Immune checkpoint inhibitor-based combinations have become the standard of care for treatment-naive metastatic renal cell carcinoma (mRCC). Tyrosine kinase inhibitor (TKI) monotherapy, however, may remain an option particularly for patients with a favourable International Metastatic Database Consortium (IMDC) risk.
APOLON is a non-interventional, multicentric prospective study with mRCC patients receiving frontline pazopanib treatment, designed to assess progression-free survival (PFS), overall survival (OS), objective response rate, tolerability, and subsequent post-pazopanib therapy sequences.
The 217 patients were 71.0% male, with a median age of 69.6 years, an Eastern Cooperative Oncology Group performance status ≥2 in 17.6%, and mRCC with a favourable (27.1%), intermediate (52.1%) or poor (20.8%) IMDC score. Metastases were mainly located in lung (64.1%), bone (28.6%), mediastinal (18%)/abdominal (17.1%) lymph nodes. Median PFS was 10.6 months [95% confidence interval (CI) 9-12.5 months], similarly in patients aged <65 years with PFS 11.3 months (95% CI 6.8-16.1 months) and aged ≥65 years with PFS 10.1 months (95% CI 9.0-12.4 months). The median PFS was 17.1 months (95% CI 9.9-23.2 months), 12.5 months (95% CI 9.0-15.4 months) and 6.2 months (95% CI 3.5-9.5 months) in patients with a favourable, intermediate, and poor IMDC score, respectively. The median OS was 29.1 months (95% CI 24.3-41.3 months). Objective response rate was 48.3% with a complete response in 6 (3.5%) and a partial response in 77 patients (44.8%). Grade 3/4 adverse events were reported in 45.8% of patients. No safety signals were newly identified.
The APOLON study confirmed pazopanib effectiveness and safety in patients with mRCC in a real-world setting. The efficacy remained significant in patients aged ≥65 years and was highly associated with the risk score.
ESMO real world data and digital oncology. 2025 Jun 03*** epublish ***
P Barthelemy, A Thiery-Vuillemin, T Lebret, P Bigot, U Stein, L M Dourthe, R Longo, P Gimel, B Auberger, J De La Cruz, D Malak, Z Samia, N Texier, L Albiges
Institut de Cancérologie Strasbourg Europe, Strasbourg, France., University Hospital Jean Minjoz, Besançon, France., Hospital Foch, Suresnes, France., University Angers, Angers, France., Strasbourg Oncologie Libérale, Strasbourg, France., Hospital de Mercy, Metz Thionville, Ars-Laquenexy, France., Centre Catalan d'Urologie, Cabestany, France., University Hospital Morvan, Brest, France., Novartis Oncology France, Rueil-Malmaison Cedex, France., Kappa Santé, Paris, France., Gustave Roussy Cancer Campus, Université Paris-Saclay, Villejuif, France.