WASHINGTON -- More than half of patients with previously treated non-muscle invasive bladder cancer (NMIBC) had complete responses (CRs) with an intravesical gene therapy, according to preliminary results from an ongoing study.
The interim data showed that 54% of 125 patients achieved a CR with detalimogene voraplasmid, and the 12-month CR rate was 25%. Among patients attaining CRs, 84% remained in CR at the 9-month evaluation and 59% remained in CR at the 12-months evaluation.
The therapy has been well tolerated, as fewer than 5% of patients had grade ≥3 treatment-related adverse events (TRAEs), reported Ashish Kamat, MD, of the MD Anderson Cancer Center in Houston, at the American Urological Association (AUA) annual meeting.
Kamat highlighted that the "durability data" were encouraging, but also cautioned that the findings are preliminary. Still, he said it was "also encouraging to note that 96.8% of patients were free of progression to T2 or more advanced disease. A primary analysis with longer follow-up is planned in the second half of 2026, and the [therapy developer] is planning to have discussions with the FDA later this year."
The study involved patients whose disease had proven unresponsive to traditional first-line treatment with intravesical bacillus Calmette-Guérin (BCG). Multiple therapies are in development to meet that need. During a post-presentation discussion, AUA session co-moderator Adam Kibel, MD, of Brigham and Women's Hospital in Boston, asked how urologic oncologists might use the different treatments.
