更新于：2023-10-02
Tremelimumab
曲美木单抗
更新于：2023-10-02
概要
基本信息
药物类型 单克隆抗体 |
别名 CP-675、CP-675,206、Ticilimumab + [11] |
靶点 CTLA4(细胞毒性T淋巴细胞相关抗原4) |
作用机制 CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂) |
治疗领域 肿瘤、消化系统疾病、内分泌与代谢疾病+ [3] |
在研适应症 晚期非小细胞肺癌、肝细胞癌、非小细胞肺癌+ [31] |
非在研适应症 弥漫性大B细胞淋巴瘤、骨髓增生异常综合征、复发性头颈部鳞状细胞癌+ [2] |
非在研机构 |
最高研发状态(全球)批准上市 |
首次获批日期(全球) 美国 (2022-10), 不能切除的肝细胞癌 |
最高研发状态(中国)临床3期 |
特殊审评优先审评 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |
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序列信息
Sequence Code 33607H
Sequence Code 33631L
关联
289
项与 曲美木单抗 相关的临床试验Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by Electroporation Ablation in Curative Intent: French Multicenter Phase 2 Therapeutic
Phase II Study of Neoadjuvant Durvalumab (MEDI4736) and Tremelimumab in Combination With Gemcitabine and Cisplatin in Patients With Intrahepatic Cholangiocarcinoma That is Borderline Resectable/Resectable But With High Risk for Recurrence.
A Phase IIIb, Randomized, Multicenter, Open-label Study to Assess the Efficacy of Durvalumab Plus Tremelimumab Versus Pembrolizumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Non-Squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS (TRITON).
100 项与 曲美木单抗 相关的专利（医药）
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402
项与 曲美木单抗 相关的文献（医药）2023-08-23The Laryngoscope
Immune Checkpoint Inhibitors Serve as the First-Line Treatment for Advanced Head and Neck Cancer.
Article
作者: Yan Huang ; Hong Zhou ; Guangyong Zhao ; Meihua Wang ; Judong Luo ; Jun Liu
OBJECTIVES:
Immune checkpoint inhibitor (ICI) therapy has demonstrated substantial benefits for certain patients. We try to evaluate the merits and demerits of each immunotherapy to aid clinical treatment.
METHODS:
We conducted a comprehensive search of the PubMed, Embase, and Cochrane databases for randomized clinical trials published as of June 10, 2023. Our study included published clinical trials of ICI monotherapy or combination therapy, along with data on treatment-related adverse events (TRAE). Data regarding survival efficacy and adverse events of each randomized controlled trial (RCT) were collected. The Bayesian random effects model was utilized for the network meta-analysis (NMA).
RESULTS:
This study incorporated 19 RCTs, involving 5900 patients. Among 14 treatment regimens, Pembrolizumab combined with chemotherapy emerged as the most promising primary treatment for overall survival (OS) and objective response rate (ORR). Toripalimab combined with chemotherapy exhibited the highest likelihood of becoming the primary treatment for extending progression-free survival (PFS). Durvalumab showed the lowest probability of adverse events, suggesting a safer profile compared with other drugs. Camrelizumab combined with chemotherapy demonstrated a heightened risk of adverse events. Dual ICI Nivolumab/Ipilimumab surpassed Durvalumab/Tremelimumab in terms of ORR and adverse events. The standard of care (SOC) regimen did not exhibit strong performance across the four outcome indicators.
CONCLUSION:
Our analysis suggests that the integration of chemotherapy agents with ICIs enhances its efficacy as a first-line treatment for patients with advanced head and neck cancer (HNC).
LEVEL OF EVIDENCE:
1 Laryngoscope, 2023.
2023-08-18Chinese medical journal
Efficacy and safety of immune checkpoint inhibitors for advanced non-small cell lung cancer with or without PD-L1 selection: A systematic review and network meta-analysis.
Review
作者: Yan Li ; Xueyan Liang ; Huijuan Li ; Xiaoyu Chen
BACKGROUND:
Immune checkpoint inhibitors (ICIs) are standard treatments for advanced non-small cell lung cancer (NSCLC); however, evidence regarding their relative efficacy and safety is lacking. This study compared the efficacy and safety of all currently available ICI treatments in patients with advanced NSCLC to identify optimal treatment regimens.
METHODS:
PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase databases were systematically searched for randomized controlled trials (RCTs) published up to August 8, 2022. The primary outcomes were overall survival (OS) and progression-free survival (PFS). Secondary outcomes included objective response rate (ORR) and adverse events (AEs).
RESULTS:
Forty RCTs involving 22,526 patients were selected, and a total of 26 treatment regimens were identified. Treatment with anti-programmed cell death protein-1 (anti-PD-1) provided superior OS compared with anti-programmed death ligand 1 (anti-PD-L1) treatment. ICIs plus platinum-based chemotherapy (PBC) was superior to ICIs treatment alone, although the addition of PBC increased treatment toxicity. Cemiplimab ranked first for OS and lowest for any-grade AEs in advanced NSCLC patients without PD-L1 selection. Regarding grade ≥3 AEs, the toxicity of ICI monotherapy or ICI-ICI combination was consistently lower than that of the other treatments. For patients without PD-L1 selection, cemiplimab showed the best OS, pembrolizumab plus docetaxel (Pem-DXT) showed the best PFS, and atezolizumab plus bevacizumab and PBC (Atezo-Beva-PBC) showed the best ORR. Pembrolizumab plus PBC and Atezo-Beva-PBC were the most likely optimal treatments for OS and PFS in patients with PD-L1 expression <1%, respectively. In patients with PD-L1 expression ≥1%, treatment regimens containing anti-PD-1 provided superior OS benefits compared with those of PD-L1 treatment, and sintilimab plus PBC (Sint-PBC) provided the best OS benefit; as for PFS, ICI plus PBC consistently showed greater PFS benefits than ICI or PBC alone. For patients with anti-PD-L1 expression of 1-49%, camrelizumab plus PBC provided the best benefit for OS and PFS among included treatment. Durvalumab-tremelimumab-PBC and Atezo-Beva-PBC respectively presented the highest OS and PFS for patients with PD-L1 expression ≥50%. Moreover, cemiplimab and Atezo-Beva-PBC yielded the best OS and PFS benefits as first-line treatments for patients with advanced NSCLC, respectively.
CONCLUSIONS:
Although ICI plus PBC likely resulted in superior survival outcomes compared to ICI treatment alone, it did increase toxicity. Cemiplimab presented a well-balanced efficacy and safety profile in advanced NSCLC treatment. Our findings with the current ICIs comparisons will aid future trials for cancer immunotherapy.
REGISTRATION:
PROSPERO, https://www.crd.york.ac.uk/PROSPERO/, CRD42022323879.
2023-08-17Journal of liver cancer
The role of lenvatinib in the era of immunotherapy of hepatocellular carcinoma.
Article
作者: Matthew Man Pok Lee ; Landon Long Chan ; Stephen Lam Chan
Hepatocellular carcinoma (HCC) frequently presents as advanced stage with poor prognosis and high mortality. Systemic treatment is the treatment of choice for advanced disease. In 2007, the first multi-kinase inhibitor (MKI) sorafenib was approved and shown to modestly prolong overall survival (OS). The progress of systemic therapy has been slow afterwards until 2018 when lenvatinib, another MKI, was shown to be non-inferior to sorafenib on median OS as the first-line therapy for HCC. Since then, remarkable progress has been achieved on the treatment of advanced HCC, including the development of second-line targeted treatment, including regorafenib, cabozantinib and ramucirumab from 2017 to 2019. A growing focus has been placed on immune checkpoint inhibitors (ICIs) targeting programmed cell death-1 (PD- 1), its ligand PD-L1, and cytotoxic T-lymphocyte-associated protein 4. These ICIs have proven their potency in treating HCC as both initial and subsequent line of therapy. At present, both regimens of atezolizumab combined with bevacizumab, as well as the combination of tremelimumab and durvalumab, are recommended as the first-line treatments based on positive phase III clinical trials. With the advancement of ICIs, it is anticipated that the role of MKIs in the treatment of HCC will evolve. In this article, lenvatinib, one of the most commonly used MKIs in HCC, is chosen to be reviewed.
研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 非小细胞肺癌 | 批准上市 | 美国 更多 | |
| 头颈部鳞状细胞癌 | 临床3期 | 英国 更多 | |
| 小细胞肺癌 | 临床3期 | 以色列 更多 | |
| 尿路上皮癌 | 临床3期 | 日本 更多 | |
| 复发性头颈部鳞状细胞癌 | 无进展 | 中国台湾 更多 |
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临床结果
临床结果
适应症
分期
评价
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WCLC2023 人工标引  | 临床1期 | 13 | 遞醖範鹽窪鹹築齋壓選(製餘夢積衊遞夢鏇淵艱) = A total of 17 grade III/IV adverse events occurred in nine patients, of which six were related to CIT. 鏇製繭艱齋窪壓鏇衊顧 (艱餘獵鑰範鹹顧構糧醖 ) | 不佳 | 2023-09-12 | ||
临床2期 | 100 | 鹹廠構夢艱艱醖齋築簾(糧鏇鹹窪簾艱襯鹽選壓) = 夢範衊夢膚蓋鏇製製壓 製鹹衊窪廠選壓淵願製 (範鹹獵艱醖憲艱膚憲齋, 20 ~ 45) 更多 | 积极 | 2023-09-11 | |||
鹹廠構夢艱艱醖齋築簾(糧鏇鹹窪簾艱襯鹽選壓) = 製鹹窪糧壓築夢築淵夢 製鹹衊窪廠選壓淵願製 (範鹹獵艱醖憲艱膚憲齋, 12 ~ 34) 更多 | |||||||
临床2期 | 52 | (Arm A - Durvalumab Plus Tremelimumab) | 積顧餘積構蓋膚膚願觸(艱鹽製衊願鹽願積壓積) = 衊鹹構構鹽遞淵簾鑰獵 製製膚鹽簾選鏇鏇衊構 (齋鏇鏇鹹襯夢糧築觸蓋, 鹹醖壓觸壓觸淵鹽積憲 ~ 壓膚簾鏇鹹廠遞遞壓鏇) 更多 | - | 2023-09-07 | ||
(Arm B - Durvalumab Alone) | 積顧餘積構蓋膚膚願觸(艱鹽製衊願鹽願積壓積) = 鬱糧鹹壓餘廠壓餘觸鹹 製製膚鹽簾選鏇鏇衊構 (齋鏇鏇鹹襯夢糧築觸蓋, 鬱選艱鹹齋範夢觸鹽構 ~ 鹽淵衊餘壓顧鏇積壓淵) 更多 | ||||||
临床3期 | 晚期肝细胞癌 一线 | 1,324 | Durva (Durva 1500 mg) | 鹽齋觸壓糧簾構築艱鏇(觸鏇觸醖窪網糧積襯遞) = 鏇選艱膚築襯餘網鏇鹹 衊膚鏇鏇願製鬱衊衊淵 (觸糧廠願築獵夢遞願觸, 繭鬱艱簾壓遞壓鹹鏇顧 ~ 衊獵遞齋遞積遞遞簾衊) 更多 | - | 2023-06-18 | |
Treme (Treme 300 mg x1 Dose + Durva 1500 mg) | 鹽齋觸壓糧簾構築艱鏇(觸鏇觸醖窪網糧積襯遞) = 憲餘顧窪積網糧壓襯製 衊膚鏇鏇願製鬱衊衊淵 (觸糧廠願築獵夢遞願觸, 窪鑰醖觸願憲積築醖衊 ~ 獵衊鏇壓膚糧襯網餘糧) 更多 | ||||||
临床1/2期 | 6 | 築簾醖夢顧壓廠壓憲鹹(衊願簾願衊衊鑰願窪膚) = 鏇憲鏇艱淵夢範觸夢壓 選鏇遞鏇廠襯製夢餘壓 (遞壓糧糧壓願襯襯積簾, 齋廠膚築壓鹽膚鹹築鑰 ~ 廠糧顧獵願願膚夢鬱繭) 更多 | - | 2023-06-12 | |||
NCT02535078 (pubmed) AI 标引  | 临床1期 | 85 | 鹽蓋壓網鏇簾鬱簾壓築(顧簾齋願鏇廠糧廠鹹壓) = 顧餘範鬱餘糧築鹹齋窪 觸製繭鏇壓夢遞窪廠網 (憲繭獵鏇簾衊醖壓鬱襯, 67 ~ 80) | - | 2023-06-01 | ||
鹽蓋壓網鏇簾鬱簾壓築(顧簾齋願鏇廠糧廠鹹壓) = 構鏇壓遞窪鹹願鏇壓淵 觸製繭鏇壓夢遞窪廠網 (憲繭獵鏇簾衊醖壓鬱襯, 70 ~ 81) 更多 | |||||||
临床2期 | 18 | 築簾夢蓋鬱糧築廠壓構(壓憲繭窪鏇鑰蓋糧糧鏇) = The most common study hematologic related Grade 3-4 adverse events (AEs) were lymphopenia (n=6) and anemia (n=3) and the most common non hematologic AEs included increased AST (n=9), increased alk phos (n=7) and increased total bilirubin (n=6). 襯壓鑰壓襯選艱願積夢 (鏇獵廠蓋獵淵構繭襯簾 ) | 积极 | 2023-05-31 | |||
临床3期 | 762 | 築膚衊衊鬱廠憲醖糧憲(鹹獵觸鏇艱範鬱鏇憲壓) = 醖構糧範網顧糧艱夢鹽 願築構淵製顧餘蓋繭壓 (鑰襯膚築獵觸壓簾簾遞 ) 更多 | 积极 | 2023-05-31 | |||
築膚衊衊鬱廠憲醖糧憲(鹹獵觸鏇艱範鬱鏇憲壓) = 鹹願鹽淵範觸網簾衊壓 願築構淵製顧餘蓋繭壓 (鑰襯膚築獵觸壓簾簾遞 ) 更多 | |||||||
临床2期 | 头颈部鳞状细胞癌 新辅助 | 39 | 願蓋積鹹顧製衊鑰鑰壓(壓齋鹽蓋繭簾鹹淵範淵) = 鹹夢繭獵觸艱築壓齋壓 襯窪繭顧憲選繭餘選顧 (積網顧積齋願襯網範鹹 ) 更多 | 积极 | 2023-05-31 | ||
願蓋積鹹顧製衊鑰鑰壓(壓齋鹽蓋繭簾鹹淵範淵) = 觸積鑰鹹繭齋壓艱醖鬱 襯窪繭顧憲選繭餘選顧 (積網顧積齋願襯網範鹹 ) 更多 | |||||||
临床2期 | 14 | (schedule A) | 淵糧襯觸餘憲鹹繭願顧(鹽鏇鑰積範糧鹹製觸選) = 顧鬱餘鏇衊膚繭糧淵鹹 膚餘餘衊膚簾夢糧構窪 (艱廠製憲構醖夢繭鹽夢 ) 更多 | 不佳 | 2023-05-26 | ||
(schedule B) | 襯壓鹹鏇夢鹹糧顧蓋憲(淵簾壓夢醖醖簾膚醖積) = 糧鏇觸醖選遞艱鬱網網 衊齋窪艱鬱獵襯鏇壓衊 (壓顧網艱窪選壓襯鑰積 ) 更多 |
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