UK’s MHRA approves nogapendekin alfa inbakicept plus BCG in NMIBC

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for nogapendekin alfa inbakicept-pmln (NAI, Anktiva) in combination with BCG for the treatment of BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), ImmunityBio announced.¹

According to the company, the MHRA approval represents the first marketing approval outside the US for NAI. NAI was approved in the US in April 2024 for use in combination with BCG in the treatment of patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors.

“With the MHRA’s authorization of Anktiva plus BCG, we can now offer our immunotherapy outside the US to help patients with a disease that, if not effectively treated, can lead to bladder removal,” said Patrick Soon-Shiong, MD, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “This immune-boosting, lymphocyte-stimulating agent, the first of its kind, is central to our Cancer BioShield platform, which is designed to restore immune function and support long-term disease control.”

“ImmunityBio is honored to have received this important authorization from the UK MHRA. In light of the United States Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025, we are actively evaluating our go-to-market strategy for the UK,” added Richard Adcock, CEO and President of ImmunityBio.

At the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada, updated data from the phase 2/3 QUILT-3.032 trial (NCT03022825) demonstrated high complete response and avoidance of cystectomy rates in patients with high-risk BCG-unresponsive bladder CIS, with or without papillary disease, treated with NAI.²

Sam S. Chang, MD, MBA

During his presentation of the data at AUA 2025, QUILT-3.032 principal investigator Sam S. Chang, MD, MBA, explained, “This IL-15 superagonist does several things uniquely. First of all, within the bloodstream, you have actually an increased duration or half life. You have an ability to improve binding and then accelerate its ability to bring about an improvement in the immune response. We have proliferation and activation of natural killer cells. We have an impact on the dendritic as well as the T cells themselves, and it’s a combination of increasing this cell kill but not yet stimulating the suppressive T regulatory cells that make this IL-15 superagonist unique.” Chang is a professor of urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center in Nashville, Tennessee.

Chang also gave an overview of the QUILT-3.032 study, an open-label, single-arm multicenter trial evaluating NAI in patients with BCG-unresponsive NMIBC. The trial included cohort A, which included 100 patients with BCG-unresponsive NMIBC carcinoma in situ (CIS) with or without papillary disease, and cohort B, which included 80 patients with BCG-unresponsive NMIBC papillary disease without CIS. In the induction phase, patients in both cohorts received 400 ug NAI plus 50 mg BCG intravesically for 6 consecutive weeks. There was also a re-induction phase for participants who had not achieved a CR at month 3. The primary end point for cohort A was biopsy-confirmed CR rate that was based on responses at 3- or 6-month assessment. The primary end point for cohort B was disease-free rate assessed at the end of 12 months.

In the release, ImmunityBio said it has submitted regulatory applications for NAI to the European Medicines Agency as well as Iceland, Norway, and Lichtenstein.

REFERENCES

1. UK MHRA approves ImmunityBio’s ANKTIVA plus BCG for BCG-unresponsive non-Muscle invasive bladder cancer carcinoma in situ. News release. ImmunityBio. July 7, 2025. Accessed July 8, 2025. https://www.businesswire.com/news/home/20250707451616/en/UK-MHRA-Approves-ImmunityBios-ANKTIVA-Plus-BCG-for-BCG-Unresponsive-Non-Muscle-Invasive-Bladder-Cancer-Carcinoma-In-Situ

2. Chang SS, Chamie K, Kramolowsky E, et al. An update on QUILT-3.032: Complete responses to N-803 plus BCG therapy in BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease. J Urol. 2025;213(5S):e392. doi:10.1097/01.JU.0001109848.08748.9e.12