Difference between revisions of "Non-small cell lung cancer, RET-positive"

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=Advanced or metastatic disease=
 
=Advanced or metastatic disease=
 
==Pralsetinib monotherapy {{#subobject:eahg7q|Regimen=1}}==
 
==Pralsetinib monotherapy {{#subobject:eahg7q|Regimen=1}}==
−
 
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<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:91yg11|Variant=1}}===
 
===Regimen {{#subobject:91yg11|Variant=1}}===
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
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|}
 
|}
 
''Note: this trial is denoted as ARROW<sub>RET</sub> to distinguish from other trials of the same name. This is the phase II dosing.''
 
''Note: this trial is denoted as ARROW<sub>RET</sub> to distinguish from other trials of the same name. This is the phase II dosing.''
 +
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
 
*RET fusion positive
 
*RET fusion positive
−
 
+
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Pralsetinib (Gavreto)]] 400 mg PO once per day
 
*[[Pralsetinib (Gavreto)]] 400 mg PO once per day
−
 
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
−
 
+
</div></div>
 
===References===
 
===References===
 
#'''ARROW<sub>RET</sub>:''' 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. [https://doi.org/10.1016/s1470-2045(21)00247-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34118197/ PubMed] NCT03037385
 
#'''ARROW<sub>RET</sub>:''' 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. [https://doi.org/10.1016/s1470-2045(21)00247-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34118197/ PubMed] NCT03037385
−
 
+
##'''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 Aug 13:S0923-7534(22)03866-2. Epub ahead of print. [https://doi.org/10.1016/j.annonc.2022.08.002 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35973665/ PubMed]
 
==Selpercatinib monotherapy {{#subobject:ea894c|Regimen=1}}==
 
==Selpercatinib monotherapy {{#subobject:ea894c|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:9134b2|Variant=1}}===
 
===Regimen {{#subobject:9134b2|Variant=1}}===
 
{| class="wikitable" style="color:white; background-color:#404040"
 
{| class="wikitable" style="color:white; background-color:#404040"
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
 
*RET fusion positive
 
*RET fusion positive
−
 
+
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Selpercatinib (Retevmo)]] by the following weight-based criteria:
 
*[[Selpercatinib (Retevmo)]] by the following weight-based criteria:
 
**Less than 50 kg: 120 mg PO twice per day
 
**Less than 50 kg: 120 mg PO twice per day
 
**50 kg or more: 160 mg PO twice per day
 
**50 kg or more: 160 mg PO twice per day
−
 
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
−
 
+
</div></div>
 
===References===
 
===References===
−
 
 
<!-- #'''Abstract.''' Drilon, A., Oxnard, G., Wirth, L., Besse, B., Gautschi, O., Tan, S.W.D., Loong, H., Bauer, T., Kim, Y.J., Horiike, A., Park, K., Shah, M., McCoach, C., Bazhenova, L., Seto, T., Brose, M., Pennell, N., Weiss, J., Matos, I., Peled, N., Cho, B.C., Ohe, Y., Reckamp, K., Boni, V., Satouchi, M., Falchook, G., Akerley, W., Daga, H., Sakamoto, T., Patel, J., Lakhani, N., Barlesi, F., Burkard, M., Zhu, V., Moreno Garcia, V., Medioni, J., Matrana, M., Rolfo, C., Lee, D.H., Nechushtan, H., Johnson, M., Velcheti, V., Nishio, M., Toyozawa, R., Ohashi, K., Song, L., Han, J., Spira, A., De Braud, F., Staal Rohrberg, K., Takeuchi, S., Sakakibara, J., Waqar, S., Kenmotsu, H., Wilson, F., B.Nair, Olek, E., Kherani, J., Ebata, K., Zhu, E., Nguyen, M., Yang, L., Huang, X., Cruickshank, S., Rothenberg, S., Solomon, B., Goto, K., Subbiah, V. PL02.08 Registrational Results of LIBRETTO-001: A Phase 1/2 Trial of LOXO-292 in Patients with RET Fusion-Positive Lung Cancers. [https://www.jto.org/article/S1556-0864(19)30742-7 link to abstract] -->
 
<!-- #'''Abstract.''' Drilon, A., Oxnard, G., Wirth, L., Besse, B., Gautschi, O., Tan, S.W.D., Loong, H., Bauer, T., Kim, Y.J., Horiike, A., Park, K., Shah, M., McCoach, C., Bazhenova, L., Seto, T., Brose, M., Pennell, N., Weiss, J., Matos, I., Peled, N., Cho, B.C., Ohe, Y., Reckamp, K., Boni, V., Satouchi, M., Falchook, G., Akerley, W., Daga, H., Sakamoto, T., Patel, J., Lakhani, N., Barlesi, F., Burkard, M., Zhu, V., Moreno Garcia, V., Medioni, J., Matrana, M., Rolfo, C., Lee, D.H., Nechushtan, H., Johnson, M., Velcheti, V., Nishio, M., Toyozawa, R., Ohashi, K., Song, L., Han, J., Spira, A., De Braud, F., Staal Rohrberg, K., Takeuchi, S., Sakakibara, J., Waqar, S., Kenmotsu, H., Wilson, F., B.Nair, Olek, E., Kherani, J., Ebata, K., Zhu, E., Nguyen, M., Yang, L., Huang, X., Cruickshank, S., Rothenberg, S., Solomon, B., Goto, K., Subbiah, V. PL02.08 Registrational Results of LIBRETTO-001: A Phase 1/2 Trial of LOXO-292 in Patients with RET Fusion-Positive Lung Cancers. [https://www.jto.org/article/S1556-0864(19)30742-7 link to abstract] -->
 
# '''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. [https://doi.org/10.1056/nejmoa2005653 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7506467/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32846060 PubMed] NCT03157128
 
# '''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. [https://doi.org/10.1056/nejmoa2005653 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7506467/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32846060 PubMed] NCT03157128
−
 
 
[[Category:Non-small cell lung cancer regimens]]
 
[[Category:Non-small cell lung cancer regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Non-small cell lung cancers]]
 
[[Category:Non-small cell lung cancers]]

Revision as of 10:48, 26 October 2022

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

7 regimens on this page
7 variants on this page


Advanced or metastatic disease

Pralsetinib monotherapy

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. 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 NCT03037385
    1. 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 Aug 13:S0923-7534(22)03866-2. Epub ahead of print. link to original article PubMed

Selpercatinib monotherapy

Regimen

FDA-recommended dose
Study Years 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

  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 link to PMC article PubMed NCT03157128
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