Boston [US], For the first time in 50 years, a phase 3 randomized placebo-controlled trial found that an adjuvant therapy improved overall survival in kidney cancer patients. Patients are being treated with Clear-Cell, according to a review of KEYNOTE-564 research findings. Renal-cell carcinoma (ccRCC) at high risk for recurrence with pembrolizumab, an immunotherapy drug, significantly improved overall survival after surgery. Pembrolizumab reduced the risk of death by 38 percent compared with placebo, "We can now tell our patients that pembrolizumab after surgery not only delays recurrence but also helps them live longer, " said Tony Choueiri, MD, of the Dana-Farber Cancer Institute, the study's principal investigator. Choueiri, director of the Lank Center for Genitourinary Oncology at Dana-Farber, is first author of the study published today in the New England Journal O Medicine.Choueiri previously presented the findings at the American Society for Clinical Oncology (ASCO) Genitourinary Cancer Symposium on January 27, 2024. The KEYNOTE-564 trial was designed to evaluate adjuvant pembrolizumab following nephrectomy (removal of the cancerous kidney) within 12 weeks before randomization. The double-blind, phase 3 study, conducted at hundreds of sites internationally, enrolled 994 patients who were given pembrolizumab or a placebo once every three weeks for about a year. Pembrolizumab targets molecular pathways that cancer cells control to avoid attack by the body's immune system. By blocking this "checkpoint" pathway, the drug helps release the immune system's army of T cells to fight the tumor.To be included in the trial, patients must have a clear-cell component to the tumor and be at intermediate or high risk of recurrence. Some patients with resected metastases after nephrectomy were also eligible. For patients with ccRCC, surgery is intended to be curative. However, between 30 and 50% of patients may experience recurrence after surgery. Recurrence is often the result of metastatic disease, which is usually incurable.Investigators have been trying to find ways to reduce recurrence and increase survival for this patient group since 1973, which dates to the first randomized controlled trial of an adjuvant therapy. An adjuvant therapy is a drug intended to increase efficacy after primary treatment of cancer, which in this case is surgery "Since 1973, more than 12,000 patients with kidney cancer participated in adjuvant studies versus a control arm and No studies have shown the experimental arm extends life with the KEYNOTE-564 study so far," Choueiri says. “We showed that pembrolizumab prolongs survival. It just doesn't prevent recurrence."