Clinical-stage immunotherapy company ImmunityBio Inc (NASDAQ: IBRX) on Monday declared encouraging findings from the Patient-Reported Outcomes (PROs) in the QUILT 3.032 study for N-803 plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

These PROs indicate stable physical function and global health in participants, supporting the positive interim results where 71% of patients achieved a complete response.

The PROs, based on a 16 May 2022 data cutoff, revealed stability in physical function and global health in participants over the two-year study period. Those achieving a complete response with the novel combination therapy reported better physical function by month six compared to non-complete responders.

Combined with the positive response rates and a favorable safety profile, these findings support a beneficial risk-benefit ratio for N-803 plus BCG. The FDA is currently reviewing the Biologics License Application (BLA) for N-803 plus BCG, with a PDUFA date set for 23 April 2024.

The QUILT 3.032 study assesses the safety and efficacy of N-803 plus BCG in BCG-unresponsive NMIBC patients, addressing the need for a safe therapeutic option for this population.