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T. Choueiri

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Review Open access Oct 2026

Pembrolizumab plus lenvatinib with belzutifan or quavonlimab as first-line therapy for advanced renal-cell carcinoma: randomized open-label phase 3 LITESPARK-012 study.

BACKGROUND Pembrolizumab plus lenvatinib is a first-line standard of care for advanced clear-cell renal-cell carcinoma (ccRCC). The phase 3 LITESPARK-012 study (NCT04736706) evaluated efficacy and safety of adding belzutifan (HIF-2α inhibitor) or quavonlimab (anti-CTLA-4) to this regimen. PARTICIPANTS AND METHODS Adu...

B. Rini, T. Choueiri, M. Voss et al. · 0 citations
Nov 2026

Survival in patients with renal cell carcinoma and brain metastases: an update of the Renal Graded Prognostic Assessment.

BACKGROUND Brain metastases are a common and serious consequence for patients with renal cell carcinoma. This study aimed to determine if survival has changed since the introduction of current therapies, identify prognostic factors, update the prognostic index (the Renal Graded Prognostic Assessment [GPA]) in the conte...

P. Sperduto, F. Johri, Hany Soliman et al. · 0 citations
Open access Oct 2026

Quantitative gene-level inference of tumor transcription from plasma epigenomes

Across 559 plasma samples spanning 24 cancer types and clinically relevant tumor fractions, APEX outperforms existing approaches for individual-gene inference, resolves pancreatic cancer transcriptional subtypes, tracks therapeutic targets in small-cell lung cancer, and identifies NECTIN4 expression as a biomarker of r...

G. Gulati, D. Vasseur, R. Nawfal et al. · 0 citations
Open access Sep 2026

49 Effect of Co-Morbidity Burden on the Efficacy and Tolerability of Belzutifan in Patients with Metastatic Renal Cell Carcinoma

Abstract Background Belzutifan, a hypoxia-inducible factor-2α (HIF-2α) inhibitor, has demonstrated efficacy in advanced clear-cell renal cell carcinoma (ccRCC) in patients previously received immunotherapy (IO) and anti-angiogenics. However, comorbidities pose a challenge in cancer management and often limit inclusion...

Ali Hajj Ali, Liliana Ascione, R. Nawfal et al. · 0 citations
Open access Sep 2026

3 Safety Profile of Casdatifan Monotherapy in Patients with Clear Cell Renal Cell Carcinoma: Pooled Analysis of the ARC-20 Study (NCT05536141)

Abstract Background Hypoxia-inducible factor 2α (HIF-2α) is highly dysregulated in clear cell renal cell carcinoma (ccRCC), resulting in increased expression of proteins involved with angiogenesis, proliferation, and metastasis. Casdatifan is a potent, selective, orally bioavailable HIF-2α inhibitor that has demonstrat...

R. McKay, J. Merchan, A. Patnaik et al. · 0 citations
Open access Sep 2026

1 Pembrolizumab Plus Belzutifan Versus Pembrolizumab Plus Placebo as Adjuvant Therapy for Renal Cell Carcinoma: Patient-Reported Outcomes in LITESPARK-022

Abstract Background The randomized, double-blind, phase 3 LITESPARK-022 study (NCT05239728) showed significant disease-free survival benefit with the addition of belzutifan to adjuvant pembrolizumab in participants with clear cell renal cell carcinoma (ccRCC) at increased risk of recurrence following surgery. We presen...

T. Powles, T. Choueiri, J. Karam et al. · 0 citations
Open access Sep 2026

72 Time-of-day of Immune Checkpoint Inhibitor Infusion and Overall Survival in Renal Cell Carcinoma: A Real-World Cohort Analysis

Abstract Background Previous retrospective work found an association between earlier immune-checkpoint inhibitors (ICI) infusion times and survival outcomes in renal cell carcinoma (RCC). A recent randomized trial in non-small cell lung cancer (NSCLC) also reported benefit, however, a recent analysis of several randomi...

P. Barrios, Mustafa Saleh, Liliana Ascione et al. · 0 citations
Open access Sep 2026

11 Long-Term Follow-Up from the OMNIVORE Trial: Response-Adaptive Nivolumab and Ipilimumab in Advanced Renal Cell Carcinoma (NCT03652142)

Abstract Background Immune checkpoint inhibitor-based combinations represent the standard of care for advanced renal cell carcinoma (RCC). The OMNIVORE trial (NCT03652142) investigated a response-adaptive strategy including treatment discontinuation in early nivolumab responders (Arm A) and salvage ipilimumab addition...

M. Serzan, Wan-Ling Xie, B. McGregor et al. · 0 citations
Open access Sep 2026

70 Lymphocyte Hsp70 is a Novel Predictive Biomarker for Response to Immune Checkpoint Inhibitors in Metastatic Renal Cell Carcinoma

A scRNA-seq atlas of tumors from metastatic RCC found a novel factor, Hsp70, that in lymphocytes strongly predicts response and greatly extended PFS after ICI, indicating that Hsp70 expression in lymphocytes predicts response to ICI across timepoints and cohorts.

Ethan C. Burns, S. Kashima, Rishabh Rout et al. · 0 citations
Open access Oct 2026

Pharmacologic HIF-2α inhibition preserves T cell effector function in clear cell renal cell carcinoma.

Hypoxia-inducible factor 2α (HIF-2α) is a central oncogenic driver in clear cell renal cell carcinoma (ccRCC) and a therapeutic target of the small-molecule inhibitor belzutifan. Genetic studies in murine models have suggested that hypoxia signaling may support T cell effector programs, raising concern that HIF-2α inhi...

Katrine N. Madsen, S. Kashima, H. Soulati et al. · 0 citations
Sep 2026

Spatially confined IL-12 programs CAR-NK through mTORC1 to coordinate antitumor immune networks.

Solid tumors evade immunotherapy because of immunosuppressive microenvironments that limit immune cell persistence and function. Although interleukin-12 (IL-12) potently activates antitumor immunity, its clinical use has been constrained by systemic toxicity. Here we engineered a CAR natural killer (NK) cell platform t...

Mubin Tarannum, K. Dinh, Mila Stanojevic et al. · 0 citations
Open access Aug 2026

Adjuvant pembrolizumab for the treatment of clear cell renal cell carcinoma: Five-year results from the phase III KEYNOTE-564 study.

BACKGROUND The randomized phase III study KEYNOTE-564 (NCT03142334) established pembrolizumab after surgery as the standard of care for patients with clear cell renal cell carcinoma (ccRCC) at increased risk of recurrence. Prior analyses showed significantly improved disease-free survival (DFS) and overall survival (OS...

N. Haas, T. Powles, P. Tomczak et al. · 1 citation

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