Boehringer Ingelheim’s Giotrif® / Gilotrif® (afatinib) demonstrated superiority to Iressa® (gefitinib) in reducing the risk of disease progression and treatment failure in first-line treatment of...
Boehringer Ingelheim’s Giotrif ® / Gilotrif ® (afatinib) demonstrated superiority to Iressa ® (gefitinib) in reducing the risk of disease progression and treatment failure in first-line treatment of patients with EGFR mutation-positive advanced non-small cell lung cancer
- Results of global Phase IIb LUX-Lung 7 trial demonstrate afatinib superior in reducing the risk of lung cancer progression and the risk of treatment failure both by 27% compared to gefitinib
- More patients on afatinib were free of cancer growth 18 and 24 months after the start of treatment (27% vs 15% and 18% vs 8%, respectively)
- The overall frequency of patients experiencing serious adverse events and discontinuing treatment due to adverse events was similar in both arms
Boehringer Ingelheim announced today the results of the LUX-Lung 7 trial. Superiority in progression-free survival and time to treatment failure was demonstrated with second-generation EGFR-directed therapy afatinib, versus first-generation gefitinib in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with common EGFR mutations (del19 or L858R). The Phase IIb trial met two of its co-primary endpoints of progression-free survival (PFS) by independent review and time to treatment failure (a measure of time between start and discontinuation of treatment for any reason). The LUX-Lung 7 trial results will be presented today at the 14th Annual British Thoracic Oncology Group (BTOG) Conference in Dublin, Ireland. Data for the third co-primary endpoint, overall survival (OS), are not yet mature and will be presented in the future.
Results from the LUX-Lung 7 trial showed that afatinib significantly reduced the risk of lung cancer progression by 27% versus gefitinib. The improvement in PFS became more pronounced over time, with a significantly higher proportion of patients alive and progression-free at 18 months (27% vs 15%) and 24 months (18% vs 8%), showing a greater long-term benefit to using afatinib versus gefitinib. In addition to superior PFS, patients on afatinib had a significantly longer time on treatment: risk of treatment failure reduced by 27%, versus gefitinib. Significantly more patients had an objective tumour response (a clinically meaningful decrease in tumour size) with afatinib when compared to gefitinib (70% vs 56%), with a median duration of response of 10.1 months and 8.4 months, respectively. The improvement in PFS with afatinib was consistent across most pre-defined clinical subgroups, including gender, age, race and EGFR mutation type.
LUX-Lung 7 lead investigator Professor Keunchil Park, director of Innovative Cancer Medicine Institute (ICMI) at Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea commented, “LUX-Lung 7 is the first global trial directly comparing two EGFR-directed therapies and the results demonstrate the benefits of second-generation inhibitor afatinib, compared to first-generation drug, gefitinib, in first-line therapy. These results provide important guidance on the choice of first-line treatment for patients with EGFR mutation-positive lung cancer.”
Adverse events (AEs) observed in the LUX-Lung 7 trial were consistent with the known safety profiles of both treatments. Treatment with both afatinib and gefitinib was generally tolerable, leading to an equally low rate of treatment-related discontinuation in both arms (6.3%). The overall frequency of serious AEs was similar for both (afatinib: 44.4% vs gefitinib: 37.1%); the most common grade ≥3 related AEs with afatinib were: diarrhoea (12.5%) and rash/acne (9.4%), and with gefitinib: aspartate aminotransferase (AST)/alanine aminotransferase (ALT) increase (8.8%) and rash/acne (3.1%). Drug-related interstitial lung disease was reported for four patients on gefitinib and no patients on afatinib.
“LUX-Lung 7 is the second positive head-to-head trial of afatinib versus first-generation EGFR TKIs in lung cancer, showing that first- and second-generation EGFR targeted agents are not the same,” said Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim. “Interestingly, the progression-free survival difference observed in the LUX-Lung 7 trial became more prominent over time so that by 24 months the rate of patients who were free of cancer growth was more than doubled with afatinib.”
About the LUX-Lung 7 trial
LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positive NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harbouring common EGFR mutations (del19 or L858R). The trial’s co-primary endpoints were PFS by independent review, time to treatment failure and OS; and the secondary endpoints included objective response rate, disease control rate, tumour shrinkage, patient-reported outcomes and safety.
Results: compared to gefitinib, afatinib significantly improved:
- PFS (HR=0.73; 95% CI, 0.57‒0.95; p=0.0165; median: 11.0 months [afatinib] versus 10.9 months [gefitinib])
- Time to Treatment Failure (HR=0.73; 95% CI, 0.58‒0.92; p=0.0073; median: 13.7 months [afatinib] versus 11.5 months [gefitinib])
- Objective Response Rate (70% vs 56%, p=0.0083)
Afatinib is approved in more than 60 countries for the first-line treatment of distinct types of EGFR mutation-positive NSCLC (under the brand names: Giotrif® / Gilotrif®). Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to have shown an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.
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:
For more information please visit www.boehringer-ingelheim.com
Further Media Channels
Media + PR
Phone: +49 6132 – 77 93319
Fax: +49 6132 – 77 6601
Om Business Wire
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
Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201720.10.2017 21:00 | Pressemelding
Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are
More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08 | Pressemelding
The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable
Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15 | Pressemelding
Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside
Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03 | Pressemelding
Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f
Schlumberger Announces Third-Quarter 2017 Results20.10.2017 11:00 | Pressemelding
Schlumberger Limited (NYSE:SLB) today reported results for the third quarter of 2017. (Stated in millions, except per share amounts) Three Months Ended Change Sept. 30, 2017 Jun. 30, 2017 Sept. 30, 2016 Sequential Year-on-year
SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47 | Pressemelding
SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom