Pembrolizumab-Axitinib Association in First-Line Metastatic Renal Cell Carcinoma: Preliminary Results of a Series of Five Patients

Introduction: Metastatic renal cell carcinoma (mRCC) remains a disease with a poor prognosis. The pembrolizumab-axitinib combination has established itself as the standard first-line treatment for intermediate and poor-risk patients according to the International Metastatic Renal Cell Database (IMDC) criteria. However, real-world clinical data remain limited in the Algerian context. This study evaluates the feasibility and tolerability of the pembrolizumab-axitinib association in a series of intermediate-risk mRCC patients managed at the Medical Oncology Department of Didouche Mourad Hospital, Constantine. Materials and Methods: We report a series of 5 patients with intermediate-risk mRCC treated with pembrolizumab-axitinib between August 2024 and July 2025. Clinical characteristics, tolerability, and tumor responses were collected and analyzed. Results: The median age was 70 years (interquartile range [IQR]: 58–79), with a male predominance (80%). Histology revealed clear cell carcinoma in all cases. Predominant metastatic sites included bone (80%), lung (60%), and liver (40%). All patients received pembrolizumab-axitinib, with denosumab added for bone involvement. After a median follow-up of 6 cycles, four patients were prematurely evaluated (1–2 cycles), while one patient who received 6 cycles demonstrated stable disease. Tolerability was satisfactory, with adverse events (AEs) of grade ≤2 and no permanent treatment discontinuation. Conclusion: This preliminary series demonstrates the feasibility and acceptable tolerability of the pembrolizumab-axitinib combination in real-world practice. Despite limitations related to sample size and follow-up duration, these results provide an encouraging first local experience supporting the integration of this regimen in clinical practice. Larger studies with extended follow-up are necessary to confirm these observations.