CLINICAL AND REGULATORY
ImmunityBio submits BLA for N-803 + BCG for patients with BCG-unresponsive NMIBC in situ
ImmunityBio has submitted BLA to FDA for N-803, IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder carcinoma in situ with or without Ta or T1 disease. The BLA is supported by the results of ImmunityBio’s studies in bladder cancer including the pivotal QUILT 3032 study, where 71% of patients who had failed on previous therapies showed an over 50% increase in both response and median duration compared to the FDA-approved alternatives Valrubicin and Pembrolizumab, a systemic checkpoint inhibitor therapy for this indication. The FDA previously granted N-803 Breakthrough Therapy and Fast Track designations when used in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS. If approved by the FDA, N-803 plus BCG would be the first new immunotherapy for this indication in 23 years that can be delivered directly to the bladder intravesically to induce natural killer cells and T cells, providing a new treatment option for patients with this form of bladder cancer. The results of the pivotal Phase 2/3 clinical trial demonstrated the therapeutic combination gives patients a greater chance to avoid removal of the bladder itself—a surgical procedure referred to as radical cystectomy. This surgery is one of the last remaining options for many patients that do not respond to other therapies, but is costly to the healthcare system and comes with a high risk of mortality and complications that affect patient quality of life.
Alkermes announced four abstracts related to nemvaleukin alfa were accepted for ASCO
Alkermes announced the acceptance of four abstracts related to nemvaleukin alfa, the company's engineered IL-2 variant immunotherapy at ASCO meeting. The final dataset from the phase 1/2 ARTISTRY-1 clinical trial, evaluating the safety, tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with pembrolizumab, will be shared in an oral presentation. In addition, trial-in-progress posters from the ongoing ARTISTRY-3 trial and the potential registration-enabling studies ARTISTRY-6 and ARTISTRY-7 will be presented.