The US Food and Drug Administration (FDA) has approved ImmunityBio’s IL-15 receptor antagonist Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to treat patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
The combination aims to treat NMIBC patients who are unresponsive to the BCG vaccine with carcinoma in situ (CIS) and with or without papillary tumours.
Bladder cancer is currently the tenth most commonly diagnosed cancer globally and NMIBC, when cancer cells are only located in the inner lining of the bladder, is responsible for up to 80% of all bladder cancer cases.
The FDA’s decision was based on results from the ongoing single-arm, multicentre trial, QUILT 3.032, which is evaluating Anktiva and BCG maintenance therapy in 77 evaluable patients with NMIBC.
Results showed that the combination therapy demonstrated a 62% complete response (CR), with the upper end of the confidence interval being 73%, between 37 and 47 months.
The duration of response (DOR) currently determined showed that 58% of patients with CR had a DOR of at least 12 months and 40% had a DOR of at least 24 months – a “game changer for NMIBC patients,” said Karim Chamie, principal investigator of the study.
Set to become available in the US by mid-May 2024, Anktiva works to proliferate and activate the patient’s own NK cells and CD8+ killer T cells, as well as CD4+ T helper cells, to enhance the proliferation of memory killer T cells.
BCG is a benign bacterium that induces an immune response in the bladder, leading to the clearance of cancer cells in patients. However, in up to 40% of patients, BCG will fail and in 50%, cancer will recur.
“The FDA’s approval of Anktiva marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” commented Patrick Soon-Shiong, executive chairman and global chief scientific and medical officer, ImmunityBio.
Chamie added: “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.”