08-07-2025
MHRA Approves New Immunotherapy for Bladder Cancer
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved nogapendekin alfa inbakicept (Anktiva, ImmunityBio) for use in adults with carcinoma in situ (CIS) non-muscle-invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guérin (BCG).
Approval applies to patients who are either ineligible for or decline cystectomy.
Inbakicept is administered in combination with BCG. It is not a replacement for BCG but acts as a complementary agent. The therapy enhances immune system activity by stimulating CD8+ T cells and natural killer cells, while avoiding the activation of regulatory T cells.
Durable Response Demonstrated in Clinical Trial
The approval was supported by data from the phase 2/3 QUILT-3.032 trial, which enrolled patients with BCG-unresponsive NMIBC with CIS.
The trial showed a complete response (CR) rate of 71%, with a median duration of 26.6 months. Among patients achieving CR, 58% maintained it for at least 12 months, and 40% remained disease-free at 24 months. Overall, 62% of patients with CIS achieved CR during treatment. The treatment also demonstrated a significant bladder-sparing effect, with a 90% probability of avoiding cystectomy in responders at 24 months.
Treatment involves direct instillation into the bladder via catheter. Patients receive weekly induction doses for 6 weeks, followed by maintenance doses at months 4, 7, 10, 13, and 19.
Safety Profile
The most common adverse events were urinary in nature and included dysuria, haematuria, urinary frequency, and urinary tract infections. Most were mild to moderate in severity.
Dr Patrick Soon-Shiong, executive chairman and global chief scientific officer at ImmunityBio, said the therapy offers 'a meaningful option for BCG-unresponsive NMIBC.'
The approval was granted through the International Recognition Procedure, with Serum Life Science Europe GmbH as the marketing authorisation holder.
Full prescribing information, including the Patient Information Leaflet and Summary of Product Characteristics, will be published on the MHRA website within 7 days of approval.
Healthcare professionals and patients are encouraged to report any adverse events through the Yellow Card scheme.
