ImmunityBio’s latest clinical findings reveal a significant development in the ongoing battle against non-muscle-invasive bladder cancer, with three-year follow-up data suggesting that combining Anktiva with standard immunotherapy could fundamentally alter how physicians approach a difficult patient population. The pharmaceutical company has released evidence, reported by FiercePharma.com, that its treatment maintains benefits well beyond the initial one-year assessment period, a critical finding as the field grapples with an increasingly complex competitive environment.
The Surgical Question
For bladder cancer patients who fail conventional treatment, radical cystectomy, complete bladder removal, traditionally represents the expected outcome. ImmunityBio’s data challenges this narrative. Among patients with high-grade papillary-only tumors, approximately four out of five patients maintained their bladders at the three-year mark, with over 81% avoiding surgery entirely. One-year data showed even more dramatic preservation, with 92% of patients spared this invasive procedure.
Measuring Success Beyond Surgery Avoidance
The clinical picture extends beyond surgical outcomes. Disease progression halted in approximately 83% of the study population through three years, while 96% of patients remained alive from bladder cancer-specific causes. The one-year disease-free survival metric of 58.2% provides context for the durability of these benefits, though long-term DFS declined to 38.2% by year three, suggesting disease recurrence remains a challenge even with this intervention.
A Market Under Siege
ImmunityBio faces mounting pressure from well-funded competitors. Johnson & Johnson recently unveiled comparable data from its competing immunotherapy, demonstrating a 74.3% one-year disease-free survival rate with 92.3% of patients avoiding cystectomy. Merck’s established checkpoint inhibitor Keytruda and Ferring’s gene therapy option Adstiladrin round out an increasingly crowded therapeutic space.
Regulatory Setbacks and Expansion Plans
The company encountered FDA resistance when seeking approval specifically for the papillary-only subtype, receiving a surprising refusal-to-file letter. Following mid-year regulatory discussions, ImmunityBio is recalibrating its strategy. Meanwhile, the company maintains momentum, reporting $31.8 million in quarterly sales since Anktiva’s initial approval, driven by persistent patient demand.
Looking ahead, ImmunityBio is evaluating its treatment in previously untreated patient populations—a substantially larger market that could transform the drug’s commercial trajectory. The combination of solid clinical performance, growing sales adoption, and untapped patient populations suggests the company plans to establish meaningful market share despite formidable competition.
