ImmunityBio is nearing final results from a trial testing whether adding ANKTIVA to BCG improves complete response rates and response durability in patients with BCG-naïve bladder cancer.
- The QUILT-2.005 trial enrolled 366 patients and compares ANKTIVA plus BCG with BCG alone.
- An FDA-requested interim analysis found a statistically significant longer duration of complete response with the combination, according to ImmunityBio.
- The company expects to report topline results in November 2026 and submit an sBLA to the FDA in Q4 2026 to seek an expanded indication for ANKTIVA.
ImmunityBio (IBRX) shares were in focus on Wednesday after the immunotherapy company said it had completed the database lock for a 366-patient trial testing ANKTIVA plus BCG in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC), setting up a final data readout expected in November.
“The final analysis of this study will determine whether adding ANKTIVA to BCG improves complete response rates and the durability of those responses when compared with BCG alone,” said Patrick Soon-Shiong, ImmunityBio’s founder, executive chairman and global chief medical and scientific officer.
IBRX shares traded 2% higher at the time of writing.
ImmunityBio Targets November Readout After Database Lock
The QUILT-2.005 trial compares ANKTIVA plus Bacillus Calmette-Guérin (BCG) with BCG alone in 366 patients. ImmunityBio said the database lock followed the review, verification and reconciliation of data from all randomized patients, allowing the final efficacy analysis to proceed. A database lock is a data-processing milestone.
Cohort A completed enrollment in February 2026. In March, an independent data monitoring committee reviewed data from 183 evaluable patients and determined that the study had sufficient statistical power to detect the prespecified clinically meaningful difference between the treatment groups. The committee concluded that no additional enrollment was needed.
An interim analysis requested by the U.S. Food and Drug Administration (FDA) showed a statistically significant longer duration of complete response with ANKTIVA plus BCG than with BCG alone, according to ImmunityBio. The final analysis will assess the trial’s primary efficacy endpoint and key secondary endpoints, including duration of response.
The immunotherapy company expects to report topline results in November 2026 and said its supplemental Biologics License Application (sBLA) submission to the FDA remains on track for the fourth quarter of 2026.
ANKTIVA’s Current Approval Status
The FDA expanded Anktiva’s approval to cover adults with BCG-unresponsive non-muscle-invasive bladder cancer who have papillary-only tumors. The drug is given alongside Bacillus Calmette-Guerin (BCG).
QUILT-2.005 is studying the combination in BCG-naïve patients receiving BCG-based therapy for the first time. The planned filing could seek to extend ANKTIVA’s use to this population.
How Retail Views IBRX
On Stocktwits, retail sentiment toward IBRX remained in the ‘bullish’ territory over the past 24 hours, while message volume remained ‘High’.
One bullish Stocktwits user highlighted the “statistically significant” interim findings for IBRX.
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Another user expressed hope about IBRX, describing the potential treatment as a “life changer.”
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IBRX shares have surged over 313% year-to-date.
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