TY  - JOUR
AU  - Livingstone, E.
AU  - Gogas, H. J.
AU  - Kandolf, L.
AU  - Meier, F.
AU  - Eigentler, T. K.
AU  - Ziemer, M.
AU  - Terheyden, P.
AU  - Gesierich, A.
AU  - Herbst, R. A.
AU  - Kähler, K. C.
AU  - Ziogas, D. C.
AU  - Mijušković, Ž
AU  - Garzarolli, M.
AU  - Garbe, C.
AU  - Roesch, A.
AU  - Ugurel, S.
AU  - Gutzmer, R.
AU  - Gaudy-Marqueste, C.
AU  - Kiecker, F.
AU  - Utikal, J.
AU  - Hartmann, M.
AU  - Miethe, S.
AU  - Eckhardt, S.
AU  - Zimmer, Laura
AU  - Schadendorf, D.
TI  - Early switch from run-in with targeted to immunotherapy in advanced BRAFV600-positive melanoma: final results of the randomised phase II ImmunoCobiVem trial.
JO  - ESMO open
VL  - 10
IS  - 5
SN  - 2059-7029
CY  - [London]
PB  - Elsevier
M1  - DKFZ-2025-00949
SP  - 105053
PY  - 2025
AB  - Optimal sequencing of immune checkpoint inhibitors (ICIs) and targeted therapies (TTs) in BRAFV600-positive advanced melanoma should achieve rapid tumour control and durable progression-free survival (PFS), translating into prolonged overall survival (OS).The 1 : 1 randomised phase II ImmunoCobiVem trial compared-after a 3-month run-in phase with vemurafenib (VEM, 960 mg twice daily) and cobimetinib (COB, 60 mg daily days 21-28, q4w)-continuous VEM + COB until disease progression (PD1) and second-line atezolizumab (ATEZO, 1200 mg, q3w) in arm A versus early switch to ATEZO after run-in, followed by crossover to VEM + COB at PD1, in arm B. PFS from the start of run-in until PD1 was the primary endpoint (PFS1); secondary efficacy endpoints were OS, overall PFS (PFS2) and PFS3 (time from PD1 to PD after crossover, i.e. PD2) and best overall response rates (BORRs).The final analysis (median follow-up 57.0 months, interquartile range 22.7-63.0 months) confirmed longer PFS1 for continuous TT [arm A (69 patients) versus arm B (early switch, 66 patients); hazard ratio (HR) 0.61, 95
KW  - crossover design (Other)
KW  - immunotherapy (Other)
KW  - melanoma (Other)
KW  - sequential therapy (Other)
KW  - targeted therapy (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:40345056
DO  - DOI:10.1016/j.esmoop.2025.105053
UR  - https://inrepo02.dkfz.de/record/301264
ER  -