Nimotuzumab Improved Survival Outcomes for Patients With KRAS Wild-Type Pancreatic Cancer

In a phase 3 trial, a regimen of nimotuzumab, a recombinant humanized monoclonal antibody against EGFR, plus gemcitabine significantly improved survival outcomes among patients with KRAS wild-type pancreatic cancer.

Shukui Qin, MD, Cancer Center of Jinling Hospital, Nanjing, China, and coauthors explained, “there is an urgent need for effective therapies to prolong the survival of patients with [pancreatic cancer].” A previous phase 2b study suggested nimotuzumab plus gemcitabine may improve the overall survival of patients with locally advanced or metastatic pancreatic cancer, particular for the KRAS wild-type subgroup.

In this double-blind, multicenter phase 3 study, 82 patients with locally advanced or metastatic KRAS wild-type pancreatic cancer were enrolled. Patients were randomized on a 1-to-1 basis to receive either 400 mg nimotuzumab once per week (n = 41) or placebo (n = 41), followed by gemcitabine. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS) and safety.

The mean duration of follow-up was 57.6 months for the nimotuzumab group and 16.6 months for the placebo group. The median OS was 10.9 months in the nimotuzumab group vs 8.5 months in the placebo group (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.42 to 1.05; log-rank P = .08). The median PFS was 4.2 months in the nimotuzumab group vs 3.6 months in the placebo group (HR, 0.60; 95% CI, 0.37 to 0.99; log-rank P = .04).

There were similar rates of treatment-related adverse events between the two groups (69% in the nimotuzumab group vs 65% in the placebo group). There was 1 serious treatment-related adverse event in the nimotuzumab group (grade 3 bilirubin increase and anemia) and 2 in the placebo group. There were no grade 4 or 5 adverse events on trial.

Dr Qin et al concluded, “the combination of nimotuzumab and gemcitabine was safe and increased the OS and PFS of patients with locally advanced or metastatic [pancreatic cancer] with KRAS wild-type tumors.”

Journal of Clinical Oncology associate editor Eileen O’Reilly, MD, Memorial Sloan Kettering Cancer Center, New York, New York, added, “This randomized trial confirms that identification of KRAS wild-type [pancreatic cancer] is clinically important and therapeutically relevant and can be successfully targeted.”

Source:

Qin S, Li J, Bai Y, et al. Nimotuzumab plus gemcitabine for K-Ras wild-type locally advanced or metastatic pancreatic cancer. J Clin Oncol. Published online August 30, 2023. doi:10.1200/JCO.22.02630