Clinical-stage immunotherapy company, ImmunityBio, announced on Monday the successful resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for N-803 (Anktiva), a pioneering IL-15 superagonist, combined with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. Following this development, the stock of ImmunityBio surged significantly on Tuesday.
At the time of this publication, ImmunityBio Inc stock (IBRX) has witnessed a decline.
Immunitybio Inc
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The BLA is backed by extensive research in bladder cancer, notably the pivotal QUILT-3.032 study (NCT03022825), featured in NEJM Evidence1 in November 2022. The BLA resubmission includes an updated analysis of the duration of response among the FDA-identified responders in the efficacy population for BCG unresponsive subjects with high-risk CIS disease. This analysis revealed an extended period of remission in responding subjects, with a median duration of complete remission (CR) not yet reached, even after a follow-up exceeding 28 months. The safety profile remains consistent with previous reports. Notably, the updated CR duration for these responsive BCG-unresponsive subjects indicates a 60% probability of maintaining CR for ≥ 24 months, with a cystectomy-free rate at ≥ 24 months exceeding 90%.
Additionally, ImmunityBio furnished an update on the long-term follow-up of subjects receiving N-803 plus BCG for CIS ± Ta/T1 in the Phase 1b trial. This examined the survival outcomes of nine subjects who entered the trial since 2014. Impressively, all nine subjects (100%) achieved complete remission, a result documented in Oncoimmunology2-5. Among these subjects, two passed away from causes unrelated to bladder cancer, and one was lost to follow-up. Among the six subjects available for follow-up in QUILT-205, all six displayed sustained complete remission with bladder preservation over a median survival span of 8.8 years. Remarkably, all six subjects have managed to avoid cystectomy thus far.
The resubmitted BLA for N-803 by ImmunityBio to FDA marks a significant stride towards advancing treatment options for individuals grappling with BCG-unresponsive non-muscle-invasive bladder cancer CIS. The compelling data presented in support of the application underscores the potential of this innovative immunotherapeutic approach. As the FDA proceeds with its review, anticipation and interest in the outcome of this application continue to grow within the medical and investment communities.
Investors responded promptly to this milestone, propelling ImmunityBio’s stock to a notable surge in value, reflecting the market’s optimism surrounding the potential impact of N-803 in revolutionizing the treatment landscape for this challenging form of bladder cancer.
