Dr Bellmunt on Avelumab Maintenance in Advanced Urothelial Carcinoma With Low Tumor Burden

Joaquim Bellmunt, MD, PhD, senior physician, director, Bladder Cancer Center, Dana-Farber Cancer Institute, associate professor of medicine, Harvard Medical School, discusses findings from post-hoc analysis of the phase 3 JAVELIN Bladder 100 trial (NCT02603432) evaluating first-line avelumab (Bavencio) maintenance in patients with advanced urothelial carcinoma.

This post-hoc analysis focused on patients enrolled in the study who had low tumor burden. Previous findings from the study supported the FDA approval of avelumab for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

During the study, patients who had a response or stable disease following 4 to 6 cycles of cisplatin plus gemcitabine or carboplatin plus gemcitabine were randomly assigned to receive maintenance avelumab plus best supportive care (BSC) or BSC alone.

At the 2024 ASCO Annual Meeting, findings from the post-hoc analysis showed that maintenance avelumab plus BSC led to prolonged overall survival (OS) and progression-free survival (PFS) compared with BSC alone in subgroups of patients with low tumor burden.

Specifically, OS benefits were observed in patients with nonvisceral metastases (HR, 0.60; 95% CI, 0.45-0.79), lymph node–only disease (HR, 0.86; 95% CI, 0.51-1.47), and pelvic/retroperitoneal lymph node–only disease (HR; 0.72; 95% CI, 0.39-1.31). The PFS benefits were also observed in subgroups of patients with nonvisceral metastases (HR, 0.45; 95% CI, 0.35-0.59), lymph node–only disease (HR, 0.51; 95% CI, 0.31-0.84), and pelvic/retroperitoneal lymph node–only disease (HR, 0.44; 95% CI, 0.24-0.79).

Findings from the post-hoc analysis, along with continued long-term data from the overall trial population, continue to point to the benefit of utilizing avelumab as maintenance therapy in patients with advanced urothelial carcinoma who do not experience disease progression during first-line platinum-based chemotherapy, Bellmunt says. Notably, the safety data in the subgroups of patients with low tumor burden were also consistent with the data from the overall trial population.