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

Today, Citius Pharmaceuticals announced positive top-line results from a pivotal Phase 3 clinical trial of its investigational therapy I/ONTAK (E7777) in patients with persistent or relapsed cutaneous T-cell lymphoma (CTCL)

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma

I/ONTAK is a recombinant fusion protein that combines the IL-2 receptor binding domain with a fragment of diphtheria toxin

▲The 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

▲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 will become an important treatment option for patients with persistent or relapsing CTCL,

References:

[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.