THURSDAY, April 18, 2024 (HealthDay News) — For patients with clear-cell renal cell carcinoma, adjuvant pembrolizumab is associated with a significant and clinically meaningful improvement in overall survival, according to a study published in the April 18 issue of the New England Journal of Medicine.

Toni K. Choueiri, M.D., from the Dana-Farber Cancer Institute and Harvard Medical School in Boston, and colleagues randomly assigned participants with clear-cell renal cell carcinoma with an increased risk for recurrence after surgery to receive pembrolizumab (200 mg) or placebo (496 and 498 patients, respectively) every three weeks for up to 17 cycles or until recurrence, unacceptable toxic effects, or withdrawal of consent. The median follow-up was 57.2 months as of Sept. 15, 2023.

The researchers observed a consistent disease-free survival benefit, as seen in the previous analyses (hazard ratio for recurrence or death, 0.72). In addition, there was a significant improvement in overall survival with pembrolizumab versus placebo (hazard ratio for death, 0.62). At 48 months, estimated overall survival was 91.2 and 86.0 percent in the pembrolizumab and placebo groups, respectively; consistent benefit was seen across key subgroups. A higher incidence of serious adverse events of any cause was seen in association with pembrolizumab (20.7 percent versus 11.5 percent with placebo), as was the incidence of grade 3 or 4 adverse events related to pembrolizumab or placebo (18.6 versus 1.2 percent). There were no deaths attributed to pembrolizumab therapy.

“These results further support the use of adjuvant pembrolizumab as a standard intervention after surgery in this disease context,” the authors write.

The study was funded by Merck, the manufacturer of pembrolizumab.

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