In a Phase 2 study called THOR-2, the Janssen Pharmaceutical Companies of Johnson & Johnson have released data showing that the oral drug BALVERSA® (erdafitinib) offers substantial benefits compared to intravesical chemotherapy for patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who have specific fibroblast growth factor receptor (FGFR) alterations. These patients had already experienced recurrence after Bacillus Calmette-Guérin (BCG) therapy and were reluctant or ineligible for radical cystectomy.
In this study, BALVERSA® was found to reduce the risk of disease recurrence or death by a significant 72 percent in comparison to intravesical chemotherapy for these patients. Moreover, with a median follow-up period of 13.4 months, the data revealed that median recurrence-free survival was not reached in the BALVERSA® group, whereas it was 11.6 months for those who received chemotherapy. The six-month recurrence-free survival rate was 96 percent for BALVERSA® patients, compared to 73 percent in the chemotherapy group. At 12 months, the recurrence-free survival rate was 77 percent for BALVERSA® patients versus 41 percent in the chemotherapy group.
The safety data showed that there were generally more Grade 3 or 4 serious treatment-related adverse events (TRAEs) in the BALVERSA® group (31 percent) compared to the chemotherapy group (4 percent). Some of the common TRAEs included COVID-19, injection site reactions, cough, and headache. Notably, central serous retinopathy occurred in a significant portion of the BALVERSA® group (39 percent), but it resolved in a majority of the patients (58 percent).
These results are promising, especially since patients with HR-NMIBC who experience disease recurrence after BCG treatment have limited treatment options. The findings from the THOR-2 study highlight the potential of BALVERSA® to effectively treat high-risk non-muscle-invasive bladder cancer, where traditional therapies have often fallen short. The therapy is currently being reviewed for approval by regulatory authorities, and the results emphasize the importance of genetic testing to identify patients who could benefit from targeted treatments like BALVERSA®.
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