ImmunityBio, has achieved a significant milestone with the FDA’s approval of ANKTIVA (N-803) in combination with Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS), with or without papillary tumors. Dr. Patrick Soon-Shiong, ImmunityBio’s Executive Chairman, hailed this as a leap beyond checkpoint inhibitors, emphasizing ANKTIVA’s unique mechanism of action in enhancing the immune response. ANKTIVA activates various immune cells, including NK cells, CD8+ killer T cells, and CD4+ T helper cells, promoting the proliferation of memory killer T cells for durable responses.
The approval was based on encouraging data from a multicenter trial involving 77 patients who received ANKTIVA alongside BCG maintenance therapy for up to 37 months. Impressively, the complete response (CR) rate reached 62%, surpassing benchmarks for meaningful clinical results set by experts. The duration of complete response exceeded 47 months, showcasing the therapy’s long-lasting efficacy. Notably, 58% of patients maintained a duration of response (DOR) of at least 12 months, and 40% had a DOR of at least 24 months.
The significance of ANKTIVA’s approval lies in its potential to revolutionize NMIBC treatment, offering a non-surgical alternative with superior outcomes. Bladder cancer patients, particularly those facing the prospect of radical surgeries due to BCG failure or recurrence, now have a promising therapeutic option. Dr. Ashish Kamat highlighted the importance of expanding treatment choices for patients post-BCG failure, emphasizing ANKTIVA’s safety and efficacy profile.
Dr. Sam S. Chang underscored the potency of ANKTIVA’s combination therapy in enhancing immune response against tumor cells, while Andrea Maddox-Smith of the Bladder Cancer Advocacy Network welcomed this advancement, emphasizing its impact on patient care.
ANKTIVA’s safety profile was consistent with BCG alone, providing reassurance regarding its tolerability. Ongoing studies are exploring ANKTIVA’s efficacy in various patient populations, including BCG-unresponsive and BCG-naive individuals.
Experts, including Drs. Peter Black, Jonathan Suderman, and Marie-Pier St-Laurent, recognized ANKTIVA’s potential as a new standard of care for NMIBC patients, given its robust clinical trial data and favorable safety profile.
Looking ahead, Dr. Soon-Shiong highlighted ImmunityBio’s commitment to developing cancer vaccines and expanding ANKTIVA’s application across multiple tumor types. With ongoing trials in various cancers, ANKTIVA holds promise as a versatile immunotherapy option.