Non-small cell lung cancer, RET-positive

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Eric K. Singhi, MD
MD Anderson Cancer Center
Houston, TX

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Amit Kulkarni, MBBS
University of Minnesota
Minneapolis, MN

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Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.

2 regimens on this page
2 variants on this page


Advanced or metastatic disease

Pralsetinib monotherapy

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Regimen

Study Years of enrollment Evidence
Gainor et al. 2021 (ARROWRET) 2017-2020 Phase 1/2 (RT)

Note: this trial is denoted as ARROWRET to distinguish from other trials of the same name. This is the phase II dosing.

Biomarker eligibility criteria

  • RET fusion positive

Targeted therapy

Continued indefinitely

References

  1. ARROW: Gainor JF, Curigliano G, Kim DW, Lee DH, Besse B, Baik CS, Doebele RC, Cassier PA, Lopes G, Tan DSW, Garralda E, Paz-Ares LG, Cho BC, Gadgeel SM, Thomas M, Liu SV, Taylor MH, Mansfield AS, Zhu VW, Clifford C, Zhang H, Palmer M, Green J, Turner CD, Subbiah V. Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol. 2021 Jul;22(7):959-969. Epub 2021 Jun 9. Erratum in: Lancet Oncol. 2021 Aug;22(8):e347. link to original article PubMed NCT03037385

Selpercatinib monotherapy

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Regimen

FDA-recommended dose
Study Evidence
Drilon et al. 2020 (LIBRETTO-001) Phase 1/2 (RT)

Biomarker eligibility criteria

  • RET fusion positive

Targeted therapy

  • Selpercatinib (Retevmo) by the following weight-based criteria:
    • Less than 50 kg: 120 mg PO twice per day
    • 50 kg or more: 160 mg PO twice per day

Continued indefinitely

References

  1. LIBRETTO-001: Drilon A, Oxnard GR, Tan DSW, Loong HHF, Johnson M, Gainor J, McCoach CE, Gautschi O, Besse B, Cho BC, Peled N, Weiss J, Kim YJ, Ohe Y, Nishio M, Park K, Patel J, Seto T, Sakamoto T, Rosen E, Shah MH, Barlesi F, Cassier PA, Bazhenova L, De Braud F, Garralda E, Velcheti V, Satouchi M, Ohashi K, Pennell NA, Reckamp KL, Dy GK, Wolf J, Solomon B, Falchook G, Ebata K, Nguyen M, Nair B, Zhu EY, Yang L, Huang X, Olek E, Rothenberg SM, Goto K, Subbiah V. Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Aug 27;383(9):813-824. link to original article PubMed NCT03157128