Difference between revisions of "Non-small cell lung cancer, BRAF-mutated"
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[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
| − | {{#lst: | + | {{#lst:Editorial board transclusions|nsclc}} |
Note: these are regimens tested in biomarker-specific populations, please see the '''[[Non-small cell lung cancer|main NSCLC page]]''' for other regimens. | Note: these are regimens tested in biomarker-specific populations, please see the '''[[Non-small cell lung cancer|main NSCLC page]]''' for other regimens. | ||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
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{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
=Guidelines= | =Guidelines= | ||
| + | '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.''' | ||
==[https://www.asco.org/ ASCO]== | ==[https://www.asco.org/ ASCO]== | ||
| − | *'''2022:''' Singh et al. [https://doi.org/10.1200/jco.22.00824 Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline] | + | *'''2022:''' Singh et al. [https://doi.org/10.1200/jco.22.00824 Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline] [https://www.ncbi.nlm.nih.gov/pubmed/35816666 PubMed] |
| + | |||
==[https://www.esmo.org/ ESMO]== | ==[https://www.esmo.org/ ESMO]== | ||
| − | *'''2023:''' Hendriks et al. [https://doi.org/10.1016/j.annonc.2022.12.009 Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up] | + | *'''2023:''' Hendriks et al. [https://doi.org/10.1016/j.annonc.2022.12.009 Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up] [https://www.ncbi.nlm.nih.gov/pubmed/36872130 PubMed] |
| + | |||
| + | ==NCCN== | ||
| + | *''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450 NCCN Guidelines - Non-Small Cell Lung Cancer].'' | ||
=Advanced or metastatic disease, first-line= | =Advanced or metastatic disease, first-line= | ||
| Line 31: | Line 36: | ||
|- | |- | ||
|[https://doi.org/10.1016/S1470-2045(17)30679-4 Planchard et al. 2017 (BRF113928 untreated)] | |[https://doi.org/10.1016/S1470-2045(17)30679-4 Planchard et al. 2017 (BRF113928 untreated)] | ||
| − | {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26" | + | <!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26" |
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-130-1 <span style="color:white;">ESMO-MCBS (2)</span>]''' | |'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-130-1 <span style="color:white;">ESMO-MCBS (2)</span>]''' | ||
|- | |- | ||
| − | |} | + | |} --> |
|2014-2015 | |2014-2015 | ||
|style="background-color:#91cf61"|Phase 2 (RT) | |style="background-color:#91cf61"|Phase 2 (RT) | ||
| Line 50: | Line 55: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | # '''BRF113928 untreated:''' Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland Å, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. Epub 2017 Sep 11. [https://doi.org/10.1016/S1470-2045(17)30679-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28919011 PubMed] NCT01336634 | + | # '''BRF113928 untreated:''' Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland Å, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. Epub 2017 Sep 11. [https://doi.org/10.1016/S1470-2045(17)30679-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28919011/ PubMed] [https://clinicaltrials.gov/study/NCT01336634 NCT01336634] |
##'''Update:''' Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. [https://doi.org/10.1016/j.jtho.2021.08.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34455067/ PubMed] | ##'''Update:''' Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. [https://doi.org/10.1016/j.jtho.2021.08.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34455067/ PubMed] | ||
=Advanced or metastatic disease, previously treated, BRAF inhibitor-naive= | =Advanced or metastatic disease, previously treated, BRAF inhibitor-naive= | ||
| + | ==Binimetinib & Encorafenib {{#subobject:05e885|Regimen=1}}== | ||
| + | <div class="toccolours" style="background-color:#eeeeee"> | ||
| + | ===Regimen {{#subobject:cicx97|Variant=1}}=== | ||
| + | {| class="wikitable" style="color:white; background-color:#404040" | ||
| + | |<small>'''FDA-recommended dose'''</small> | ||
| + | |- | ||
| + | |} | ||
| + | {| class="wikitable" style="width: 60%; text-align:center;" | ||
| + | !style="width: 33%"|Study | ||
| + | !style="width: 33%"|Dates of enrollment | ||
| + | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | |- | ||
| + | |[https://doi.org/10.1200/jco.23.00774 Riely et al. 2023 (PHAROS)] | ||
| + | |2019-06-04 to 2022-06-02 | ||
| + | |style="background-color:#91cf61"|Phase 2 (RT) | ||
| + | |- | ||
| + | |} | ||
| + | <div class="toccolours" style="background-color:#fdcdac"> | ||
| + | ====Biomarker eligibility criteria==== | ||
| + | *Biomarker: BRAF V600E | ||
| + | </div> | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
| + | ====Targeted therapy==== | ||
| + | *[[Binimetinib (Mektovi)]] 45 mg PO twice per day on days 1 to 28 | ||
| + | *[[Encorafenib (Braftovi)]] 450 mg PO once per day on days 1 to 28 | ||
| + | '''28-day cycles''' | ||
| + | </div></div> | ||
| + | |||
| + | ===References=== | ||
| + | #'''PHAROS:''' Riely GJ, Smit EF, Ahn MJ, Felip E, Ramalingam SS, Tsao A, Johnson M, Gelsomino F, Esper R, Nadal E, Offin M, Provencio M, Clarke J, Hussain M, Otterson GA, Dagogo-Jack I, Goldman JW, Morgensztern D, Alcasid A, Usari T, Wissel P, Wilner K, Pathan N, Tonkovyd S, Johnson BE. Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non-Small-Cell Lung Cancer. J Clin Oncol. 2023 Jul 20;41(21):3700-3711. Epub 2023 Jun 4. Erratum in: J Clin Oncol. 2023 Dec 5;:JCO2302518. [https://doi.org/10.1200/jco.23.00774 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/37270692/ PubMed] [https://www.clinicaltrials.gov/study/NCT03915951 NCT03915951] | ||
| + | |||
==Dabrafenib & Trametinib {{#subobject:05e601|Regimen=1}}== | ==Dabrafenib & Trametinib {{#subobject:05e601|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| Line 66: | Line 102: | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4993103/ Planchard et al. 2016 (BRF113928 previously treated)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4993103/ Planchard et al. 2016 (BRF113928 previously treated)] | ||
| − | {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26" | + | <!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26" |
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-131-1 <span style="color:white;">ESMO-MCBS (2)</span>]''' | |'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-131-1 <span style="color:white;">ESMO-MCBS (2)</span>]''' | ||
|- | |- | ||
| − | |} | + | |} --> |
|2013-2015 | |2013-2015 | ||
|style="background-color:#91cf61"|Phase 2 (RT) | |style="background-color:#91cf61"|Phase 2 (RT) | ||
| Line 87: | Line 123: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | # '''BRF113928 previously treated:''' Planchard D, Besse B, Groen HJ, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-93. Epub 2016 Jun 6. [https://doi.org/10.1016/S1470-2045(16)30146-2 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4993103/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27283860/ PubMed] NCT01336634 | + | # '''BRF113928 previously treated:''' Planchard D, Besse B, Groen HJ, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-93. Epub 2016 Jun 6. [https://doi.org/10.1016/S1470-2045(16)30146-2 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4993103/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27283860/ PubMed] [https://clinicaltrials.gov/study/NCT01336634 NCT01336634] |
##'''Update:''' Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. [https://doi.org/10.1016/j.jtho.2021.08.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34455067/ PubMed] | ##'''Update:''' Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. [https://doi.org/10.1016/j.jtho.2021.08.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34455067/ PubMed] | ||
[[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]] | ||
Latest revision as of 11:28, 13 May 2024
| Page editor | Section editor | ||
|---|---|---|---|
 |
Eric K. Singhi, MD MD Anderson Cancer Center Houston, TX, USA |
 |
Amit Kulkarni, MBBS University of Minnesota Minneapolis, MN, USA |
Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.
3 regimens on this page
3 variants on this page
|
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
ASCO
- 2022: Singh et al. Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline PubMed
ESMO
- 2023: Hendriks et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up PubMed
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Non-Small Cell Lung Cancer.
Advanced or metastatic disease, first-line
Dabrafenib & Trametinib
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Planchard et al. 2017 (BRF113928 untreated) | 2014-2015 | Phase 2 (RT) |
Biomarker eligibility criteria
- Biomarker: BRAF V600E
Targeted therapy
- Dabrafenib (Tafinlar) 150 mg PO twice per day
- Trametinib (Mekinist) 2 mg PO once per day
Continued indefinitely
References
- BRF113928 untreated: Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland Å, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. Epub 2017 Sep 11. link to original article PubMed NCT01336634
- Update: Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. link to original article PubMed
Advanced or metastatic disease, previously treated, BRAF inhibitor-naive
Binimetinib & Encorafenib
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Riely et al. 2023 (PHAROS) | 2019-06-04 to 2022-06-02 | Phase 2 (RT) |
Biomarker eligibility criteria
- Biomarker: BRAF V600E
Targeted therapy
- Binimetinib (Mektovi) 45 mg PO twice per day on days 1 to 28
- Encorafenib (Braftovi) 450 mg PO once per day on days 1 to 28
28-day cycles
References
- PHAROS: Riely GJ, Smit EF, Ahn MJ, Felip E, Ramalingam SS, Tsao A, Johnson M, Gelsomino F, Esper R, Nadal E, Offin M, Provencio M, Clarke J, Hussain M, Otterson GA, Dagogo-Jack I, Goldman JW, Morgensztern D, Alcasid A, Usari T, Wissel P, Wilner K, Pathan N, Tonkovyd S, Johnson BE. Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non-Small-Cell Lung Cancer. J Clin Oncol. 2023 Jul 20;41(21):3700-3711. Epub 2023 Jun 4. Erratum in: J Clin Oncol. 2023 Dec 5;:JCO2302518. link to original article contains dosing details in manuscript PubMed NCT03915951
Dabrafenib & Trametinib
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Planchard et al. 2016 (BRF113928 previously treated) | 2013-2015 | Phase 2 (RT) |
Prior treatment criteria
- 1 to 3 prior regimens, with progression
Biomarker eligibility criteria
- Biomarker: BRAF V600E
Targeted therapy
- Dabrafenib (Tafinlar) 150 mg PO twice per day
- Trametinib (Mekinist) 2 mg PO once per day
Continued indefinitely
References
- BRF113928 previously treated: Planchard D, Besse B, Groen HJ, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-93. Epub 2016 Jun 6. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01336634
- Update: Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. link to original article PubMed