《肿瘤瞭望》:[asco2015] thomas lynch教授、石远凯教授现场解读asco热点-奔驰宝马电玩城

 《肿瘤瞭望》:[asco2015] thomas lynch教授、石远凯教授现场解读asco热点-奔驰宝马电玩城

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《肿瘤瞭望》:[asco2015] thomas lynch教授、石远凯教授现场解读asco热点
日期: 2015-06-02

  在肺癌治疗、特别是egfr突变的晚期非小细胞肺癌(nsclc)治疗领域,asco 2015展示了哪些重要的研究进展?

 

  lynch教授:本次asco会议展示了肺癌领域的诸多研究进展,比如在5月31日上午口头报告专场,azd9291一线治疗egfr突变晚期nsclc显示出非常好的抗肿瘤活性;rociletinib治疗t790m突变阳性nsclc患者也显示出较好效果。这两种新药给egfr突变患者更多治疗选择。相比美国,中国nsclc患者中egfr突变更加常见,针对这类患者的治疗更重要。

 

  石远凯教授:根据中国的多中心研究结果,中国晚期肺腺癌患者中egfr突变阳性者超过50%,而西方国家的比例大约是17%。因此,egfr-tki在中国有更多的应用空间。

 

  lynch教授:本届asco会议有一点让我感到失望,本次会议展示了pd-1/pd-l1抑制剂免疫治疗的成果,却没有展示egfr突变患者pd-1/pd-l1抑制剂治疗有多少获益,这方面还需要更多的临床试验,特别是在亚洲。

 

  石远凯教授:我同意您的观点,目前证明有效的pd-1/pd-l1抑制剂是由西方国家药企研发,中国的研究刚刚起步。目前我们正在开展转化研究以确认egfr突变阳性同时pd-1/pd-l1阳性表达患者的比例,目前还没有确切数据,但不久的将来我们会宣布试验结果。

 

  nsclc免疫治疗是2015 asco 会议热点之一,您如何评价pd-1/pd-l1抑制剂的疗效?

 

  lynch教授:免疫疗法治疗癌症的效果令人振奋,其治疗egfr突变患者的疗效还不清楚。本次asco会议展示了pd-1/pd-l1抑制剂治疗黑色素瘤的良好疗效。这一类药物都比较有前景。

 

  石远凯教授:请问lynch教授,您如何看待egfr-tki联合pd-1/pd-l1抑制剂治疗nsclc患者?

 

  lynch教授:目前还没有确切答案,许多egfr-tki联合pd-1/pd-l1抑制剂治疗的试验正在进行中,我们需要等待研究数据。

 

  在egfr突变阳性肺癌一线治疗方面有哪些新的选择?您如何评价中国自主创新药物埃克替尼?

 

  lynch教授:我多年前就对埃克替尼有所了解,是因为贝达药业在康涅狄格州纽黑文设有公司,就在耶鲁。我曾与许多埃克替尼的研发者和企业领导接触过。埃克替尼的研究数据令我印象深刻,不仅仅是疗效,其毒性数据也比较好,腹泻、皮疹等副作用的发生率较低。我认为埃克替尼也是egfr突变阳性nsclc患者一线治疗的良好选择。

 

  石远凯教授:埃克替尼为中国自主研发、亚洲首个egfr-tki原创新药。埃克替尼iii期icogen研究[随机、双盲双模拟、平行对照、多中心评价埃克替尼和吉非替尼治疗既往接受过一个或两个化疗的局部晚期或转移的非小细胞肺癌患者的疗效和安全性iii期临床试验]被接受为2011年世界肺癌大会(wclc)的口头报告,在2013年肿瘤领域影响因子最高的《柳叶刀.肿瘤》分册上发表。icogen iii期研究显示埃克替尼与吉非替尼二、三线治疗晚期nsclc患者的疗效相当,但埃克替尼显示出更好的安全性,总体不良事件发生率减少,患者耐受性更佳。上市后iv研究(isafe研究)与icogen 研究的结果一致,显示出良好的疗效。

 

  目前正在开展埃克替尼一线治疗与化疗对比的convince研究,研究进展顺利,不久之后会发布研究结果。2014年,埃克替尼获得了中国的国家食品药品监督管理局(sfda)批准的一线治疗egfr突变晚期nsclc患者的适应证。convince研究试验设计具有独特性,在化疗对照组(培美曲塞 顺铂)又加上了维持治疗,所以结果更值得期待。

  

        未来应如何改进肺癌治疗策略?

 

  lynch教授:在过去10年中,肺癌领域取得诸多研究成果。目前已有 5 种治疗egfr突变肺癌患者的药物,正在对免疫治疗egfr突变肺癌的潜力进行研究。问题是,对患者进行分子检测后,我们是否有可用的药物针对分子机制进行治疗?目前需要更多临床研究的是ras突变肺癌患者的治疗。美国有30%腺癌患者有ras突变,但是我们治疗ras突变肺癌的药物极其有限。

 

  石远凯教授:在中国的ras突变肺癌患者比西方国家少。但是下一步的确需要针对这类患者开展更多研究工作。

  近年来,中国原创性药物的发展突飞猛进,您如何看待中国研发创新药物的能力?

 

  lynch教授:我强烈认为,中国在药物研发方面做了许多工作,并投入大量资金。中国在基因组研究和理解癌症基因机制方面做了很多工作,使中国患者获益,并有利于新药研发。

 

  石远凯教授:中国本土药企不仅致力于仿制药研发,也致力于创新药物研发。目前越来越多的中国医生参与肿瘤药物的创新研发和转化研究的工作。

 

  lynch教授:中国在白血病药物创新研发方面成果显著,也有其他领域的重要创新药物成果。在这方面我们应开展合作。最近有何创新药物研发进展?

 

  石远凯教授:在中国,一些创新药物由本土企业独立研发,一些创新药物为中外制药企业合作研发。有些癌症在国外较少见,而中国有庞大的患者群体。例如中国有非常多的肝细胞瘤、鼻咽癌和食管癌患者,一半以上的食管癌发生在中国。针对这类肿瘤的药物研发中国医生做了大量工作。

 

  比如,在2015年asco会议上,来自中国的临床研究“埃克替尼二线治疗egfr过表达或扩增的晚期食管癌的ii期单臂试点试验”在壁报专场展示。试验入组患者为活检确诊有 egfr 过表达[免疫组织化学(ihc)3 ]或扩增[荧光原位杂交(fish)阳性]晚期食管癌鳞癌患者,患者已经接受铂类为基础的一线化疗。试验结果良好,初步研究结果提示,埃克替尼二线治疗 egfr过表达或扩增的晚期食管癌展现出良好的抗肿瘤活性和安全性。

 

  lynch教授:试验结果良好,真是太好了!

  

         专家介绍

 

1.jpg

 

  thomas james lynch, md,国际著名肺癌专家,靶向抗癌药的国际权威,肺癌领域新的治疗方法研究的佼佼者,康涅狄格洲纽黑文耶鲁肿瘤中心的主任、康涅狄格洲纽黑文smilow肿瘤医院的主任。他对肺癌治疗的贡献已获得世界认可,作为egfr突变的首位发现者之一,2013年被授予癌症护理巨人奖(giants of cancer caretm award)。thomas lynch教授在2004年报告了egfr基因突变可预示egfr酪氨酸激酶抑制剂治疗,掲开了肺癌个体化治疗的序幕。

 

2.jpg

 

  石远凯教授,肿瘤学博士、肿瘤内科主任医师、博士研究生导师,中国医学科学院肿瘤医院副院长,国家抗肿瘤药物临床研究机构副主任,抗肿瘤分子靶向药物临床研究北京市重点实验室主任,中国医师协会肿瘤医师分会会长,中国药学会抗肿瘤药物专业委员会主任委员,中国抗癌协会常务理事、学术部部长,中国抗癌协会肿瘤临床化疗专业委员会主任委员,中国抗癌协会淋巴瘤专业委员会副主任委员,中国抗癌协会癌症康复会副主任委员,中国老年学学会老年肿瘤学专业委员会副主任委员,中国药学会药物临床评价研究专业委员会副主任委员,中国抗癌协会临床肿瘤学协作专业委员会(csco)执行委员,亚洲临床肿瘤学会副主席,国家食品药品监督管理局药品审评专家,“重大新药创制”科技重大专项gcp组和化药组责任专家。


中英对照原文

 

  oncology frontier: dr lynch, as a pioneer in the egfr-mutated cancer field, what progress have we have seen at this 2015 asco annual meeting?

 

  《肿瘤瞭望》:在肺癌治疗、特别是egfr突变的晚期非小细胞肺癌(nsclc)治疗领域,asco 2015展示了哪些重要的研究进展?

 

  dr lynch: we have had a lot of good examples of progress at this year’s asco meeting. we have learned that azd9291 looks like having excellent activity as first-line treatment in patients with egfr-mutated lung cancer. we have learned that the clovis compounds also have activity in t790m-mediated resistant tumors and maybe some patients without resistance. these two new drugs, in addition to afatinib, icotinib, erlotinib and gefitinib will give doctors more choice. in china, i would imagine the disease is a bigger issue for you than in the united states given how much more common egfr-related mutations are in china.

 

  lynch教授:本次asco会议展示了肺癌领域的诸多研究进展,比如在5月31日上午口头报告专场,azd9291一线治疗egfr突变晚期nsclc显示出非常好的抗肿瘤活性;rociletinib治疗t790m突变阳性nsclc患者也显示出较好效果。除了阿法替尼、埃克替尼、厄洛替尼和吉非替尼,这两种新药给egfr突变患者更多治疗选择。相比美国,中国nsclc患者中egfr突变更加常见,针对这类患者的治疗更重要。

 

  dr shi: because of the genetic background, the disease differs between the caucasian and oriental populations. for egfr mutations, patients in the caucasian population make up about 17%, but from our chinese multi-center study, we found 50% of our adenocarcinoma patients had the egfr-active mutation. so i believe the egfr tkis will be used more frequently in chinese adenocarcinoma patients because of the higher incidence of the egfr-active mutation.

 

  石远凯教授:这与不同人种的基因背景差异有关。根据中国的多中心研究结果,中国晚期肺腺癌患者中egfr突变阳性者超过50%,而西方国家的比例大约是17%。因此,egfr-tki在中国有更多的应用空间。

 

  dr lynch: i agree. one thing i was disappointed about here at asco was that we had the presentation on the pd-1/pd-l1 study and it didn’t look like the egfr mutation group seemed to benefit as much. we aren’t completely certain of that yet as the numbers are small and more study is needed particularly in asia.

 

  lynch教授:我同意您的观点,本届asco会议有一点让我感到失望,本次会议展示了pd-1/pd-l1抑制剂免疫治疗的成果,却没有展示egfr突变患者pd-1/pd-l1抑制剂治疗有多少获益,这方面还需要更多的临床试验,特别是在亚洲。需要确认egfr突变阳性同时pd-1/pd-l1表达的患者占多大比例,及其采用pd-1/pd-l1抑制剂治疗的获益。

 

  dr shi: the pd-1/pd-l1 therapies are developed by western pharmaceutical companies and we are only beginning clinical study and development in china. in the future, we will have more experience and data.we are currently doing translational research to determine what percentage of egfr-mutated patients has pd-1 expression. i don’t have precise data so far but you can expect us to announce our findings later.

 

  石远凯教授:目前证明有效的pd-1/pd-l1抑制剂是由西方国家药企研发,中国的研究刚刚起步。目前我们正在开展转化研究以确认egfr突变阳性同时pd-1/pd-l1阳性表达患者的比例,目前还没有确切数据,但不久的将来我们会宣布研究结果。

 

  oncology frontier: what has been your experience with the clinical use of the pd-1 and pd-l1 therapies?

 

  《肿瘤瞭望》:nsclc免疫治疗是2015 asco 会议热点之一,您如何评价目前的pd-1/pd-l1抑制剂研究进展?

 

  dr lynch: i think the pd-1 and pd-l1 drugs are very exciting in cancer. in the egfr setting, i don’t think we know enough yet. data presented today showed good results with melanoma, but the whole class of drugs is very promising.

 

  lynch教授:免疫疗法治疗癌症的效果令人振奋,其治疗egfr突变患者的疗效还不清楚。本次asco会议展示了pd-1/pd-l1抑制剂治疗黑色素瘤的良好疗效。这一类药物都比较有前景。

 

  dr shi: i would like to ask dr lynch what is your opinion on combining egfr tkis and pd-1/pd-l1s?

 

  石远凯教授:请问lynch教授,您如何看待egfr-tki联合pd-1/pd-l1抑制剂治疗nsclc患者?

 

  dr lynch: it’s a great question but we just don’t know yet. there are many ongoing trials now looking at combinations so we will have to wait for that data.

 

  lynch教授:目前还没有确切答案,许多egfr-tki联合pd-1/pd-l1抑制剂治疗的试验正在进行中,我们需要等待研究数据。

 

  oncology frontier: icotinib is china’s innovative drug for advanced egfr mutation-positive nsclc. the icogen study, what is your comment on the efficacy of icotinib and its significance in treating egfr mutation-positive advanced nsclc?

 

  《肿瘤瞭望》:您如何评价中国自主创新药物埃克替尼?

 

  dr lynch: i have known about icotinib for many years. because beta pharmaceuticals has us office in new haven, yale, i have chance to meet the investigators and leaders in new haven, connecticut. i was always impressed by the toxicity profile of icotinib. the data i have seen has always looked very encouraging. the only downside was it has to be taken three times a day but that may be more tolerable with a reduced side effect profile.

.

  lynch教授:我多年前就对埃克替尼有所了解,是因为贝达药业在康涅狄格州纽黑文设有公司,就在耶鲁。我曾与许多埃克替尼的研发者和企业领导接触过。埃克替尼的研究数据令我印象深刻,不仅仅是疗效,其毒性数据也比较好,腹泻、皮疹等副作用的发生率较低。唯一的不足是需要1日用药三次,但是既然副作用降低,这点可以忍受。

 

  dr shi: from the icogen trial here in china, my experience is also is that icotinib has low toxicity compared to other egfr tkis. even though the dosing is three times daily, it is easily tolerated by patients. we also designed the clinical trial as a first-line treatment compared to pemetrexed and cisplatin.after four cycles of induction chemotherapy, we use pemetrexed as maintenance therapy and the results will be announced soon. i am really looking forward to the results for icotinib in the first-line setting. last year, we received chinese fda approval for the use of icotinib as a first-line therapy in egfr-mutated tumors.

 

  石远凯教授:根据icogen iii期研究,埃克替尼的总体不良事件发生率减少,即使1日用药3次,患者也容易耐受。目前正在开展埃克替尼一线治疗与化疗(培美曲塞 顺铂)对比的convince研究,化疗对照组后续培美曲塞维持治疗,该研究进展顺利,不久之后会发布研究结果。我们在上市后iv研究(isafe研究)中获得了一线治疗的经验。2014年,埃克替尼获得了中国的国家食品药品监督管理局批准的一线治疗egfr突变晚期nsclc患者的适应证。

 

  oncology frontier: as we have discussed, there have been several novel therapies coming available for use. what has to be done, particularly in terms of clinical trials, to further improve our treatment strategies?

 

  《肿瘤瞭望》:未来应如何改进肺癌治疗策略?

 

  dr lynch: we are very lucky in the field of lung cancer as there has been so much development over the last ten years. we now have five drugs that are effective in egfr-mutated lung cancer. we also look at the potential of incorporating immunotherapy. the challenge for us as doctors is that when doing molecular profiling, do we have enough options to meet a patient’s molecular profile? one place i think we need more help with better clinical trials is with ras -mutated lung cancer. in the united states, ras makes up about 30% of our adenocarcinomas and we have very few options for treating ras-mutated adenocarcinomas.

 

  lynch教授:在过去10年中,肺癌领域取得诸多研究成果。目前已有5种有效治疗egfr突变肺癌患者的药物,我们也对免疫治疗的潜力进行研究。问题是,对患者进行分子检测后,我们是否有可用的药物针对分子机制进行治疗?目前需要更多临床研究的是ras突变肺癌患者的治疗。美国有30%腺癌患者有ras突变,但是我们治疗ras突变肺癌的药物极其有限。

 

  dr shi: in china, the incidence is less than in your population, but it is certainly the next problem to be solved for that percentage of patients.

 

  石远凯教授:中国的ras突变肺癌患者比西方国家少。但是下一步的确需要针对这类患者开展更多研究工作。

 

  oncology frontier: in the recent times, china’s pharmaceutical industry has undergone an historic transformation from imitation to innovation.  if you look forward, will china evolve into a major force in drug innovation?

 

  《肿瘤瞭望》:近年来,中国原创性药物的发展突飞猛进,原来的仿制药大国开始了原创药物研发历程,您如何看待中国研发创新药物的能力?

 

  dr lynch: my opinion is very strong. we have seen tremendous commitment to science and investment in science from china. the commitment i see to genomics and understanding the genetics of cancer, for example, will be of huge benefit to china and the whole of asia by allowing us to do profiling and bring new drugs to market.

 

  lynch教授:我强烈认为,中国在药物研发方面做了许多工作,并投入大量资金。中国在基因组研究和理解癌症基因机制方面做了很多工作,使中国患者获益,并有利于新药研发。

 

  dr shi: i agree. in recent years, chinese domestic pharmaceutical companies have made huge efforts to develop drugs; not just generic drugs but also innovative agents. there are more and more drugs going to clinical trials and consequently more chinese doctors contributing to clinical research for anti-cancer therapies and also translational medicine.

 

  石远凯教授:中国本土药企不仅致力于仿制药研发,也致力于创新药物研发。目前越来越多的中国医生参与肿瘤药物的创新研发和转化研究的工作。

 

  dr lynch: the chinese have lead the way in retinoic acid and arsenic in leukemia, for instance, and there are other examples of great innovation from china and that is something we should eagerly embrace and collaborate with.

 

  lynch教授:中国在白血病药物创新研发方面成果显著,也有其他领域的重要创新药物研发,我们应积极开展合作。最近有何创新药物研发进展?

 

  dr shi: some drugs are developed by chinese companies; some ones by cooperating with international companies. some cancer types are quite specific to the chinese population such as esophageal cancer, hepatoma and nasopharyngeal carcinoma. the incidence of these cancers is quite different in western populations. furthermore, the incidence of cancers like nasopharyngeal cancer has spread to northern china as well as southern china over twenty years or so. so chinese doctors need to make great efforts to do research on these cancers. for example, we have a poster at this conference describing the use of icotinib as second-line treatment for squamous cell esophageal carcinoma with good results.

 

  石远凯教授:在中国,一些创新药物由本土企业独立研发,一些创新药物为中外制药企业合作研发。中国的癌症人群有其特殊性,有些癌症在国外较少见,而中国有庞大的患者群体。例如中国有非常多的肝细胞瘤、鼻咽癌、食管癌患者。针对这类肿瘤的药物研发中国医生需要做大量工作。比如,在2015年asco会议上,来自中国的临床研究“埃克替尼二线治疗egfr过表达或扩增的晚期食管癌的ii期单臂试点试验”在壁报专场展示,试验结果良好。

 

  dr lynch: it is good!

 

  lynch教授:试验结果良好,真是太好了!

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