ImmunityBio announced progress in discussions with the FDA concerning its non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC) treatments. The company anticipates submitting applications for an alternative BCG source, expanding ANKTIVA’s use in NMIBC, and using ANKTIVA in combination with checkpoint inhibitors for NSCLC. These advancements aim to address significant unmet needs in cancer treatment by offering potentially less toxic and more effective options.
This progress is particularly important for patients facing limited treatment choices and potentially serious outcomes. The potential expansion of ANKTIVA’s use in NMIBC could benefit patients with papillary disease who might otherwise face radical cystectomy. Additionally, the combination therapy for NSCLC could offer a new lifeline for patients who have progressed on existing checkpoint inhibitors, potentially prolonging survival without the harsh side effects of chemotherapy. Securing an alternative BCG source could stabilize supply and ensure broader access to a vital component of bladder cancer treatment.
ImmunityBio is preparing a supplemental Biologics License Application (sBLA) in 2025 for ANKTIVA in BCG-unresponsive NMIBC with papillary tumors. A Phase 2b study showed promising results for ANKTIVA combined with checkpoint inhibitors in NSCLC patients, with a median overall survival of 14.1 months. A BLA for this combination therapy is also planned for 2025. Collaborating with the Serum Institute of India, ImmunityBio aims to submit an application for an alternative BCG source in the first quarter of 2025.
These developments position ImmunityBio to significantly impact the cancer treatment landscape. Positive regulatory outcomes could lead to new treatment paradigms for both NMIBC and NSCLC, providing patients with more effective and tolerable options. Furthermore, a stable BCG supply would be a crucial step towards ensuring consistent access to vital bladder cancer therapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.