▎ WuXi AppTec content team editor
Today, Citius Pharmaceuticals announced that it has obtained positive top-line results in a critical Phase 3 clinical trial of the study therapy I/ONTAK (E7777) for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK is an engineered IL-2 diphtheria toxin fusion protein. Based on this positive result, the company expects to file a licensing application for biological products with the U.S. FDA in the second half of this year.
Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma. The patient's T cells become cancerous and develop skin lesions, resulting in a decrease in the patient's quality of life due to severe pain or itching. CTCL may progress slowly, taking years or even 10 years to progress to the stage of cancer. Once this stage is reached, however, the cancer may spread to the lymph nodes and internal organs, leading to a poor prognosis.
I/ONTAK is a recombinant fusion protein that binds the IL-2 receptor binding domain to a diphtheria toxin fragment. It can specifically bind to IL-2 receptors on the surface of cells, causing diphtheria toxins to enter cells and inhibit protein synthesis. This therapy kills cancerous T cells and temporarily removes regulatory T cells (Treg), thereby enhancing the anti-cancer immune response. I/ONTAK is a purified and more bioactive formulation of the approved therapy ONTAK.
▲The mechanism of I/ONTAK (Image source: Citius official website)
In the study, a total of 71 patients with persistent or recurrent CTCL were treated, and 69 patients were included in the primary efficacy analysis. The results of the trial showed that I/ONTAK achieved an objective response rate of 36.2% (95% CI, 25.0%, 48.7%) as assessed by the Independent Review Committee (IRC). Efficacy analyses conducted by the investigators found an ORR of 42.3% (95% CI, 30.6%, 54.6%).
I/ONTAK's partial preliminary analysis data (Source: Reference[1])
"The results of this trial are encouraging, we see it as clinically relevant, and hopefully I/ONTAK will be an important treatment option for patients with persistent or recurrent CTCL." Citius CEO Mr. Myron Holubiak said.
Resources:
[1] Citius Pharmaceuticals Reports Topline Data from the Pivotal Phase 3 Study of Cancer Immunotherapy I/ONTAK (E7777) for the Treatment of Persistent or Recurrent Cutaneous T-Cell Lymphoma (CTCL) in Support of BLA Submission. Retrieved April 6, 2022, from https://www.prnewswire.com/news-releases/citius-pharmaceuticals-reports-topline-data-from-the-pivotal-phase-3-study-of-cancer-immunotherapy-iontak-e7777-for-the-treatment-of-persistent-or-recurrent-cutaneous-t-cell-lymphoma-ctcl-in-support-of-bla-submission-301518707.html
Disclaimer: WuXi AppTec's content team focuses on the global biomedical health research process. This article is for informational purposes only and the views expressed herein do not represent the position of WuXi AppTec, nor do they represent WuXi AppTec's support for or opposition to the views expressed herein. This article is also not recommended for treatment options. For guidance on treatment options, please visit a regular hospital.
Copyright note: This article is from WuXi AppTec content team, welcome to forward to the circle of friends, refuse the media or institutions to reprint to other platforms in any form without authorization. Reprint authorization, please reply to "Reprint" on the "WuXi AppTec" WeChat public account to obtain the reprint instructions.
Share, like, watch, focus on global biomedical health innovation