Non-small cell lung cancer, RET-positive
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| Page editor | Section editor | ||
|---|---|---|---|
 |
Eric K. Singhi, MD MD Anderson Cancer Center Houston, TX |
 |
Amit Kulkarni, MBBS University of Minnesota Minneapolis, MN |
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
|
Guidelines
ASCO
- 2022: Singh et al. Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline
ESMO
- 2023: Hendriks et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
Advanced or metastatic disease, all lines of therapy
Pralsetinib monotherapy
Regimen
| Study | Dates 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
References
- ARROWRET: 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 Clinical Trial Registry
- Update: Griesinger F, Curigliano G, Thomas M, Subbiah V, Baik CS, Tan DSW, Lee DH, Misch D, Garralda E, Kim DW, van der Wekken AJ, Gainor JF, Paz-Ares L, Liu SV, Kalemkerian GP, Houvras Y, Bowles DW, Mansfield AS, Lin JJ, Smoljanovic V, Rahman A, Kong S, Zalutskaya A, Louie-Gao M, Boral AL, Mazières J. Safety and efficacy of pralsetinib in RET fusion-positive non-small-cell lung cancer including as first-line therapy: update from the ARROW trial. Ann Oncol. 2022 Nov;33(11):1168-1178. Epub 2022 Aug 13. link to original article PubMed
Selpercatinib monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence | |
|---|---|---|---|
Drilon et al. 2020 (LIBRETTO-001)
|
2017-2018 | 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
- 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 link to PMC article PubMed Clinical Trial Registry
- PRO analysis: Minchom A, Tan AC, Massarelli E, Subbiah V, Boni V, Robinson B, Wirth LJ, Hess LM, Jen MH, Kherani J, Olek E, McCoach CE. Patient-Reported Outcomes with Selpercatinib Among Patients with RET Fusion-Positive Non-Small Cell Lung Cancer in the Phase I/II LIBRETTO-001 Trial. Oncologist. 2022 Feb 3;27(1):22-29. link to original article link to PMC article PubMed
- Update: Drilon A, Subbiah V, Gautschi O, Tomasini P, de Braud F, Solomon BJ, Shao-Weng Tan D, Alonso G, Wolf J, Park K, Goto K, Soldatenkova V, Szymczak S, Barker SS, Puri T, Bence Lin A, Loong H, Besse B. Selpercatinib in Patients With RET Fusion-Positive Non-Small-Cell Lung Cancer: Updated Safety and Efficacy From the Registrational LIBRETTO-001 Phase I/II Trial. J Clin Oncol. 2023 Jan 10;41(2):385-394. Epub 2022 Sep 19. link to original article link to PMC article PubMed