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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.

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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.

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