ImmunityBio Achieves 71% Complete Response In Bladder Cancer With ANKTIVA-BCG Therapy

ImmunityBio, Inc., a pioneer in immunotherapy, shared promising results from its ongoing QUILT 3.032 clinical trial. As of November 2024, the study has treated 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), using its experimental drug, ANKTIVA® (nogapendekin alfa inbakicept-pmln), in combination with BCG. The treatment achieved a 71% complete response (CR) rate, with some patients maintaining durable reactions for up to 54 months.

These findings will be included in a Marketing Authorization Application (MAA) for ANKTIVA, which the company plans to submit to the European Medicines Agency (EMA) later this year. The data highlights ANKTIVA's potential to offer long-lasting benefits for patients with limited therapeutic options.

 Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, said, “We are encouraged by the consistent, complete response rates observed in our expanded patient cohort. 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.

He also commented, “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.”

The QUILT 3.032 trial is a single-arm, multicenter study assessing the safety and effectiveness of combining ANKTIVA with BCG in this challenging patient population. The 71% CR rate is consistent with earlier results published in the New England Journal of Medicine (NEJM Evidence Chamie, 2022), further solidifying the promise of this therapeutic approach. ImmunityBio continues to track patient outcomes, focusing on durability and overall survival rates, as part of its commitment to advancing cutting-edge cancer immunotherapies that leverage the immune system's power.