Efficacy

About one-third of patients experienced an objective response with BALVERSA™ based on BIRC assessment1,2

The efficacy of BALVERSA™ was studied in a multicenter, open-label, single-arm phase 2 trial. There were 87 patients eligible for the efficacy analysis; these were patients with locally advanced or metastatic urothelial carcinoma who had had at least 1 prior platinum-based chemotherapy regimen. The major efficacy outcome measures were objective response rate (ORR = complete response [CR] + partial response [PR]) and duration of response (DOR).

Chart showing the objective response rate percentage of patients who responded to BALVERSA

Responders included patients who had previously not responded to anti PD-L1/PD-1 therapy

Chart showing the objective response rate by genetic alteration as a percentage of patients who responded to BALVERSA

*Both responders had FGFR3-TACC3_V1 fusion.
One patient with an FGFR2-CASP7/FGFR3-TACC3_V3 fusion is reported in both FGFR2 fusion and FGFR3 fusion above.

Median duration of response was 5.4 months based on BIRC assessment1

Chart showing the median duration of response to BALVERSA at 5.4 months

BIRC = Blinded Independent Review Committee; CI = confidence interval.

References

1. BALVERSA™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.