CheckMate 141 (ASCO 2016) nivolumab (Optivo / BMS)

Essai randomisé phase III: Nivolumab vs (methotrexate ou docetaxel oucetuximab) pour progression ou métastases résistantes aux sels de platine

Checkmate 141 design.png
Checkmate 141 OS.png

The median overall survival was 7.5 months (95% confidence interval [CI], 5.5 to 9.1) in the nivolumab group versus 5.1 months (95% CI, 4.0 to 6.0) in the group that received standard therapy.

Overall survival was significantly longer with nivolumab than with standard therapy (hazard ratio for death, 0.70; 97.73% CI, 0.51 to 0.96; P=0.01),

The estimates of the 1-year survival rate were approximately 19 percentage points higher with nivolumab than with standard therapy (36.0% vs. 16.6%).

Checkmate 141 PFS.png

The median progression-free survival was 2.0 months (95% CI, 1.9 to 2.1) with nivolumab versus 2.3 months (95% CI, 1.9 to 3.1) with standard therapy (hazard ratio for disease progression or death, 0.89; 95% CI, 0.70 to 1.13; P=0.32).

The rate of progression-free survival at 6 months was 19.7% with nivolumab versus 9.9% with standard therapy.

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The response rate was 13.3% in the nivolumab group versus 5.8% in the standard-therapy group.

Checkmate 141 OS fonction PDL1.png

Patients with a tumor PD-L1 expression level of 1% or more or p16-positive tumors (or both) may have a greater magnitude of effect from nivolumab therapy than those whose PD-L1 level was less than 1% 

Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of the patients in the nivolumab group versus 35.1% of those in the standard-therapy group.

Physical, role, and social functioning was stable in the nivolumab group, whereas it was meaningfully worse in the standard-therapy group.

Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck

R.L. Ferris, G. Blumenschein, Jr., J. Fayette, J. Guigay, A.D. Colevas, L. Licitra, K. Harrington, S. Kasper, E.E. Vokes, C. Even, F. Worden, N.F. Saba, L.C. Iglesias Docampo, R. Haddad, T. Rordorf, N. Kiyota, M. Tahara, M. Monga, M. Lynch, W.J. Geese, J. Kopit, J.W. Shaw, and M.L. Gillison

N Engl J Med​. 2016 Nov 10;375(19):1856-1867