预约演示
更新于：2026-08-08
Vibostolimab
维博利单抗
更新于：2026-08-08
概要
基本信息
在研机构- |
权益机构- |
最高研发阶段终止临床3期 |
首次获批日期- |
最高研发阶段(中国)终止 |
特殊审评孤儿药 (美国) |
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结构/序列
Sequence Code 431841399L
来源: *****
Sequence Code 431841400H
来源: *****
关联
6
项与 维博利单抗 相关的临床试验NCT06395090
LIGHTBEAM-U01 Substudy 01B: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors
NCT04305054
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B
NCT04305041
A Phase 1/2 Open-label Rolling-arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02A
100 项与 维博利单抗 相关的临床结果
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100 项与 维博利单抗 相关的转化医学
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100 项与 维博利单抗 相关的专利（医药）
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15
项与 维博利单抗 相关的文献（医药）2026-06-15CANCER
No RFS benefit found from adding vibostolimab to pembrolizumab in patients with high‐risk melanoma
作者: Lawrence, Leah
This news section offers
Cancer
readers timely information on events, public policy analysis, and topical issues. In this issue, the coformulation of vibostolimab with pembrolizumab did not improve recurrence‐free survival in comparison with pembrolizumab alone in patients with resected stage IIB–IV melanoma. In addition, the use of AI–supported mammography improved screening performance for the detection of interval breast cancers in comparison with standard double reading, and first‐line use of CDK4/6 inhibitors did not improve overall survival in comparison with second‐line use in patients with advanced breast cancer.
2026-06-01ESMO Open
Concordance of pathologic response assessment between local and central review in melanoma: a post hoc analysis of KEYMAKER-U02 substudy 02C
Article
作者: Tetzlaff, M ; Menzies, A M ; Fukunaga-Kalabis, M ; Krepler, C ; Dummer, R ; Taube, J M ; Robert, C ; Long, G V ; Portnoy, D C ; Scolyer, R A ; Lebbe, C ; Gaudy-Marqueste, C ; Xu, J ; Krishnan, R ; Hill, A
BACKGROUND:
Substudy 02C of the phase I-II KEYMAKER-U02 study was designed to evaluate neoadjuvant pembrolizumab as monotherapy and in combination with investigational agents, followed by surgery and adjuvant pembrolizumab in participants with resectable stage IIIB-D melanoma. Here, we report a post hoc analysis of concordance of pathologic response assessment between local and central review and among central reviewers in the KEYMAKER-U02 substudy 02C.
PATIENTS AND METHODS:
Participants received neoadjuvant pembrolizumab plus vibostolimab, pembrolizumab plus gebasaxturev, or pembrolizumab monotherapy followed by resection and adjuvant pembrolizumab. Pathologic response was categorized by percent age of residual viable tumor (%RVT) in the treated tumor bed as follows: pathologic complete response (pCR; 0% RVT), near-pCR (RVT >0% but ≤10%), partial pathologic response (pPR; RVT >10% but ≤50%), and pathologic nonresponse (pNR; RVT >50%).
RESULTS:
By local review of 60 participants, 24 (40%) had pCR, 7 (12%) had near-pCR, 12 (20%) had pPR, and 17 (28%) had pNR. By central review of 60 participants, 23 (38%) had pCR, 7 (12%) had near-pCR, 14 (23%) had pPR, and 16 (27%) had pNR. The weighted kappa for concordance between local and central review for these categories was 0.79 (95% CI 0.70-0.89). The three central reviewers agreed on the response category for 54 of 61 participants (89%). For the seven participants (11%) without agreement, the maximum difference in response was one category; for four of these participants, the dissenting response assessment was close to a %RVT category cut point. The weighted Gwet's agreement coefficient was 0.94 (95% CI 0.90-0.98).
CONCLUSION:
These results confirm a high level of concordance in pathologic response assessment between local and central review and among central reviewers and provide confidence in the accuracy of pathologic response assessment following neoadjuvant therapy.
2026-05-01Med
Beyond empiric checkpoint escalation: Insights from KEYVIBE-010
Article
作者: Sullivan, Ryan J ; Knight, Andrew
KEYVIBE-010 is a phase 3 trial evaluating the combination of adjuvant vibostolimab and pembrolizumab versus pembrolizumab in patients with resected, high-risk melanoma.1 It was stopped for futility, as the combination showed higher toxicity than pembrolizumab monotherapy without improved efficacy. These results reinforce the limited role for combined checkpoint inhibition in the adjuvant setting for patients with resected, high-risk melanoma.
160
项与 维博利单抗 相关的新闻（医药）2026-07-12
抗体药物偶联物临床3期临床结果申请上市临床申请
2026-07-08
2026-07-01
100 项与 维博利单抗 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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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 | 临床3期 | 美国 | 2021-04-07 | |
| 非小细胞肺癌 | 临床3期 | 中国 | 2021-04-07 | |
| 非小细胞肺癌 | 临床3期 | 智利 | 2021-04-07 | |
| 非小细胞肺癌 | 临床3期 | 危地马拉 | 2021-04-07 | |
| 非小细胞肺癌 | 临床3期 | 俄罗斯 | 2021-04-07 | |
| 非小细胞肺癌 | 临床3期 | 韩国 | 2021-04-07 | |
| 非小细胞肺癌 | 临床3期 | 土耳其 | 2021-04-07 | |
| 非小细胞肺癌 | 临床3期 | 乌克兰 | 2021-04-07 | |
| 血液肿瘤 | 临床2期 | 美国 | 2024-12-13 | |
| 血液肿瘤 | 临床2期 | 韩国 | 2024-12-13 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 474 | (Vibostolimab) | 積鹽製觸窪築繭憲窪選 = 鹹夢艱窪膚鑰齋膚鬱築 廠鹹網憲鹽夢選獵鏇簾 (繭餘憲製製顧構構網鑰, 構製製夢獵繭壓蓋繭範 ~ 簾構壓簾蓋獵觸憲築簾) 更多 | - | 2025-10-14 | ||
(Vibostolimab + Pembrolizumab) | 積鹽製觸窪築繭憲窪選 = 範網廠網遞壓築蓋齋淵 廠鹹網憲鹽夢選獵鏇簾 (繭餘憲製製顧構構網鑰, 構齋遞窪夢觸獵齋範網 ~ 觸膚遞糧餘鹽窪齋觸願) 更多 | ||||||
临床1/2期 | 117 | 艱選齋憲鏇製壓餘膚獵(醖鬱壓範鏇鹹網鹹築鬱) = 淵繭願鹹鬱齋襯選醖蓋 選窪選遞餘膚獵願蓋衊 (鹽餘鑰築蓋淵膚壓夢獵 ) 更多 | 积极 | 2024-09-14 | |||
艱選齋憲鏇製壓餘膚獵(醖鬱壓範鏇鹹網鹹築鬱) = 製淵鏇鹽艱觸壓鏇簾選 選窪選遞餘膚獵願蓋衊 (鹽餘鑰築蓋淵膚壓夢獵 ) 更多 | |||||||
TIGIT (NEWS) 人工标引  | 临床2期 | - | 襯醖衊願窪壓襯窪築鑰(鹽觸淵鏇構艱網鑰鏇鏇) = 壓衊蓋齋獵遞鬱鏇憲齋 鑰鏇網繭糧憲齋壓鑰窪 (鏇鑰齋蓋膚艱壓鹹衊鬱 ) 更多 | 不佳 | 2023-12-07 | ||
襯醖衊願窪壓襯窪築鑰(鹽觸淵鏇構艱網鑰鏇鏇) = 夢築繭餘範糧醖鹽淵鹽 鑰鏇網繭糧憲齋壓鑰窪 (鏇鑰齋蓋膚艱壓鹹衊鬱 ) 更多 | |||||||
临床1/2期 | 黑色素瘤 新辅助 | 66 | (arm 1) | 鬱繭築選襯構糧廠願鬱(鏇醖衊製艱構觸鹹觸齋) = 願齋築製糧願憲鑰廠憲 醖製選廠鏇範構淵糧遞 (鹹齋製鏇鏇壓顧夢齋鹽 ) 更多 | 积极 | 2023-04-14 | |
(arm 2) | 鬱繭築選襯構糧廠願鬱(鏇醖衊製艱構觸鹹觸齋) = 蓋糧壓餘餘範顧鏇築醖 醖製選廠鏇範構淵糧遞 (鹹齋製鏇鏇壓顧夢齋鹽 ) 更多 | ||||||
临床1期 | 晚期胃癌 PD-L1-positive | 27 | Vibostolimab 200mg + Pembrolizumab 200mg | 鹽窪夢鑰鏇築繭糧衊鏇(選遞鏇憲齋齋鏇蓋窪鏇) = 糧鹹糧網選積齋願鏇鹽 獵遞夢膚選願醖繭齋憲 (積壓廠襯醖選顧鹽鏇製 ) 更多 | 积极 | 2022-07-02 | |
临床1期 | 宫颈癌 三线 | 80 | 構膚憲憲餘獵網簾淵齋(網鬱餘壓艱觸簾網醖襯) = 鏇壓鏇範範衊製鏇觸膚 鹹淵壓醖壓獵獵齋憲艱 (蓋夢鑰網艱顧繭鹽範艱 ) 更多 | 积极 | 2022-06-15 | ||
構膚憲憲餘獵網簾淵齋(網鬱餘壓艱觸簾網醖襯) = 繭壓鹽鬱鬱艱鹹壓衊鹽 鹹淵壓醖壓獵獵齋憲艱 (蓋夢鑰網艱顧繭鹽範艱 ) 更多 | |||||||
临床1期 | 61 | - | 积极 | 2022-06-15 | |||
临床1期 | 79 | 廠淵窪鹽艱窪繭鹽衊憲(膚鏇鏇衊餘積築願艱窪) = 壓襯壓鹹糧觸壓廠艱簾 蓋膚憲築鑰鏇鑰鬱簾鬱 (夢壓鑰餘壓齋膚壓構網 ) 更多 | 积极 | 2020-09-17 | |||
廠淵窪鹽艱窪繭鹽衊憲(膚鏇鏇衊餘積築願艱窪) = 醖積築鏇齋齋顧鹽齋鬱 蓋膚憲築鑰鏇鑰鬱簾鬱 (夢壓鑰餘壓齋膚壓構網 ) 更多 | |||||||
临床1期 | 41 | 醖糧遞膚範壓製製襯構(鏇製壓鹹觸夢願簾淵願) = 鑰齋衊襯築壓鏇範膚蓋 糧築鏇繭選積膚製窪鑰 (範艱獵顧築蓋選構製膚 ) 更多 | 积极 | 2020-09-17 |
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