Approvals
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.
The drug gained Breakthrough Therapy Designation and approval from the FDA following the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR). A trial assessed the drug in 77 evaluable patients who received Anktiva and BCG maintenance therapy for up to 37 months. The CR rate in these patients was 62% with DOR analysis ongoing.
Patrick Soon-Shiong MD, executive chairman and global chief scientific and medical officer at ImmunityBio, commented: “The FDA’s approval of Anktiva marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors. Anktiva not only proliferates and activates the patient’s own NK cells and CD8+ killer T-cells, but also activates CD4+ T helper cells, thus enhancing the proliferationofmemorykillerT-cells.Thisnovelmechanism of action, which mimics the biology of the dendritic cell, begins the evolution of immunotherapy beyond T-cells alone. The combination of the proliferation of key cancer-killing immune cells, together with the activation of T-cells with memory, results in durable complete responses. The ‘triangle offence’ of tumour cell killing by the body’s immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumour types, regardless of the site of origin.”
Karim Chamie MD, associate professor of Urology at UCLA and principal investigator for the QUILT 3.032 study, added: “The long duration of complete response ranging over 47 months is a game changer for NMIBC patients and provides further clinical evidence of Anktiva’s effectiveness for patients who historically have faced high rates of recurrence and significantly diminished quality of life due to radical surgeries. With this approval, Anktiva could represent a new standard of care for patients with NMIBC and has the potential to change the way we treat bladder cancer.”