楊志新 拚 新 肺癌治療指引 (Gilotrif(R) ,afatinib)

新藥 改寫晚期肺癌治療指引【聯合晚報╱記者李樹人╱即時報導】 2014.06.03 07:27 am 被列為惡性腫瘤之首的肺癌，治療上出現重大突破！台大醫院教授楊志新於美東時間6月2日19時（台北6月3日8時）在美國臨床癌症學會（ASCO）正式發表跨國性研究成果，第二代（不可逆）標靶藥物延長EGFR基因突變的轉移肺癌患者整體存活期達12.3個月。這項名為LUX-lung3的跨國性臨床試驗則證實不可逆標靶口服藥物是全球第一個能延長晚期肺癌患者整體存活期的藥物。楊志新強調，晚期肺癌治療指引將因此被改寫。這項試驗從2009年起執行，共收345人，受試者均為常見的EGFR基因突變，其中七成為亞洲人，台灣則有八家醫學中心、60名肺癌轉移患者參與這項新藥試驗。受試者分為兩組，一組使用不可逆標靶藥物，另一則則僅接受化療，兩組皆持續用藥，直到治療無效為主。第一階段研究發現，在抑制腫瘤成長方面，新藥組可達13.6個月，化療組則為6.9個月。在整體存活期上，新藥延長罹患常見EGRF突變陽性的肺腺癌患者達三個月，降低19%死亡風險。如患者EGRF突變屬最常見第19外因子突變，降低死亡風險高達41%，整體存活期平均33.3個月，遠高於化療平均21.1個月。楊志新強調，不可逆標靶藥物抑制腫瘤生長的能力較強，因而有效延長晚期肺癌患者存活期。不過，新藥副作用為腹瀉、皮疹，約有二分之一患者因症狀嚴重，而需停藥，減輕劑量，研究發現，即使藥物減量，病患存活期並未受到影響。 【2014/06/03 聯合晚報】

May 30, 2014

ASCO 2014: Boehringer Ingelheim to present its latest oncology research including new data for Gilotrif® (afatinib) in advanced lung cancer patients  • 7 total abstracts accepted for afatinib and other compounds from the company's oncology research program • New overall survival data for afatinib to be presented on June 2nd (3:00 - 6:00 PM CDT, E Hall D2 [Abstract #8004 scheduled for 4:00 - 4:12 PM]) Ridgefield, CT, May 30, 2014 – Boehringer Ingelheim today announced that new data will be presented from 7 abstracts for Gilotrif® (afatinib) and investigational compounds, including nintedanib and BI 836845, from its oncology pipeline at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, on May 30 – June 3, 2014. Data include results from global Phase III trials of afatinib in different patient groups with advanced non-small cell lung cancer (NSCLC): LUX-Lung 3 and LUX-Lung 6 overall survival analysis (abstract #8004, oral presentation) comparing first-line afatinib to chemotherapy in patients with advanced NSCLC whose tumors have common epidermal growth factor receptor (EGFR) mutations LUX-Lung 5 (abstract #8019, poster session) evaluating treatment beyond disease progression with afatinib and paclitaxel versus investigator's choice of chemotherapy alone in patients with late-stage NSCLC whose disease has progressed after afatinib alone and have also failed several treatments, including chemotherapy, erlotinib or gefitinib "Boehringer Ingelheim is proud to present at this ASCO meeting the results from several abstracts for GILOTRIF as well as other investigational compounds from our growing oncology pipeline," said Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "Here at Boehringer Ingelheim, we are committed to advancing the care of patients, and these data underscore our efforts to investigate our research and clinical development programs in a variety of cancer types."

Title	Authors	Abstract Details
Gilotrif® (afatinib)
Overall survival (OS) in patients with advanced non-small cell lung cancer (NSCLC) harboring common Epidermal Growth Factor Receptor mutations (EGFR M+): pooled analysis of two large phase III studies (LUX-Lung 3 [LL3] and LUX-Lung 6 [LL6]) comparing afatinib with chemotherapy (CT)	James Chih-Hsin Yang, Lecia V. Sequist, Martin Schuler, Tony Mok, Kenneth O’Byrne, Vera Hirsch, Sarayut L Geater, Caicun Zhou, Dan Massey, Victoria Zazulina, Yi Long Wu	Monday, June 2 Oral abstract session Lung Cancer—Non-Small Cell Metastatic 3:00 - 6:00 PM E Hall D2 (Abstract #8004 scheduled for 4:00 - 4:12 PM)
LUX-Lung 5: a randomized, open-label, phase III trial of afatinib (A) plus paclitaxel (P) versus investigator’s choice of chemotherapy (ICC) in patients (pts) with metastatic non-small cell lung cancer (NSCLC) who had progressed on erlotinib/gefitinib (E/G) and afatinib	Martin Schuler, Chih-Hsin Yang, Keunchil Park, Jaafar Bennouna Yuh-Min Chen, Christos Chouaid, Filippo De Marinis, Jifeng Feng, Francesco Grossi, Dong-Wan Kim, Xiaoqing Liu, Shun Lu, Janos Strausz, Yuriy Vinnyk, Rainer Wiewrodt, Caicun Zhou, Vikram K. Chand, Bushi Wang, Joo-Hang Kim and David Planchard	Tuesday, June 3 Poster Highlights Session Lung Cancer—Non-Small Cell Metastatic 8:00 - 11:00 AME354b (Abstract #8019 Poster #33)
Nintedanib*
Antiangiogenic-specific adverse events (AEs) in patients with non-small cell lung cancer (NSCLC) treated with nintedanib (N) and docetaxel (D)	Martin Reck, Anders Mellemgaard, Sergey V. Orlov, Maciej Jerzy Krzakowski, Joachim Von Pawel, Maya Gottfried, Igor Bondarenko, Mei-Lin Liao, Jose Barrueco, Julia Hocke, Rolf Kaiser, Silvia Novello, Jean-Yves Douillard, LUME-Lung 1 Study Group	Saturday, May 31 General Poster Sessions: Lung Cancer—Non-Small Cell Metastatic 1:15 - 5:00 PM S Hall A2 (Abstract #8100 Poster #281)
Nintedanib plus pemetrexed/cisplatin followed by maintenance nintedanib for unresectable malignant pleural mesothelioma (MPM)–an international, multicenter, randomized, doubleblind, placebo-controlled phase II study	Giorgio V. Scagliotti, Natasha B. Leighl, Anna K. Nowak, Nick Pavlakis, Sanjay Popat, Jens Benn Sorensen, Jose Barrueco, Rolf Kaiser, Arsene-Bienvenu Loembe, Martha Mueller, Ute von Wangenheim, Martin Reck	Saturday, May 31 General Poster Sessions: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers 1:15 - 5:00 PM S Hall A2 (Abstract #TPS7612 Poster #218A)
Independent review of AGO-OVAR 12, a GCIG/ENGOT-intergroup phase III trial of nintedanib (N) in firstline therapy for ovarian cancer (OC)	Gunnar Kristensen, Philipp Harter, Olivier Trédan, Martin Oliver Sailer, Aristotelis Bamias, Nicoletta Colombo, Alexander Reinthaller, Frederic Goffin, Margarita Romeo, Petronella Ottevanger, Rainer Kimmig, Susanne Malander, Florence Joly, Nikolaus De Gregorio, Mansoor Raza Mirza, Jacobus Pfisterer, Tomas Minarik, Sandro Pignata, Michael Merger, Andreas Du Bois	Saturday, May 31 General Poster Sessions: Gynecologic Cancer 8:00 - 11:45 AM S Hall A2 (Abstract #5556 Poster #338)
BI 836845 (IGF ligand antibody)*
A Phase I dose escalation study of weekly BI 836845, a fully human, affinity-optimized, insulin-like growth factor (IGF) ligand neutralizing antibody, in patients with advanced solid cancers	Chia-Chi Lin, Kwang-Yu Chang, Dennis Chin-Lun Huang, Vicky Marriott, Ludy van Beijsterveldt, Li-Tzong Chen, Ann-Lii Cheng	Sunday, June 1 8:00 - 11:45 AM S Hall A2 (Abstract #2617 Poster #80)
Phase I dose escalation study of 3-weekly BI 836845, a fully human, affinity optimized, insulin-like growth factor (IGF) ligand neutralizing antibody, in patients with advanced solid tumours	Rihawi K, Ong M, Michalarea V, Bent L, Buschke S4, Bogenrieder T, Anthoney A, de Bono J, Twelves CJ	Sunday, June 1 8:00 - 11:45 AM S Hall A2 (Abstract #2622 Poster #85)

About Gilotrif® (afatinib) tablets  GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations. GILOTRIF is an oral, once-daily kinase inhibitor that is designed to irreversibly bind and inhibit the following receptors: EGFR (ErbB1), HER2 (ErbB2) and ErbB4.*Nintedanib and BI 836845 are investigational compounds. Their safety and efficacy have not been established.