ImmunityBio's First-in-Class IL-15 Superagonist N-803 Receives FDA Breakthrough Therapy Designation for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma In Situ

Today, ImmunityBio announced that the U.S. FDA has granted Breakthrough Therapy Designation to its IL-15 superagonist N-803 for use in combination with Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle-invasive bladder carcinoma in situ (CIS).

Bladder cancer is a common malignancy. Globally, approximately 430,000 individuals are diagnosed with this disease annually, making it the ninth most common cancer worldwide. Carcinoma in situ (CIS) is a high-grade form of non-muscle-invasive bladder cancer (NMIBC). In patients with NMIBC, cancerous cells are confined to the inner lining of the bladder or have grown into the bladder lumen but have not yet invaded the muscle layer or other tissues. Patients with this type of cancer account for a proportion of all bladder cancer cases.

75% to 85%. BCG is the standard therapy for treating such patients; although effective, patients receiving BCG therapy have high rates of recurrence and progression. In this scenario, the recommended treatment regimen is radical cystectomy (cystectomy) to prevent cancer spread.

ImmunityBio’s N-803 is a novel IL-15 superagonist complex. Compared with endogenous, non-complexed IL-15 in vivo, N-803 exhibits improved pharmacokinetic properties, prolonged persistence in lymphoid tissues, and enhanced antitumor activity. Currently, N-803 is being evaluated in clinical trials for the treatment of adult patients with non-muscle-invasive bladder cancer (NMIBC). Previously, N-803 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

▲Introduction to N-803 (Image source: ImmunityBio official website)

This Breakthrough Therapy designation is based on the positive results achieved by N-803 in Phase 1 and Phase 2 clinical trials for the treatment of patients with carcinoma in situ (CIS). Previously, data from Phase 2 trials published by ImmunityBio demonstrated that 90% of patients receiving combination therapy with N-803 and BCG achieved complete response (CR) in the subgroup of patients with Ta/T1 papillary/non-papillary CIS. In the subgroup of patients with high-grade Ta/T1 papillary CIS, disease stability lasted up to 6 months in 75% of patients and up to 9 months in 54% of patients.

“We are pleased that the FDA has granted Breakthrough Therapy Designation to N-803 in combination with BCG for the treatment of patients with non-muscle-invasive bladder cancer (NMIBC) who have previously responded inadequately to BCG. We hope to accelerate the development of N-803 to bring hope to hundreds of thousands of bladder cancer patients, addressing the unmet needs of these high-risk patients,” said Dr. Patrick Soon-Shiong, Chairman and Chief Executive Officer of ImmunityBio. “Currently, many patients with carcinoma in situ (CIS) do not achieve optimal therapeutic outcomes with standard care, and cystectomy poses significant risks of mortality and disease progression for these patients. We believe that N-803 has the potential to avoid cystectomy and improve disease outcomes.”

References:

[1] ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer，Retrieved December 04, 2019, from https://www.businesswire.com/news/home/20191204005300/en

[2] Preliminary phase 2 clinical results of IL-15R!Fc superagonist N-803 with BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients，Retrieved December 04, 2019, from https://immunitybio.com/wp-content/uploads/2019/06/ASCO19-BCG-NMIBC-Final.pdf

Original Title: Express | “First-in-Class” IL-15 Superagonist Receives Breakthrough Therapy Designation for Bladder Cancer Treatment

*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.

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