The pivotal Phase 3 clinical results of Express IL-2 receptor-targeted therapy are positive, and a marketing application is expected to be submitted this year

▎WuXi AppTec content team editors Today, Citius Pharmaceuticals announced that its investigational therapy I/ONTAK (E7777) has achieved positive top line in a pivotal Phase 3 clinical trial in patients with persistent or relapsed cutaneous T-cell lymphoma (CTCL).
result
.

I/ONTAK is an engineered IL-2 diphtheria toxin fusion protein
.

Based on this positive result, the company expects to submit a Biologics License Application to 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 into skin lesions, resulting in a reduced quality of life due to severe pain or itching
.

CTCL can progress slowly, taking years or even 10 years to develop to the cancer stage
.

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 combines the IL-2 receptor binding domain with a fragment of diphtheria toxin
.

It can specifically bind to the IL-2 receptor on the cell surface, leading to the entry of diphtheria toxin into cells and inhibiting protein synthesis
.

The therapy kills cancerous T cells and temporarily eliminates regulatory T cells (Treg), thereby enhancing the anticancer immune response
.

I/ONTAK is a purified and more biologically active formulation of the previously marketed approved therapy ONTAK
.

▲ Mechanism of action of I/ONTAK (Image source: Citius official website) In this study, a total of 71 patients with persistent or recurrent CTCL were treated, and 69 patients were included in the primary efficacy analysis
.

Trial results showed that I/ONTAK achieved an objective response rate of 36.
2% (95% CI, 25.
0%, 48.
7%) as assessed by an independent review committee (IRC)
.

The investigator-performed power analysis found an ORR of 42.
3% (95% CI, 30.
6%, 54.
6%)
.

▲Part of the preliminary analysis data of I/ONTAK (Image source: Reference [1]) "The results of this trial are encouraging, we believe it is clinically meaningful, and we hope that I/ONTAK can become an important treatment for patients with persistent or recurrent CTCL.
Choice
,
” said Mr.
Myron Holubiak, Chief Executive Officer of Citius
.

Reference: [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:// for-the-treatment-of-persistent-or-recurrent-cutaneous-t-cell-lymphoma-ctcl-in-support-of-bla-submission-301518707.
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