Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinumbased first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis
Abstract No : LBA1
Abstract Type : Plenary Session, Sun, 1:00 PM-4:00 PM
Indication : Urothelial Carcinoma
Intervention : Avelumab
Company : Pfizer
Technology : Monoclonal antibody
700 patients were randomly assigned to maintenance avelumab + BSC (n=350) or BSC alone (n=350) and were followed for a median of 19.6 and 19.2 months, respectively. Overall, 358 (51%) had PD-L1+ tumors. Avelumab + BSC significantly prolonged OS vs BSC alone in all randomized patients (hazard ratio [HR] 0.69; 95% CI 0.56, 0.86; 1-sided p=0.0005); 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 PD-L1+ tumors (HR 0.56; 95% CI 0.40, 0.79; 1-sided p=0.0003); median OS was not reached vs 17.1 months, respectively. An OS benefit was also observed across all prespecified subgroups. The HR for PFS based on blinded independent central review with avelumab + BSC vs BSC alone was 0.62 (95% CI 0.52, 0.75) in all randomized 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) arms, respectively, 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%, and 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%).
JAVELIN Bladder 100 met its primary objective, demonstrating significantly prolonged OS with 1L maintenance avelumab + BSC vs BSC alone in advanced UC in all randomized patients and patients with PD-L1+ tumors. Efficacy benefits were seen across all prespecified subgroups, and the safety profile of avelumab was consistent following previous studies of monotherapy.
The results are consistent as per expectations and will help Avelumab to establish further its position in Urothelial Carcinoma.