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A bladder cancer combo therapy just cleared a major hurdle. Nogapendekin alfa inbakicept (Anktiva) plus BCG met its primary endpoint in the QUILT-2.005 trial, showing statistically significant efficacy improvement over BCG alone in BCG-naive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ. The combination maintained quality of life and showed a safety profile consistent with BCG alone — with no treatment-related deaths.
A bladder cancer combo therapy just cleared a major hurdle. Nogapendekin alfa inbakicept (Anktiva) plus BCG met its primary endpoint in cohort A of the phase 1b/2b QUILT-2.005 trial, demonstrating a statistically significant improvement in complete response rate at 6 months compared to BCG alone in BCG-naive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. Patient-reported quality of life was maintained, and no treatment-related deaths were reported.
This result builds on earlier success in BCG-unresponsive NMIBC — where the FDA approved Anktiva + BCG in 2024 and expanded that approval in October 2026 to include high-grade papillary-only tumors. Now, the combination is showing promise even earlier in the treatment journey, in patients who haven't yet received BCG.
Key Takeaways
Why it matters: If approved for BCG-naive patients, Anktiva + BCG could become the first chemotherapy-free immunotherapy combo to improve outcomes at this earlier disease stage — potentially reshaping the standard of care for NMIBC.
