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Rigel Announces Publication of Final ARROW Clinical Trial Data on GAVRETO® (pralsetinib) in Patients with RET+ NSCLC in the Journal of Clinical Oncology
Pralsetinib induced robust and durable responses with a manageable safety profile, reinforcing the benefits of selective RET inhibitors in treating RET
About this update from Rigel Pharmaceuticals, Inc.
[{"type":"text","content":"Pralsetinib induced robust and durable responses with a manageable safety profile, reinforcing the benefits of selective RET inhibitors in treating RET fusion-positive NSCLCSOUTH SAN FRANCISCO, Calif., March 31, 2026 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced publication of the final data from the Phase 1/2 ARROW study evaluating pralsetinib for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) in the Journal of Clinical Oncology. The final data includes an additional 42 months of follow-up from previously published data. 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 Justin F. Gainor, M.D., Phase 1/2 trial investigator and Director of the Center for Thoracic Cancers at Mass General Brigham Cancer Institute. \"In addition, the responses observed in the subset of patients with measurable CNS metastases at baseline further expand the potential clinical value of pralsetinib in everyday practice.\"\"The results published in the Journal of Clinical Oncology demonstrate the positive impact pralsetinib can have for patients with RET fusion-positive NSCLC,\" said Lisa Rojkjaer, M.D, Rigel's chief medical officer. \"These longer-term data further support pralsetinib's role as a first-line treatment option for RET fusion-positive NSCLC patients.\"Additional key points from the paper include:Consistent with previous reports from the ARROW study NSCLC cohort, pralsetinib was generally well tolerated with a manageable toxicity profile. Three treatment-related deaths occurred in treatment-naive patients in Asia (pneumonia, n=2; interstitial lung disease and rhabdomyolysis, n=1 each), no new safety signals were observed and no hypersensitivity reactions were reported in patients receiving prior immunotherapies.Among patients with measurable diseas...