Science and Research

Final Efficacy and Safety Data From the Phase I/II ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer

RET fusions appear in 1%-2% of non-small cell lung cancers (NSCLCs). The results from the ARROW study (ClinicalTrials.gov identifier: NCT03037385) supported US Food and Drug Administration approval of pralsetinib, an oral selective RET inhibitor, for metastatic RET-altered NSCLC and RET fusion-positive thyroid cancers. ARROW was a phase I/II open-label study of pralsetinib 400 mg once daily in RET fusion-positive NSCLCs. Coprimary end points were overall response rate (ORR) and safety. Key secondary end points included duration of response, progression-free survival, and overall survival (OS). At data lock (May 20, 2024), 281 patients initiated pralsetinib (median treatment duration, 15.0 months). ORR (measurable disease patients; n = 259) was 78% (95% CI, 69 to 86) for treatment-naïve patients and 63% (95% CI, 54 to 71) for prior platinum-based chemotherapy patients. Median OS was 44.3 months (95% CI, 30.9 to 53.1), 50.1 months (95% CI, 28.3 to not reached) in treatment-naïve patients, and 39.7 months (95% CI, 27.8 to 53.2) in prior platinum patients. Common grade

  • Besse, B.
  • Subbiah, V.
  • Curigliano, G.
  • Bowles, D. W.
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  • Mansfield, A. S.
  • Baik, C. S.
  • de Lima Lopes, G.
  • Paz-Ares, L.
  • Taylor, M. H.
  • Tan, D. S. W.
  • Alonso, G.
  • Gadgeel, S. M.
  • Kalemkerian, G. P.
  • Ou, S. I.
  • van der Wekken, A. J.
  • Becerra, C. R.
  • Evangelist, M.
  • Griesinger, F.
  • Liu, S. V.
  • Lou, Y.
  • Mazières, J.
  • Melear, J. M.
  • Narang, M.
  • Saxena, A.
  • Thomas, M.
  • Wang, S.
  • Thomassen, A.
  • Lee, D. H.
  • Kim, D. W.
  • Gainor, J. F.
Publication details
DOI: 10.1200/jco-25-01489
Journal: J Clin Oncol
Pages: Jco2501489 
Work Type: Original
Location: TLRC
Disease Area: LC
Partner / Member: Thorax
Access-Number: 41886723


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