Malignant solid neoplasm, BRAF-mutated

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

Regimen

Study	Evidence
Salama et al. 2020 (EAY131-H)	Non-randomized

Biomarker eligibility criteria

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

Prior treatment criteria

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

Targeted therapy

• Dabrafenib (Tafinlar) 150 mg PO twice per day on days 1 to 28
• Trametinib (Mekinist) 2 mg PO once per day on days 1 to 28

28-day cycles

References

1. 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 original article link to PMC article contains dosing details in manuscript PubMed NCT02465060

Vemurafenib monotherapy

Regimen

Study	Dates of enrollment	Evidence
Hyman et al. 2015 (VE-BASKET)	2012-2014	Phase 2
Hainsworth et al. 2018 (MyPathway)	2014-2016	Phase 2a

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

Prior treatment criteria

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

Targeted therapy

• Vemurafenib (Zelboraf) 960 mg PO twice per day

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 dosing details in abstract 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 dosing details in manuscript PubMed NCT02091141