ImmunityBio says ANKTIVA plus BCG hits primary endpoint in BCG-naïve bladder cancer trial

ImmunityBio, Inc. announced on November 9, 2026 that ANKTIVA plus BCG met the primary endpoint in Cohort A of the randomized QUILT-2.005 trial, a registrational study of 370 subjects comparing intravesical ANKTIVA plus BCG against BCG alone in patients with BCG-naïve, high-grade non-muscle invasive bladder cancer.¹ The company said the combination showed a statistically significant efficacy improvement over BCG alone in patients with carcinoma in situ, with or without papillary tumors.¹

ImmunityBio noted that BCG-naïve patients receive BCG-based therapy for the first time, an earlier stage of treatment than the BCG-unresponsive population for which ANKTIVA is currently approved.¹ Enrollment completed in February 2026 with 370 randomized patients, and following a March 2026 interim review the independent data monitoring committee determined no additional enrollment was needed to preserve statistical power.¹ Database lock occurred on October 20, 2026, and the company said the supplemental BLA remains on track for submission to the FDA by year-end 2026.¹

The update follows an October 14, 2026 FDA approval, reported in the same quarterly release, that expanded ANKTIVA's indication in combination with BCG to include adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors.² ImmunityBio also said it received approval in Israel for ANKTIVA plus BCG in BCG-unresponsive NMIBC with CIS, with or without papillary tumors, bringing global approvals to 35,² and that first patients in Europe had received treatment with the combination.²

On financials, the company reported net product revenue of $48.7 million for the third quarter, up 53% year-over-year, and $143.6 million for the first nine months of 2026, up 92% from the same period in 2025.² As of September 30, 2026, the company had $334.3 million in cash and cash equivalents, and marketable securities.²