ImmunityBio's Anktiva Shows 71% Complete Response Rate

By Bobby Samwell • Tuesday, November 19 15:21 • Permanent Link

ImmunityBio, Inc. (NASDAQ: IBRX) has recently shared new data from its ongoing Quilt 3.032 study, which has demonstrated promising results for its anktiva® (nogapendekin alfa inbakicept-pmln) treatment in combination with BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS).

The company revealed that as of November 2024, 100 patients have been treated with anktiva in combination with BCG, achieving a complete response (CR) rate of 71%. Notably, the range of durable response extended to 54 months for responders. This represents a significant milestone for the company and underscores the potential of anktiva to provide durable responses in patients with limited treatment options.

The data update is intended to be submitted to the European Medicines Agency (EMA) in a marketing authorization application for anktiva in the European Union, which is anticipated during Q4 2024. This suggests ImmunityBio's commitment to advancing innovative immunotherapies and seeking regulatory approval for its promising treatment.

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.

ImmunityBio's Executive Chairman and Global Chief Scientific and Medical Officer, Patrick Soon-Shiong, M.D., expressed his encouragement with the consistent complete response rates observed in the expanded patient cohort. He highlighted 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.

The company emphasized its commitment to monitoring patients to assess the durability of responses and overall survival outcomes, indicating a dedication to understanding the long-term impact of its treatment.

Anktiva, a first-in-class IL-15 agonist IgG1 fusion complex, targets the cytokine interleukin-15 (IL-15) to activate NK cells, overcoming the tumor escape phase and restoring memory T cell activity, resulting in prolonged duration of complete response. This innovative approach aims to harness the body's immune system to combat cancer, and the company is applying its science and platforms to treating cancers and developing potential cancer vaccines.

Following these announcements, the company's shares moved 5.8%, and are now trading at a price of $5.3. If you want to know more, read the company's complete 8-K report here.

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