ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA regarding the Company’s supplemental Biologics License Application (sBLA) for ANKTIVA^® (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

The Company presented an overview of the clinical status of its papillary disease program, including more than five years of follow-up data supporting the papillary indication. Highlights included durable disease-specific survival of approximately 96% at 36 months, with the median survival not yet reached even with five years of follow-up; high rates of cystectomy avoidance of 92% and 82% at one and three years, respectively; and a safety profile consistent with the currently approved indication in CIS disease with or without papillary tumors. In addition, several thought-leading urologists who attended the meeting presented real-world treatment approaches for patients with BCG-unresponsive disease, where the remaining alternative is often radical cystectomy.

Based on these discussions, the FDA recommended that the Company provide certain additional information for its consideration to support a potential resubmission of the sBLA initially submitted in 2025 for the papillary indication. ImmunityBio has compiled the requested information and will submit it to the Agency within the next 30 days. This additional information does not contemplate the initiation or design of a new clinical trial.

This submission follows a productive face-to-face meeting with senior FDA officials, during which the regulatory path forward for ANKTIVA in papillary NMIBC was collaboratively defined. Topics included current standards of care, challenges associated with chemotherapy, patient management considerations, and perspectives on the interpretation of the Company’s data. BCG-unresponsive disease remains a serious condition, with risks of progression to muscle-invasiveness disease, higher mortality, and limited bladder-sparing treatment options for patients.

“We appreciate the FDA’s collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails,” said Richard Adcock, President and CEO of ImmunityBio. “We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the Agency’s review.”