Kidney Cancer

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.

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

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.

A recap of the FDA submissions and regulatory decisions in urology from November 2025.

[68Ga]Ga-DPI-4452 is a gallum-68-radiolabeled PET imaging agent that forms a theranostic pair with the therapeutic candidate, [177Lu]Lu-DPI-4452 (ITM-91).

Andrew W. Hahn, MD, highlights safety and tolerability data on lenvatinib/everolimus vs cabozantinib for metastatic ccRCC.

Marc Machaalani, MD, shares data on soluble MAdCAM-1 as a predictive biomarker in metastatic renal cell carcinoma.

Mobley also shares her treatment approach to BPH and explains the challenges of treating OAB.

Data suggest that KIM-1 is prognostic for clinical outcomes in aRCC.

Merck plans to share these data with regulatory authorities worldwide.

The phase 3 LITESPARK-011 trial has met its primary end point.

Beckermann explained that adenosine blockade may be better shown in the durability of response, so data collection in the study remains ongoing.

Data indicates that the DFS improvement was largely driven by the treatment effect in the higher risk population.

The median progression-free survival was 15.7 months with the combination of lenvatinib plus everolimus compared with 10.2 months with cabozantinib (HR, 0.51; 95% CI, 0.29-0.89; P = .02).