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What are the main benefits of BRAF inhibitors in metastatic melanoma?

What are the main benefits of BRAF inhibitors in metastatic melanoma?. Should patients expect prolonged overall survival, prolonged progression-free survival, or simply palliation without chance of a cure?.

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What are the main benefits of BRAF inhibitors in metastatic melanoma?

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  1. What are the main benefits of BRAF inhibitors in metastatic melanoma? Should patients expect prolonged overall survival, prolonged progression-free survival, or simply palliation without chance of a cure?

  2. Vemurafenib in previously untreated Stage IV BRAFV600 mutant melanoma (BRIM3 trial): Overall survival Overall survival (%) Hazard ratio 0.70 (95% CI, 0.57–0.87) P<0.001 (post-hoc) at February 1, 2012 cutoffCensored at crossover 100 90 80 70 Vemurafenib (n = 337) Median f/u 12.5 months 60 50 DTIC (n = 338) Median f/u 9.5 months 40 30 20 10 9.7 13.6 0 0 6 12 18 24 Months No. at risk Dacarbazine Vemurafenib 338 337 244 326 173 280 111 231 79 178 50 109 24 44 4 7 0 1 Chapman et al, ASCO 2012; #8502

  3. Vemurafenib in previously treated Stage IV BRAFV600 mutant melanoma (BRIM2 trial): Progression-free survival Progression-free Survival (%) 100 90 80 70 60 50 40 30 20 6.9 10 0 Months 6 12 18 24 No. at risk 132 118 88 67 48 33 31 22 12 5 0 Treatment duration (weeks) Sosman et al, N Engl J Med 2012; 366: 707–14

  4. Vemurafenib in previously treated Stage IV BRAFV600 mutant melanoma (BRIM2 trial): Overall survival Overall Survival (%) 100 90 80 70 60 50 40 30 20 15.9 10 0 24 Months 6 12 18 No. at risk 132 128 118 97 83 77 70 60 39 18 1 0 Treatment duration (weeks) Sosman et al, N Engl J Med 2012; 366: 707–14

  5. 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 Dabrafenib in previously untreated Stage IV BRAFV600 mutant melanoma (BREAK3 trial):Progression-free survival (independent review) Proportion Alive Without Progression Hazard ratio 0.35 (95% CI, 0.20–0.61) (Dec 19, 2011 cut-off) Dabrafenib DTIC 6.7 2.9 Months No. at risk Hauschild et al, ASCO 2012; LBA8500 Hauschild et al, Lancet 2012; 380: 358–65

  6. Open label study of combined BRAF/MEK inhibition in stage IV melanoma: Progression-free survival Estimated survival function 1.0 0.8 0.6 0.4 0.2 Median follow up time 14 mo 5.8 9.2 9.4 0.0 0 3 6 9 12 15 18 Patients at risk Months Long et al, ESMO 2012; LBA27 Flaherty et al, N Engl J Med 2012; 367: 1694–703

  7. Benefits of BRAF inhibition Front line BRAF inhibitors provide • Significant PFS (5–7 months) • Prolonged survival (13–18 months) There are few data on cures • <10% of the BRIM2 patients are alive free of disease 3–5 years from treatment The drugs provide significant palliation, especially in patients with rapidly growing or symptomatic disease

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