Top-line data from Phase III study of cancer immunotherapy I/ONTAK

6 April 2022

US company Citius Pharmaceuticals (Nasdaq: CTXR) today reported top-line results from the pivotal Phase III trial of I/ONTAK (E7777; denileukin diftitox)), an engineered interleukin (IL)-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL).

Citius acquired rights to E7777 from Dr Reddy’s Laboratories (BSE: 500124) in September 2021, paying the Indian drugmaker $40 million upfront.

The top-line results for I/ONTAK (denileukin diftitox), a purified and more bioactive formulation of previously marketed Ontak, were consistent with the prior formulation. Moreover, no new safety signals were identified. Based on this data, Citius anticipates filing a biologics license application (BLA) with the US Food and Drug Administration in the second half of 2022.

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