AP26113 对付 EGFR T790M 突变
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以下是ARIAD 公司总裁Harvey J. Berger 5月20日发言的节选 -
& l8 [2 i- R7 ^2 R, Q"So let's spend the last couple of minutes talking about 113. 113 -- 26113, another one of our internally discovered cancer medicines, is a triple threat. It's a single medicine with 3 well-defined lung cancer targets: ALK, EGFRm and ROS1. We've already proven without question, it's a compelling new medicine for patients with ALK-positive lung cancer. We see promising opportunities that, based on future data, will become clear a potential lung cancer medicine as well for these other categories of genetically defined forms of lung cancer.. D6 [7 R3 C/ G5 D9 n' H
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Here, again, the numbers of patients are large. The opportunity is great for each one: ALK, ROS1 and EGFRm. Knowing the biology and knowing the failures of patients who have EGFR forms of lung cancer patients who are being treated with drugs such as Tarceva, about half of those patients -- of the patients who fail drugs like Tarceva fail because of a single well-defined mutation, the T790M mutation, and 113 is a highly potent and strong inhibitor of T790M EGFRm. It spares the other forms of EGFR, so we anticipate that as one looks going forward, that its safety profile will distinguish it from all of the other forms of EGFR inhibitors. And as well, it is targeted, specifically, for the T790M mutation.5 f9 V* ~2 q. Z7 i
2 l/ j8 e# C, [! X5 |6 h% DLet's look at where we are and what to expect in the next couple of weeks. We have announced that we'll transition the Phase I/II trials of 113 to Phase II by ASCO. ASCO's 2 to 3 weeks from now, so this is imminent.1 V7 w& |1 J6 _7 u3 h3 A
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The pivotal trial in ALK-positive non-small cell lung cancer will begin in the third quarter. We are on track to achieve that. We have shared all of the safety and efficacy data obtained to date on 113 with the regulatory agencies in the U.S., major countries in Europe, as well as more broadly, and have a clear unified plan that will lead us to evaluation of 113 and ALK-positive lung cancer and a registration strategy that will allow us to achieve registration of 113 quickly and with a very straightforward approach.# {8 Y- \1 K' T" h! }) H' e4 A
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We have escalated the dose in our Phase I trial to 300 milligrams per day and have studied multiple doses at and below 300 milligrams. And we will provide a lot of additional insights into the Phase I trial, the safety and efficacy of 113 at the upcoming American Society of Clinical Oncology Meeting where the focus will be on the Phase I data, on dose escalation, dose and schedule, safety, tolerability and pharmacokinetics. We'll also lay out our strategy and plan for Phase II and the focus in the Phase II program on the T790M mutated form of EGFR for the third of the 5 cohorts in the Phase II trial.
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So a clear focus, both in terms of registration and expanding our knowledge of 113 in the expanded Phase II program.* Q0 [8 e9 q+ F! M4 b6 b [
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We see 113 moving rapidly now through clinical development through the Phase II cohorts, which are -- have been targeted to begin this quarter, and we are on track to achieve that. We expect, as I indicated earlier, to start the pivotal Phase III trial in parallel with continuing the Phase II program. So we are on track, as planned, last year to move 113 forward quickly and on a clear path to registration.
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3 W! N8 a1 u( A# L; i- Q113, as I started, represents really 3 threats in 1: ALK, ROS1 and EGFRm. We already have compelling clinical data on ALK. We have definitive preclinical data on ROS1, and we'll study ROS1 patients in Phase II and EGFRm, a clear focus on the T790M patients in the Phase II program. So clarity with respect to what we're going to study, where we have the data and our plans going forward for registration of 113.
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So as we look at 2013, it's a big year, a lot of activity and a huge amount of activities that we anticipate and drivers of value through the year; ......; initiation of the pivotal trial for 113; expansion to the multiple Phase II cohorts for 113 to really expand out our comprehensive knowledge of 113 as an important new targeted cancer medicine in lung cancer; and lastly, presenting -- we anticipate the initial Phase II data on 113 in the fall, particular focus on the EGFRm T790M patients at the European Society of Medical Oncology.". U1 x' |+ N: ^: e4 z
0 K2 m" h- p$ @) U+ L3 k+ \ n他的说法和我的医生透露的信息一致: 就是AP26113针对EGFR T790M突变有效(但是记住: 其它突变无效). 病友们, 你们若用易瑞沙,特罗凯或凯美纳失效, 检查确定有T790M突变, 应该考虑选用AP26113.
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7 E4 G: y: F0 r: [: S& `另外, AP26113 药试II期马上要开始, III期也会与II期并行(不是等II期完成以后). |
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