INGELHEIM, Germany - Wednesday, April 13th 2016 [ME NewsWire]
- LUX-Lung 7 trial showed afatinib significantly reduced the risk of lung cancer progression and treatment failure as well as increased overall response rate compared to gefitinib without compromising overall health-related quality of life, safety and tolerability
- Results provide oncologists who treat patients with EGFR mutation-positive lung cancer with important information for clinical practice
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 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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