FDA approved regorefanib, Stivarga, for GIST and for colon cancer, based on the CORRECT trial. This drug alone has support in one study showing an OS benefit. Regorafenib (Stivarga) improved overall survival (OS) and progression-free survival (PFS) compared with lomustine (Gleostine) for patients with glioblastoma (GBM) that recurred following surgery and treatment with the Stupp regimen, according to updated results presented in a poster at the 2018 ASCO Annual Meeting. Updated findings from the randomized, multicenter, controlled open-label phase II REGOMA trial (NCT02926222) showed that the OS rate at 12 months favored patients assigned to regorafenib 38.9% vs 15.0%. The median OS was 7.4 months (95% CI, 4.7-7.3) in the regorafenib group compared with 5.6 months (95% CI, 4.7-7.3) in the lomustine arm (HR, 0.5; 80% CI, 0.38-0.65; P = .0007).Lombardi G, De Salvo GL, Ruda R, et al. Updated results of REGOMA: A randomized, multicenter, controlled open-label phase II clinical trial evaluating regorafenib in relapsed glioblastoma (GBM) patients (PTS). J Clin Oncol. 36, 2018 (suppl; abstr 2047).
Lombardi G, De Salvo GL, Brandes AA, et al. REGOMA: A randomized, multicenter, controlled open-label phase II clinical trial evaluating regorafenib activity in relapsed glioblastoma patients. In: Proceedings from the 2017 ESMO Congress; September 8-12, 2017; Madrid, Spain. Abstract LBA16.