Anktiva Plus BCG Meets Primary End Point in Bladder Cancer
ImmunityBio's combination therapy showed statistically significant efficacy improvement over BCG alone in a trial of BCG-naive patients with non-muscle-invasive bladder cancer.
Updated on Nov. 9, 2026 in Cancer
ImmunityBio announced that nogapendekin alfa inbakicept plus BCG met the primary end point in cohort A of the QUILT-2.005 trial in patients with BCG-naive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ. The combination demonstrated statistically significant efficacy improvement versus BCG alone.
Why it matters
The trial results suggest a potential new option for patients with a form of bladder cancer that has not previously been treated with BCG, a standard therapy. Patient-reported quality of life was maintained with the combination, and the company plans to seek regulatory approval.
The trial is an open-label, multicenter study with a randomized phase 2b expansion phase, using 400 μg of intravesical nogapendekin alfa inbakicept plus 50 mg of BCG weekly for 6 weeks. Cohort A's primary end point is complete response rate at 6 months, while cohort B's disease-free survival results remain unreported.
The players
ImmunityBio
ImmunityBio is a biopharmaceutical company developing immunotherapies, including Anktiva (nogapendekin alfa inbakicept), for cancer treatment.
The details
No treatment-related deaths were reported, and the most common adverse effects were consistent with BCG alone. Nogapendekin alfa inbakicept is an IL-15 receptor agonist that promotes the proliferation and activation of natural killer cells and CD8-positive T cells.
Timeline
November 9, 2026: ImmunityBio announced primary end point results for QUILT-2.005.
Year-end 2026: ImmunityBio plans to submit a supplemental biologics license application.
Health Landscape
The results build on decades of reliance on BCG intravesical therapy as the standard treatment for non-muscle-invasive bladder cancer. The trial tests whether pairing BCG with an IL-15 receptor agonist can improve on that long-established baseline in BCG-naive patients.
For patients with BCG-naive non-muscle-invasive bladder cancer, the combination therapy represents a possible alternative to BCG alone if approved. Reported side effects were consistent with BCG, and quality of life was maintained in the trial.
The takeaway
Patients with bladder cancer should discuss all available treatment options with their oncologists, as this combination remains investigational pending regulatory review. Clinical trial participation is one route for patients seeking access to emerging therapies.
What happens next
ImmunityBio plans to submit a supplemental biologics license application before year-end 2026 and to present additional findings at a medical congress.
Further reading
Explore more on Cancer treatment research and developments.
More information
Read the ImmunityBio news release on QUILT-2.005 primary endpoint.
