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

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Metastatic clear-cell renal cell carcinoma (n=108). Intervention: High comorbidity burden (CCI > 3) vs. Low comorbidity burden (CCI ≤ 3). Primary outcome: Overall survival (aHR 0.94, 95% CI 0.48-1.83).

Q: What does this research mean for the field?

Belzutifan maintains consistent efficacy and tolerability in patients with metastatic clear-cell renal cell carcinoma, regardless of their baseline comorbidity burden. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

Ali Hajj Ali; Liliana Ascione; Rashad Nawfal; Wassim Daoud Khatoun; Pablo Barrios; Marc Machaalani; Razane El Hajj Chehade; Jad El Masri; Mustafa Saleh; Marc Eid; Élio Ibrahim; Gaelle Nafeh; Tarek Baroud; Sara El Sarout; Bradley A. McGregor; Toni K Choueiri

doi:10.1093/oncolo/oyag312.050

September 1, 2026The OncologistOpen Access

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

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Key result

High comorbidity burden is not associated with overall survival in belzutifan-treated metastatic clear-cell RCC.

aHR 0.94
95% CI 0.48-1.83
n=108

Figures

Why the study?

The impact of comorbidity burden on clinical outcomes and tolerability in patients with metastatic clear-cell renal cell carcinoma treated with belzutifan remained unclear.

Does comorbidity burden affect the efficacy and tolerability of belzutifan in patients with metastatic clear-cell renal cell carcinoma?

Key Points

To evaluate the impact of baseline comorbidity burden on the survival outcomes and tolerability of belzutifan in patients with advanced clear-cell renal cell carcinoma.
Analyzed data from N=108 patients with metastatic clear-cell renal cell carcinoma treated with belzutifan beyond the first-line setting.
Stratified patients by Charlson Comorbidity Index (CCI) score into low (≤3, n=63) and high (>3, n=45) comorbidity groups.
Assessed overall survival, progression-free survival, and grade ≥3 toxicities using Kaplan–Meier methods and multivariable Cox regression models adjusted for clinical covariates.
High comorbidity burden was not associated with differences in overall survival (aHR 0.94, 95% CI: 0.48–1.83) or progression-free survival (aHR 1.18, 95% CI: 0.69–2.02).
Severe toxicities were similar between CCI-high and CCI-low groups, including grade ≥3 anemia (17.8% vs 9.5%, p = 0.33), grade ≥3 hypoxia (11.1% vs 7.9%, p = 0.82), and toxicity-related treatment discontinuation (28% vs 17%, p = 0.24).

Study Design

Type

Cohort (n=108)

Structured PICO

Does comorbidity burden affect the efficacy and tolerability of belzutifan in patients with metastatic clear-cell renal cell carcinoma?

P

Population

108 patients with metastatic clear-cell renal cell carcinoma treated with belzutifan beyond the first-line setting, stratified by Charlson Comorbidity Index.

E

Exposure

Belzutifan treatment in patients with high comorbidity burden (Charlson Comorbidity Index > 3)

C

Comparator

Belzutifan treatment in patients with low comorbidity burden (Charlson Comorbidity Index ≤ 3)

O

Outcome

Overall survival (OS) and Progression-free survival (PFS)hard clinical

Main Result

Hazard Ratio: 0.94 (95% CI 0.48–1.83)

Belzutifan demonstrates consistent efficacy and tolerability in metastatic clear-cell renal cell carcinoma regardless of baseline comorbidity burden, supporting its use in medically complex patients.

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Implication

Comorbidity burden did not affect belzutifan survival; extends trial data to real-world patients but should not yet alter practice.

Abstract

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Discussion

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Cite This Study

Ali et al. (2026) conducted a cohort in Metastatic clear-cell renal cell carcinoma (n=108). High comorbidity burden (CCI > 3) vs. Low comorbidity burden (CCI ≤ 3) was evaluated on Overall survival (aHR 0.94, 95% CI 0.48-1.83). In patients with metastatic clear-cell renal cell carcinoma treated with belzutifan, high comorbidity burden was not associated with overall survival.

synapsesocial.com/papers/6a99365f636c6408cfa7f7b2 https://doi.org/10.1093/oncolo/oyag312.050

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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