Boehringer Reports Data from Afatinib Phase III LUX-Lung 3 Trial in Asian NSCLC Patients

The gist: Asian people with non-small cell lung cancer (NSCLC) whose tumors have a common mutation in the EGFR gene called del19 might have better survival when treated with the drug afatinib instead of chemotherapy. That was the conclusion of a recent clinical trial that tested afatinib in volunteer patients.

“Boehringer Ingelheim has reported positive data from a pre-specified subgroup-analysis of the pivotal Phase III LUX-Lung 3 trial of afatinib in Asian non-small cell lung cancer (NSCLC) patients.

“The trial showed that these patients with the most common type of EGFR mutation, (exon 19 deletion; del19), lived significantly longer after receiving first-line treatment with afatinib compared to chemotherapy.

“The company noted that overall survival results from this pre-specified Asian subgroup-analysis are consistent with the overall del19 population in LUX-Lung , and with the previously reported Asian Phase III LUX-Lung 6 trial, in which patients with the del19 mutation lived a median of more than one year longer if they started treatment with afatinib rather than standard chemotherapy…

“Guangdong Academy of Medical Sciences and Guangdong General Hospital vice-president and principal investigator of the LUX-Lung 6 trial Yi-Long Wu said: ‘Afatinib is the first treatment to demonstrate a significant overall survival benefit for NSCLC patients with the del19 mutation, the most common EGFR mutation.

” ‘More than half of the world’s lung cancer cases occur in Asia. Therefore, EGFR testing for NSCLC patients is important in order to identify the patients eligible for targeted therapy.’ “


Afatinib is FDA-Approved: What It Means For NSCLC Patients


On July 12, the FDA announced that it had approved the targeted therapy afatinib (Gilotrif) for the treatment of metastatic non-small cell lung cancer (NSCLC) with mutations in the epidermal growth factor receptor (EGFR) gene.

EGFR mutations occur in about 10 to 15 percent of all NSCLC patients. The overexpression of the EGFR protein caused by the mutation leads to rapid cell division in tumors. Prior to the approval of afatinib, patients in the United States could only take erlotinib (Tarceva) to combat the EGFR mutation. The third major drug available to treat EGFR-mutated tumors, gefitinib (Iressa) has not yet been approved by the United States but is readily available in many other countries. Erlotinib has consistently outperformed gefitinib, so its lack of availability in the U.S. is no huge loss. Continue reading…


Afatinib May Be Candidate for First-Line Treatment in Certain Lung Cancers

Results from the LUX-Lung 3 clinical trial show that afatinib appears to be well tolerated and more effective than chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Afatinib produced higher response rates and longer periods without cancer progression than cisplatin (Platinol) plus pemetrexed (Alimta), suggesting that it could be considered as a first-line therapy in advanced EGFR-mutant NSCLC. Afatinib, which is under priority review for approval by the FDA, may be effective in patients resistant to other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa). However, no trials so far have directly compared afatinib with Tarceva or Iressa.