肾癌新药Tivozanib的最新数据

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Aveo Oncology To Present New Clinical Data On Tivozanib At ESMO 2012 Congress
Announced Date : Sep 20, 2012

Aveo Oncology announced that new clinical data on its lead product candidate tivozanib, partnered with Astellas Pharma Inc. will be presented at the European Society of Medical Oncology (ESMO) 2012 Congress in Vienna, Austria, September 28 – October 2, 2012.

The schedule for the tivozanib data presentations at ESMO is as follows:

• Title: 'Patient preference for tivozanib hydrochloride or sunitinib in the treatment of metastatic renal cell carcinoma (mRCC): TAURUS study' will be presented by Bernard Escudier on September 29, 2012

• Title: 'Detailed comparison of the safety of tivozanib versus sorafenib in patients with advanced/metastatic renal cell carcinoma (mRCC) from a Phase 3 trial' will be presented by Tim Eisen on October 1, 2012.

• Title: 'Tivozanib pharmacokinetic (PK)/pharmacodynamics (PD) analysis of blood pressure (BP) and soluble vascular endothelial growth factor receptor 2 (sVEGFR2) in patients with advanced renal cell carcinoma (RCC)' will be presented by Dmitry Nosov on October 1, 2012.

William Slichenmyer, chief medical officer of Aveo Oncology, said, "At this year’s ESMO, investigators will present new data on both our lead product candidate tivozanib and our HGF inhibitory antibody ficlatuzumab. We believe the additional TIVO-1 analyses underscore the safety profile of tivozanib in RCC while the new ficlatuzumab data demonstrate its targeted inhibition of the HGF ligand. We look forward to sharing these data with the medical oncology community soon."
Aveo Oncology announced that new clinical data on its lead product candidate tivozanib, partnered with Astellas Pharma Inc. will be presented at the European Society of Medical Oncology (ESMO) 2012 Congress in Vienna, Austria, September 28 – October 2, 2012.

The schedule for the tivozanib data presentations at ESMO is as follows:

• Title: 'Patient preference for tivozanib hydrochloride or sunitinib in the treatment of metastatic renal cell carcinoma (mRCC): TAURUS study' will be presented by Bernard Escudier on September 29, 2012

• Title: 'Detailed comparison of the safety of tivozanib versus sorafenib in patients with advanced/metastatic renal cell carcinoma (mRCC) from a Phase 3 trial' will be presented by Tim Eisen on October 1, 2012.

• Title: 'Tivozanib pharmacokinetic (PK)/pharmacodynamics (PD) analysis of blood pressure (BP) and soluble vascular endothelial growth factor receptor 2 (sVEGFR2) in patients with advanced renal cell carcinoma (RCC)' will be presented by Dmitry Nosov on October 1, 2012.

William Slichenmyer, chief medical officer of Aveo Oncology, said, "At this year’s ESMO, investigators will present new data on both our lead product candidate tivozanib and our HGF inhibitory antibody ficlatuzumab. We believe the additional TIVO-1 analyses underscore the safety profile of tivozanib in RCC while the new ficlatuzumab data demonstrate its targeted inhibition of the HGF ligand. We look forward to sharing these data with the medical oncology community soon."

老马 · 发表于 2012-10-21 14:10:35

本帖最后由老马于 2012-10-21 14:25 编辑

2012-10-9, Aveo制药与合作伙伴安斯泰来（Astellas）周五宣布，已向FDA提交了tivozanib的上市许可申请（MAA），用于治疗晚期肾细胞癌，这是一种最常见类型的肾癌。

AVEO and Astellas Announce New Data Presented at ESMO 2012 Congress Demonstratin.pdf (62.14 KB, 下载次数: 61)

ESMO 2012 Tivozanib TIVO-1 Safety Poster - Eisen.pdf (104.48 KB, 下载次数: 55)

lostm · 发表于 2012-10-21 21:24:51

剂量，1.5mg每天，吃三周休一周

把结论翻译一下：
Tivo相比多吉美，更少人因为副作用而减量或中止。
tivo组，高血压、发声困难的发生率更高，腹泄、手足综合症、秃头的发生率更少。

此外，低血红蛋白的发生率，tivo相比sorafenib是36% 对46%
低白细胞，10%对9%
低血小板，17%对11%.

奇怪，原来多吉美的低血红蛋白的发生率这么高吗？

Tivozanib was well tolerated with low rates of off-target AEs and fewer dose
reductions and interruptions than sorafenib in patients with mRCC. Patients
receiving tivozanib experienced more hypertension and dysphonia, but less
diarrhea, palmar–plantar erythrodysesthesia syndrome, and alopecia than
patients on sorafenib
ll The overall incidences of drug-related AEs and drug-related ≥Grade 3 AEs
were lower with tivozanib than with sorafenib
ll Although hypertension was common and occurred early (within the first 2–3
weeks) with tivozanib, it was generally managed medically and was rarely
a reason for dose reduction, interruption or discontinuations, and there
was no evidence of increased cardiovascular consequences with tivozanib,
compared with sorafenib
ll Given its tolerability profile, tivozanib may present a potential treatment
option for patients with advanced renal cell carcinoma

老马 · 发表于 2012-10-22 10:42:19

Randi翻译：
AVEO Oncology公司与安思泰来（Astellas）公司今日公布了TIVO-1三期临床（Tlvozanib与sOrafenib作为一线药在晚期RCC治疗中的比较）试验新数据，此次公布的试验数据能够很好的对比tivozanib和索拉菲尼在转移性肾细胞癌（RCC）一线临床治疗中的安全性和可耐受性。2012年欧洲肿瘤学术年会上公布的结果表明：与使用索拉菲尼的患者相比，使用tivozanib的患者中，3级不良事件或无关不良事件者较少，坚持服药时间更长，且减量和中断次数较少。同时公布的还有RCC患者的生物标志物，TAURUS（TIVO和索坦在晚期肾癌细胞治疗对比）试验的设计研究，该试验已经招募到了第一位病人。AVEO公司最近就tivozanib向美国食品药品监督局提交了一份新药申请。

“在抗VEGF受体的治疗中如何尽量减少毒害是肾细胞癌治疗的关键因素，不良事件的发生可以导致抗VEGF治疗药物剂量的减少、中断甚至停止，”研究者Timothy Eisen博士如是说，“TIVO-1试验表明相对于索拉菲尼，tivozanib的副作用更小，药量调整也更少。这说明使用tivozanib的患者可以更稳定持久的完成治疗。”

本次名为TIVO-1的第三期全球性随机临床试验，在517位晚期RCC患者中，对比了 tivozanib和索拉菲尼的安全性和可耐受性。在今年稍早前举行的美国肿瘤学术年会上，公司公布的研究结果表明，从数理统计上看，使用tivozanib的患者总体无进展生存期长于使用索拉菲尼的患者（中位无进展生存期11.9个月vs.9.1个月；系数p=0.042, HR=0.797）。此外，在一群初次接受靶向治疗的患者中，使用tivozanib的患者中位无进展生存期达到了12.7个月，亦优于索拉菲尼9.1个月(系数p=0.037; HR=0.75)，使得tivozanib成为第一种可以使此类病人无进展生存期突破一年的药物。

研究者为更好的了解 tivozanib的安全性，就这两种药物所引起的不良反应对比研究，结果如下：

与使用索拉菲尼的患者相比，使用tivozanib的患者药物减量和治疗中断次数较少：药物减量(11.6% vs. 42.8%, p<0.001),中断(17.8% vs. 35.4%,p<0.001)，用药终止(4.2% vs. 5.4%)。药物引起的副作用发生概率(67.6% vs. 83.3%)， 3级以上不良反应发生概率(36.3% vs. 51.0%)。3级以上高血压tivozanib组概率虽然高于索拉菲尼组(23.6% vs. 15.2%)，然而手足症(1.9% vs. 16.7%)，腹泻(1.9% vs. 5.8%)，脂肪酶含量上升(0.8% vs. 5.8%)这些不良反应在索拉菲尼组发生概率较高。

[有点乱，总的来说就是除了高血压概率tivo高于索拉，其他都好于索拉]

“我们的tivozanib研发项目是全面的并且在继续推进。TIVO-1试验的数据结果表明tivozanib有很好的安全性和有效性，我们将继续探索研究生物标志物的作用和患者个体差异，以帮助优化RCC治疗方案”， AVEO首席医疗官 William Slichenmyer博士说，“对正在进行的生物标志物项目所取得结果的进一步分析将在今后的会议上公布，TSURUS试验（TIVOzanib对比索坦对rcc的疗效）也正在进行之中。”

为进一步说明安全性，TIVO-1试验中的药动学/药效学数据也在会议上得到公布。