ImmunityBio Inc. (NASDAQ: IBRX) announced the completion of patient enrollment in its Phase 3 QUILT 2.005 trial ahead of schedule, with 366 participants enrolled in the study evaluating its investigational therapy Anktiva combined with Bacillus Calmette-Guérin (BCG) immunotherapy. The trial demonstrated a 85% complete response rate at six months when combining Anktiva with BCG, compared to a 57% response rate in the BCG-alone control group. The company anticipates submitting a biologics license application to the FDA by the fourth quarter of 2026.
The immunotherapy company's commercial performance reflects strong early market adoption of Anktiva. Revenue climbed to $38.29 million, surpassing consensus estimates, while unit sales of the treatment increased 750% year-over-year. The acceleration in sales indicates growing physician and patient utilization despite the medication's current limited approval status.
Market response to the announcement was positive, with ImmunityBio shares gaining 3.97% during premarket trading. The trial results represent a significant milestone for the company's clinical pipeline and may support a competitive positioning for Anktiva in the oncology market upon regulatory approval.