Kidney Cancer

Robert J. Motzer, MD, discusses the significance of the belzutifan plus lenvatinib approval, adverse event management with the combination, and the evolving role of HIF-2α inhibition in ccRCC.

The approval is supported by data from the phase 3 LITESPARK-011 trial.

A recap of the FDA submissions and regulatory decisions in urology from August 2026.

The designations were based on preliminary clinical data with 68Ga-NYM096, including a small, multicenter study presented at ASCO 2026.

The phase 2 RadiCaL trial found that adding radium-223 to cabozantinib did not improve skeletal event-free survival in metastatic RCC.

Belzutifan plus lenvatinib significantly improved progression-free survival vs cabozantinib in patients with previously treated advanced clear cell renal cell carcinoma.

OMCAZIO demonstrated bioequivalence to CABOMETYX at a lower dose and was found to have no clinically significant food effect.

Darlifarnib plus cabozantinib demonstrated encouraging antitumor activity with a manageable safety profile in patients with ccRCC, including both cabozantinib-naive and cabozantinib-exposed populations.

This marks the first phase 3 study of a targeted radiopharmaceutical therapy in clear cell renal cell carcinoma.

Data from the ARC-20 study are the first to link HIF-2a inhibitor-associated changes in circulating serum EPO, tumor biology, and clinical activity.

Data from the RAMPART trial showed that durvalumab monotherapy missed the DFS threshold in resected RCC, though the combination with tremelimumab showed significant benefit.

The application is supported by data from the phase 3 LITESPARK-022 trial.

Long-term data from the phase 2 TROG 15.03 FASTRACK II trial support the safety and efficacy of stereotactic ablative body radiotherapy for primary renal cell carcinoma.

Data also showed that ctDNA positivity at baseline was associated with worse DFS outcomes.

Although the primary end point was not met, Rana R. McKay, MD, highlighted a notable divergence in OS curves after 1 year that she described as a signal warranting further investigation.

HistoSonics has submitted a de novo request to the FDA seeking an expanded indication for its Edison Histotripsy System.

Phase 3 LITESPARK-012 shows adding belzutifan or quavonlimab to pembrolizumab-lenvatinib fails to boost survival in first-line advanced clear cell RCC.