The US Food and Drug Administration (FDA) has granted approval for ImmunityBio‘s ANKTIVA, plus Bacillus Calmette-Guérin (BCG), for treating patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The treatment is indicated for use in NMIBC patients with carcinoma in situ, irrespective of their papillary tumour status.

The approval of ANKTIVA, an IL-15 agonist immunotherapy, is expected to provide a new therapeutic option for NMIBC patients in the US by mid-May this year.

This therapy activates the body’s natural killer (NK) and killer T-cell immune system to attack tumour cells and received breakthrough therapy designation from the FDA previously.

Based on the safety and efficacy results of a single-arm, multicentre trial involving 77 evaluable patients, the FDA granted approval.

During the trial, subjects received ANKTIVA plus BCG maintenance therapy for up to 37 months.

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Trial data showed that the complete response rate was 62%, with the upper end of the confidence interval at 73%.

As of November 2023, the duration of complete response for subjects who received ANKTIVA plus BCG was over 47 months with evaluations underway.

These results are claimed to surpass the benchmark for the magnitude of meaningful clinical outcomes as suggested by the International Bladder Cancer Group, with a significant proportion of patients experiencing prolonged responses.

Furthermore, 58% of trial subjects with a complete response had a duration of response (DOR) of 12 months or more, and 40% had a DOR of 24 months or more.

ANKTIVA was found to be well-tolerated in the trial with adverse events in line with those of BCG alone.

This approval provides hope for NMIBC patients who might otherwise require highly invasive surgery.

ImmunityBio executive chair, global chief scientific, and medical officer MD Patrick Soon-Shiong said: “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 proliferation of memory killer T cells.”

In January 2024, ImmunityBio entered a deal with Oberland Capital involving a $320m revenue interest purchase agreement.

The investment aids the company in advancing the marketing of Anktiva and supports its efforts to expand this therapy into multiple solid tumour indications.