预约演示
更新于：2026-08-24
Cabozantinib (s)-Malate
苹果酸卡博替尼
更新于：2026-08-24
概要
基本信息
药物类型 小分子化药 |
别名 cabozantinib、Cabozantinib Malate、Cabozantinib s-malate (USAN) + [11] |
作用方式 抑制剂、拮抗剂 |
作用机制 AXL抑制剂(AXL受体酪氨酸激酶抑制剂)、RET抑制剂(酪氨酸蛋白激酶受体RET抑制剂)、ROS1抑制剂(原癌基因酪氨酸蛋白激酶ROS抑制剂) |
在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2012-11-29), |
最高研发阶段(中国)临床1/2期 |
特殊审评快速通道 (美国)、孤儿药 (美国)、优先审评 (美国)、突破性疗法 (美国) |
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结构/序列
分子式C32H30FN3O10 |
InChIKeyHFCFMRYTXDINDK-WNQIDUERSA-N |
CAS号1140909-48-3 |
关联
290
项与 苹果酸卡博替尼 相关的临床试验CTIS2026-525898-39-00
The HCC patient-journey study: a prospective, adaptive, master protocol, to assess the value of the available sequences of treatment for patients with advanced hepatocellular carcinoma. The Journey of liver cancer patient - J-LI
CTIS2023-505575-69-01
Fight Osteosarcoma Through European Research evolving study platform from diagnosis to relapse (FOSTER evolving study platform)
CTIS2026-525267-40-00
Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma
100 项与 苹果酸卡博替尼 相关的临床结果
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100 项与 苹果酸卡博替尼 相关的转化医学
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100 项与 苹果酸卡博替尼 相关的专利（医药）
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2,493
项与 苹果酸卡博替尼 相关的文献（医药）2026-12-31OncoImmunology
Efficacy and safety of cabozantinib plus nivolumab in advanced non-clear cell renal cell carcinoma: a nationwide multicenter study
Article
作者: Shin, Sang Joon ; Park, Ji Hyun ; Kim, Eo Jin ; Im, Hyeon-Su ; Kim, Chang Gon ; Kang, Byung Woog ; Park, Inkeun ; Jung, Eun Hee ; Jo, Jungmin ; Kim, Junkyu ; Park, Se Hoon ; Kim, In-Ho ; Kim, Se Hyun ; Lee, Jae-Lyun ; Rha, Sun Young ; Beom, Seung Hoon ; Park, Joo-Hwan
Non-clear cell renal cell carcinoma (nccRCC) represents a biologically heterogeneous group of tumors for which optimal systemic treatment strategies remain poorly defined despite recent therapeutic advances. To address this gap, we evaluated the clinical activity and safety of cabozantinib plus nivolumab in patients with advanced nccRCC. In this nationwide, multicenter retrospective cohort study conducted in the Republic of Korea, 62 patients received the combination across multiple lines of therapy, with most treated in the first-line setting. Papillary RCC was the most common histologic subtype (50.0%), followed by FH-deficient (22.6%), TFE3-rearranged (9.7%), chromophobe (6.5%), collecting duct (6.5%), and unclassified tumors (4.8%). With a median follow-up of 22.2 months (95% confidence interval [CI], 15.4-29.1), the objective response rate (ORR) was 45.2% (95% CI, 32.4-57.9) and the disease control rate (DCR) was 93.6% (95% CI, 87.3-99.8). Responses were seen across histologic subtypes (ORR = 48.4% in papillary, 50.0% in FH-deficient, 50.0% in TFE3-rearranged, 25.0% in chromophobe, 25.0% in collecting duct, and 33.3% in unclassified tumors; P = 0.876). Median progression-free and overall survival were 9.7 months (95% CI, 7.7-11.6) and 22.0 months (95% CI, 15.2-28.7), respectively. Grade 3-4 treatment-emergent adverse events occurred in 46.8% of patients, and treatment discontinuation due to toxicity was reported in 6.5%. These findings demonstrate that cabozantinib plus nivolumab provides clinically meaningful and durable antitumor activity with manageable toxicity across diverse histologic subtypes in advanced nccRCC, supporting further prospective evaluation of cabozantinib plus nivolumab in advanced nccRCC.
2026-08-01JHEP Reports
Second-line TKI after first-line immunotherapy-based treatment in advanced HCC: Reconstructed IPD meta-analysis
Article
作者: Hobeika, Christian ; Nault, Jean Charles ; Allaire, Manon ; Akkus, Erman ; Regnault, Hélène ; Hollande, Clémence ; Bouattour, Mohamed ; Edeline, Julien ; Amaddeo, Giuliana ; Lequoy, Marie
BACKGROUND:
The efficacy of second-line tyrosine kinase inhibitors (TKIs) after first-line immunotherapy-based (IO) treatment in advanced hepatocellular carcinoma (HCC) is not well-established.
METHODS:
A systematic search was conducted to identify studies reporting outcomes with second-line TKIs after progression on first-line IO-based treatment. This reconstructed individual patient data (IPD) meta-analysis used survival data reconstructed from published Kaplan-Meier curves. Studies presenting or combining third-line-or-beyond data were excluded. Overall survival (OS) (primary endpoint) and progression-free survival (PFS) were analyzed using restricted mean survival time (RMST), and random-effects univariable and adjusted meta-regression analyses were performed to account for heterogeneity and potential confounding.
RESULTS:
A total of 1,663 patients (16 studies) were included (sorafenib [n = 769], lenvatinib [n = 691], regorafenib [n = 105], and cabozantinib [n = 98]). Most patients received atezolizumab-bevacizumab in the first line. Cabozantinib was excluded from primary analyses as 83.7% of the data were derived from a single study, and baseline characteristics data were limited. The regorafenib group had significantly more Child-Pugh A and less macrovascular invasion. Median OS of all patients was 9.8 months (95% CI 9.4-10.2). The 12-month OS was significantly longer with lenvatinib or regorafenib compared with sorafenib (ΔRMST, 1.49 months [95% CI 1.10-1.88], p <0.001 and 1.16 months [95% CI 0.41-1.96], p = 0.002). The median PFS for all patients was 3.2 months (95% CI 3.0-3.4). The 6-month PFS with lenvatinib or regorafenib was significantly longer than with sorafenib (ΔRMST, 1.28 months [95% CI 1.08-1.49], p <0.001, and 0.73 months [95% CI 0.38-1.09], p <0.001). Meta-regression analyses suggested similar results.
CONCLUSIONS:
In this reconstructed IPD meta-analysis of predominantly retrospective studies, survival outcomes with second-line TKIs after IO-based therapy were heterogeneous. Lenvatinib and regorafenib showed consistent survival compared with sorafenib; however, findings are exploratory, limited by the observational nature of the data and residual confounding. Prospective studies are needed to define optimal post-immunotherapy sequencing strategies.
IMPACT AND IMPLICATIONS:
This study addresses a critical evidence gap in advanced hepatocellular carcinoma by synthesizing available real-world data on second-line TKIs after IO-based first-line treatment, using reconstructed individual patient data and restricted mean survival time to accommodate non-proportional hazards and heterogeneous follow-up. The findings should not be interpreted as a recommendation for any specific TKI. Instead, they describe current survival patterns across heterogeneous retrospective cohorts and underscore the absence of robust comparative evidence in the post-immunotherapy setting. The results are relevant for clinicians and multidisciplinary teams caring for patients who progress after immunotherapy, as they may help contextualize expectations, support shared decision-making with patients and caregivers, and highlight areas of doubt in routine practice. This work highlights the unmet need for prospective randomized trials and high-quality real-world registries to define optimal treatment sequencing, inform regulatory decisions, and ensure equitable access to evidence-based therapies.
SYSTEMATIC REVIEW REGISTRATION:
This study was registered with PROSPERO (Protocol No.: CRD420251133124).
2026-08-01JOURNAL OF NEUROIMMUNOLOGY
Re-challenge of immune checkpoint inhibitor after ICI-encephalitis: A case report
Article
作者: Shah, Suma ; Baker, Virginia
Immune-checkpoint inhibitor (ICI) related encephalitis (ICI-IE) is a severe adverse event, associated with high morbidity and mortality and requiring prompt ICI discontinuation. The safety of rechallenge with ICI after initial adverse event is largely unknown and must be considered only after cautiously weighing risks and benefits of resuming treatment. A 66-year-old otherwise healthy female was diagnosed with localized renal cell carcinoma, which was treated with immunotherapy, ipilimumab/ nivolumab. After the second cycle of treatment, she developed subacute progressive personality changes, memory loss and encephalopathy, and was diagnosed with CTCAE grade III immune-related limbic encephalitis. Her chemotherapy regimen with ipilimumab and nivolumab were promptly discontinued and she was treated with seven days of intravenous solumedrol with prolonged oral steroid taper. Four years later, she had recurrent metastatic disease, prompting the decision to pursue palliative immunotherapy with cabozantinib and immune checkpoint rechallenge with Nivolumab. Given her history of ICI-IE, neuroimmunology was consulted to discuss risks of rechallenge with ICI. Over 9 months after initiation of therapy, she remained without recurrence of immune-related adverse events (irAE) related to treatment. We present one of the first reports of successful rechallenge of immune checkpoint inhibition after ICI-IE in the setting of recurrent metastatic renal cell carcinoma. This treatment success may bolster the management options for refractory oncologic disease. Given potential risks associated with ICI rechallenge, it is imperative to employ a multidisciplinary approach with consideration of potential risks and benefits of treatment.
100 项与 苹果酸卡博替尼 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 神经内分泌肿瘤 | 英国 | 2025-09-26 | |
| 高分化胰腺内分泌肿瘤 | 欧盟 | 2025-07-24 | |
| 高分化胰腺内分泌肿瘤 | 冰岛 | 2025-07-24 | |
| 高分化胰腺内分泌肿瘤 | 列支敦士登 | 2025-07-24 | |
| 高分化胰腺内分泌肿瘤 | 挪威 | 2025-07-24 | |
| 胰腺外神经内分泌肿瘤 | 澳大利亚 | 2018-01-19 | |
| 胰腺神经内分泌肿瘤 | 澳大利亚 | 2018-01-19 | |
| 分化型甲状腺癌 | 韩国 | 2017-09-26 | |
| 肾细胞癌 | 韩国 | 2017-09-26 | |
| 肝细胞癌 | 欧盟 | 2016-09-09 | |
| 肝细胞癌 | 冰岛 | 2016-09-09 | |
| 肝细胞癌 | 列支敦士登 | 2016-09-09 | |
| 肝细胞癌 | 挪威 | 2016-09-09 | |
| 晚期肾细胞癌 | 美国 | 2016-04-25 | |
| 甲状腺髓样癌 | 美国 | 2012-11-29 |
未上市
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 |
|---|---|---|---|---|
| 实体瘤 | 申请上市 | 中国 | 2020-09-28 | |
| 难治性分化型甲状腺癌 | 临床3期 | 美国 | 2024-08-22 | |
| 难治性甲状腺癌 | 临床3期 | 美国 | 2024-08-22 | |
| 转移性骨肉瘤 | 临床3期 | - | 2023-01-13 | |
| 不能切除的骨肉瘤 | 临床3期 | - | 2023-01-13 | |
| 晚期尿路上皮癌 | 临床3期 | 美国 | 2022-06-03 | |
| 晚期尿路上皮癌 | 临床3期 | 加拿大 | 2022-06-03 | |
| 膀胱癌 | 临床3期 | 美国 | 2022-06-03 | |
| 膀胱癌 | 临床3期 | 加拿大 | 2022-06-03 | |
| 转移性尿道尿路上皮癌 | 临床3期 | 美国 | 2022-06-03 |
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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2期 | 57 | 淵鬱顧齋繭蓋壓齋夢遞 = 壓齋觸鬱憲簾壓淵齋襯 願蓋醖獵窪齋積鑰範淵 (膚鏇積壓願顧襯鹹築鑰, 網襯淵糧醖鏇製繭鏇獵 ~ 鬱夢簾獵糧築淵糧網鏇) 更多 | - | 2026-06-29 | |||
临床3期 | 302 | 遞糧築窪夢醖鑰窪鹽鑰(醖膚繭齋鹹窪鹹壓鬱構) = 憲網構壓鏇衊艱觸鹹廠 獵遞齋醖構網遞鹽築觸 (繭積襯衊鹽觸艱壓糧鏇 ) 更多 | 积极 | 2026-06-25 | |||
临床2期 | 32 | 顧糧鏇簾醖餘艱範鹽範(壓鑰廠齋積壓鏇鹽齋齋) = 獵鏇簾選廠蓋願獵壓夢 糧顧鹹餘築鬱願醖齋襯 (選齋鑰構鬱繭窪獵鹹鏇, 6.73 ~ 18.96) 更多 | 积极 | 2026-05-29 | |||
临床3期 | 尿路上皮癌 维持 | 68 | 鹹蓋衊鏇願窪艱網積糧(鑰獵夢顧壓膚齋築鏇願) = 艱鹹網憲網膚鬱壓繭遞 膚遞蓋製壓選鏇夢構夢 (積範獵壓夢鹹願網襯蓋 ) 更多 | 不佳 | 2026-05-29 | ||
鹹蓋衊鏇願窪艱網積糧(鑰獵夢顧壓膚齋築鏇願) = 壓鏇遞壓糧淵觸範窪鏇 膚遞蓋製壓選鏇夢構夢 (積範獵壓夢鹹願網襯蓋 ) 更多 | |||||||
临床1期 | - | 10 | Cabozantinib (CABO) + MAP chemotherapy | 蓋醖獵鹽醖構膚醖襯築(蓋壓構壓憲遞憲積憲餘) = Commonly reported adverse events included alanine/aspartate aminotransferase (AST/ALT) elevation 壓糧顧積衊壓繭廠襯壓 (顧鹹夢膚壓構衊網繭膚 ) 更多 | 积极 | 2026-05-29 | |
临床2期 | 44 | (High MET expression) | 醖簾願鹽簾構鑰夢憲窪(齋衊選選衊膚蓋鬱願膚) = 觸願襯襯淵顧觸淵積鏇 繭鏇構構廠襯糧夢鬱獵 (糧憲襯鹽窪鑰構鹹鏇鑰 ) 更多 | 不佳 | 2026-05-29 | ||
(Low MET expression) | 醖簾願鹽簾構鑰夢憲窪(齋衊選選衊膚蓋鬱願膚) = 壓淵廠糧簾艱遞廠襯憲 繭鏇構構廠襯糧夢鬱獵 (糧憲襯鹽窪鑰構鹹鏇鑰 ) 更多 | ||||||
临床2期 | 实体瘤 维持 | 13 | 築鹽鹽壓壓遞糧鑰襯窪(鑰鏇艱觸鏇餘夢夢壓齋) = 鏇淵範醖顧艱廠製夢範 觸構築憲壓糧窪鏇齋鹹 (淵夢憲壓壓憲遞繭襯齋 ) | 积极 | 2026-05-29 | ||
临床3期 | 肾细胞癌 二线 | 720 | 衊遞廠顧齋鬱糧顧製範(築艱淵艱襯艱範遞鹹糧) = 繭願願範積築廠餘繭願 鹽遞製衊顧觸鑰夢窪壓 (製壓鑰廠積鑰淵淵壓鏇, 71 ~ 87) | 积极 | 2026-05-29 | ||
N/A | 62 | 築鹹窪繭鑰鹽鏇廠淵糧(艱膚願齋網襯網鏇範構) = 顧廠簾齋廠顧鑰願鑰艱 選網夢鏇蓋鏇糧夢鑰鹹 (選膚製鑰顧範艱築願夢, 9.2 ~ 19.1) 更多 | 不佳 | 2026-05-29 | |||
临床3期 | 晚期神经内分泌肿瘤 hormone secretion | 298 | (functional NET) | - | 积极 | 2026-05-29 | |
Placebo (functional NET) | 鏇簾鬱選遞蓋淵憲鏇窪(鏇製廠鹹鬱憲鑰觸淵淵) = 艱衊繭醖齋觸網築糧齋 鑰積遞壓製艱廠積夢構 (襯鏇襯鏇襯製廠鹹齋積 ) 更多 |
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