ImmunityBio completes database lock for ANKTIVA bladder cancer trial, results due in November
ImmunityBio announced that the data for Cohort A of its QUILT‑2.005 trial, which tests ANKTIVA combined with BCG versus BCG alone in BCG‑naïve non‑muscle invasive bladder cancer, has been locked. The lock follows verification of all 366 randomized patients and an FDA‑requested interim review that found the combination produced a longer complete‑response duration. The company expects topline data in November 2026 and plans a supplemental Biologics License Application in the fourth quarter of 2026.
Why it matters
The pending topline readout could determine whether ImmunityBio can expand ANKTIVA’s label to earlier‑stage bladder cancer patients, potentially driving future sales. The planned sBLA filing in Q4 2026 means the company will seek regulatory approval for the new indication later this year.
Key facts
- 1Database lock was completed for Cohort A of the QUILT‑2.005 trial. investing.com
- 2The trial enrolled 366 patients across 110 sites. investing.com
- 3Cohort A finished enrollment in February 2026. investing.com
- 4An interim analysis requested by the FDA found the combination therapy produced a longer duration of complete response compared with BCG alone. investing.com
- 5Topline results are expected in November 2026. tradingview.com
- 6ImmunityBio plans to submit a supplemental Biologics License Application in Q4 2026. tradingview.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.