Eli Lilly Reports Positive Results For NSCLC Drug Necitumumab

Eli Lilly & Co. reported positive results from the largest ever Phase III trial conducted in first line squamous non-small cell lung cancer (NSCLC) investigating potential treatment necitumumab.

Necitumumab (IMC-11F8) is a recombinant human IgG1 monoclonal antibody intended to target and block the ligand binding site of the human epidermal growth factor receptor 1 (EGFR). Research has linked the activation of EGFR to malignant progression, inhibition of apoptosis, and induction of angiogenesis.

In the Phase III SQUIRE trial, the drug in combination with gemcitabine and cisplatin as first-line treatment showed statistically meaningful improvement of overall survival in patients with stage IV metastatic squamous NSCLC. Patients achieved a median survival of 11.5 months when receiving the combination treatment compared to 9.9 months with chemotherapy alone.

Richard Gaynor, SVP of product development and medical affairs for Lilly Oncology, said, “The SQUIRE trial results offer an important step in our pursuit of improving outcomes for patients with advanced squamous NSCLC. With these findings, Lilly anticipates a regulatory submission of necitumumab before the end of 2014.”

Lung cancer is responsible for the most number of cancer related deaths in the U.S. and most other countries. While non-small cell lung cancer disease is highly prevalent and represents about 85 percent of all lung cancer cases, advanced squamous NSCLC remains an urgent unmet medical need as research has yet to identify and confirm a molecular oncogenic target that could lead to an effective treatment.

Clinical progress in squamous NSCLC has been minimal in the last two decades, says Nick Thatcher, SQUIRE lead investigator and professor of oncology in University of Manchester, Christie Hospital NHS Trust in Manchester, UK. “The addition of necitumumab to the current chemotherapy regimen of gemcitabine and cisplatin opens the door to a potential new approach to treat patients with advanced squamous NSCLC.”

The results of the SQUIRE study were presented in advance of the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago.