ESMO 2020 Virtual Congress: Avelumab First-Line Maintenance + Best Supportive Care vs. BSC Alone with 1L Chemotherapy for Advanced Urothelial Carcinoma: Subgroup Analyses from JAVELIN Bladder 100

( The JAVELIN Bladder 100 trial, previously presented at ASCO 2020, was a phase 3 trial of platinum-eligible patients with advanced urothelial carcinoma who had stable disease after standard first line chemotherapy and then were randomized to avelumab maintenance therapy versus best supportive care. This trial demonstrated a significantly longer overall survival in patients who received standard platinum-based chemotherapy for advanced urothelial carcinoma followed by avelumab maintenance therapy.

The schema and key results from the trial are shown below.


In this presentation, Dr. Grivas discussed the overall survival data within pre-specific patient subgroups from this trial.

With regards to physician choice of first-line carboplatin or cisplatin, patient characteristics were relatively balanced between subgroups with regards to PD-L1 status, metastatic sites, and best response, but as expected, the carboplatin patients had lower kidney function and performance status. The PFS and OS benefit of maintenance avelumab was present relative to best supportive care regardless of platinum chemotherapy administered. The median OS for cisplatin/gemcitabine was 25.3 months versus 16.5 months for BSC (HR 0.64, 0.51-0.94) and 19.0 months for carboplatin/gemcitabine versus 12.9 months for BSC (HR 0.66, 0.47 – 0.91).

The trend towards benefit of maintenance avelumab was also observed regardless of best response (complete versus partial versus stable disease).


Additional pre-specified subgroup analyses are shown below. Importantly, no significant interaction was noted between any subgroup variable and overall survival.


In summary, the overall conclusion of the JAVELIN Bladder 100 trial that maintenance avelumab results in significantly longer overall survival in patients with advanced urothelial carcinoma who have stable disease after first-line platinum chemotherapy appears to be consistent across all studied subgroups.

Presented by: Petros Grivas, MD, PhD, Medical Oncologist, Associate Professor, University of Washington School of Medicine, University of Washington, Seattle Washington

Written by: Alok Tewari, MD, PhD, Medical Oncologist at the Dana-Farber Cancer Institute, at the European Society for Medical Oncology Virtual Congress, ESMO Virtual Congress 2020 #ESMO20, 18 Sept - 21 Sept 2020.
email news signup