Adjuvant pembrolizumab extends survival in high-risk kidney cancer
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Pembrolizumab as adjuvant therapy significantly prolonged OS compared with placebo among adults with renal cell carcinoma who underwent nephrectomy with or without resection of metastatic lesions, according to the agent’s manufacturer.
Results from a prespecified interim analysis of the randomized phase 3 KEYNOTE-564 trial showed no new safety issues associated with adjuvant use of pembrolizumab (Keytruda, Merck), a PD-1 inhibitor.
Previous results from the study showed that adjuvant pembrolizumab significantly extended DFS compared with placebo, leading the FDA to approve its use among adults with renal cell carcinoma who underwent nephrectomy with or without resection of metastatic lesions. Pembrolizumab — in combination with axitinib (Inlyta, Pfizer) — is also indicated as first-line treatment of adults with advanced renal cell carcinoma.
“As we continue to evaluate the potential of Keytruda in earlier stages of disease across multiple types of cancer, we hope to reduce disease recurrence and, ultimately, improve overall survival outcomes,” Marjorie Green, MD, senior vice president and head of late-stage oncology development at Merck Research Laboratories, said in a company-issued press release. “These new results from KEYNOTE-564 are notable and mark the first time a therapy has demonstrated a statistically significant survival benefit compared [with] placebo in patients with [renal cell carcinoma] at a higher risk [for] recurrence following surgery, building on the positive disease-free survival findings from this study that led to approvals around the world for this Keytruda-based regimen.”
The double-blind KEYNOTE-564 trial enrolled 994 adults with renal cell carcinoma at intermediate-high or high risk for recurrence following nephrectomy.
Researchers randomly assigned patients to receive either 200 mg pembrolizumab via IV or placebo on day 1 of each 3-week cycle, for up to 17 cycles. DFS served as the study’s primary endpoint. Secondary endpoints included OS and safety.
The manufacturer plans to submit the results to regulatory authorities and present the data at an upcoming major medical meeting, according to the release.
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