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).

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

There was a 32.2% ORR with 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

Median duration of response to BALVERSA™ was 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.