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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

Aim - 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...

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Main Authors: Livingstone, Elisabeth (Author) , Gogas, H. (Author) , Kandolf-Sekulovic, L. (Author) , Meier, F. (Author) , Eigentler, T. K. (Author) , Ziemer, M. (Author) , Terheyden, P. A. M. (Author) , Gesierich, A. H. (Author) , Herbst, R. A. (Author) , Kähler, K. C. (Author) , Ziogas, D. C. (Author) , Mijuskovic, Z. (Author) , Garzarolli, M. (Author) , Garbe, C. (Author) , Roesch, A. (Author) , Ugurel, S. (Author) , Gutzmer, R. (Author) , Grob, J. J. (Author) , Kiecker, F. (Author) , Utikal, Jochen (Author) , Windemuth-Kieselbach, C. (Author) , Eckhardt, S. (Author) , Zimmer, L. (Author) , Schadendorf, Dirk (Author)
Format: Article (Journal)
Language:English
Published: September 2023
In: European journal of cancer
Year: 2023, Volume: 190, Pages: 1-13
ISSN:1879-0852
DOI:10.1016/j.ejca.2023.112941
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ejca.2023.112941
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0959804923002903
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Author Notes:E. Livingstone, H. Gogas, L. Kandolf-Sekulovic, F. Meier, T.K. Eigentler, M. Ziemer, P.A.M. Terheyden, A.H. Gesierich, R. A. Herbst, K. C. Kähler, D.C. Ziogas, Z. Mijuskovic, M. Garzarolli, C. Garbe, A. Roesch, S. Ugurel, R. Gutzmer, J.J. Grob, F. Kiecker, J. Utikal, C. Windemuth-Kieselbach, S. Eckhardt, L. Zimmer, D. Schadendorf

MARC

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245 1 0 |a 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  |b the ImmunoCobiVem phase 2 randomised trial  |c E. Livingstone, H. Gogas, L. Kandolf-Sekulovic, F. Meier, T.K. Eigentler, M. Ziemer, P.A.M. Terheyden, A.H. Gesierich, R. A. Herbst, K. C. Kähler, D.C. Ziogas, Z. Mijuskovic, M. Garzarolli, C. Garbe, A. Roesch, S. Ugurel, R. Gutzmer, J.J. Grob, F. Kiecker, J. Utikal, C. Windemuth-Kieselbach, S. Eckhardt, L. Zimmer, D. Schadendorf 
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520 |a Aim - 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. - Methods - 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. - Results - 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. - Conclusion - 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. 
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