On January 27, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported the European Medicines Agency (EMA) has accepted for review and begun assessing the marketing authorization application (MAA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors (Press release, ImmunityBio, JAN 27, 2025, View Source [SID1234649886]). The EMA covers 27 countries in the European Union (EU), as well as Iceland, Norway and Liechtenstein.
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"We are encouraged by the speed in which the EMA accepted our marketing authorization application and determined it would begin its assessment of our innovative treatment for this serious condition, just nine months after it was first approved by the FDA for use in the United States," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "Along with our submission to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), this action by the EMA is strong evidence of the momentum for putting ANKTIVA+BCG into the hands of physicians who are treating patients with NMIBC."
The EMA submission is based on the ongoing QUILT 3.032 study in which the complete response rate for the 100 evaluable patients in Cohort A as of the July 15, 2024 cut-off was 71%. In these responders, the range of duration of response is 0.03 to 54 months and is ongoing. These prolonged duration of complete response results beyond four years with ANKTIVA and BCG exceed the benchmark of 18 months for the magnitude of meaningful clinical results suggested by a panel of experts at the International Bladder Cancer Group.
About ANKTIVA
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.
ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.
ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.