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Nogapendekin Alfa Inbakicept With BCG Approved for Type of Bladder Cancer


The principal investigator of the study leading to approval said this new immunotherapy could be a "game changer" in bladder cancer.

FDA last night approved nogapendekin alfa inbakicept-pmln (NAI) (Anktiva; ImmunityBio) with Bacillus Calmette-Guérin (BCG) to treat adult patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ. The immunotherapy, a first-in-class IL-15 receptor agonist, was approved for patients with or without papillary tumors, according to a statement issued by the FDA.1

Previously designated a breakthrough therapy, NAI has been dubbed a “superagonist” and was approved based on data from the phase 3 QUILT-3.032 trial (NCT0302285). The results showed 62% of the 77 patients treated with the combination had a complete response (CR); in addition, 58% of those with a CR had duration of response of at least 12 months, and 40% had a CR of at least 24 months.1

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

Patrick Soon-Shiong, MD | Image credit: Wikipedia

Patrick Soon-Shiong, MD | Image credit: Wikipedia

“The FDA’s approval of [NAI] marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” Patrick Soon-Shiong, MD, executive chairman and global chief scientific officer at ImmunityBio, said in a statement from the company. He explained the drug’s mechanism as follows2:

  • The drug “not only proliferates and activates the patient’s own [natural killer] cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells,” Soon-Shiong said.
  • This mechanism of action behaves like a dendritic cell, which works by boosting responses to immunotherapy “beyond T cells alone,” he said.

“The ‘triangle offense’ of tumor 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 tumor types, regardless of the site of origin,” Soon-Shiong explained.

In NMIBC, the cancer is located on the inside layer of the bladder wall, making treatment challenging. About 80% of all bladder cancer cases are this type, and the American Cancer Society estimates it will account for 16,000 deaths in the United States this year.

Thus, the long duration of response from NAI could be a “game changer” for patients with NMIBC, Karim Chamie, MD, associate professor of urology at UCLA and principal investigator for the QUILT-3.032 study, said in ImmunityBio's statement. “With this approval, [NAI] could represent a new standard of care for patients with NMIBC and has the potential to change the way we treat bladder cancer.”

One caveat is that most of the QUILT-3.032 study participants were White males; when the initial results were published in NEJM Evidence in December 2022, Chamie and coauthors noted that the poor responses for some of the female participants, coupled with their small sample, pushed the CR rate for women below the overall response rate.3

Last night’s approval is a turnaround for ImmunityBio, which a year ago received a complete response letter from FDA over manufacturing issues uncovered at third-party facilities during an inspection.4

The combination is approved for maintenance therapy for up to 37 months. Company officials said NAI will be available in mid-May. Additional updates will be presented at the American Urological Association meeting on May 3, 2024.


1. FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. FDA. April 22, 2024. Accessed April 23, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer

2. ImmunityBio announces FDA approval of Anktiva, first-in-class IL-15 receptor agonist for BCG unresponsive non-muscle invasive bladder cancer. News release. ImmunityBio. April 22, 2024. Accessed April 23, 2024. https://immunitybio.com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer/

3. Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non-muscle invasive bladder cancer. NEJM Evid. 2023;2(1). doi: 10.1056/EVIDoa2200167

4. FDA decline to approve ImmunityBio’s bladder cancer therapy, shares slump. Reuters. May 11, 2023. Accessed April 23, 2024. https://www.reuters.com/business/healthcare-pharmaceuticals/immunitybio-slumps-fda-declines-approve-bladder-cancer-treatment-2023-05-11/

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