Rigel Pharmaceuticals’ pralsetinib shows efficacy in NSCLC clinical trial

Rigel Pharmaceuticals (RIGL) announced publication of the final data from the Phase 1/2 ARROW study evaluating pralsetinib for the treatment of metastatic rearranged during transfection fusion-positive non-small cell lung cancer, or NSCLC, in the Journal of Clinical Oncology. Pralsetinib is the only once daily, oral RET-inhibitor therapy that is designed to selectively target RET in metastatic NSCLC and advanced or metastatic thyroid carcinoma. “The final data from the ARROW study shows robust and durable responses with a manageable safety profile in patients with RET fusion-positive NSCLC, emphasizing the importance of early biomarker testing and suggesting that pralsetinib may be a valuable tool in the treatment armamentarium,” said Phase 1/2 trial investigator Justin Gainor. Pralsetinib was generally well tolerated with a manageable toxicity profile. Three treatment-related deaths occurred in treatment-naive patients in Asia, no new safety signals were observed and no hypersensitivity reactions were reported in patients receiving prior immunotherapies. Overall response rate was 70%, including 7% complete responses and 63% partial responses. ORR was 78% among treatment-naive patients and 63% among patients receiving prior platinum-based chemotherapy. At final data lock, median treatment duration was 15.0 months. Median overall survival was 44.3 months in the overall measurable disease patient population, 50.1 months in treatment-naive patients, and 39.7 months in prior-platinum patients. Median overall progression-free survival was 13.1 months in the overall measurable disease patient population.