Highly anticipated results from LUX-Lung 3, the pivotal Phase III lung
cancer trial investigating Boehringer Ingelheim's front running oncology
investigational compound, the ErbB Family Blocker afatinib, in patients
with EGFR mutations, will be presented at the 48th Annual
Meeting of the American Society of Clinical Oncology (ASCO) in Chicago
from 1 - 5 June 2012. LUX-Lung 3, which compares afatinib to standard
platinum based chemotherapy, is the largest Phase III trial in
first-line EGFR mutation positive, advanced, metastatic non-small cell
lung cancer (NSCLC) patients. LUX-Lung 3 is also the first
study using pemetrexed/cisplatin as a comparator.
Comprehensive data from 16 abstracts in both late and early Phase
clinical trials will be presented at ASCO demonstrating Boehringer
Ingelheim´s ongoing commitment to delivering innovative cancer therapies
to patients. The presentation of the LUX-Lung 3 trial in
particular will shed light on the results for afatinib as a first-line
treatment for those NSCLC patients who harbour a mutation in their
Epidermal Growth Factor Receptor genes (EGFR M+), a distinct or specific
patient population who is known to respond differently to targeted
therapies (e.g. Tyrosine Kinase Inhibitors).
The LUX-Lung 3 results will be presented as a late breaking oral
presentation on Monday 4 June at 15:00 Central Daylight Time / 22:00
Central European Time.
"We are excited to present the results of this pivotal Phase III trial,
the largest and most robust of its kind," said Prof. Dr. Gerd Stehle, VP
and Therapeutic Area Head of Oncology at Boehringer Ingelheim. "As we
are continuously advancing the development of our irreversible ErbB
Family Blocker, we have initiated two additional trials, LUX-Lung 7 and
8, to further assess the potential benefit of afatinib in patients with
NSCLC. These are all important steps in establishing personalised care
for lung cancer patients and it highlights the importance of early
assessment of EGFR mutation status."
The two newly initiated trials are currently recruiting patients.
LUX-Lung 7 is a Phase IIb trial evaluating afatinib head-to-head versus
gefitinib as a first-line treatment in EGFR mutation positive NSCLC
patients. LUX-Lung 8 is a Phase III trial evaluating afatinib
head-to-head versus erlotinib in second-line treatment of squamous cell
carcinoma of the lung. Genome research in oncology in recent years has
revealed that NSCLC patients with EGFR mutations need to be considered a
distinct group of NSCLC patients, who require a different treatment
approach for more effective outcomes.