The phase III JAVELIN Bladder 100 trial met its primary endpoint of overall survival at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy and who were randomly assigned to receive first-line maintenance therapy with avelumab and best supportive care lived significantly longer than those who received best supportive care alone.
A statistically significant improvement in overall survival was demonstrated in the avelumab arm in each of the co-primary populations: all randomly assigned patients and patients with programmed cell death ligand 1 (PD-L1)-positive tumors. The safety profile for avelumab in the trial was consistent with that in the JAVELIN monotherapy clinical development program. The results of the study will be submitted for presentation at an upcoming medical congress and shared with the U.S. Food and Drug Administration (FDA) and other health authorities.
In 2017, the FDA approved avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication was approved under accelerated approval based on tumor response and duration of response. JAVELIN Bladder 100 is the confirmatory study for the conversion to full approval.
About JAVELIN Bladder 100
JAVELIN Bladder 100 is a phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with avelumab plus best supportive care vs best supportive care alone in patients with locally advanced or metastatic urothelial carcinoma whose disease did not progress after completion of first-line platinum-containing chemotherapy. A total of 700 patients whose disease had not progressed after induction chemotherapy as per Response Evaluation Criteria in Solid Tumors, version 1.1, were randomly assigned to receive either avelumab plus best supportive care or best supportive care alone.
The primary endpoint is overall survival in co-primary populations of all patients and patients with PD-L1–positive tumors. Secondary endpoints include progression-free survival, antitumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers, and patient-reported outcomes in the co-primary populations. ■