Journal
NATURE MEDICINE
Volume 28, Issue 8, Pages 1640-+Publisher
NATURE PORTFOLIO
DOI: 10.1038/s41591-022-01931-y
Keywords
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Funding
- Jacquelyn A. Brady Fund
- US National Institutes of Health [R01CA242845, R01CA273168]
- Cancer Prevention and Research Institute of Texas [RP1100584]
- Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy [1U01 CA180964]
- National Center for Advancing Translational Sciences grant [UL1 TR000371]
- MD Anderson Cancer Center Support grant [P30 CA016672]
- Blueprint Medicines
- Caixa Research Advanced Oncology Research Program (Fundacio La Caixa) [LCF/PR/CE07/50610001]
- Carlos III National Health Institute grant [PI21/00789]
- Horizon 2020 [H2020-SC1-2019-Single-Stage-RTD]
- Oncology Center of Excellence Grant/German Cancer Aid [70112273]
- German Cancer Consortium, partner site: University Hospital Essen [BMBF 613-71043-1]
- OPTIMA (optimal treatment for patients with solid tumors in Europe through artificial intelligence) grant [101034347]
- F. Hoffmann-La Roche
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Pralsetinib is a potent and selective inhibitor of RET receptor tyrosine kinase, showing promising efficacy in patients with diverse RET fusion-positive solid tumors. It demonstrates rapid, robust, and durable anti-tumor activity, regardless of tumor type or RET fusion partner.
Oncogenic RET fusions occur in diverse cancers. Pralsetinib is a potent, selective inhibitor of RET receptor tyrosine kinase. ARROW (NCT03037385, ongoing) was designed to evaluate pralsetinib efficacy and safety in patients with advanced RET-altered solid tumors. Twenty-nine patients with 12 different RET fusion-positive solid tumor types, excluding non-small-cell lung cancer and thyroid cancer, who had previously received or were not candidates for standard therapies, were enrolled. The most common RET fusion partners in 23 efficacy-evaluable patients were CCDC6 (26%), KIF5B (26%) and NCOA4 (13%). Overall response rate, the primary endpoint, was 57% (95% confidence interval, 35-77) among these patients. Responses were observed regardless of tumor type or RET fusion partner. Median duration of response, progression-free survival and overall survival were 12 months, 7 months and 14 months, respectively. The most common grade >= 3 treatment-related adverse events were neutropenia (31%) and anemia (14%). These data validate RET as a tissue-agnostic target with sensitivity to RET inhibition, indicating pralsetinib's potential as a well-tolerated treatment option with rapid, robust and durable anti-tumor activity in patients with diverse RET fusion-positive solid tumors.
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