Phase 3 trial shows belzutifan and pembrolizumab combination reduces kidney cancer recurrence risk after surgery

Phase 3 trial data shows belzutifan plus pembrolizumab reduces kidney cancer recurrence by 28% in high risk patients after surgery.

By: AXL Media

Published: Mar 2, 2026, 6:02 AM EST

Source: The information in this article was sourced from Dana-Farber Cancer Institute

Significant reduction in cancer recurrence rates

Clinical trial results presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium indicate that a combination therapy significantly improves outcomes for kidney cancer patients. The phase 3 LITESPARK 022 study found that patients with clear cell renal cell carcinoma who received belzutifan alongside the standard immunotherapy pembrolizumab experienced a 28 percent decrease in cancer recurrence. Among participants receiving the two drug regimen, 81 percent remained cancer free after a median follow up of 28.4 months, compared to 74 percent of those receiving the standard treatment.

Targeting high risk clear cell renal cell carcinoma

The study focused specifically on patients with the most common form of kidney cancer who underwent surgery to remove tumors but remained at an elevated risk of relapse. While pembrolizumab has previously been shown to reduce death and disease progression, approximately 20 percent of patients still experience a recurrence within five years due to undetected microscopic cancer cells. Dr. Toni Choueiri, director of the Lank Center for Genitourinary Oncology at Dana Farber Cancer Institute, emphasized the clinical need for therapies that work together to prevent the disease from returning in these high risk populations.

Mechanism of HIF 2α inhibition

The addition of belzutifan to the treatment regimen targets the HIF 2α protein, which is often overabundant in kidney cancer cells and acts as a driver for tumor growth. The development of this inhibitor was based on Nobel Prize winning research conducted at Dana Farber regarding how cells sense and adapt to oxygen availability. By blocking this specific pathway while simultaneously using pembrolizumab to help the immune system identify and attack remaining cancer cells, the combination therapy provides a dual mechanism to suppress disease progression following surgical intervention.