% IMPORTANT: The following is UTF-8 encoded. This means that in the presence % of non-ASCII characters, it will not work with BibTeX 0.99 or older. % Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or % “biber”. @ARTICLE{Livingstone:277708, author = {E. Livingstone$^*$ and H. Gogas and L. Kandolf-Sekulovic and F. Meier and T. K. Eigentler and M. Ziemer and P. A. M. Terheyden and A. H. Gesierich and R. A. Herbst and K. C. Kähler and D. C. Ziogas and Z. Mijuskovic and M. Garzarolli and C. Garbe and A. Roesch$^*$ and S. Ugurel$^*$ and R. Gutzmer and J. J. Grob and F. Kiecker and J. Utikal$^*$ and C. Windemuth-Kieselbach and S. Eckhardt and L. Zimmer$^*$ and D. Schadendorf$^*$}, title = {{E}arly 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 {BRAFV}600-positive melanoma: {T}he {I}mmuno{C}obi{V}em phase 2 randomised trial.}, journal = {European journal of cancer}, volume = {190}, issn = {0014-2964}, address = {Amsterdam [u.a.]}, publisher = {Elsevier}, reportid = {DKFZ-2023-01425}, pages = {112941}, year = {2023}, abstract = {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; $95\%$ confidence interval [CI], 0.37-0.84; PStratified=0.001). Median OS was not reached in either arm (HR 1.22; $95\%CI,$ 0.69-2.16; PStratified=0.389); 2-year OS was higher in Arm B versus Arm A $(67\%;$ $95\%CI,$ 53-78 versus $58\%;$ $95\%CI,$ 45-70). Grade 3/4 AEs occurred in $55\%$ of patients in Arm A and $64\%$ in Arm B; treatment-related AEs led to discontinuation of any drug in $7\%$ and $9\%$ of patients, respectively.In patients with BRAFV600-mutated advanced melanoma who achieve tumour control with TT, early switch at 3months to atezolizumab led to rapid loss of tumour control but provided a numerical OS benefit at 2years compared with continued TT.}, keywords = {Checkpoint inhibition (Other) / First-line (Other) / Melanoma (Other) / Run-in (Other) / Sequence (Other) / Targeted therapy (Other)}, cin = {ED01 / A370}, ddc = {610}, cid = {I:(DE-He78)ED01-20160331 / I:(DE-He78)A370-20160331}, pnm = {311 - Zellbiologie und Tumorbiologie (POF4-311)}, pid = {G:(DE-HGF)POF4-311}, typ = {PUB:(DE-HGF)16}, pubmed = {pmid:37482012}, doi = {10.1016/j.ejca.2023.112941}, url = {https://inrepo02.dkfz.de/record/277708}, }