The results of the LUX-Lung 7 study show that a head-to-head Phase IIb clinical study compared afatinib and gefitinib in the treatment of tumors with EGFR mutations The results are published in the “Lancet Oncology” magazine.
Chief researcher and first author of LUX-Lung 7, Keunchil Park, director of the Institute of Innovative Cancer Medicine (ICMI) at Samsung Medical Center, he is a professor at the Medical College of Sungkyunkwan University in Seoul, South Korea, “The key findings from this study show that Alfa Tinib and gefitinib have significant differences in efficacy between multiple end points and predefined patient subgroups. “
The results of the LUX-Lung 7 clinical trial show that afatinib can significantly reduce the risk of lung cancer progression by 27% compared to gefitinib. Improvements in progression-free survival (PFS) have become apparent over time. About 2 years after the end of treatment, the number of patients receiving afatinib is still alive and the disease has not progressed more than twice the number of patients receiving gefitinib (after 18 months; 27% vs. 15% and after 24 months; 18 % Vs. 8%).
In addition, the treatment duration of afatinib was significantly longer than that of gefitinib, and the treatment failure rate was reduced by 27%. Compared with gefitinib, patients receiving afatinib had a significantly higher objective tumor response rate (ORR; clinically meaningful index of tumor size reduction) (70% vs 56%), with a median response duration of 10.1 Month vs. 8.4 months. The total survival joint primary endpoint (OS) data is not yet mature enough and will be announced in the future.
In the LUX-Lung 7 clinical trial, afatinib and gefitinib showed similar improvements in patient-reported efficacy measures, and afatinib did not significantly differ in health-related quality of life compared to gefitinib treatment. Both afatinib and gefitinib treatments are well tolerated generally, resulting in an equal discontinuation rate (6%) in terms of discontinuation caused by treatment.
The total frequency of serious negative events was afatinib 44.4% and gefitinib 37.1%. The most common negative events with afatinib grade ≥3 are: diarrhea (13%) and rash / acne (9%), gefitinib: aspartate aminotransferase (AST) / alanine aminotransferase ( ALT) increased (9%), rash / acne (3%). Four cases of drug-related interstitial lung disease gefitinib were reported, and none occurred in afatinib patients. In order to better manage negative events (AEs), afatinib dose changes are feasible in some patients who meet a set of criteria. Because gefitinib can only use a single dose, it cannot be given in small doses.
LUX-Lung 7 is the second head-to-head clinical trial of afatinib to compare the first generation EGFR tyrosine kinase inhibitor (TKI). The first clinical trial LUX-Lung 8 compared afatinib and erlotinib in the treatment of squamous cell lung cancer.
We are very pleased that the “Lancet Oncology” magazine published the results of the LUX-Lung 7 clinical trial and believe that these results can be applied in the treatment of EGFR-mutated non-small cell lung cancer. ”Boehringer Ingelheim Oncology Clinical Development and Medical Division Vice Chairman Tarek Sahmoud, M.D., Doctor of Science.“ LUX-Lung 7 is a head-to-head clinical trial of afatinib based on our clinical experience, demonstrating our commitment to better afatinib makes a commitment to understand and use.“