ImmunityBio said on November 9 that its final analysis of Cohort A of the QUILT-2.005 trial met the primary efficacy endpoint. The randomised, controlled registrational trial enrolled 370 patients with BCG-naive, high-grade non-muscle invasive bladder cancer across more than 75 sites, comparing intravesical ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin against BCG alone. The company said the chemotherapy-free combination produced a statistically significant improvement in efficacy in patients with carcinoma in situ, with or without papillary tumours.
The company did not publish response rates with the announcement. It said additional study details will be presented at an upcoming medical congress, that patient-reported quality of life was maintained, and that median duration of response had not yet been reached on the combination. The most common treatment-emergent adverse events were consistent with BCG alone, and no treatment-related deaths were reported.
BCG has been the standard first treatment for high-risk non-muscle invasive bladder cancer for nearly four decades, and ANKTIVA is currently approved only for the later BCG-unresponsive population, first in April 2024 for carcinoma in situ with or without papillary disease and with the indication expanded in October 2026 to cover BCG-unresponsive disease including papillary disease. BCG-naive patients sit earlier in the treatment course, so this trial tests the combination in a larger and earlier population than the one it is sold into today.
Enrollment completed in February 2026, an independent data monitoring committee found in March 2026 that no additional enrollment was needed to preserve the trial’s statistical power, and the database locked on October 20, 2026. ImmunityBio said a supplemental Biologics License Application remains on track for submission to the FDA by the end of 2026.
The open question is the size of the effect. The release asserts significance without numbers, and the commercial case for moving an IL-15 agonist into first-line use will turn on the response rates and durability shown when the full dataset is presented. Until then, the filing path is the concrete development: a year-end supplemental application, on a product whose label has already been expanded once this year.