New drug combination (belzutifan + pembrolizumab) cuts kidney cancer recurrence by 28% for high-risk patients after surgery.
The combination of belzutifan drug (Welireg) and pembrolizumab (Keytruda) immunotherapy, improves disease-free survival for clear cell renal cell carcinoma (ccRCC) or kidney cancer.
For patients at a high risk of kidney cancer recurrence following a nephrectomy (surgery), this oral and immune therapy regimen reduces the risk of relapse by 28%.(1✔ ✔Trusted Source
Kidney Cancer Study Finds Belzutifan Plus Pembrolizumab Post-Surgery Helps Patients at High Risk for Relapse Stay Cancer-Free Longer
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The data was revealed by the Phase 3 LITESPARK-022 study and the findings were presented by Dr. Toni Choueiri at the 2026 ASCO GU symposium.
How Does the Belzutifan and Pembrolizumab Combination Prevent Kidney Cancer Relapse?
Previous Dana-Farber research led by Dr. Choueiri showed that pembrolizumab alone reduced the risk of death and disease progression for advanced kidney cancer patients after surgery. Pembrolizumab is an immune checkpoint inhibitor that helps the immune system find and fight cancer cells. While effective, about 1 in 5 people who take it will relapse.
This study was designed to combine the immunotherapy with belzutifan to improve the current overall survival of patients considered high risk for kidney cancer relapse.
“A significant percentage of patients with high-risk kidney cancer will recur within five years after surgery because microscopic cancer cells can remain undetected,” says Dr. Choueiri, director of the Lank Center for Genitourinary Cancer at Dana-Farber. “We need new therapies that can work together to better prevent the cancer from coming back.”
What is the Difference Between Pembrolizumab plus Belzutifan vs. Pembrolizumab alone?
The HIF-2α inhibitor belzutifan helps to reduce risk of progression by blocking HIF-2α, which is overabundant in ccRCC cells and drives cancer growth. Dana-Farber’s Dr. William G. Kaelin, Jr., was awarded a Nobel Prize in Physiology or Medicine in 2019 for the science behind the development of belzutifan.
LITESPARK-022 is a global, multicenter, double-blind, randomized, phase 3 study that included 1,841 participants with ccRCC. Participating patients underwent surgery to remove the tumor and had no signs of cancer but had an elevated risk of recurrence.
Patients were randomized to receive either pembrolizumab and belzutifan after surgery or pembrolizumab and a placebo after surgery.
The Safety Profile of Belzutifan Compare to Standard Immunotherapy
With a median follow-up of 28.4 months, the combination of pembrolizumab plus belzutifan resulted in a 28% decrease in recurrence. About 81% of participants who took the two-drug regimen were cancer-free, compared to 74% of those who received standard of care.
Side effects were consistent with data from previously reported studies. The study has not collected enough information yet to determine if adding belzutifan helps people live longer overall.
“People at high risk of ccRCC coming back after surgery may have a new option to reduce that risk,” says Dr. Choueiri.
“In this study, belzutifan, in combination with pembrolizumab, reduces the chance of recurrence compared with the current standard treatment of pembrolizumab alone,” says Dr. Choueiri.
Reference:
- Kidney Cancer Study Finds Belzutifan Plus Pembrolizumab Post-Surgery Helps Patients at High Risk for Relapse Stay Cancer-Free Longer – (https://www.dana-farber.org/newsroom/news-releases/2026/kidney-cancer-study-finds-belzutifan-plus-pembrolizumab-post-surgery-helps-patients-at-high-risk-for-relapse-stay-cancer-free-longer)
Source-Eurekalert