BOEHRINGER-INGELHEIM
Head-to-head study demonstrating Giotrif ® (afatinib) significantly improved clinical outcomes compared to Iressa ® (gefitinib) in EGFR mutation-positive advanced non-small cell lung cancer published in The Lancet Oncology
Results from LUX-Lung 7, a global head-to-head Phase IIb trial comparing treatment with Giotrif® (afatinib* ) to Iressa® (gefitinib) in patients whose tumours harbour the most common EGFR mutations were published in The Lancet Oncology .
LUX-Lung 7 lead investigator and lead author Professor Keunchil Park, Director of Innovative Cancer Medicine Institute (ICMI) at Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea commented: “The key finding from this study suggests a significant difference in efficacy between afatinib and gefitinib across multiple endpoints and pre-defined patient subgroups.”
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 progression-free survival (PFS) became more pronounced over time. After two years of treatment, more than twice as many patients on afatinib were alive and progression-free than those on gefitinib (after 18 months; 27% vs 15% and after 24 months; 18% vs 8%).
In addition, patients on afatinib had a significantly longer time on treatment, and risk of treatment failure was reduced by 27% versus gefitinib. Significantly more patients had an objective tumour response (ORR; 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.
Data for the co-primary endpoint of overall survival (OS) are not yet mature and will be presented in the future.
Both afatinib and gefitinib demonstrated similar improvements in patient-reported outcome measures in the LUX-Lung 7 trial with no significant differences in health-related quality of life with afatinib compared to gefitinib treatment. Treatment with both afatinib and gefitinib was generally tolerable, leading to an equal rate of treatment-related discontinuation in both arms (6%). Adverse events (AEs) observed in the trial were consistent with the known safety profiles of both treatments.
The overall frequency of serious AEs was 44.4% for afatinib and 37.1% for gefitinib. The most common grade ≥3 related AEs with afatinib were: diarrhoea (13%) and rash/acne (9%), and with gefitinib: aspartate aminotransferase (AST)/alanine aminotransferase (ALT) increase (9%) and rash/acne (3%). Drug-related interstitial lung disease was reported for four patients on gefitinib and no patients on afatinib. Dose modification of afatinib was available in patients who met a set criteria in order to better manage AEs. As gefitinib is only available in one dose formulation, no dose reduction was administered.
LUX-Lung 7 is the second head-to-head trial of afatinib versus a first-generation EGFR tyrosine kinase inhibitor (TKI). The first, LUX-Lung 8, compared afatinib to erlotinib in squamous cell carcinoma of the lung.
“We are delighted with The Lancet Oncology publication of LUX-Lung 7, the second direct head-to-head trial of afatinib versus a first-generation EGFR TKI,” said Mehdi Shahidi, M.D., Medical Head, Solid Tumour Oncology, Boehringer Ingelheim. “The totality of the efficacy data from LUX-Lung 7 clearly differentiates the second-generation inhibitor afatinib from the first-generation inhibitor gefitinib with no significant differences observed in overall safety, tolerability and health-related quality of life between the two TKIs. We expect the results to guide treatment practices in EGFR mutated NSCLC.”
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 ORR, 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=0.017; median: 11.0 months [afatinib] versus 10.9 months [gefitinib]). The improvement in PFS with afatinib was consistent across pre-defined clinical subgroups, including gender, age, race and EGFR mutation type
- 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])
- ORR (70% vs 56%, p=0.0083)
Afatinib is approved in over 60 countries for the first-line treatment of EGFR mutation-positive NSCLC*. 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.
* Afatinib is approved in the EU under the brand name GIOTRIF ® for the first-line treatment of tyrosine kinase inhibitor naïve adult patients with advanced EGFR mutation-positive NSCLC and in the US under the brand name GILOTRIF ® for the first-line treatment of patients with metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Registration conditions differ internationally, please refer to locally approved prescribing information.
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:
For more information please visit http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2016/13_april_2016_oncology.html
Further Media Channels
www.facebook.com/boehringeringelheim
www.youtube.com/user/boehringeringelheim
View source version on businesswire.com: http://www.businesswire.com/news/home/20160413005601/en/
Contact:
Media Contact
Boehringer Ingelheim
Corporate
Communications
Media + PR
Susanne Granold
Phone:
+49 6132 – 77 93319
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
Link:
Social Media:
About Business Wire
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
HCLTech and Equinor Expand Digital Collaboration2.7.2025 13:08:00 CEST | Press release
HCLTech, a global technology leader, and Equinor, Europe's largest energy supplier and a pioneer in renewables and low-carbon solutions, have expanded their IT collaboration to support the next phase of Equinor’s digital transformation. This expanded relationship will cover Equinor’s IT landscape across several key strategic areas. HCLTech will support Equinor as it accelerates its digital transformation by: Accelerating its cloud migration and standardizing services across operations Enhancing its cyber resilience and network performance Improving workplace experience through automation Enabling advanced user experiences with technologies like augmented reality (AR) "We’re pleased to continue our long-standing collaboration with Equinor," said Sandeep Kumar Saxena, Executive Vice President, HCLTech. "This collaboration reflects our shared commitment to innovation and sustainability.” Over the past decade, HCLTech has been a trusted advisor to Equinor, supporting the company’s global e
Wizz Air Tops Major Airline Emissions Rankings2.7.2025 11:00:00 CEST | Press release
Cirium, the aviation analytics company, creates a new transparent standard and ranking for airline CO2 emissions, identifying the best performing airlines in specific categories Wizz Air is the world's most emissions-efficient airline in new rankings released today by Cirium, the aviation analytics firm. The Cirium Flight Emissions Review ranks the top 20 airlines globally, through a consistent benchmark for flight emissions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702342529/en/ The top 20 Major airlines globally, ranked by lowest CO2/ASK Wizz Air, the Hungary-based ultra-low-cost airline emits an industry low of 53.9 grams of CO₂ per Available Seat Kilometer (ASK)*, followed by Frontier Airlines (54.4 grams) and Pegasus (57.1 grams) according to the report. The rankings provide the aviation industry with verified comparable data on an equal playing field as the sector advances toward Net Zero by 2050 commitments.
L&T Technology Services Chosen by TRATON GROUP as Strategic Engineering Partner in Global R&D Transformation2.7.2025 10:59:00 CEST | Press release
Multi-year collaboration in LTTS’ Mobility segment to drive platform synergies, electrification, and innovation for TRATON GROUP L&T Technology Services (BSE: 540115, NSE: LTTS), today announced that it has been chosen by the TRATON GROUP, one of the world’s leading manufacturers of commercial vehicles, as a strategic engineering partner. This collaboration in LTTS’ Mobility segment will support TRATON’s roadmap to build a unified, future-ready product-development platform that delivers scale, speed, and sustainable mobility solutions worldwide. TRATON is reshaping its global R&D ecosystem to unlock cross-brand synergies while expanding the share of battery-electric vehicles in line with its 2029 profitability and sustainability targets. LTTS’ selection will see the company provide engineering support, from mechanical and software engineering to digital systems integration - across key development hubs in Sweden, Germany, the United States, Poland, and India. The collaboration position
Nexo Becomes First-Ever Digital Wealth Platform of the DP World Tour, Launches Nexo Championship2.7.2025 10:30:00 CEST | Press release
Named Official Digital Wealth Platform of the DP World Tour through 2027 Nexo becomes Title Partner of the Nexo Championship, which takes place at Trump International Golf Links in August 2025 Nexo, the premier digital assets wealth platform, has signed a three-year landmark partnership with the DP World Tour, becoming an Official Marketing Partner and the Tour’s Official Digital Wealth Platform through 2027. This agreement marks the first-ever multi-year partnership between a digital assets company and a major global golf tour — a historic convergence of crypto and golf — reflecting both organizations’ shared commitment to performance, innovation, and a global outlook. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702770847/en/ Nexo becomes the first-ever Official Digital Wealth Platform of the DP World Tour. Nexo has also become the Title Partner of the newly renamed Nexo Championship — previously the Scottish Champion
Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta2.7.2025 10:00:00 CEST | Press release
Data presented today at the ESHRE congress builds evidence for conventional-based Follicular Stimulating Hormone (FSH) dosing for Rekovelle® (follitropin delta); alongside its existing unique algorithm-based dosing Follitropin delta starting dose of 15 micrograms (µg)/day has comparable efficacy and safety as a starting dose of 225 International Units (IU)/day of follitropin alfa for ovarian stimulation in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) gonadotrophin-releasing hormone (GnRH) antagonist protocol cycles. This is the key finding of a trial presented today at the European Society of Human Reproduction and Embryology (ESHRE) Congress in Paris and published in Human Reproduction. These data build on previous studies which have established an estimated point of clinical correspondence for 10 µg follitropin delta to 150 IU follitropin alfa in this class of medications.1,2 The ADAPT-1 trial was a multicentre, randomised, assessor-blind study involving 300 wome
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom