Effectiveness and safety of avelumab maintenance in patients aged ≥75 years with advanced urothelial cancer: a sub-analysis of the meet-URO 25 (MALVA) study

Background Avelumab maintenance therapy is an established therapeutic approach for patients with advanced urothelial carcinoma (UC) whose disease has not progressed after first-line platinum-based chemotherapy. However, evidence on its effectiveness and safety in elderly patients remains limited. Methods This multicenter retro-prospective Italian study included 251 patients with advanced UC who received avelumab maintenance between 2021 and 2023. Outcomes were compared between patients aged ≥75 and <75 years. Primary endpoints were progression-free survival (PFS) and overall survival (OS). Results Among 96 elderly and 155 younger patients, median PFS was 7.2 months (95% CI, 4.9–17.5) and 6.7 months (95% CI, 4.9–9.3), respectively (p = 0.547), while median OS was 28.1 months (95% CI, 17.3–42.1) versus 18.5 months (95% CI, 12.0–38.6) (p = 0.238). Immune-related adverse events were infrequent and generally comparable across age groups. In multivariable analyses, lung metastases independently predicted worse OS in elderly patients, whereas bone metastases and concomitant corticosteroid therapy were adverse prognostic factors in younger patients. Conclusions Avelumab maintenance demonstrated similar efficacy and safety in elderly and younger patients, supporting its use regardless of age. In the evolving therapeutic landscape of advanced UC, this treatment strategy remains a relevant and practical option, particularly for elderly or comorbid patients who may not be candidates for more intensive first-line combinations.