Efficacy and safety of pralsetinib as first-line treatment of RET fusion–positive advanced or metastatic non–small cell lung cancer (NSCLC): The phase 3 AcceleRET-Lung study.
Randomized trial demonstrates improved progression-free survival in advanced NSCLC patients treated with pralsetinib, suggesting its clinical value.
Key Points
The study aimed to evaluate the efficacy and safety of pralsetinib versus standard of care in first-line treatment of RET fusion-positive advanced non-small cell lung cancer.
Randomized phase 3 trial (NCT04222972) conducted at 74 sites across 22 countries.
Patients received pralsetinib 400 mg/d or platinum-based standard of care therapy, with optional crossover upon progression.
Primary endpoint was progression-free survival assessed per RECIST v1.1 in the intent-to-treat population.
Pralsetinib yielded a median progression-free survival of 18.7 months compared to 9.0 months for SOC (P=0.003).
Overall response rate was significantly higher in the pralsetinib group (65.5%) compared to SOC (41.6%) (P<0.001).
Safety profile included higher infection rates in the pralsetinib group, with pneumonia rates at 19.4% versus 5.8% in SOC.