In patients with advanced urothelial carcinoma (UC), avelumab plus best supportive care (BSC) continues to demonstrate overall survival benefits when compared with BSC alone, according to findings presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium.

The long-term follow-up study reported trial data on patients who were included in the phase 3 JAVELIN Bladder 100 trial ( Identifier: NCT02603432) with at least 2 years of follow-up. Patients included in the trial had unresectable locally advanced or metastatic UC without progression of disease with 4 to 6 cycles of first-line gemcitabine plus cisplatin or carboplatin.

A total of 700 patients were randomly assigned to receive avelumab, a programmed death-ligand 1 (PD-L1) blocking antibody, plus BSC (n=350) or BSC alone (n=350). The primary endpoint of the analysis was OS, which was assessed in all randomized patients as well as in those with PD-L1+ tumors. Progression free survival (PFS) and safety were secondary endpoints of the study.

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A total of 358 (51.1%) patients included in the study had PD-L1+ tumors. Findings of the analysis revealed OS to be significantly longer in patients who received avelumab plus BSC compared with those who received BSC alone in all randomized patients (23.8 months vs 15.0 months, respectively; hazard ratio [HR], 0.76 [0.631-0.915]; P =.0036), as well as in those with PD-L1+ tumors (30.9 months vs 18.5 months, respectively; HR, 0.69 [0.521-0.901]; P =.0064). Additionally, a benefit in OS was observed across prespecified groups.

Data analysis also revealed PFS to be longer in patients who received avelumab plus BSC compared with BSC alone in both groups (all randomized patients and PD-L1+ tumor patients). “In the avelumab + BSC and BSC alone arms, respectively, 185 (52.9%) vs 252 (72.0%) patients received a subsequent anticancer drug therapy, including a PD-(L)1 inhibitor in 40 (11.4%) vs 186 (53.1%) patients,” the authors stated. Long-term safety data were also found to be consistent with previous studies.

“These results further support the standard-of-care role for avelumab as 1L maintenance in patients with advanced UC that has not progressed with 1L platinum-containing chemotherapy,” the investigators concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Powles T, Park SE, Voog E, et al. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial. Presented at: ASCO-GU 2022; February 17-19, 2022; Abstract 487.

This article originally appeared on MPR