Pembrolizumab vs. placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma

| Post date: 2022/04/5 |

Researchers investigated whether pembrolizumab, which has improved the prognosis for patients with stage III melanoma, might have a similar effect on survival outcomes in patients with stage II disease. The sample population for the KEYNOTE-716 study included newly diagnosed patients aged 12 years and older from the United States and 15 other countries. Participants were randomly assigned to I.V. pembrolizumab or placebo every 3 weeks for 17 cycles or until reaching disease recurrence or unacceptable toxicity. The main endpoint, recurrence-free survival, was assessed at two different intervals: after about 128 patients experienced events and after 179 patient events. During the first interim analysis, 11% of 487 patients in the intervention group had a first recurrence of disease or died vs. 17% of 489 control patients. For the second interim analysis, first recurrence or death occurred in 15% and 24% of patients in the pembrolizumab and placebo treatment arms, respectively. No treatment-related deaths were documented. "Pembrolizumab as adjuvant therapy for up to approximately 1 year for stage IIB or IIC melanoma resulted in a significant reduction in the risk of disease recurrence or death versus placebo, with a manageable safety profile," the study authors wrote. The Lancet (03/31/22) Luke, Jason J.; Rutkowski, Piotr; Queirolo, Paola; et al.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00562-1/fulltext

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