Bladder Cancer Immunotherapy Reports Response Rate of 71% with a Durable Duration of Response Ranging Up to 54 Months

ImmunityBio, Inc. recently announced compelling new data from its ongoing QUILT 3.032 study. As of November 2024, 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated with ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG, achieving a 71% complete response rate.

This significant milestone underscores the potential of ANKTIVA to provide durable responses in patients with limited treatment options. 

In these responders, the range of durable response extended to 54 months.

 Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, commented in a press release on November 19, 2024, "These results highlight the potential of ANKTIVA to transform the treatment landscape for patients with BCG-unresponsive NMIBC CIS, offering hope for improved outcomes and cystectomy avoidance, especially with the prolonged duration of response now ranging as much as 54 months in this 100-patient analysis."

"Duration of complete response is the key efficacy element in driving cystectomy avoidance in this BCG-unresponsive population."

"I am pleased that this updated ANKTIVA data confirms that one of the highest durable responses is achieved compared to other approved products in this indication."

According to the company, this data update will be submitted to the European Medicines Agency in a Marketing Authorization Application for ANKTIVA in the European Union, which is anticipated during Q4 2024. 

In 2024, the U.S. Food and Drug Administration (FDA) approved ANKTIVA plus BCG for treating patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. The FDA has also approved Merck's TICE® BCG vaccine for this therapy.