6/27/23, 11:47 PM BRIM-3 Pathway Feedback Search Clinical Topics Home Studies BRIM 3 BRIM 3 Disease Cutaneous melanoma Trial question What is the effect of vemurafenib in patients with metastatic melanoma with the BRAF V600E mutation? Study design Multi-center Open label RCT Population Characteristics of study participants 44.0% female N = 675 56.0% male 675 patients (294 female, 381 male) Inclusion criteria: patients with previously untreated, metastatic melanoma with the BRAF V600E mutation Key exclusion criteria: history of cancer within the past 5 years or metastases to the CNS, unless such metastases had been definitively treated > 3 months previously with no progression and no requirement for continued corticosteroid therapy, and concomitant treatment with any other anticancer therapy Interventions N=337 vemurafenib (at a dose of 960 mg BID PO) N=338 dacarbazine (at a dose of 1,000 mg per square meter of body-surface area by intravenous infusion every 3 weeks) Primary outcome https://web.pathway.md/studies/recpmoXwPeCWJw5Ke 1/2 6/27/23, 11:47 PM BRIM-3 Pathway Progression-free survival 5.3 months 5.3 4.0 months 2.6 months 1.6 1.3 months Significant decrease 0.0 months Vemurafenib Dacarbazine Significant decrease in progression-free survival (5.3 months vs. 1.6 months; HR 0.26, 95% CI 0.2 to 0.33) Secondary outcomes Significant increase in response rate (48% vs. 5%; AD 43%, 95% CI 17.49 to 68.51) Safety outcomes No significant difference in fatigue and vomiting. Significant differences in adverse events leading to dose modification/interruption (38% vs. 16%), arthralgia (21% vs. 1%), rash (18% vs. 0%), SCC (12% vs. < 1%), keratoacanthoma (8% vs. 0%), and alopecia (8% vs. 0%). Conclusion In patients with previously untreated, metastatic melanoma with the BRAF V600E mutation, vemurafenib was superior to dacarbazine with respect to a progression-free survival. Reference Chapman PB, Hauschild A, Robert C et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011 Jun 30;364(26):2507-16. Open reference URL https://web.pathway.md/studies/recpmoXwPeCWJw5Ke 2/2