Kidney Cancer

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.

Investigators in the BioFront trial are evaluating whether CBM588 enhances the efficacy of immune checkpoint inhibitors in renal cell carcinoma.

Katy Beckermann, MD, PhD, discusses how emerging data from the LITESPARK trials—particularly LITESPARK-011 and LITESPARK-022—may expand the role of belzutifan-based combinations across renal cell carcinoma treatment, while emphasizing the clinical significance of durable responses, careful toxicity management, and the need for longer-term survival data to guide practice.

"Emerging evidence indicates that molecular imaging may enable more accurate detection of primary RCC, improve surveillance for recurrence, and enhance identification of metastatic lesions compared with conventional imaging," write the authors.

Robert J. Motzer, MD, discusses the scientific rationale for the LITESPARK-011 study, its design and key findings, and how this combination could potentially influence treatment strategies in renal cell carcinoma.

The PDUFA target action date is set for October 4, 2026.

The target action date for the application is June 19, 2026.

"Belzutifan plus lenvatinib addresses an unmet clinical need and represents a potential new treatment option for patients with RCC that progressed after PD 1 or-L1 therapy,” said Robert J. Motzer, MD.

“After 28 months’ follow-up, the combination of pembrolizumab and belzutifan resulted in a statistically significant and clinically meaningful improvement in disease-free survival over pembrolizumab single agent,” said Toni K. Choueiri, MD.

Savannah Grandy, DO, highlights key takeaways from a MUSIC-KIDNEY study comparing single port vs. multiport robotic partial nephrectomy.

The study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of NEO-811 in clear cell renal cell carcinoma.

Maxwell L. Sandberg, MD, highlights a study on survival outcomes between patients who underwent CN-TT via an open, laparoscopic, or robotic approach.

Harras Zaid, MD, discusses the complex decision-making involved in managing renal tumors with associated tumor thrombus.

Although the trial includes multiple tumor types, the presented data focus on RCC, predominantly clear cell disease.

Maxwell L. Sandberg, MD, highlights recent study findings on the role for perioperative systemic therapy for renal cell carcinoma with a tumor thrombus.

Madison Krischak, MD, outlines key findings from a study looking at the use of nephrometry scores to guide routine renal mass biopsies.