The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) has been awarded a $2-million grant from Boehringer Ingelheim Pharmaceuticals, Inc. to develop a program to evaluate scientifically targeted combination approaches with afatinib in the treatment of non-small cell lung cancer (NSCLC).
"Lung cancer accounts for more deaths than any other cancer in men and women in the United States," said Diane E. Paul, MS, RN, Vice President, NCCN ORP. "The ongoing collaboration between NCCN and Boehringer Ingelheim indeed puts NCCN Member Institution investigators at the helm of oncology research with the potential to improve the lives of people with cancer."
The first phase of the program will involve the establishment of an NCCN Afatinib Request for Proposals Development Team charged with evaluating existing data and defining the data and types of studies necessary to further characterize the safety and clinical effectiveness of afatinib in combination with other targeted agents in NSCLC.
Afatinib is FDA approved under the brand name Gilotrif® for the first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. According to Boehringer Ingelheim, approval of afatinib in this indication was based on the primary endpoint of progression-free survival from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumor growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to show an overall survival (OS) benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.
The NCCN ORP draws on the expertise of investigators at NCCN Member Institutions and the NCCN Affiliate Research Consortium (ARC) to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer.
The NCCN ORP will utilize the grant from Boehringer Ingelheim, Inc. to support investigator-initiated clinical and correlative studies at NCCN Member Institutions and their affiliate community hospitals for afatinib. To date, this successful research model has received approximately $54 million in research grants and supported 125 studies that have produced a number of publications in peer-reviewed journals.
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