The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) has funded three studies in its first multi-industry collaborative research project, in which Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company are collaborating with NCCN to study combination therapeutic agents in lung cancer and head and neck cancers.
The following three studies were awarded funding through the NCCN Oncology Research Program:
- Aarti Bhatia, MD, MPH, of Yale Cancer Center/Smilow Cancer Hospital: “Single-Arm Phase II Trial of Dual Inhibition of EGFR with Afatinib and Cetuximab With Correlative Studies in the Second-Line Treatment of Recurrent or Metastatic Squamous Cell Cancers of the Head and Neck”
- Michael Gibson, MD, PhD, of Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute: “Afatinib and Nivolumab for Second-Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck”
- Leora Horn, MD, of Vanderbilt-Ingram Cancer Center: “Phase I Trial of Combination Afatinib and Necitumumab in EGFR Mutation–Positive Non–Small Cell Lung Cancer With Acquired Resistance to First- or Third-Generation EGFR Tyrosine Kinase Inhibitors”
Boehringer Ingelheim awarded the NCCN Oncology Research Program a $2 million research grant to support NCCN investigator–initiated preclinical, clinical, and correlative studies of combination therapies containing afatinib (Gilotrif) in the treatment of lung and head/neck cancers. Afatinib is approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with metastatic non–small cell lung cancer (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.
NCCN and Boehringer Ingelheim collaborated with Lilly for access to necitumumab (Portrazza). In combination with gemcitabine and cisplatin, necitumumab is approved for the first-line treatment of metastatic squamous NSCLC.
Proposals of other afatinib combination therapies were also accepted. Submissions were peerreviewed by the NCCN Afatinib Combination Scientific Review Committee. The funded concepts were selected based on several criteria, including scientific merit, existing data, and types of studies necessary to further evaluate the efficacy of afatinib.
“In facilitating this innovative research initiative, NCCN ORP indeed leads the way in laying the groundwork for future collaborative clinical research endeavors,” said Susan Most, RN, MBA, Director, Clinical Operations, NCCN Oncology Research Program. “The study of the effectiveness of combination therapies in oncology requires collaboration among various stakeholders, and NCCN applauds Boehringer Ingelheim and Lilly in their combined efforts to advance cutting-edge research.” ■
