Business Wire

Boehringer Ingelheim 3rd-generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designation in lung cancer

Del

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.”

Regulatory update

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, 3 rd -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).

Intended audiences

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

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/21_december_2015_oncology.html

Contact information

Media:
Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
Tel.: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com
or
Further Media Channels
www.facebook.com/boehringeringelheim
www.twitter.com/boehringer
www.youtube.com/boehringeringelheim

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

AURAK Enters into a Memorandum of Understanding with Al-Farabi Kazakh National University22.7.2018 09:52Pressemelding

The American University of Ras Al Khaimah (AURAK) President, Professor Hassan Hamdan Al Alkim, and the Al-Farabi Kazakh National University (KazNU) Rector, Professor Galimkair Mutanov, of the Republic of Kazakhstan, signed a Memorandum of Understanding (MoU), agreeing to exchange students, faculty, and research. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180722005025/en/ The Al-Farabi Kazakh National University (KazNU) Rector, Professor Galimkair Mutanov, of the Republic of Kazakhstan and the American University of Ras Al Khaimah (AURAK) President, Professor Hassan Hamdan Al Alkim, exchange a gift to commemorate their universities uniting in an MoU agreement. (Photo: AETOSWire) In the spirit of fostering a close international relationship between the Republic of Kazakhstan and the United Arab Emirates, developing bilateral relations in educational and scientific fields, and wishing to make their own contributions to the

Philip Morris International Announces Non-Executive Board Chairman Louis Camilleri to Assume CEO Role at Ferrari S.p.A.21.7.2018 18:19Pressemelding

The board of directors of Philip Morris International (NYSE:PM) has its board member, Sergio Marchionne, and his family in our thoughts and prayers during this challenging time. We congratulate our board chairman, Louis Camilleri, as he assumes the role of CEO of Ferrari S.p.A. The long term relationship between our two companies is deep and meaningful and we look forward to continued business collaboration. Mr. Camilleri will continue to serve as non-executive chairman of the PMI board. Philip Morris International: Who We Are We are a leading international tobacco company engaged in the manufacture and sale of cigarettes and other nicotine-containing products in markets outside the United States of America. We’re building our future on smoke-free products. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, we aim to ensure that our smoke-free products meet adult consumer preferences and rigorous regulatory requirem

Loxam Announces a Conditional Agreement to Acquire UK Platforms20.7.2018 14:51Pressemelding

Loxam Group (“Loxam”) announces that its wholly-owned subsidiary Nationwide Platforms Limited (“Nationwide”) has entered into a conditional agreement with HSS Hire Group plc (“HSS”) with respect to the acquisition of UK Platforms Limited (“UKP”). UKP specializes in renting powered access equipment from its 12 branches located throughout the United Kingdom. The company has approximately 130 employees and operates a fleet of 3,000 units. UKP is controlled by HSS since 2013. As part of this transaction, Nationwide has entered into a commercial agreement with HSS to provide powered access equipment to complement HSS’ existing fleet. The closing of the transaction is subject to the approval by HSS’ shareholders and the confirmation that it will not be referred to the Competition and Mergers Authority. The transaction is expected to close before year end 2018. Don Kenny, CEO of Loxam’s Powered Access Division states: “I am delighted with the acquisition of UKP which will further reinforce NW

Schlumberger Announces Second-Quarter 2018 Results20.7.2018 11:00Pressemelding

Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2018 Mar. 31, 2018 Jun. 30, 2017 Sequential Year-on-year Revenue $8,303 $7,829 $7,462 6% 11% Pretax operating income $1,094 $974 $950 12% 15% Pretax operating margin 13.2% 12.4% 12.7% 75 bps 45 bps Net income - GAAP basis $430 $525 $(74) -18% n/m Net income, excluding charges & credits* $594 $525 $488 13% 22% Diluted EPS - GAAP basis $0.31 $0.38 $(0.05) -18% n/m Diluted EPS, excluding charges & credits* $0.43 $0.38 $0.35 13% 23% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “The second quarter was both busy and exciting for Schlumberger as we completed a number of major milestones in preparation for the broad-based global activity upturn that is now emerging. We delivered solid top-line gro

H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 19:50Pressemelding

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&

SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 16:01Pressemelding

We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact investor.relations@sig.biz . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough investor.relations@sig.biz