Eli Lilly and Company announced results from the largest Phase 3 SQUIRE trial of necitumumab (IMC-11F8) for the first-line treatment of squamous non-small cell lung cancer (NDCLC). Necitumumab is a recombinant human IgG1 monoclonal antibody designed to target the human epidermal growth factor receptor 1 (EGFR).
The SQUIRE study enrolled 1,093 patients with histologically- or cytologically-confirmed, stage IV squamous NSCLC, who had received no prior therapy for metastatic disease. Patients were randomized to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study Arm B. Patients underwent radiographic assessment of disease status every six weeks (± 3 days), until radiographic documentation of progressive disease (PD). The primary endpoint was overall survival.
Patients with stage IV metastatic squamous NSCLC demonstrated 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.
Eli Lilly and Company plans to announce additional safety and efficacy results at the American Society of Clinical Oncology (ASCO) Annual Meeting.
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