晚期肾细胞癌（RCC）一线治疗药物Tivozanib完胜多吉美

备受关注的可能作为晚期肾细胞癌（RCC）一线治疗药物Tivozanib的名为TIVO-1的Ⅲ期临床研究结果于2012年第一季度公布。Tivozanib 是一种口服的可针对全部3种血管内皮生长因子的受体抑制剂。在Ⅱ期临床研究中，Tivozanib在晚期RCC治疗组患者中的疾病无进展生存期（PFS）高达11.7个月，在经肾切除手术的肾透明细胞癌患者中，采用Tivozanib治疗的PFS 为14.8个月。而目前RCC一线治疗药物由辉瑞开发的苹果酸舒尼替尼（sunitinib malate，Sutent）在初治肾透明细胞RCC中的PFS 为11月。同时，安全性评价研究中发现与其他的血管内皮因子受体抑制剂治疗药物相比tivozanib明显减少非靶向毒性。预计Ⅲ期临床药物详细结果将支持本品在2012年提交新药上市申请。
　　Tivozanib由AVEO Pharmaceuticals公司与安斯泰来制药公司联合开发，1周前两公司联合发布了TIVO-1的试验进展情况。该报道称Tivozanib 在这项Ⅲ期临床试验中获得了肯定结果，试验终末点目标肾细胞癌患者中的无疾病进展生存期优于对照组药物索拉非尼。

Tivozanib Successfully Demonstrated Progression-Free Survival Superiority over Sorafenib in TIVO-1 Trial

BatonIn January 2012, AVEO and its collaborator Astellas Pharma Inc. announced that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase 3 clinical trial evaluating the efficacy and safety of investigational drug tivozanib compared to sorafenib in 517 patients with advanced RCC.


TIVO-1 is the first registration study in first-line RCC that is comparing an investigational agent against an approved VEGF therapy. The trial is being led by Robert Motzer, M.D. from the Memorial Sloan-Kettering Cancer Center.


All patients in TIVO-1 had clear cell RCC, had undergone a prior nephrectomy, and had not previously been treated with either a VEGF or mTOR therapy. Based on the top-line analysis of events in TIVO-1, determined by a blinded, independent review committee, key top-line findings include:

     tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 11.9 months compared to a median PFS of 9.1 months for sorafenib in the overall study population
    tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 12.7 months compared to a median PFS of 9.1 months for sorafenib in the pre-specified subpopulation of patients who were treatment naïve (no prior systemic therapy); this subpopulation was approximately 70% of the total study population
    tivozanib demonstrated a well-tolerated safety profile consistent with the Phase 2 experience; the most commonly reported side effect was hypertension, a well established on-target and manageable effect of VEGFR inhibitors

In February 2011, AVEO and Astellas entered into a worldwide agreement outside of Asia to develop and commercialize tivozanib for the treatment of a broad range of cancers. AVEO and Astellas are evaluating tivozanib in additional clinical trials in other solid tumors.


Tivozanib Phase 2 Trial Showed Positive Safety and Efficacy Data

Prior to initiating TIVO-1, AVEO successfully completed a 272-patient, multi-center, randomized Phase 2 clinical trial of tivozanib in patients with advanced RCC. Median PFS achieved among all patients (n=272) in the Phase 2 trial was 11.7 months4.


The safety profile of tivozanib observed in the Phase 2 trial was notable for the minimal off-target toxicities often associated with VEGF, multi-targeted therapies. There was a low incidence of diarrhea, fatigue, stomatitis and hand-foot syndrome. Hypertension and dysphonia (hoarseness of voice), which are mechanism-related side effects associated with angiogenesis inhibitors, were the most commonly reported drug-related side effects, and both were manageable and reversible4.

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1.5 mg/d tivozanib orally in 4-week cycles (3 wks on, 1 wk off)
我在阿里巴巴搜索到的价格是2元一mg，非常的便宜。
目前亟需知道的是这个药的形态，是酸，碱，还是盐？
请大家帮忙找找专利和相关信息。

是完胜索坦吗？ 又多了一种药。

不知道对肝上面有没有用~

请大家开始探讨

简单说就是效果比索坦好点，副作用比索坦小点

新的希望

药品名：Tivozanib

开发商：Aveo Pharmaceuticals

合作伙伴：安斯泰来制药（ Astellas Pharma）

主要适应症：肾细胞癌

关键日期：预计第三季度提交新药申请（NDA ）

今年，Aveo Pharmaceuticals公布了其主导药物tivozanib在一个关键性试验中的良好数据，使得该药物很有可能成为一个安全和有效的下一代肾细胞癌治疗药物。虽然这些数据未能引起投资者的兴趣，但是公司正计划今年夏天向FDA提交该药的申请。

怎么没有多靶点的药呢？VEGFR,MTOR,C-MET全抑制的,索坦加依维莫司加197的混合体什么时候才可以面世啊

leeefeng 发表于 2012-5-15 20:46

                               
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怎么没有多靶点的药呢？VEGFR,MTOR,C-MET全抑制的,索坦加依维莫司加197的混合体什么时候才可以面世啊

多靶点 多副作用 就算有了这药,副作用也会受不了

又有新药了，希望肝癌也能用。

希望我老公能够等到这药。