Sustained benefits seen in overall survival, progression-free survival, objective response rate with combo versus sunitinib
By Elana Gotkine HealthDay Reporter
FRIDAY, Aug. 8, 2025 (HealthDay News) — For patients with advanced renal cell carcinoma (RCC), there is a sustained clinical benefit with pembrolizumab plus axitinib, according to a study published online Aug. 6 in Nature Medicine.
Brian I. Rini, M.D., from the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, and colleagues performed efficacy and prespecified exploratory biomarker analyses from the phase 3 KEYNOTE-426 trial, which included first-line pembrolizumab plus axitinib, with at least five years of follow-up to examine long-term durability of clinical outcomes for RCC.
The researchers found that compared with sunitinib, there were sustained benefits in overall survival (OS) and progression-free survival (PFS) with pembrolizumab plus axitinib (hazard ratios, 0.84 and 0.69, respectively); in addition, an increased objective response rate (ORR) was seen (60.6 versus 39.6 percent). Within the pembrolizumab plus axitinib arm, an 18-gene T-cell-inflamed gene expression profile was positively associated with OS, PFS, and ORR. Positive associations were seen for an angiogenesis signature with OS within the pembrolizumab plus axitinib arm and with OS, PFS, and ORR within the sunitinib arm. Within the pembrolizumab plus axitinib arm, the PBRM1 mutation had a positive association with ORR.
“There is an unmet need for biomarkers that are predictive of patient outcomes following treatment with available first-line therapies for advanced renal cell carcinoma,” Rini said in a statement. “Although our analysis showed potential clinical utility of some RNA signatures in identifying patients who are likely to benefit the most from each treatment, further prospective clinical studies are needed.”
Several authors disclosed ties to biopharmaceutical companies, including Merck, which manufactures pembrolizumab and funded the study.
Copyright © 2025 HealthDay. All rights reserved.
