JOHNSON & JOHNSON 
Data from Cohort 1 of the study were featured today in a Proffered Paper Late-Breaking Session (Abstract #LBA102) at the
Of the 73 patients included in Cohort 1, 49 were randomized to BALVERSA and 24 were randomized to chemotherapy. Oral erdafitinib reduced the risk of recurrence of disease or death by 72 percent compared with intravesical chemotherapy in patients with high-risk resected papillary Ta/T1 NMIBC harboring FGFR mutations or fusions with recurrence after BCG treatment and who refused or were ineligible for radical cystectomy.
With a median follow-up of 13.4 months at the data cutoff, median recurrence-free survival (RFS) was not met in patients who received BALVERSA and was 11.6 months for patients who received chemotherapy (Hazard Ratio [HR]=0.28; 95 percent Confidence Interval [CI], 0.13-0.62; nominal p=0.0008). The six-month RFS in patients randomized to BALVERSA was 96 percent compared to 73 percent in those assigned to chemotherapy. The 12-month RFS in patients assigned to BALVERSA was 77 percent compared to 41 percent in patients who received chemotherapy.
Grade 3 or 4 serious treatment-related adverse events (TRAEs) were observed in fifteen patients (31 percent) who received BALVERSA and one patient (4 percent) randomized to chemotherapy. Fourteen patients (29 percent) assigned to BALVERSA and zero patients who received intravesical chemotherapy had TRAEs that lead to discontinuation of treatment. Central serous retinopathy occurred in 19 patients (39 percent) who received BALVERSA and resolved in 11 patients (58 percent).
'Patients with NMIBC who experience disease recurrence after BCG treatment have limited treatment options, and those eligible patients with FGFR alterations who received erdafitinib in the THOR-2 trial had far fewer recurrences against patients treated by the current standard of care,' said
'Janssen's ongoing development of BALVERSA reinforces our commitment to bringing targeted, precision medicines to patients with FGFR-driven bladder cancer,' said
About THOR-2
THOR-2 (NCT04172675) is a Phase 2 randomized, open-label study evaluating BALVERSA versus investigator choice of intravesical chemotherapy in participants with NMIBC who recurred after BCG therapy. Patients are categorized to one of three cohorts based on their disease presentation: patients with HR-NMIBC and a papillary tumour only, where early cancer cells are still confined within the innermost layer of the bladder lining (Cohort 1), patients with HR-NMIBC presenting as carcinoma in situ (CIS) with or without a concurrent papillary tumour (Cohort 2), or patients with intermediate-risk NMIBC presenting with papillary disease only (Cohort 3).Patients in Cohort 1 are randomized to receive either BALVERSA or chemotherapy (mitomycin C or gemcitabine) in a 2:1 ratio and all patients in Cohorts 2 and 3 will receive BALVERSA. The Cohort 1 primary endpoint is RFS; secondary endpoints include RFS at six- and 12-months, time to progression, overall survival, plasma concentration of BALVERSA and number of patients with adverse events. The study consists of screening period, treatment phase, follow-up phase and long-term extension phase.
About BALVERSA
BALVERSA (erdafitinib) is a once-daily, oral FGFR kinase inhibitor that received accelerated approval in 2019 for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Patients are selected for therapy based on an FDA-approved companion diagnostic for BALVERSA.
In addition to the Phase 2 THOR-2 study, BALVERSA is being studied in the Phase 3 THOR (NCT03390504) study comparing BALVERSA in two cohorts; BALVERSA versus standard of care chemotherapy (investigators choice of docetaxel or vinflunine) after at least one line of treatment including an anti-programmed death (ligand) 1 (PD-[L]1) agent (Cohort 1) and BALVERSA compared to pembrolizumab after one prior treatment not containing an anti-PD-(L)1 agent (Cohort 2) in patients with metastatic or unresectable urothelial carcinoma, with selected FGFR genetic alterations, who showed disease progression during or after one or two prior lines of treatment.
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About High-Risk Non-Muscle-Invasive Bladder Cancer
High-risk non-muscle-invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC.[vi],[vii] HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, and CIS. Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.[viii],[ix] Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.[x] The high rates of recurrence and progression can pose significant morbidity and distress for these patients.
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of BALVERSA (erdafitinib). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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