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OVERALL SURVIVAL – ALL RANDOMIZED PATIENTS

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

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all-randomized-patient-chart
all-randomized-patient-chart

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  • 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 OTHER POPULATIONS

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.

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efficacy-table

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*Includes patients who switched platinum regimens while receiving first-line chemotherapy.

SUBSEQUENT DRUG THERAPY

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 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.

Safety profile

 

Mechanism of action 

 

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.