Adjuvant Pembrolizumab Succeeds For Patients With Renal Cell Carcinoma At Increased Risk of Relapse
Third Interim Analysis Results from Phase 3 KEYNOTE-564
Third Interim Analysis Results from Phase 3 KEYNOTE-564
According to results from the phase 3 KEYNOTE-564 study, adjuvant pembrolizumab yielded a statistically significant and clinically meaningful improvement in overall survival (OS) among patients with renal cell carcinoma at an increased risk of recurrence following nephrectomy, compared with placebo.
These results were first presented by Toni Choueiri, MD, Dana-Farber Cancer Institute at Harvard Medical School, Boston, Massachusetts, at the 2024 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium.
In this double-blind, multicenter phase 3 trial, 994 patients with clear cell renal cell carcinoma with an increased risk for recurrence who underwent nephrectomy and/or metastasectomy up to 12 weeks prior to randomization were enrolled. Patients were randomized to receive either 200 mg pembrolizumab (n = 496) or placebo (n = 498) every 3 weeks. The primary end point was disease-free survival (DFS) by investigator assessment, with OS and safety as secondary end points.
The median time from randomization to data cut-off on September 15, 2023 was 57.2 months. The median OS was not met in either arm. There was a statistically significant improvement in OS reported with pembrolizumab compared with placebo (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.44 to 0.87; P = .0024). The estimated OS rate at 48 months was 91.2% in the pembrolizumab arm and 86.0% in the placebo arm. This benefit to OS was seen across key subgroups including patients with M0 disease or M1 with no evidence of disease (NED), with PD-L1 combined positive score (CPS) <1 or CPS ≥1, and with presence or absence of sarcomatoid features. This benefit with pembrolizumab was consistent with the results of previous interim analyses, and no new safety signals were observed.
Dr Choueiri and coauthors wrote, “KEYNOTE-564 is the first phase 3 study to show improved survival with any adjuvant therapy in [renal cell carcinoma]. These results continue to support adjuvant pembrolizumab as a standard of care.”
Source:
Choueiri TK, Tomczak P, Park SH, et al. Overall survival results from the phase 3 KEYNOTE-564 study of adjuvant pembrolizumab versus placebo for the treatment of clear cell renal cell carcinoma (ccRCC). Presented at the 2024 ASCO Genitourinary Cancers Symposium; January 25-27, 2024; San Francisco. Abstract LBA359
