Necitumumab by Eli Lilly Improves OS in a Phase 3, First-Line Treatment of NSCLC

Stage IV NSCLC patients with metastatic SCC showed significantly improved survival when necitumumab, an EGFR-targeted antibody, was combined with gemcitabine and cisplatin (11.5 months), compared to chemotherapy alone (9.9 months).

Lung cancer patients with metastatic squamous cell carcinoma have seen few treatment advancements over the last two decades, leaving these patients with a poor prognosis. This is in contrast to the progress seen in nonsquamous non-small cell lung cancer (NSCLC).[1] Results from the largest ever Phase III trial in first-line squamous NSCLC announced by

Eli Lilly and Company

(NYSE: LLY) today provide the first detailed look at a potential new treatment option for these patients.

Necitumumab (IMC-11F8) is a recombinant human IgG1 monoclonal antibody designed to target the human epidermal growth factor receptor 1 (EGFR). In the Phase III SQUIRE trial, patients with stage IV metastatic squamous NSCLC showed a statistically significant improvement in overall survival (HR=0.84, p=0.012) with a median survival of 11.5 months when receiving necitumumab in combination with gemcitabine and cisplatin as a first-line treatment, as compared to 9.9 months for those treated with chemotherapy alone. Consistent efficacy results were observed across endpoints and subgroups. Grade 3 or higher adverse events occurring more frequently in patients on the necitumumab arm were hypomagnesemia and rash. The SQUIRE study results (Abstract #8008) were released in advance of the

American Society of Clinical Oncology

(ASCO) Annual Meeting to be held in

Chicago, Ill.

Additional safety and efficacy information will be presented at the meeting.

"The SQUIRE trial results offer an important step in our pursuit of improving outcomes for patients with advanced squamous NSCLC," said

Richard Gaynor

, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "With these findings, Lilly anticipates a regulatory submission of necitumumab before the end of 2014."

The news release:

http://bit.ly/1oU56ce

Source: Eli Lilly