ASCO GU 2024: Adjuvant Pembrolizumab Improves Survival in Patients With Kidney Cancer
Survival benefit seen across a variety of patient subgroups
TUESDAY, Jan. 30, 2024 (HealthDay News) -- Adjuvant pembrolizumab improved overall survival in patients with clear-cell renal cell carcinoma at high risk for recurrence, according to study results presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium, held from Jan. 25 to 27 in San Francisco.
Toni Choueiri, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues conducted the KEYNOTE-564 trial, a double-blind, phase 3 study that included 994 patients with clear-cell renal cell carcinoma who were randomly assigned (1:1) to pembrolizumab 200 mg or placebo every three weeks for approximately one year or until disease recurrence, intolerable toxicity, or withdrawal of consent.
After a median of 57.2 months of follow-up, the researchers found a significant improvement in overall survival with pembrolizumab (hazard ratio, 0.62; 95 percent confidence interval, 0.44 to 0.87). There were 55 overall survival events in the pembrolizumab arm and 86 events in the placebo arm. At 48 months, the estimated overall survival rate was 91.2 percent in the pembrolizumab arm and 86.0 percent in the placebo arm. The researchers observed the survival benefit across several subgroups, regardless of stage, risk stratification, immunological biomarkers, or other characteristics. Approximately 18 percent of patients stopped therapy due to side effects related to pembrolizumab.
“We can now tell our patients that pembrolizumab after surgery not only delays recurrences, but also helps them live longer,” Choueiri said in a press release. “Since 1973, more than 12,000 patients with kidney cancer participated in adjuvant studies versus a control arm and none of the studies showed the experimental arm extends lives until now with the KEYNOTE-564 study. We showed pembrolizumab extends survival. It doesn’t only delay recurrence.”
Several authors disclosed financial ties to the pharmaceutical industry, including to Merck Sharp & Dohme LLC, which funded the study.
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