According to a study published in the journal Annals of Oncology, researchers have found that the addition of ganitumab to gemcitabine did not improve overall survival in unselected patients with metastatic pancreatic cancer.
For the double-blind, phase 3 study, researchers sought to assess the efficacy and safety of ganitumab plus gemcitabine versus gemctiabine alone as first-line treatment of metastatic pancreatic cancer.
Researchers enrolled 800 patients and randomly assigned them 2:2:1 to receive intravenous gemcitabine 1000mg/m2 on days 1, 8, and 15 of each 28-day cycle plus placebo, ganitumab 12mg/kg, or ganitumab 20mg/kg on days 1 and 15 of each cycle.
RELATED: High Resection Rates in Pancreatic Cancer with mFOLFIRINOX, Aggressive Surgery
Results showed that the median overall survival was 7.2 months (95% CI: 6.3 – 8.2) in the placebo arm, 7.0 months (95% CI: 6.2 – 8.5) in the ganitumab 12mg/kg arm (HR = 1.00; 95% CI: 0.82 – 1.21; P = 0.494), and 7.1 months (95% CI: 6.4 – 8.5) in the ganitumab 20mg/kg arm (HR = 0.97; 95% CI: 0.76 – 1.23; P = 0.520).
In addition, progression-free survival was 3.7 months in the placebo arm, 3.6 months in the ganitumab 12mg/kg arm (HR = 1.00; 95% CI: 0.84 – 1.20; P = 0.520), and 3.7 months in the ganitumab 20mg/kg arm (HR = 0.97; 95% CI: 0.77 – 1.22; P = 0.403).
In regard to safety, no unexpected toxicity was observed with ganitumab in combination with gemcitabine.
- Fuchs CS, Azevedo S, Okusaka T, et al. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015. [Epub ahead of print]. doi: 10.1093/annonc/mdv027.