What's Happening?
ImmunityBio, Inc. has announced significant progress in its clinical trial for BCG-naive non-muscle-invasive bladder cancer (NMIBC), known as QUILT-2.005. The trial, which compares the effects of BCG alone versus BCG combined with ANKTIVA, has exceeded enrollment expectations, with over 85% of participants already enrolled. The company anticipates completing enrollment by the second quarter of 2026 and plans to submit a biologics license application to the U.S. Food and Drug Administration (FDA) by the end of 2026. An interim analysis requested by the FDA showed that the combination of ANKTIVA and BCG significantly prolonged the duration of complete response in patients compared to BCG alone. At six months, 85% of patients receiving the combination maintained
a complete response, compared to 57% with BCG alone. This difference was statistically significant at nine months, with 84% of the combination group maintaining a response versus 52% in the BCG-only group.
Why It's Important?
The trial's promising results could have significant implications for the treatment of bladder cancer, particularly for patients who are BCG-naive. The combination of ANKTIVA and BCG may offer a more effective treatment option, potentially improving patient outcomes and reducing the risk of cancer progression. This development is particularly crucial given the ongoing shortage of TICE BCG, a standard treatment for bladder cancer. ImmunityBio's progress in this trial could lead to a new standard of care, providing an alternative for patients who may not respond to BCG alone. The success of this trial could also bolster ImmunityBio's position in the biotechnology sector, enhancing its reputation as a leader in innovative cancer therapies.
What's Next?
ImmunityBio plans to continue its trial and complete enrollment by mid-2026, with a submission to the FDA expected by the end of the year. The company is also seeking consultation with the FDA to address the use of recombinant BCG as an alternative supply source, anticipating continued clinical need. If the trial results continue to be positive, ImmunityBio may secure FDA approval for the combination therapy, potentially leading to widespread adoption in clinical practice. The company will likely focus on expanding its access program to ensure patients can benefit from this new treatment option.
