Avelumab significantly improves survival in patients with advanced urothelial carcinoma (UC), according to results from a phase 3 clinical trial led by Queen Mary University of London and Barts Cancer Institute. This is the first time an immune therapy has resulted in a survival advantage in this setting in bladder cancer.
The results, presented at the American Society of Clinical Oncology virtual 2020 conference, suggest avelumab is associated with a reduced risk of death and extended median survival.
This randomized, phase 3 trial (JAVELIN Bladder 100) evaluated avelumab as maintenance therapy in participants with unresectable locally advanced or metastatic UC without disease progression after 4-6 cycles of gemcitabine with either cisplatin or carboplatin. Of 700 participants, 350 received maintenance avelumab+best supportive care (BSC) and 350 received BSC alone.
Avelumab+BSC significantly prolonged overall survival (OS) vs BSC alone (HR, 0.69; 95% CI, 0.56-0.86; one-sided P=.0005). Median OS with avelumab+BSC vs BSC alone was 21.4 vs 14.3 months, respectively.
Avelumab+BSC also significantly prolonged OS vs BSC alone in patients with programmed death-ligand 1 (PD-L1)+ tumors (HR, 0.56; 95% CI, 0.40-0.79; one-sided P=.0003); median OS was not reached vs 17.1 months, respectively.
The HR for progression-free survival based on blinded independent central review with avelumab+BSC vs BSC alone was 0.62 (95% CI, 0.52-0.75) in all randomly assigned patients and 0.56 (95% CI, 0.43-0.73) in patients with PD-L1+ tumors.
In treated patients in the avelumab+BSC (n=344) vs BSC alone (n=345) groups, all-causality adverse events (AEs) were reported at any grade in 98.0% vs 77.7% and at grade ≥3 in 47.4% vs 25.2%, respectively. The most frequent grade ≥3 AEs were urinary tract infection (4.4% vs 2.6%), anemia (3.8% vs 2.9%), hematuria (1.7% vs 1.4%), fatigue (1.7% vs 0.6%), and back pain (1.2% vs 2.3%).
Howard A. Burris III, MD, the president of ASCO, commented that “given these promising results, as well as the reduced toxicity compared with chemotherapy, avelumab merits additional investigation as a potential treatment for these patients.”