Dr Ryan on the Implications of Updated Findings from JAVELIN Bladder 100 in Urothelial Cancer

Christopher W. Ryan, MD, professor of medicine, the School of Medicine at the Oregon Health & Science University, discusses the implications of updated findings from the phase 3 JAVELIN Bladder 100 trial (NCT02603432) in patients with locally advanced or metastatic urothelial cancer.

In this trial, investigators examined maintenance immunotherapy with avelumab (Bavencio) after a response or stable disease to frontline chemotherapy, and data made this a practice-changing study, Ryan notes. The addition of avelumab to best supportive care demonstrated an improvement in overall survival (OS) compared with best supportive care alone, and in June 2020, the FDA approved avelumab as maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-based chemotherapy, based on findings from JAVELIN Bladder 100.

Updated data from a subgroup analysis of the trial presented at the 2023 Genitourinary Cancers Symposium further displayed the OS benefit associated with avelumab maintenance, irrespective of choice of frontline chemotherapy, Ryan explains. In patients who received a frontline chemotherapy regimen consisting of cisplatin plus gemcitabine, those in the avelumab arm had a median OS of 25.1 months (95% CI, 19.3-30.9), compared with 17.5 months (95% CI, 13.7-24.2) for those given best supporting care alone. Among patients given carboplatin plus gemcitabine as frontline chemotherapy, the median OS was 20.8 months (95% CI, 17.9-28.7) for the avelumab arm vs 13.0 months (95% CI, 9.4-16.1) for the best supportive care arm.

Notably, the median OS was higher for both the avelumab and best supportive care arms among patients who received cisplatin vs carboplatin, and it has been debated in the urothelial cancer space whether cisplatin is better than carboplatin as first-line chemotherapy, Ryan says, who notes that these findings may reflect that patients who receive carboplatin tend to have other medical comorbidities.

Given that the addition of maintenance avelumab improved OS over best supportive care, regardless of frontline chemotherapy choice, it is important to emphasize the use of maintenance immunotherapy for patients with metastatic bladder cancer who do not progress on chemotherapy, Ryan concludes.