First commercial doses of N-803 for NMIBC administered across US

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N-803 was approved by the FDA in April 2024 for the treatment of patients with BCG-unresponsive NMIBC carcinoma in situ with or without papillary tumors.

The first commercial doses of N-803 (nogapendekin alfa inbakicept-pmln; Anktiva) have been administered in the United States to patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), coming just on the heels of the therapy’s FDA approval in April 2024, ImmunityBio announced in a news release.1

N-803 is an IL-15 agonist administered in combination with BCG.

N-803 is an IL-15 agonist administered in combination with BCG.

“We are grateful to be able to offer this first-in-class immunotherapy to qualified bladder cancer patients less than 2 months after the therapeutic was approved by the FDA,” said Patrick Soon-Shiong, MD, executive chairman and global chief scientific and medical officer at ImmunityBio, in the news release.1 “The interest in this next era of immunotherapy beyond checkpoint inhibitors—the era of cytokines—from urologists treating NMIBC patients has been strong, and we look forward to offering more patients an alternative to bladder removal.”

N-803 is an IL-15 agonist administered in combination with BCG, “activating the body’s NK and killer T-cell immune system to attack tumor cells, while simultaneously activating memory T cells,” according to ImmunityBio.1

The first doses of N-803 were administered to patients across the United States, with many being treated by community urologists.

“In addition to its unique mechanism of action, Anktiva can be readily administered by urologists in their own offices and clinics, enabling more patients to receive it in familiar settings from their own providers,” said Richard Adcock, President and CEO of ImmunityBio, in the news release.1 “We look forward to Anktiva reaching more and more eligible NMIBC patients and for our science to deliver even more therapies from our pipeline.”

In addition to the first commercial doses of the therapy being administered, ImmunityBio also announced that N-803 reimbursement is now covered by health insurance plans across multiple states in the United States. Patients may also receive N-803 through the ImmunityBio CARE program, designed to help patients access the therapy by providing help with benefits investigation, prior authorization support and tracking, coding and billing assistance, guidance on claim denials, and payer specific appeal assistance.

In May 2024, ImmunityBio reported that it had completed supply sufficient for 170,000 doses of 400 mcg N-803 for commercial and clinical trial use.2 In addition, the company announced a collaboration with the Serum Institute of India to provide global supply of standard BCG and next-generation recombinant BCG, intended for use in combination with N-803, further ensuring a significant initial supply of the combination therapy.3

Data on N-803

N-803 was approved by the FDA in April 2024 for the treatment of patients with BCG-unresponsive NMIBC carcinoma in situ with or without papillary tumors.4 The approval was supported by findings from the ongoing QUILT-3.032 trial (NCT03022825), which is assessing N-803 in combination with BCG for patients with BCG-unresponsive, high-grade Ta/T1 papillary NMIBC.

In total, the phase 2/3, open-label, multicenter study included 77 patients who received N-803 with BCG maintenance therapy for up to 37 months.

Data from the trial showed a complete response (CR) rate of 62% to 73% among all patients. Among those who achieved a CR, 58% demonstrated a duration of response (DOR) of 12 months or longer, and 40% demonstrated a DOR of 24 months or longer.

As of the data cutoff in November 2023, the longest duration of CR was over 47 months, which exceeded the threshold for meaningful clinical results per a panel of experts at the International Bladder Cancer Group. The median duration of CR has not yet been reached and is currently ongoing.

References

1. ImmunityBio announces insurance coverage of ANKTIVA across multiple states with first commercial doses administered just weeks after FDA approval—opening new era for immunotherapy beyond checkpoint inhibitors. News release. ImmunityBio, Inc. Published online and accessed June 20, 2024. https://immunitybio.com/immunitybio-announces-insurance-coverage-of-anktiva-across-multiple-states-with-first-commercial-doses-administered-just-weeks-after-fda-approval-opening-new-era-for-immunotherapy-beyond/

2. ImmunityBio completes GMP drug substance manufacturing sufficient for 170,000 doses of ANKTIVA. News release. May 7, 2024. Accessed June 20, 2024. https://immunitybio.com/immunitybio-completes-gmp-drug-substance-manufacturing-sufficient-for-170000-doses-of-anktiva/

3. ImmunityBio, Serum Institute of India agree on an exclusive arrangement for global supply of Bacillus Calmette-Guerin (BCG) across all cancer types. News release. May 2, 2024. Accessed June 20, 2024. https://immunitybio.com/immunitybio-serum-institute-of-india-agree-on-an-exclusive-arrangement-for-global-supply-of-bacillus-calmette-guerin-bcg-across-all-cancer-types/

4. 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 June 20, 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/

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