阿斯利康的T790M牛逼新药AZD9291的1期临床结果出来了

AZD9291 First Time In Patients Ascending Dose Study
http://clinicaltrials.gov/show/NCT01802632
Drug: AZD9291
Starting dose 20 mg, administered once daily. If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined


D. Ross Camidge, MD, PhD, Director, Thoracic Oncology Clinical Program, University of Colorado Cancer Center, discusses a phase I study looking at AZD9291 in patients with non-small cell lung cancer.

AZD9291 is an irreversible inhibitor of epidermal growth factor receptor (EGFR) activating and resistance mutations and seemed to be well tolerated in the trial. Camidge says he found it interesting that some patients did have a little bit of rash, possibly indicating that researchers are already approaching the ideal dose. AZD9291 demonstrated about a 46% response rate overall and about a 56% response rate in T790M+ patients.

Right now, Camidge says, AZD9291 could be a "game-changer," and anticipates a fast-track approval.

"The ESMO abstract details data for 27 enrolled patients with 6 patients across 3 dose escalation cohorts and 9 patients in a T790M+ expansion cohort. In terms of safety, the most common adverse events were Grade-1 (G-1) with maximum G-1 diarrhea and rash toxicity in the 20, 40 and 80mg cohorts. Diarrhea and rash are also toxicities typical of Iressa and Tarceva," said Kozul.

"In terms of efficacy, 1) for the 20mg cohort, 2/6 patients cohort demonstrated a partial response (PR) and both of these patients had confirmed T790M+ status; 2) for the 40mg cohort, 2/6 patients demonstrated 2 unconfirmed PRs and the T790M status of these patients in unknown; 3) for the 80mg cohort, no data have yet been provided. Dose escalation continues as well as recruitment into the T790M+ expansion cohort," he added.
========================================
Response data for AZN’s drug AZD9291 includes 2 confirmed partial responses at the first (20 mg/day) dose level in
patients whose NSCLC tumors harbored a T790M mutation and 2 unconfirmed responses in the 40 mg dose (T790M
status unknown). To date, 27 patients have been treated across 20, 40 and 80 mg dose levels (n = 18) and in T790M+
expansion cohorts (n = 9) and no dose limiting toxicities have been reported. Both dose escalation and recruitment into a
T790M expansion cohort are ongoing.

AZD9291.pdf (216.43 KB, 下载次数: 184)

2013-10-4 10:37 上传

点击文件名下载附件

AZD9291联合用药方案的体外实验.PDF (1.52 MB, 下载次数: 479)

2014-12-20 22:59 上传

点击文件名下载附件

Leerink Swann maintained an Outperform rating on Clovis Oncology (NASDAQ: CLVS) with a price target of $88.00. Comments follows data from AstraZeneca's (NYSE: AZN) AZD-9291.

"At ESMO, AZD-9291 had positive data and represents strong competition to CLVS' CO-1686 in a large sand box narrowly defined by T790M+ patients and broadly by the entire nonsmall cell lung cancer (NSCLC) market," said analyst Marko Kozul. "Net-net, a MEDACorp key opinion leader (KOL) at ESMO believes AZN (MP) and CLVS are in a close first-to-market race, with resources likely to define the winner."

"ESMO AZD-9291 data demonstrate it is a strong competitor even at the 20mg dose, with potential improvement from further dose escalation just as CLVS may benefit from dose escalation with its 500mg BID bromide salt formulation and beyond. Positive Rucaparib data at ESMO continue to de-risk this compound, which should generate more value in 2014+. Assuming AZD-9291/CO-1686 split the T790M+ market, our DCF would still yield $68, with upside from front-line NSCLC penetration and Rucaparib. We reiterate our Outperform rating, $88 price target (PT) and would take advantage of any volatility going into World Lung at the end of
October," he added.

能找个坛油帮忙翻译一下吗？

azd9291患者第一次剂量递增研究
http://clinicaltrials.gov/show/nct01802632
药物：azd9291
起始剂量20毫克，每日给药一次。如果允许随后的同伙将测试azd9291剂量增加，直到最大耐受剂量和最大剂量的定义是可行的
D.罗斯Camidge，医学博士，博士，主任，胸部肿瘤临床程序，科罗拉多大学癌症中心，探讨I期研究非小细胞肺癌患者azd9291。
azd9291是表皮生长因子受体（EGFR）激活和不可逆抑制剂耐药突变似乎是很好的耐受性试验。Camidge说他发现它有趣的是，一些患者也有一点点的皮疹，这可能表明，研究人员已经接近理想的剂量。azd9291显示约46%的整体反应率和反应率约56%在患者T790M +。
现在，Camidge表示，azd9291可能“改变游戏规则，“期待快速审批。

winson0930 发表于 2013-10-3 10:33

                               
登录/注册后可看大图

azd9291患者第一次剂量递增研究
http://clinicaltrials.gov/show/nct01802632
药物：azd9291

将就着看看先吧，用百度翻译的。

用量小，原料成本可以低不少，期待。

用过4002后,用这个还会有效果吗?疑问?
应该是易瑞沙耐药后马上要用这个 药吧?
有E突变的吃这款药有效,那没突变的会有效吗?