Boehringer’s Phase III LUX-Lung 3 trial of afatinib meets primary endpoint

10th November 2014 (Last Updated November 10th, 2014 18:30)

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

Germany-based Boehringer Ingelheim has reported positive data from a pre-specified subgroup-analysis of the 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 were 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.

The LUX-Lung 3 trial also met its primary endpoint of progression-free survival in the overall study population.

"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."

According to the company, no significant difference in overall survival was seen for Asian patients with the L858R mutation in the LUX-Lung 3 and LUX-Lung 6 subgroup-analyses, respectively.

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."

The previously reported LUX-Lung 3 trial data showed that afatinib provided further benefits to NSCLC patients with common EGFR mutations (del19 and L858R), which account for 90% of all EGFR mutations.

Additionally, in a combined exploratory analysis of the LUX-Lung 3 and LUX-Lung 6 trials, afatinib prolonged overall survival (secondary endpoint) of patients with common EGFR mutations compared with standard chemotherapy by a median of three months.

National Taiwan University director of the Cancer Research Center, College of Medicine and principal investigator of the LUX-Lung 3 trial professor James Chih-Hsin Yang said: "Overall survival benefit in trials involving advanced lung cancer patients has rarely been observed up until now.

"Data from the LUX-Lung 3 and LUX-Lung 6 trials, individually demonstrating an overall survival benefit of more than 12 months in the subgroup of NSCLC patients with the del19 mutation taking afatinib versus chemotherapy, is very encouraging.

"These studies suggest that various EGFR mutations should be studied or treated differently in the future."