Dr Choueiri on Integrating Adjuvant Belzutifan Plus Pembrolizumab into Clinical Practice in RCC

“In my practice, I will only offer it in those patients that met the eligibility criteria of the study, meaning they have to have ccRCC, an intermediate- to high-risk of recurrence, high-risk [disease], or resected metastatic disease without any evidence of residual disease on [imaging] within a year [of resection].”

Toni Choueiri, MD, the director of the Lank Center for Genitourinary Oncology and the medical director of International Strategic Initiatives at Dana-Farber Cancer Institute, as well as the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School, discussed the current place of adjuvant belzutifan (Welireg) plus pembrolizumab (Keytruda) in patients with clear cell renal cell carcinoma (ccRCC).

In June 2026, the FDA approved adjuvant belzutifan plus pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the adjuvant treatment of adult patients with ccRCC who are at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. The regulatory decision was supported by data from the phase 3 LITESPARK-022 trial (NCT05239728), which demonstrated that patients who received belzutifan plus pembrolizumab experienced a significant disease-free survival (DFS) benefit compared with those who received placebo plus pembrolizumab (HR, 0.72; 95% CI, 0.59-0.87; P = .0003). The median DFS was not reached in either arm. In the intention-to-treat population, the landmark 12-, 24-, and 30-month DFS rates with the combination (n = 921) were 91.9%, 80.7%, and 75.8%, respectively; these rates were 85.2%, 73.7%, and 68.6% with pembrolizumab alone (n = 920).

Choueiri noted that he always has a multidisciplinary discussion with the patient about the risks and benefits of using the LITESPARK-022 regimen. In his practice, only offers it to patients who met the eligibility criteria of the study, he continued. This includes patients with ccRCC, an intermediate- to high-risk of recurrence, high-risk disease, or resected metastatic disease without any evidence of residual disease on imaging within a year of resection, he concluded.