ImmunityBio Completes ANKTIVA’s Post-Approval Enrollment of the 100th Patient in BCG Unresponsive NMIBC CIS Trial and Reports a Complete Response Rate of 71% with a Durable Duration of Response Ranging Up to 54 Months

In This Article:

  • High responder rate associated with a duration of response ranging as long as 54 months in QUILT-3.032 with 100 patients enrolled

  • Updated data intended to be submitted as part of a European Medicines Agency (EMA) Submission in Q4 2024

  • Complete response data in 100 patients consistent with CR rate of 71% reported for 82 patients published in NEJM

CULVER CITY, Calif., November 19, 2024--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today 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 (CR) rate. In these responders, the range of durable response extended to 54 months. This data update will be submitted to the European Medicines Agency (EMA) in a Marketing Authorization Application (MAA) for ANKTIVA in the European Union (EU), which is anticipated during Q4 2024.

This significant milestone underscores the potential of ANKTIVA to provide durable responses in patients with limited treatment options. The QUILT 3.032 study is a single-arm, multicenter trial evaluating the safety and efficacy of ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC CIS. The observed 71% CR rate aligns with previous findings reported in the New England Journal of Medicine (NEJM Evidence, Chamie 2022) and reinforces the therapeutic promise of this combination therapy.

"We are encouraged by the consistent complete response rates observed in our expanded patient cohort," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "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 when compared to other approved products in this indication."

The QUILT 3.032 study continues to monitor patients to assess the durability of responses and overall survival outcomes. ImmunityBio remains committed to advancing innovative immunotherapies that harness the body's immune system to combat cancer.

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