BAVENCIO® (avelumab) JAVELIN Bladder 100 Trial Efficacy


JAVELIN Bladder 100 Trial—a Phase 3, randomized, open-label, multicenter study in patients with unresectable, locally advanced or metastatic urothelial carcinoma that did not progress with first-line platinum-containing chemotherapy (N=700)1

BAVENCIO + best supportive care (BSC) demonstrated superior overall survival (OS) vs BSC alone

KM curve
  • OS was measured post-randomization (after chemotherapy)
  • Among all randomized patients, consistent results were observed across the prespecified subgroup of CR/PR vs SD to first-line chemotherapy
  • 44% of patients in the BSC arm received another PD-1/PD-L1 checkpoint inhibitor as subsequent therapy vs 6% of patients in the BAVENCIO + BSC arm.
    Subsequent therapy in the JAVELIN Bladder 100 Trial

*P-value based on stratified log-rank.


OS in patients with PD-L1-positive tumors* (major efficacy outcome measure)

BAVENCIO + BSC demonstrated statistically significant improvement in OS vs BSC alone in patients with PD-L1-positive tumors (n=358, 51%); the hazard ratio was 0.56 (95% CI: 0.40, 0.79; 2-sided P-value <0.001)

OS in patients with PD-L1-negative tumors* (exploratory analysis)

In patients with PD‑L1‑negative tumors (n=271, 39%), the OS hazard ratio was 0.85 (95% CI: 0.62, 1.18)

*Using the VENTANA PD-L1 (SP263) assay, PD-L1-positive status was defined as PD-L1 expression in ≥25% of tumor cells or in ≥25% or 100% of tumor-associated immune cells if the percentage of immune cells was >1% or ≤1%, respectively. If none of these criteria were met, PD-L1 status was considered negative.1

Exploratory OS analyses of prespecified subgroups in all randomized patients2

Small patient numbers can be a limitation of subgroup analyses. These results are presented for descriptive purposes and cannot be interpreted as a demonstration of efficacy in any particular subgroup. The results show the variability of the observed treatment effect over several subgroups.

efficacy table


In the JAVELIN Bladder 100 Trial (N=700), of those receiving subsequent drug therapy, the majority of patients in the BSC arm received a PD-1 or PD-L1 inhibitor after discontinuation of treatment2

At data cutoff (October 21, 2019), primary endpoint was met. DMC recommended eligible patients be allowed to cross over to BAVENCIO plus BSC2

efficacy chart

Of the patients who received subsequent drug therapy, 14.9% (n=22/148) in the BAVENCIO + BSC arm and 70.8% (n=153/216) in the BSC arm received anti-PD-1/PD-L1 inhibitors2

  • Patients discontinued treatment due to progressive disease (54%, BAVENCIO + BSC; 75%, BSC), adverse events (11%, BAVENCIO + BSC; 1%, BSC), consent withdrawal (5%, BAVENCIO + BSC; 8%, BSC), death (1%, BAVENCIO + BSC; 4%, BSC), physician decision (1%, BAVENCIO + BSC; 2%, BSC), global health deterioration (1%, BAVENCIO + BSC; 2%, BSC), or other reasons (2%, BAVENCIO + BSC; 1%, BSC). Other reasons included no longer meeting eligibility criteria (1%, BAVENCIO + BSC), lost to follow-up (0.6%, BAVENCIO + BSC; 0.6%, BSC), non-compliance with study drug (0.3%, BAVENCIO + BSC) and other (0.3%, BAVENCIO + BSC; 0.3%, BSC)1,2

*Some patients received >1 category of subsequent therapy.1

Other drug therapies included single-agent or combo chemotherapies, TKI, antibody-drug conjugates, IDO1 inhibitors, PARP inhibitors, mTOR inhibitors, monoclonal antibodies, immune-stimulating vaccines, or investigational agents.3

DMC=Data Monitoring Committee; FGFR=fibroblast growth factor receptor; ID01=indoleamine 2,3-Dioxygenase 1; mTOR=mechanistic target of rapamycin; PARP=poly (ADP-ribose) polymerase; TKI=tyrosine kinase inhibitor.

References: 1. Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med. 2020;383(13):1218-1230. 2. Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma [supplementary appendix]. N Engl J Med. 2020. doi:10.1056/NEJMoa20027883. Data on file. Rockland, Mass: EMD Serono, Inc.