The FDA has accepted for review its New Drug Applications (NDA) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable, or metastatic melanoma.
Results from the COLUMBUS Part 1 study showed that COMBO450 significantly extended progression-free survival (PFS) in patients with advanced BRAF-mutant melanoma, with a PFS of 14.9 months compared with 7.3 months observed with vemurafenib [hazard ratio (HR) 0.54, (95% CI 0.41-0.71, P<0.001)].
In COLUMBUS Part 2, the primary analysis compared PFS in patients treated with binimetinib 45 mg twice daily plus encorafenib 300 mg daily (COMBO300) to patients treated with encorafenib 300 mg daily as a single agent. Top-line results showed the mPFS for patients treated with COMBO300 was 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with HR of 0.77 [95% CI 0.61-0.97, p=0.029].