Dr. Aragon-Ching on the Use of Maintenance Avelumab in Urothelial Carcinoma

Jeanny B. Aragon-Ching, MD, FACP, the clinical program director of Genitourinary Cancers at the Inova Schar Cancer Institute, discusses the use of maintenance avelumab (Bavencio) as the standard-of-care treatment for patients with locally advanced or metastatic urothelial carcinoma.

The phase 3 JAVELIN Bladder 100 trial (NCT02603432) evaluated avelumab maintenance with best supportive care vs best supportive care alone in patients with locally advanced or metastatic urothelial carcinoma who did not progress following first-line, platinum-based chemotherapy.

In June 2020, the FDA approved avelumab as maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma who did not progress following first-line, platinum-based chemotherapy. The approval was supported by data from JAVELIN Bladder 100.

Findings from a subgroup analysis of the trial presented at the 2022 ESMO Congress showed that at a median follow-up of 38 months, 118 of 350 patients in the avelumab arm (33.7%) received a minimum of 12 months of treatment. Among these patients, the median OS was not reached (95% CI, 50.9 months–not estimable), and the median PFS was 26.7 months (95% CI, 19.4-32.2).

Following its approval, maintenance avelumab quickly carved out a role in the frontline setting for patients with locally advanced or metastatic urothelial carcinoma. Maintenance avelumab should be considered the standard of care for patients with metastatic urothelial carcinoma who respond to platinum-based chemotherapy, Aragon-Ching says. Notably, maintenance avelumab can be considered irrespective of the platinum-based chemotherapy given in the first-line setting, such as gemcitabine/cisplatin or gemcitabine/carboplatin, Aragon-Ching adds.

Although maintenance avelumab has demonstrated efficacy in this setting for this patient population, patients must be closely evaluated for adverse effects (AEs). Toxicities associated with avelumab are generally manageable; however, since the agent is immunotherapy, AEs need to be monitored, Aragon-Ching says. Informing patients of these potential toxicities can help them identify AEs and notify their physicians to allow for proper management, Aragon-Ching concludes.