Updated real-world data shows Giotrif®/Gilotrif® (afatinib) followed by osimertinib provided a median overall survival of up to almost four years in patients with EGFR Del19 and T790M mutation-positive NSCLC
Boehringer Ingelheim today announced updated, interim analysis results from the GioTag study, showing that initiating treatment with afatinib followed by osimertinib provided an overall survival (OS) of almost four years (45.7 months) in patients with Del19-positive tumours.[i] The GioTag study is a real-world retrospective, observational and unblinded study which examined the impact of treatment with Giotrif®/Gilotrif® (afatinib) followed by osimertinib in epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired T790M mutations*, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs).
The GioTag study previously provided only 2 years and 2.5 years OS rates. Now, a subsequent analysis assessed updated data from a sub-set of patients with available electronic health records (from the U.S). The use of electronic data, which facilitated rapid analysis, represented the first step of a two-stage process. After a median follow-up of 30.3 months, median overall survival was almost three and a half years (41.3 months) in patients with acquired EGFR T790M-positive NSCLC treated in a real-world clinical setting, and the updated two-year OS rate was 80%.i
OS is particularly promising in patients with Del19-positive tumours at the onset of afatinib treatment. In these patients, median OS was 45.7 months and the two-year OS rate was 82%. Updated median time on treatment for sequential afatinib and osimertinib was 28.1 months overall, and 30.6 months in patients with Del19-positive tumours. Median time on osimertinib treatment following treatment with afatinib was 15.6 months and 16.4 month for Del19 mutations.i
Dr. Maximilian J. Hochmair, Medical Pulmonologist, Department of Internal Medicine and Pneumology, Krankenhaus Nord, Klinik Floridsdorf and coordinating investigator in the study said, “As many patients with this type of lung cancer eventually acquire resistance to EGFR TKIs, it’s important to consider the order of these therapies to provide patients with as many future treatment options as possible. The updated GioTag study findings provide supportive evidence that afatinib followed by osimertinib is a viable treatment sequence option for patients with EGFR M+ NSCLC.”
Dr. Victoria Zazulina, Corporate Vice President and Global Head of Oncology, Medicine, at Boehringer Ingelheim, said, “The continued clinical development of new EGFR TKIs provides additional treatment options for patients with EGFR M+ NSCLC, and raises questions about their optimal sequence. Given that, as yet, no established targeted treatment options are available following failure of osimertinib, there is an argument for reserving osimertinib for second-line use after second-generation EGFR TKIs. Real-world data from the GioTag study supports the argument for sequential use of afatinib and osimertinib for patients with EGFR M+ NSCLC who are Del19-positive.”
The observational GioTag study provides data on a broad, real-world population of patients. 15.3% had a poor performance status of ECOG PS of ≥2 and 10.3% had stable brain metastases, ordinarily criteria which would preclude these patients from participation in clinical trials. More on the observational GioTag study can be found here. This interim analysis is the first of a two-step process. A final analysis is planned for early 2020 which will include updated data from Asian and European countries.
* 73.5% of patients had a Del19 mutation, and 26.5% a L858R mutationi
Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/updated-giotag-study-data-press-release
For more information, please visit: www.boehringer-ingelheim.com
Media + PR
Phone: +49 6132 – 77 184867
Mobile: +49 (151) 14368601
Fax: +49 6132 – 77 6601
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Dahua Technology Unveils Core Product Launch for 202019.1.2020 13:45:00 CET | Press release
Dahua Technology, a world leading video-centric smart IoT solution and service provider, unveils its 2020 core product launch at Intersec Dubai including the over-coax technology advancement HDCVI 6.0, AI (WizSense/WizMind) and Full-color technology which enables outstanding performance under extreme low light conditions, enabling and accelerating the AIoT transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200119005026/en/ Dahua Technology Unveils Core Product Launch for 2020 (Graphic: Business Wire) HDCVI 6.0 A longtime leader in HDCVI realm that offers great convenience, unparalleled quality and least cost, Dahua Technology launches HDCVI 6.0. Featuring 4K real-time (30fps live view), AI coding, two-way talk and enhanced AI, HDCVI 6.0 provides a superior visual experience where tiny details are captured with better clarity in a large monitoring coverage. Focused on human and vehicle, it significantly improves t
Bermuda Confirmed as a Global Leader in the Fight Against Money Laundering and the Financing of Terrorism and Proliferation17.1.2020 21:11:00 CET | Press release
Bermuda’s regulatory regime has been assessed by the Caribbean Financial Action Task Force (CFATF), and the global inter-governmental Financial Action Task Force (FATF), and confirmed for having some of the highest international standards when it comes to combatting money laundering and the financing of terrorism and proliferation. The mutual evaluation report (MER) of Bermuda’s systems and framework, published today by the CFATF, highlights the outstanding work that has been done to comply with the FATF 40 Recommendations, used by 180 governments to protect the integrity of the international financial system. Of the more than 75 MERs published to date, Bermuda ranks first against the Technical compliance requirements, with 39 of the 40 Recommendations rated as Compliant or Largely Compliant, is in the top six for overall level of effectiveness and one of only two jurisdictions with a high level of effectiveness in relation to its risk assessment and domestic coordination mechanisms. S
Moody’s Analytics Wins an Artificial Intelligence Award17.1.2020 13:00:00 CET | Press release
Moody’s Analytics, a global provider of financial intelligence, has won the Best Financial Services AI Solution category at the 2019 Artificial Intelligence Awards. We won this award for the QUIQspread™ solution, which helps institutions automate the spreading of financial statements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200117005191/en/ Our extensive financial spreading expertise and data resources are at the heart of the QUIQspread tool, which uses machine learning to understand an institution’s financial data spreading policies. Increased accuracy, shorter processing times, and lower costs are achieved as the tool gets smarter with every spread. As a software-as-a-service platform, QUIQspread is scalable with business growth. It contains data on the financials of more than 22 million private firms, which immediately helps it to improve spreading accuracy. The QUIQspread tool easily integrates with clients’ inter
L&T Technology Services Reports a 10% Increase in Q3FY20 Net Profit17.1.2020 12:36:00 CET | Press release
L&T Technology Services Limited (BSE: 540115, NSE: LTTS), India’s leading pure-play engineering services company, announced its results for the third quarter ended December 31, 2019. Highlights for Q3FY20 include: USD Revenue at $199 million; growth of 7% YoY Revenue at Rs 14,230 million; growth of 8% YoY EBIT margin at 16.8%; up 30bps YoY Net profit at Rs 2,041 million; growth of 10% YoY During the quarter, LTTS won 9 multi-million dollar deals across all major industry segments which includes 2 deals having TCV of USD30mn+ each. On a YoY basis, LTTS has increased its USD20mn+ clients by 2 and its USD10mn+ clients by 4. “Q3 results were consistent with our expectations. We had a strong performance in three segments - Transportation, Plant Engineering, and Medical Devices that are each growing in excess of 20% on YoY basis. Digital & leading-edge technologies - the growth driver for ER&D, contributed to 41% of Q3 revenues and grew by 29% YoY. We are seeing a new set of opportunities as
Schlumberger Announces Full-Year and Fourth-Quarter 2019 Results17.1.2020 11:50:00 CET | Press release
Schlumberger Limited (NYSE: SLB) today reported results for full-year 2019 and the fourth quarter of 2019. Full-Year Results (Stated in millions, except per share amounts) Twelve Months Ended Change Dec. 31, 2019 Dec. 31, 2018 Year-on-year Revenue $32,917 $32,815 0% Income (loss) before taxes - GAAP basis $(10,418 ) $2,624 n/m Pretax segment operating income* $3,978 $4,187 -5% Pretax segment operating margin* 12.1 % 12.8 % -68 bps Net income (loss) - GAAP basis $(10,137 ) $2,138 n/m Net income, excluding charges & credits* $2,054 $2,261 -9% Diluted EPS (loss per share) - GAAP basis $(7.32 ) $1.53 n/m Diluted EPS, excluding charges and credits* $1.47 $1.62 -9% Full-Year Revenue by Area North America $10,843 11,984 -10% Latin America 4,149 3,745 11% Europe/CIS/Africa 7,683 7,158 7% Middle East & Asia 10,017 9,543 5% Other 225 385 n/m $32,917 $32,815 0% North America revenue $10,843 $11,984 -10% International revenue $21,849 $20,446 7% North America revenue, excluding Cameron $8,525 $9,55
H.I.G. Capital Invests in Luxury Complex Near Venice17.1.2020 11:46:00 CET | Press release
H.I.G. Capital, LLC ("H.I.G."), a leading global private equity investment firm with over $35 billion of equity capital under management, announced today that one of its affiliates has recently completed an investment in Portopiccolo, a state of the art, self-contained luxury complex near Venice which includes 203 high-end residential apartments, a five-star hotel with a spa and 110 marina berths. Terms were not disclosed. H.I.G. continues to add to its sizeable holdings of real estate assets across Europe, consisting of both equity as well as debt investments, with a focus on its target market of value-add small and midcap opportunities. Riccardo Dallolio, Managing Director and Head of H.I.G. Realty Partners Europe, commented: “This marks our 10th real estate investment in Italy. The Italian real estate markets represent a key part of our European value-add strategy and we continue to actively look at opportunities in the small/midcap sector across the capital structure.” Gabriele Mag