The following is a summary of “Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer,” published in the November 2023 issue of Oncology by Qin, et al.
For a study, researchers sought to verify the efficacy and safety of the nimotuzumab plus gemcitabine combination regimen in patients with locally advanced or metastatic pancreatic cancer (PC) with K-Ras wild-type tumors.
Eligible patients were 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 primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), response rates, and safety.
Out of 480 screened patients, 82 with K-Ras wild-type tumors were eligible. In the full analysis set, nimotuzumab plus gemcitabine showed a median OS of 10.9 months compared to 8.5 months in the control group, with a restricted mean survival time (RMST) of 18.05 versus 11.14 months (ratio 0.62 [0.40-0.97]; P = .036). Median PFS was 4.2 versus 3.6 months (log-rank P = .04; hazard ratio 0.60 [0.37-0.99]), and restricted mean PFS time was 8.08 versus 4.76 months (RMST ratio 0.58 [0.38-0.90]; P = .036). Nimotuzumab plus gemcitabine demonstrated longer OS and PFS compared to the placebo group. Objective response rates and disease control rates were 7% versus 10% and 68% versus 63% for the investigational and control groups, respectively. Adverse events were comparable between the two groups.
In patients with locally advanced or metastatic K-Ras wild-type PC, the combination of nimotuzumab plus gemcitabine significantly improved OS and PFS with a favorable safety profile.
Source: ascopubs.org/doi/full/10.1200/JCO.22.02630
