Benefits with nimotuzumab plus gemcitabine in K-Ras wild-type pancreatic cancer

A phase III trial recently published in Journal of Clinical Oncology demonstrates a significant benefit in overall survival and progression-free survival with nimotuzumab plus gemcitabine in K-Ras wild-type locally advanced or metastatic pancreatic cancer patients, with a good safety profile.
Nimotuzumab is a recombinant humanized monoclonal antibody against the epidermal growth factor receptor (EGFR) and a previous phase IIb german study has been shown that nimotuzumab plus gemcitabine might significantly improve the median overall survival of locally advanced or metastatic pancreatic cancer, especially for the wild-type K-Ras gene subgroup. Thus, this new study involved 82 patients with K-Ras wild-type tumors, randomly assigned to receive nimotuzumab (400 mg once per week) or placebo followed by gemcitabine (1,000 mg/m2 on days 1, 8, and 15, once every 4 weeks) until disease progression or unacceptable toxicity. The median overall survival was 10.9 versus 8.5 months, median progression-free survival was 4.2 versus 3.6 months: both overall survival and progression-free survival were longer in the nimotuzumab group than in the placebo group. The objective response rates and disease control rates were 7% versus 10% and 68% versus 63% for the investigational and control groups, respectively, with an incidence of adverse events comparable between the two groups. «The combination of nimotuzumab and gemcitabine was safe and increased the overall survival and progression-free survival of patients with locally advanced or metastatic pancreatic cancer with wild-type KRAS, with a good safety profile», authors conclude.