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
*P-value based on stratified log-rank.
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)
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
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.
*Includes patients who switched platinum regimens while receiving first-line chemotherapy.
At data cutoff (October 21, 2019), primary endpoint was met. DMC recommended eligible patients be allowed to cross over to BAVENCIO plus BSC2
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
*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/NEJMoa2002788. 3. Data on file. Rockland, Mass: EMD Serono, Inc.