INGELHEIM, GERMANY--( / ) December 21, 2015 -- Boehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for its novel, 3rd-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI), BI 1482694* (HM61713**). The BTD is based on results from the Phase I/II HM-EMSI-101 clinical trial which were presented at the ESMO Asia 2015 Congress () in Singapore. BTDs have been established by the FDA to facilitate and expedite the development and review of promising drugs for serious or life-threatening conditions.
The HM-EMSI-101 clinical trial investigated BI 1482694 in patients with advanced and pre-treated EGFR mutation-positive non-small cell lung cancer (NSCLC). Based on these positive data, a New Drug Application for HM61713 / BI 1482694 has recently been submitted to the Korean Ministry of Food and Drug Safety by Hanmi Pharmaceutical Co. Ltd, with whom Boehringer Ingelheim has an exclusive license and collaboration agreement for the development and global commercialisation rights (except South Korea, China and Hong Kong) of BI 1482694.
Results from the Phase I/II clinical trial of BI 1482694 presented at the EMSO Asia 2015 Congress in Singapore, showcase the tumour activity and favourable safety profile of BI 1482694 at the recommended Phase II dose of 800mg once daily, previously presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting. In patients with T790M-positive NSCLC who had previously been treated with an EGFR TKI:
· Objective responses (ORs) by independent assessment were observed in 62% patients, including 32 patients (46%) whose tumour response had been confirmed by the time of data cut-off
· Disease control rate was 91% by independent assessment.
At the time of data cut off, median duration of response had not yet been reached and will be reported at a later date.
The most common treatment-related adverse events (AEs) included (total/grade 3) diarrhoea (55%/0%), nausea (37%/0%), rash (38%/5%) and pruritus (skin itching: 36%/1%) - the majority of AEs were mild-to-moderate.
Coordinating investigator Professor Keunchil Park, Division of Hematology & Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, South Korea commented, “These data further validate BI 1482694 as a potential treatment for lung cancer patients who encounter resistance to 1st- or 2nd-generation EGFR targeting treatments. Being able to improve outcomes of EGFR mutation-positive patients with minimum burden on their overall wellbeing is the goal for both patients and oncologists, so we eagerly await the duration of response and progression-free survival data from this study, as well as results of the broader clinical programme which is underway.”
The pivotal clinical development programme of BI 1482694 in lung cancer, ELUXA, encompasses multiple trials including Phase III studies starting in 2016. The first pivotal Phase II trial (ELUXA 1/HM-EMSI-202) is designed to further investigate the efficacy and safety of BI 1482694 in patients with NSCLC with acquired T790M-mediated resistance after first-line EGFR TKIs.
Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, “The clinical trial results we have seen so far for BI 1482694 are very encouraging and have led to the FDA Breakthrough Designation and a first regulatory submission in Korea. The T790M mutation is the most common resistance mechanism found in about half of the patients previously treated with currently available EGFR TKIs. Our aim at Boehringer Ingelheim is to prolong the continuum of treatment with targeted therapies for patients with EGFR mutation-positive lung cancer with a treatment that could potentially be efficacious even after the inevitable occurrence of resistance to the initial treatment.”
Boehringer Ingelheim aims to achieve first market authorisation for BI 1482694 in patients with T790M-positive NSCLC in 2017.
· In December 2015, the US FDA granted BI 1482694 with Breakthrough Therapy Designation
· In October 2015, a New Drug Application for HM61713 / BI 1482694, was filed to the Korean Ministry of Food and Drug Safety.
About the HM-EMSI-101 study
This is a Phase I/II, multicenter study of BI 1482694 in Korean patients. All patients included in the trial had been previously treated with at least one EGFR TKI and may have received additional lines of chemotherapy or other systemic treatments. At the recommended Phase II dose (RP2D: 800mg qd), all eligible patients had to have confirmed T790M mutation in the tumour. The primary endpoint was OR; secondary endpoints included duration of response, disease control rate, progression-free survival (PFS) and safety.
About the ELUXA 1 (HM-EMSI-202) study
ELUXA 1 () is an ongoing pivotal Phase II global clinical trial. It is designed to further investigate the efficacy and safety of BI 1482694 in patients with NSCLC whose tumours acquired T790M-mediated resistance after first-line EGFR TKIs. The ELUXA 1 trial is part of a broad ELUXA pivotal trial programme, which will include the initiation of Phase III studies in 2016.
*BI 1482694 is an investigational, novel, oral, 3rd-generation, EGFR mutant-specific tyrosine kinase inhibitor developed to target tumours with EGFR mutations including the resistance mutation T790M.
**Boehringer Ingelheim has an exclusive license and collaboration agreement with Hanmi Pharmaceutical Co. Ltd for the development and global commercialisation rights (except South Korea, China and Hong Kong) of BI 1482694 (HM61713).
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
For references and notes to editors please visit
View source version on businesswire.com:Korea Newswire distributes your news across every media channels through the industry’s largest press release distribution network
BURLINGAME, CALIF.--( / ) January 28, 2015 -- Misfit, makers of wearable and smart home 야동다모아 BURLINGAME,announced the integration 문래동2가고스톱 인디게이트 of their Flash Fitness and Sleep Monitor with 창성동화투치기 종아리스트레칭기구 wearable controls enabled by a series of partnerships. The 스마트폰주식거래 BURLINGAME,fully featured activity and sleep tracker under $50, Flash will soon allow users to interact with their favorite apps 문래동2가고스톱 신소율 and smart hardware by 문래동2가고스톱 뉴트리헥스 double or triple pressing its button face.
The first wearable control for Flash was demoed at CES, coinciding with 문래동2가고스톱 핵사메딘 the launch of 18 TheBolt, a connected bulb that lets 창성동화투치기 users 문래동2가고스톱 평점9점이상영화 personalize 창성동화투치기 한국백신주사기 their 창성동화투치기 평점높은액션영화 home lighting. Users will be able to turn Bolt on and off and control brightness with Flash.
Misfit 창성동화투치기 항문곤지름치료 is 다나와티비 Misfitthe following 창성동화투치기 죽기전에꼭봐야할영화 upcoming 문래동2가고스톱 평점9.0이상 integrations:
· Users will 문래동2가고스톱 DPCP be able to start 창성동화투치기 전망좋은집엑기스 and 여자가슴짱 ·창성동화투치기 their 문래동2가고스톱 곤지름치료 Spotify playlist with Flash.
바바라티비TV ·Misfit is working with 바바라티비TV ·on 문래동2가고스톱 사마귀없애는법 an integration enabling users 창성동화투치기 전망좋은집dailymotion to connect Misfit’s sleep tracking functionality and alarm with the Nest Learning Thermostat™ to wake up to their ideal temperature.
· With IFTTT, soon users 바바라티비TV ·utilize Misfit 투니모아 ·to 문래동2가고스톱 가소콜 turn on and off devices, fire off quick 창성동화투치기 messages, and send fitness information to 창성동화투치기 슬픈외국영화 an 창성동화투치기 재밌는외국영화 archive on the go.
· Logitech’s Harmony 창성동화투치기 트리암시놀론 API will allow 씹구멍 ·to 창성동화투치기 문래동2가고스톱 control smart home CA브라강치누 ·such as lights, TVs 창성동화투치기 and 바다이야기프로그램 ·players.
토토알바 ·Yo’s messaging services will let users 창성동화투치기 이지베드 stay 창성동화투치기 한국베드 connected with 문래동2가고스톱 friends and family 문래동2가고스톱 with a simple double press 문래동2가고스톱 더블베드 on Flash.
· Misfit Flash 창성동화투치기 소파베드 will allow August Smart 토토알바 ·users to 문래동2가고스톱 바이덱스플러스액 unlock 창성동화투치기 bed영화 토토알바 ·doors 창성동화투치기 without a smartphone.
Learn more about 섹툰 Learnnew 창성동화투치기 wearable controls 문래동2가고스톱 알타질 here: For a list of partners and for more 창성동화투치기 멸균생리식염수 information, visit or contact 인기릴께임 Learn
Crafted out of a special 문래동2가고스톱 폴리글러브 soft-touch plastic, Misfit 창성동화투치기 익스텐션라인 Flash is comfortable, durable, and waterproof to 30 meters. Like Shine, Flash never requires charging and can be worn virtually anywhere. Flash 문래동2가고스톱 아만다사이프리드노출영화 automatically measures 창성동화투치기 steps, calories, 문래동2가고스톱 수술용마스크 distance, sleep quality and duration, and even 지오파 Crafted창성동화투치기 레이저채혈기 cycling and swimming. Flash syncs wirelessly with the iOS and Android Misfit App.
Misfit invents and 창성동화투치기 소독용에탄올구매 문래동2가고스톱 소독용에탄올구매 manufactures great wearable and smart home products. The company was founded in 2011 by Sonny Vu with John Sculley, the former CEO of 전주성인용품사용방법에 Misfitand 금쇼핑몰추천 Misfitand Sridhar Iyengar, co-founder and former 창성동화투치기 CTO of AgaMatrix.
Copyright 2014 Misfit Wearables 알몸 Copyright하정동홀덤 Copyrightrights 창성동화투치기 곽민정 reserved.Korea Newswire distributes 문래동2가고스톱 손연재광고 your news across every 창성동화투치기 무정자증 media channels through the industry’s 창성동화투치기 체조선수노출 largest press eIbWC Copyrightdistribution network