FDA Accepts ImmunityBio's Resubmitted BLA for IL-15 Superagonist N-803 in BCG-Unresponsive NMIBC

Oct 26, 2023 22:15 CST Updated 22:15

ImmunityBio

Developer of Immunotherapy Products

On October 26, ImmunityBio announced that the FDA had accepted the resubmission of its N-803 BLA for review, with the PDUFA date set for April 23, 2024.

Affected by this news,ImmunityBio's Stock Price Rises.

N-803 is an IL-15 superagonist used in combination with Bacillus Calmette-Guérin (BCG) for the treatment of carcinoma in situ (CIS), a type of non-muscle invasive bladder cancer that is unresponsive to BCG.

N-803 is composed of a mutant IL-15 (IL-15N72D) combined with an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action involves directly and specifically stimulating CD8+ T cells and NK cells by binding to the βγ T-cell receptor, generating memory T cells while avoiding stimulation of regulatory T cells. Compared with native, non-complexed IL-15, N-803 exhibits improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity in vivo.

This marketing application is mainly based onA Phase II/III Study (QUILT 3.032), and the response determined by the FDAThe person updated the duration of the reaction.

The updated results show that the duration of remission in responders has been extended, with the median CR duration not yet reached. Responders have been followed up for over 28 months, and the safety profile remains consistent with previous reports. The latest CR duration data for these BCG-unresponsive subjects indicates,The probability of CR lasting ≥24 months is 6.0%, with a cystectomy-free rate exceeding 90% at ≥24 months.

In addition, ImmunityBio, Inc. provided an update on the long-term follow-up (QUILT-205) of subjects in the Phase 1b (QUILT-2.005) trial who received N-803 in combination with BCG for the treatment of CIS±Ta/T1, examining the survival of nine subjects who entered the trial since 2014.All 9 subjects (100%) achieved complete remission.Among these 9 subjects, 2 died due to reasons other than bladder cancer, and 1 was lost to follow-up. Among the 6 subjects (QUILT-205) who were available for follow-up,All six subjects (100%) achieved long-term complete remission and retained their bladders over a median survival period of 8.8 years.To date, all six subjects have avoided cystectomy.

ImmunityBio was last yearSubmitted for listing in May, butMay this yearRejected by the FDA due to defects in third-party contract manufacturers.

The previously announced data is as follows:

QUILT 3.032 is a Phase II/III, open-label, single-arm, multicenter study evaluating intravesical BCG plus N-803 or N-803 alone in BCG-unresponsive NMIBC patients.

The patients were divided into two groups. Group A had carcinoma in situ, and Group B had papillary tumors.

Toxicity results showed that there were almost no systemic side effects.

Results of Group A,The CR for BCG plus N-803 was 71%, with a median response duration of over two years. Only 16% of patients underwent cystectomy, and 100% of patients were diagnosed with bladder cancer at the data cutoff but remained alive.