Overall Survival

JAVELIN BLADDER 100 PRIMARY ANALYSIS: BAVENCIO + BSC demonstrated superior OS vs BSC alone⁵

Median follow-up: 19.6 months (95% CI: 18.0, 20.6) in the BAVENCIO + BSC arm and 19.2 months (95% CI: 17.4, 21.6) in the BSC-alone arm⁶

The pre-planned interim analysis was considered the primary analysis since the primary endpoint was met.^7,8

^†

LIMITATIONS: While the long-term OS analysis was prespecified, no formal hypothesis testing was performed given OS was met in the interim analysis. No conclusions can be drawn from this analysis.⁷

LONG-TERM ANALYSIS (3+ years): Consistent OS results were observed^5†

Median follow-up: 38.0 months (95% CI: 36.1, 40.5) in the BAVENCIO + BSC arm; 39.6 months (95% CI: 36.2, 41.7) in the BSC-alone arm^7,8

*P-value based on stratified log-rank.⁴

^‡

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.⁴
BSC=best supportive care; CI=confidence interval; CR=complete response; HR=hazard ratio; NE=not estimable; OS=overall survival; PD-L1=programmed death ligand-1.

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