Rigel Pharmaceuticals published the final long-term results from the Phase 1/2 ARROW study of pralsetinib (Gavreto) in metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in the Journal of Clinical Oncology. The dataset includes an additional 42 months of follow-up beyond earlier disclosures. Across patients with measurable disease (n=259), the overall response rate reached 70%, including 7% complete responses. The company also reported a manageable safety profile consistent with prior ARROW NSCLC data, including three treatment-related deaths in treatment-naive patients in Asia attributed to pneumonia and interstitial lung disease, with no new safety signals flagged. The publication also highlighted activity in a baseline measurable CNS metastases subset, expanding the clinical narrative around intracranial benefit for a therapy designed as a once-daily, selective RET inhibitor. Rigel framed the longer-term data as further support for positioning pralsetinib as a first-line option for RET fusion-positive NSCLC, with oncologists emphasizing the need for early biomarker testing to identify eligible patients.
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