According to a new study published in the journal The Lancet Oncology, researchers have found that the addition of necitumumab to cisplatin and pemetrexed did not increase survival of previously untreated patients with stage IV non-squamous non-small cell lung cancer (NSCLC).
Necitumumab is an investigational second-generation recombinant human immunoglobulin G1 EGFR monoclonal antibody.
For the international, open-label, controlled phase III study, researchers enrolled 633 patients with previously untreated non-squamous NSCLC and randomly assigned them to receive either cisplatin 75mg/m2 and pemetrexed 500mg/m2 on day 1 of a 3-week cycle for up to 6 cycles alone, or with necitumumab 800mg on days 1 and 8 until disease progression or unacceptable toxicity.
Results showed a median overall survival of 11.3 months (95% CI: 9.5 - 13.4) for the necitumumab group compared with 11.5 months (10.1 - 13.1) in the chemotherapy alone group (HR = 1.01; 95% CI: 0.84 - 1.21; P = 0.96).
The necitumumab group also experienced a higher incidence of severe adverse events, including death, versus the chemotherapy alone group.
The findings suggest that necitumumab is not likely to provide benefit to patients with previously untreated stage IV non-squamous NSCLC when used in combination with cisplatin and pemetrexed.
Addition of necitumumab to cisplatin and pemetrexed did not increase survival in stage IV non-squamous NSCLC.
The researchers aimed to compare necitumumab plus pemetrexed and cisplatin with pemetrexed and cisplatin alone in patients with previously untreated, stage IV, non-squamous non-small-cell lung cancer (NSCLC).