TY - JOUR AU - Livingstone, E. AU - Gogas, H. AU - Kandolf-Sekulovic, L. AU - Meier, F. AU - Eigentler, T. K. AU - Ziemer, M. AU - Terheyden, P. A. M. AU - Gesierich, A. H. AU - Herbst, R. A. AU - Kähler, K. C. AU - Ziogas, D. C. AU - Mijuskovic, Z. AU - Garzarolli, M. AU - Garbe, C. AU - Roesch, A. AU - Ugurel, S. AU - Gutzmer, R. AU - Grob, J. J. AU - Kiecker, F. AU - Utikal, J. AU - Windemuth-Kieselbach, C. AU - Eckhardt, S. AU - Zimmer, L. AU - Schadendorf, D. TI - Early switch from run-in treatment with vemurafenib plus cobimetinib to atezolizumab after 3 months leads to rapid loss of tumour control in patients with advanced BRAFV600-positive melanoma: The ImmunoCobiVem phase 2 randomised trial. JO - European journal of cancer VL - 190 SN - 0014-2964 CY - Amsterdam [u.a.] PB - Elsevier M1 - DKFZ-2023-01425 SP - 112941 PY - 2023 AB - ImmunoCobiVem investigated whether a planned switch to atezolizumab after achieving tumour control during run-in with vemurafenib + cobimetinib improves progression-free survival (PFS) and overall survival (OS) compared to continuous targeted therapy (TT) in patients with previously untreated advanced BRAFV600-mutated melanoma.In this multicenter phase 2 study, patients received vemurafenib plus cobimetinib. After 3months, patients without progressive disease (PD) were randomly assigned (1:1) to continue vemurafenib + cobimetinib (Arm A) or switch to atezolizumab (Arm B) until first documented PD (PD1). Primary outcome was PFS1 (time from start of run-in until PD1 or death). OS and safety were also assessed.Of 185 patients enroled between November 2016 and December 2019, 135 were randomly assigned after the run-in period (Arm A, n = 69; Arm B, n = 66). Median PFS1 was significantly longer in Arm A versus Arm B (13.9 versus 5.9months; hazard ratio [HR] 0.55; 95 KW - Checkpoint inhibition (Other) KW - First-line (Other) KW - Melanoma (Other) KW - Run-in (Other) KW - Sequence (Other) KW - Targeted therapy (Other) LB - PUB:(DE-HGF)16 C6 - pmid:37482012 DO - DOI:10.1016/j.ejca.2023.112941 UR - https://inrepo02.dkfz.de/record/277708 ER -