In China, a phase III trial of nimotuzumab plus gemcitabine shows significantly improved overall survival (OS) and progression-free survival (PFS) in patients with locally advanced or metastatic K-Ras wild-type pancreatic cancer (PC) with a good safety profile.
Participants were randomized to 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. “A total of 480 patients were screened; 92 patients were enrolled and 82 patients with K-Ras wild-type tumors were eligible,” the authors write. “In the full analysis set, the median OS was 10.9 versus 8.5 months, while the restricted mean survival time (RMST) was 18.05 versus 11.14 months for the investigational versus control arm (ratio of control v investigation = 0.62 [0.40-0.97]; P = .036). Median PFS was 4.2 versus 3.6 months in the investigational versus control arm (log-rank P = .04; hazard ratio, 0.60 [0.37-0.99]) and the restricted mean PFS time was 8.08 versus 4.76 months (RMST ratio, 0.58 [0.38-0.90]; P = .036). Both OS and PFS 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. The incidence of adverse events were comparable between the two groups.”