Data from the LITESPARK-022 study supported adding belzutifan (Welireg) to standard adjuvant pembrolizumab for patients with clear cell renal cell carcinoma (RCC) that has a high chance of recurring following nephrectomy according to a report in MedScape.com.
In this patient population, compared with adjuvant pembrolizumab alone, adjuvant belzutifan plus pembrolizumab led to a statistically significant and clinically meaningful 28% decrease in the risk for recurrence or death.
“LITESPARK-022 is the first adjuvant phase 3 trial in RCC to show a significant benefit for a combination treatment vs an active immunotherapy comparator,” lead investigator Toni Choueiri, MD, medical oncologist at Dana-Farber Cancer Institute, Boston, said in a presentation at the ASCO Genitourinary Cancers Symposium 2026.
The LITESPARK-022 results are “practice changing,” Brian Rini, MD, American Society of Clinical Oncology expert in kidney cancer, with Vanderbilt University Medical Center in Nashville, Tennessee, noted during a press briefing where the results were presented. “Pembrolizumab monotherapy is a standard of care in resected high-risk kidney cancer and this adds to that,” said Rini.
High Unmet Need
Roughly 40% of patients with clear cell RCC treated with adjuvant pembrolizumab experience recurrence or death within 5 years of nephrectomy. “Additional adjuvant therapy options are needed,” Choueiri said.
Belzutifan is a potent, first-in-class hypoxia-inducible factor-2 alpha (HIF-2 alpha) inhibitor shown to be effective in patients with advanced RCC treated with prior immunotherapy and VEGF receptor-TKI therapy.
LITESPARK-022 is testing the potential benefit of adding belzutifan to adjuvant pembrolizumab.
A total of 1841 patients with resected clear cell RCC at an increased risk for recurrence and no prior systemic therapy were randomly allocated (1:1) to pembrolizumab plus belzutifan or pembrolizumab plus placebo. Pembrolizumab was administered at 400 mg every 6 weeks for roughly 1 year, while belzutifan was given at 120 mg daily for up to 54 weeks.
To read the artical in full visit MedScape.com HERE
