FDA approves Anktiva for certain patients with bladder cancer
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The FDA approved nogapendekin alfa inbakicept-pmln plus Bacillus Calmette-Guerin for the treatment of certain patients with bladder cancer, according to a press release from the manufacturer.
The indication applies to individuals with Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ.
“A new immunotherapy that builds upon our knowledge and experience with BCG as an immune stimulant is exciting to see,” Ashish M. Kamat, MD, MBBS, endowed professor of urologic oncology and cancer research at The University of Texas MD Anderson Cancer Center, said in the release. “While patients have had limited options in the past after failure of BCG, nogapendekin alfa inbakicept-pmln, with its reported safety and efficacy, now offers them yet another choice in their quest to avoid a radical cystectomy. This is a big win for [patients with NMIBC] everywhere.”
Nogapendekin alfa inbakicept-pmln (Anktiva, ImmunityBio), also known as N-803, is an interleukin-15 agonist immunotherapy.
The FDA based its approval on a single-arm, multicenter QUILT 3.032 trial that included 77 evaluable patients.
Participants received nogapendekin alfa inbakicept with BCG maintenance therapy for 37 months.
Complete responses occurred in 62% of patients — 58% had a duration of response of at least 1 year, 40% had a response of at least 2 years, and some have maintained complete responses for 47 months.
Common adverse events reported in the QUILT 3.032 trial included increased creatinine or potassium, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, musculoskeletal pain, chills and pyrexia.
“The long duration of complete response ranging over 47 months is a game changer for [patients with NMIBC] 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,” Karim Chamie, MD, associate professor at UCLA and investigator in the study, said in the release. "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.”
BCG had been the previous standard of care for this population, but it does not work in roughly 30% to 40% of patients, and in those who do respond, about 50% will have recurrence, according to information provided in the release.
“Anktiva enhances natural killer cell recruitment as well as T cell stimulation,” Sam S. Chang, MD, professor at Vanderbilt Ingram Cancer Center and study investigator, said in the release. “By doing this and stimulating the innate immune memory response, we get an improved ability to kill tumor cells. It’s a potent and exciting combination.”
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