Distant metastasis-free survival with adjuvant pembrolizumab for resected stage IIB or IIC melanoma – Authors' reply

Dun-Chang Mo and colleagues question the validity of the definition of distant metastasis-free survival used in our analysis of the phase 3 KEYNOTE-716 study published in The Lancet Oncology. 1 Long GV Luke JJ Khattak MA et al. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2022; 23: 1378-1388 Summary Full Text Full Text PDF PubMed Scopus (23) Google Scholar The authors point out that the definition of distant metastasis-free survival that we used—time from randomisation to first diagnosis of distant metastasis—excludes deaths and might lead to an overestimation of the survival results that we reported. The authors also suggest that the dichotomous variable statistical method might more appropriately assess distant metastasis-free survival rather than the Kaplan-Meier method we used in the KEYNOTE-716 study. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trialAdjuvant pembrolizumab is an efficacious treatment option for resected stage IIB and IIC melanoma, with significant improvement in distant-metastasis free survival versus placebo and continued reduction in the risk of recurrence with an adverse event profile consistent with previous studies of pembrolizumab. The overall benefit–risk of pembrolizumab continues to be positive in the adjuvant setting. Full-Text PDF Distant metastasis-free survival with adjuvant pembrolizumab for resected stage IIB or IIC melanomaPembrolizumab, an anti-PD-1 monoclonal antibody, as adjuvant therapy was found to improve survival in patients with various resected tumours including melanoma,1,2 renal cell carcinoma,3 and non-small-cell lung cancer,4 and this immunotherapy agent has shown a very broad therapeutic prospect in the adjuvant setting for cancers. Full-Text PDF