ImmunityBio Updates About Progress With The FDA On Treatments For Bladder And Lung Cancers

ImmunityBio, Inc., an innovative immunotherapy company, shared exciting updates about its progress with the FDA on treatments regarding the areas of its clinical development pipeline in non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC).

Bladder Cancer (NMIBC):

ImmunityBio plans to submit new data to the FDA in 2025 for its treatment targeting Bacillus Calmette-Guérin (BCG) that doesn’t respond to non-muscle invasive bladder cancer (NMIBC). A study showed impressive results, with nearly half of patients remaining disease-free after two years and 93% avoiding bladder removal surgery. This therapy combines BCG with ImmunityBio’s ANKTIVA® and could give patients a much-needed alternative to major surgery, improving their quality of life.

In addition, ImmunityBio is addressing the global shortage of BCG. Partnering with the Serum Institute of India, they aim to submit a plan to the FDA in early 2025 to ensure a steady, high-quality supply of this critical treatment for bladder cancer patients.

Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio commented, “The potential to improve outcomes for NSCLC patients who have already relapsed on checkpoints is an unmet need. The combination of administering ANKTIVA plus a checkpoint even after checkpoint relapse/refractory represents a large potential for ANKTIVA to rescue checkpoint failure and prolong overall survival without the toxicities of chemotherapy.”

He also said, “This submission underscores ImmunityBio's dedication to advancing cancer treatment and providing new hope for patients battling this aggressive disease. This BLA submission and our randomised ResQ201A-NSCLC (NCT06745908) Phase 3 trial in NSCLC is a potential stepping stone towards advancing novel immunotherapies in this indication for patients who have failed checkpoint inhibitor therapy.”

Lung Cancer (NSCLC):

ImmunityBio also advances treatments for advanced non-small cell lung cancer (NSCLC). In a recent study, their therapy (ANKTIVA combined with checkpoint inhibitors) helped patients live longer, especially those who had stopped responding to standard treatments. For context, typical chemotherapy for these patients has a survival rate of 7–10 months, but ImmunityBio’s treatment extended survival to over 14 months, with some patients living nearly 16 months. The company plans to submit this data to the FDA in 2025, aiming to bring this promising treatment to patients with limited options.