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The FDA for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC), the agency announced Monday.

A first-in-class interleukin (IL)-15 receptor agonist, the drug is specifically approved in combination with BCG for adults with BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors.

Approval was supported by data from the single-arm, multicenter QUILT-3.032 trial, which included 77 evaluable patients who received the novel immunotherapy along with BCG maintenance therapy for up to 37 months. Patients achieved a complete response rate of 62% (95% CI 51-73), with 58% of those responders having a duration of response (DOR) of a year or more and 40% having a DOR stretching to 2 years or longer.

According to ImmunityBio, the drug's developer, DOR is ongoing, with some complete responses persisting for more than 47 months.

"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," said Karim Chamie, MD, of the University of California Los Angeles and a co-principal investigator for the QUILT-3.032 study, in a from the company. "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."

Nogapendekin alfa is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on natural killer, CD4, and CD8 T cells.

"Anktiva enhances natural killer cell recruitment as well as T-cell stimulation," explained co-principal investigator Sam S. Chang, MD, of the Vanderbilt Ingram Cancer Center in Nashville, Tennessee, in the press release. "By doing this and stimulating the innate immune memory response, we get an improved ability to kill tumor cells."

The most common adverse reactions were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.

The recommended dose is 400 mcg administered intravesically with BCG once a week for 6 weeks as induction therapy. A second induction course may be administered if complete response is not achieved at month 3.

The recommended maintenance dose is 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13, and 19.

For patients with an ongoing complete response at month 25 or later, maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37 for a maximum of nine additional instillations.

According to the FDA, treatment should be discontinued for disease persistence after second induction, disease recurrence or progression, or unacceptable toxicity. The maximum treatment duration is 37 months.

The FDA had in May 2023, at the time citing manufacturing issues and requesting longer-term DOR and safety data, according to ImmunityBio.

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