ImmunityBio Achieves 85% Six-Month Response Rate and 750% Anktiva Sales Growth
ImmunityBio completed enrollment of 366 patients in its pivotal QUILT 2.005 trial comparing Anktiva plus BCG vs BCG alone for non-muscle invasive bladder cancer, with interim data showing 85% vs 57% six-month complete response. Year-over-year revenue jumped from $7.56M to $38.29M, driven by a 750% unit sales increase in Anktiva.
1. Enrollment Milestone
ImmunityBio has enrolled 366 patients ahead of schedule in its pivotal QUILT 2.005 trial evaluating Anktiva plus BCG versus BCG alone for non-muscle invasive bladder cancer, marking a crucial step toward data readouts and regulatory filings.
2. Interim Efficacy Results
Interim analysis at six months showed 85% of patients on Anktiva plus BCG maintained complete response versus 57% on BCG alone, while nine-month data revealed an 84% versus 52% complete response rate, indicating sustained efficacy.
3. Commercial Performance
Anktiva sales surged, driving revenue from $7.56M to $38.29M year-over-year and reflecting a 750% increase in unit volume; the therapy is now approved in 33 countries for bladder cancer treatment.
4. Regulatory Outlook
Based on these promising interim results, ImmunityBio plans to submit a biologics license application to the FDA by the fourth quarter of 2026, positioning Anktiva for potential U.S. market approval.