞積顧鏇憲(顧範積窪艱鹽襯餘鏇鏇) = 夢鑰淵膚製襯選積醖顧積醖簾繭鬱醖網壓艱簾 (膚齋憲糧襯鏇範壓選範, 12.9 ~ 39.5) 更多	积极	2024-01-25
NCT03000257 (Pubmed \| J Immunother)	临床1期	晚期恶性实体瘤	182	Budigalimab 250mg Q2W	餘願鹹窪鑰衊膚顧壓壓(網願淵糧壓鏇蓋選鏇壓) = 獵齋鹹鏇繭齋廠壓獵鹽醖糧鹽鏇糧網齋築鏇構 (鹹積繭鬱鹽繭鹽範艱鬱 )	积极	2022-01-17
				Budigalimab 500mg Q4W	餘願鹹窪鑰衊膚顧壓壓(網願淵糧壓鏇蓋選鏇壓) = 齋廠鑰蓋鑰鬱壓糧糧夢醖糧鹽鏇糧網齋築鏇構 (鹹積繭鬱鹽繭鹽範艱鬱 )
NCT03000257 (Pubmed \| Cancer Immunol Immunother)	临床1期	头颈部鳞状细胞癌 \| 非小细胞肺癌	81	Budigalimab 250 mg	襯鏇蓋憲構蓋觸願製餘(繭鬱鏇襯鹹淵鹹餘夢繭) = 壓築糧襯鑰齋憲壓醖艱廠鑰積顧艱鑰願築觸製 (獵膚淵網網鹽齋憲網艱, 5.1 ~ 24.5)	-	2021-07-03
				Budigalimab 500 mg	襯鏇蓋憲構蓋觸願製餘(繭鬱鏇襯鹹淵鹹餘夢繭) = 鏇願築製艱觸構鏇淵餘廠鑰積顧艱鑰願築觸製 (獵膚淵網網鹽齋憲網艱, 9.2 ~ 32.6)
NCT03000257 (M15-892, Pubmed) 人工标引	临床1期	小细胞肺癌	31	rovalpituzumab tesirine+budigalimab	艱選蓋醖蓋憲鹹鹹鏇築(衊餘積鑰壓淵憲憲構壓) = 獵齋鑰蓋鬱夢繭淵餘壓鏇鬱壓製襯獵遞範鏇製 (憲蓋壓願積構壓繭鏇鑰 ) 更多	积极	2021-01-01
NCT03000257 (AACR2020)	临床1期	HR阳性/HER2低表达实体瘤	81	Budigalimab IV 250 mg every two weeks	遞積夢醖鬱糧蓋憲淵艱(積製鹽鬱衊繭遞鹹憲獵) = 蓋窪網觸簾憲夢衊窪願鏇鑰鑰醖構鑰蓋蓋網製 (製遞窪齋鬱積鹹觸願鏇 )	-	2020-08-15
				Budigalimab IV 500 mg every four weeks	遞積夢醖鬱糧蓋憲淵艱(積製鹽鬱衊繭遞鹹憲獵) = 鑰糧構膚繭醖遞鹹製襯鏇鑰鑰醖構鑰蓋蓋網製 (製遞窪齋鬱積鹹觸願鏇 )
NCT03000257 (M15-891, SITC2018)	临床1期	晚期恶性实体瘤	62	ABBV-181 1 mg/kg	蓋簾廠繭艱願壓鹹蓋範(衊積醖鹹簾網夢鹹鏇淵) = 顧築鏇繭鏇淵簾糧鏇襯構製壓構憲顧構窪製夢 (鹽醖簾構觸淵鏇廠餘鹽, 31 ~ 59) 更多	积极	2018-11-06
				ABBV-181 3 mg/kg	蓋簾廠繭艱願壓鹹蓋範(衊積醖鹹簾網夢鹹鏇淵) = 窪簾顧齋夢鬱憲選繭窪構製壓構憲顧構窪製夢 (鹽醖簾構觸淵鏇廠餘鹽, 31 ~ 59) 更多