SES AUA 2021: Avelumab First-Line Maintenance + Best Supportive Care (BSC) vs BSC Alone with 1L Chemotherapy for Advanced Urothelial Carcinoma: JAVELIN Bladder 100 Subgroup Analyses

( Advanced urothelial carcinoma carries among the worst prognoses for tumors treated by genitourinary oncologists. Standard of care dictates that patients receive platinum-based induction chemotherapy. However, even with this treatment, rates of recurrence and disease progression are high and overall survival is quite short due to the development of chemotherapy resistance. In the JAVELIN Bladder 100 study which was reported at ASCO 2020 Virtual Annual Meeting and subsequently published in the New England Journal of Medicine, the addition of avelumab, a PD-L1 directed therapy, maintenance to best supportive care following induction chemotherapy demonstrated improvements in overall survival for patients who did no have disease progression during their initial cytotoxic chemotherapy induction.


In Best of Podium presentation at this year’s Southeast Section of the American Urologic Association Virtual Annual Meeting, Dr. Grivas presented pre-specified subgroup analyses of the JAVELIN Bladder 100 trial. To briefly recap, this study enrolled 700 patients with advanced urothelial carcinoma, defined as those with unresectable locally advanced disease or metastatic disease. To be eligible, patients had to have received platinum-based induction chemotherapy with either cisplatin or carboplatin in combination with gemcitabine and have not had disease progression after 4-6 cycles of therapy. Among these patients with responsive or stable disease on induction chemotherapy, enrolled patients were randomized to avelumab and best supportive care or best supportive care alone, with stratification by best response to chemotherapy and by visceral vs non-visceral disease. The primary endpoint was overall survival.

In total, 700 patients were enrolled and randomized in a 1:1 fashion. Median follow-up exceeded 19 months. The authors identified a survival benefit for the addition of avelumab to best supportive care in all identified subgroups without significant treatment-by-subgroup interactions.

Notably, patients received benefit from avelumab maintenance regardless of initial chemotherapeutic regime.


Further, the benefit was comparable in those with complete/partial response (hazard ratio 0.69, 95% confidence interval 0.53 to 0.89) and those with stable disease (hazard ratio 0.70, 95% confidence interval 0.46 to 1.05). Additionally, stratification according to the presence of visceral disease (hazard ratio 0.82, 95% confidence interval 0.62 to 1.09) and those with non-visceral disease (hazard ratio 0.54, 95% confidence interval 0.38 to 0.76) both appeared to derive benefit.


Dr. Grivas concluded that the benefit of first-line avelumab maintenance following chemotherapy (with best supportive care) provides an overall and progression free survival benefit across all pre-specified subgroups of patients.

Presented by: Petros Grivas, MD, Ph.D., Associate Professor, Clinical Director of Genitourinary Cancers Program, University of Washington, Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center

Written by: Christopher J.D. Wallis, Urologic Oncology Fellow, Vanderbilt University Medical Center during the 85th Annual Southeastern Section of the American Urological Association, April 23-24, 2021

Related Content: 
Efficacy by Duration or Number of Cycles of First-line Chemotherapy in the JAVELIN Bladder 100 Study - Petros Grivas
A New Standard of Care in Treatment of Advanced Urothelial Carcinoma from JAVELIN Bladder 100 - Cora Sternberg