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Bending the Curve Trial by Trial
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ARROW

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

Phase 1/2NCT03037385

Population
RET fusion-positive NSCLC: previously treated with platinum-based chemotherapy, or treatment-naive and ineligible for standard therapy
Design
Multi-cohort, open-label phase 1-2 study at 71 sites in 13 countries. Phase 2: pralsetinib 400 mg orally once daily. Phase 2 primary endpoints overall response rate (RECIST 1.1, blinded independent central review) and safety. Interim analysis.
Primary endpoint
ORR
Arms
  • Pralsetinib (experimental): Pralsetinib 400 mg orally once daily
People
Gainor JF
Show the numbers
Results reported for ARROW
EndpointAnalysisPralsetinibControlEffect
ORRPreviously treated with platinum-based chemotherapy, centrally adjudicated measurable baseline disease (n=87)Overall response by blinded independent central review (RECIST 1.1)interimGainor 202161% (50–71%)—53 of 87 patients responded, including 5 (6%) complete responses. Grade 3 or worse treatment-related adverse events in 233 patients: neutropenia 18%, hypertension 11%, anaemia 10%.
ORRTreatment-naive, centrally adjudicated measurable baseline disease (n=27)interimGainor 202170% (50–86%)—19 of 27 patients responded, including 3 (11%) complete responses.
Results reported for ARROW
EndpointAnalysisPralsetinibControlEffect
ORRPreviously treated with platinum-based chemotherapy, centrally adjudicated measurable baseline disease (n=87)Overall response by blinded independent central review (RECIST 1.1)interimGainor 202161% (50–71%)—53 of 87 patients responded, including 5 (6%) complete responses. Grade 3 or worse treatment-related adverse events in 233 patients: neutropenia 18%, hypertension 11%, anaemia 10%.
ORRTreatment-naive, centrally adjudicated measurable baseline disease (n=27)interimGainor 202170% (50–86%)—19 of 27 patients responded, including 3 (11%) complete responses.
Primary publication: Gainor JF, Curigliano G, Kim DW, Lee DH, Besse B, Baik CS, et al. Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol. 2021;22(7):959-969. PubMedDOI

Appears in

Sources

  1. Gainor JF, Curigliano G, Kim DW, Lee DH, Besse B, Baik CS, et al. Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol. 2021;22(7):959-969.

    PubMedDOI