Dr. McGregor on Belzutifan Plus Lenvatinib in Advanced RCC

Bradley McGregor, MD, clinical director, Lank Center for Genitourinary Oncology, senior physician, Dana-Farber Cancer Institute; instructor, medicine, Harvard Medical School, discusses the rationale behind combining belzutifan (Welireg) with lenvatinib (Lenvima) in pretreated patients with advanced renal cell carcinoma (RCC) with clear cell components.

The phase 3 LITESPARK-011 trial (NCT04586231) is investigating belzutifan plus lenvatinib vs cabozantinib (Cabometyx) in the second line in patients with RCC who have progressed on immunotherapy-based treatment. This trial is seeking to determine the best next line of therapy in this population, McGregor says.

Belzutifan, a hypoxia-inducible factor 2-alpha inhibitor, has already demonstrated activity as a monotherapy in the phase 1 LITESPARK-001 trial (NCT02974738). It also appears to be an effective partner agent, eliciting impressive responses and a good safety profile in the phase 2 LITESPARK-003 trial (NCT03634540), McGregor explains. LITESPARK-011 is taking this research a step further by evaluating whether adding belzutifan to lenvatinib, a TKI, will be a more effective regimen than cabozantinib in pretreated advanced RCC, hopefully answering an important question, McGregor concludes.