BRAF

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2 regimens on this page
2 variants on this page


Note: most other regimen pages are tissue-specific. We will collect published information from basket trials on these pages, as well as regimens that are FDA approved.

All lines of therapy

Dabrafenib & Trametinib

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Regimen

Study Evidence
Subbiah et al. 2017 (BRF117019) Phase II
Salama et al. 2020 (EAY131-H) Non-randomized

Note: only partial results of BRF117019 have been published to date.

Biomarker eligibility criteria

  • Gene: BRAF V600E
  • Alteration: substitution
  • Acceptable methods of measurement: archival or fresh tumor tissue

Preceding treatment

  • No prior treatment with BRAF and/or MEK inhibitor(s)

Targeted therapy

28-day cycles

References

  1. BRF117019: Subbiah V, Kreitman RJ, Wainberg ZA, Cho JY, Schellens JHM, Soria JC, Wen PY, Zielinski C, Cabanillas ME, Urbanowitz G, Mookerjee B, Wang D, Rangwala F, Keam B. Dabrafenib and trametinib treatment in patients with locally advanced or metastatic BRAF V600-mutant anaplastic thyroid cancer. J Clin Oncol. 2018 Jan 1;36(1):7-13. Epub 2017 Oct 26. link to original article contains verified protocol link to PMC article PubMed NCT02034110
  2. EAY131-H: Salama AKS, Li S, Macrae ER, Park JI, Mitchell EP, Zwiebel JA, Chen HX, Gray RJ, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Armstrong DK, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Dabrafenib and Trametinib in Patients With Tumors With BRAFV600E Mutations: Results of the NCI-MATCH Trial Subprotocol H. J Clin Oncol. 2020 Nov 20;38(33):3895-3904. Epub 2020 Aug 6. link to PMC article contains verified protocol PubMed NCT02465060

Vemurafenib monotherapy

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Regimen

Study Evidence
Hyman et al. 2015 (VE-BASKET) Phase II
Hainsworth et al. 2018 (MyPathway) Phase IIa

Biomarker eligibility criteria

  • VE-BASKET
    • Gene: BRAF V600
    • Alteration: substitution
    • Acceptable methods of measurement: mutational analysis assays
  • MyPathway
    • Gene: BRAF V600E
    • Alteration: substitution
    • Acceptable methods of measurement: molecular profiling performed on tissue obtained at the most recent tumor biopsy
    • Biomarker exclusions: no coexisting KRAS mutations, or other BRAF mutations

Preceding treatment

  • VE-BASKET: no prior treatment with BRAF and/or MEK inhibitor(s)

Targeted therapy

Continued indefinitely

References

  1. VE-BASKET: Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations. N Engl J Med. 2015 Aug 20;373(8):726-736. link to original article contains protocol link to PMC article PubMed NCT01524978
  2. MyPathway: Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. link to original article contains verified protocol PubMed NCT02091141