Nimotuzumab Found Promising for EGFR-positive Gastric Cancer

Nimotuzumab shows the potential to improve both progression-free survival (PFS) and overall survival (OS) in patients with epidermal growth factor receptor (EGFR)-positive gastric cancer, according to results of a phase 2 randomized trial presented at the Gastrointestinal Cancers Symposium.

 

In this open-label trial, researchers randomized patients with advanced or recurrent gastric cancer who are refractory to a 5-fluorouracil–based regimen to nimotuzumab 400 mg weekly plus irinotecan 150 mg/m² every 2 weeks or to irinotecan alone. The researchers analyzed tumore tissue for EGFR and KRAS status. Patients were evaluated for efficacy at 6 months with a median follow-up of 197 days.

 

In 82 evaluable patients (nimotuzumab/irinotecan = 40; irinotecan = 42), researchers found that median PFS was decreased with the combination, 73 compared with 85 days (hazard ration [HR], 0.860; 95% confidence interval [CI], 0.516-1.435). OS, however, was increased to 293 from 227 days (HR, 0.717; 95% CI, 0.420=1.224). Subgroup analyses based on EGFR status found an HR in EGFR 1+/2+/3+ patients of 0.463 (95%CI, 0.177-1.212) and in EGFR 2+/3+

Patients of 0.341 (95% CI, 0.080-1.457). HR in OS was 0.584 (95% CI, 0.242-1.409) and 0.295 (95% CI, 0.077-1.129), respectively.

 

Adverse events were similar in both groups.

 

Based on these results, future studies on nimotuzumab will focus on the selection of gastric cancer patients by EGFR status.