Lung cancer filing is next for Anktiva

Days after starting a confirmatory phase 3 trial of Anktiva in lung cancer ImmunityBio has pledged to submit a US filing in this indication this year. The move follows Anktiva's success in the uncontrolled phase 2 Quilt 3.055 study in NSCLC patients pretreated with immune checkpoint inhibitors; this trial will form the basis of a BLA, suggesting an accelerated approval pathway that would then use results of the phase 3 trial, ResQ201A, as confirmation. ResQ201A tests Anktiva plus Opdivo and docetaxel versus docetaxel alone in checkpoint-relapsed NSCLC, and presumably one gating factor to a filing is enrolling most of its planned 460 patients to meet the FDA requirement that a confirmatory trial be substantially under way before approval. Anktiva, an IL-15 agonist, ended its run of bad luck when it secured approval combined with BCG for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Now ImmunityBio also plans to file it this year for NMIBC papillary disease, based on cohort B of the Quilt-3.032 trial, whose results were published in the NEJM in 2022. At a type B meeting two years ago the FDA turned down ImmunityBio's plan for such a filing, instead advising it to run a randomised trial.