Prognostic value of PD-L1 in patients with metastatic renal cell carcinoma (mRCC) treated with antiangiogenic first line drugs (PROANG-SOGUG study).

PURPOSE: To evaluate the prognostic value of programmed death-ligand 1 (PD-L1) expression in patients with metastatic renal cell carcinoma (mRCC) treated exclusively with first-line antiangiogenic agents.

METHODS/PATIENTS: This retrospective multicenter study included patients from 25 centers treated with antiangiogenic therapy without prior exposure to immune checkpoint inhibitors. Clinical and pathological data were obtained from medical records, and PD-L1 expression was centrally assessed in primary tumor samples using the 22C3 pharmDx assay. Survival was analyzed using Kaplan-Meier estimates, log-rank tests, and Cox regression models. Tumor samples were also analyzed by next-generation sequencing using a customized panel.

RESULTS

Of 340 identified patients, 242 (71.2%) were evaluable. The median age was 64 years, and 76.4% were men. International Metastatic RCC Database Consortium risk was favorable in 7.8%, intermediate in 55.4%, and poor in 36.7%. First-line therapy consisted mainly of sunitinib (70.7%) or pazopanib (26.0%). PD-L1 expression was <1% in 84.7% and ≥1% in 15.3% of tumors. Median overall survival was 14.5 months for PD-L1 <1% and 9.7 months for PD-L1 ≥1% (p = 0.0023). In multivariable analysis, PD-L1 ≥1%, poor risk, and >1 metastatic site were independently associated with worse overall survival.

CONCLUSIONS

PD-L1 expression ≥1% is an independent adverse prognostic factor in mRCC treated with antiangiogenic therapy and may help refine prognostic stratification and treatment planning.