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获FDA批准!ImmunityBio(IBRX.US)潜在重磅疗法延长难治性癌症患者OS

FDA approved! ImmunityBio (IBRX.US) Potentially Major Therapy Extends OS for Patients with Refractory Cancers

Zhitong Finance ·  Apr 25 18:52

ImmunityBio (IBRX.US) announced that its IL-15 superagonist anktiva (nogapendekin alfa inbakicept) obtained positive overall survival (OS) results in the QUILT 3.055 study.

The Zhitong Finance App learned that ImmunityBio (IBRX.US) announced that its IL-15 superagonist anktiva (nogapendekin alfa inbakicept) obtained positive overall survival (OS) results in the QUILT 3.055 study. The study involved patients with non-small cell lung cancer (NSCLC) who progressed after receiving immune checkpoint inhibitors and standardized therapy. These results further bolster ImmunityBio's confidence in Anktiva's potential efficacy as a next-generation immunotherapy in multiple physical and hematologic tumor types. This week, the US FDA just approved the marketing of anktiva to treat adult patients with non-muscle-invasive bladder cancer (NMIBC) who do not respond to BCG (BCG) and are accompanied by carcinoma in situ (CIS).

Anktiva is an IL-15 superagonist. IL-15 plays a critical role in the immune system by affecting the development, maintenance, and function of natural killer (NK) cells and immune T cells. Anktiva consists of an IL-15 mutant (IL-15N72D) that binds to the IL-15 receptor α/IgG1 Fc fusion protein. It binds to beta-gamma T-cell receptors to directly and specifically stimulate CD8-positive T cells and NK cells while avoiding stimulation of regulatory T cells (Tregs). Compared with natural, non-compound IL-15, Anktiva has better pharmacokinetic properties in patients, and can exist in lymphatic tissue for a longer period of time, showing enhanced anti-tumor activity. Anktiva was granted breakthrough therapy by the FDA in 2019 to be used in combination with BCG to treat patients with non-muscle-invasive orthotopic bladder cancer who previously had poor response to BCG.

According to reports, in NSCLC patients who relapsed or were drug resistant after checkpoint inhibitor treatment, Anktiva was used in combination with the same checkpoint inhibitor. This combination significantly increased overall survival and restored the effectiveness of checkpoint inhibitors.

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