Citius Pharma Reveals Topline Immunotherapy Data From Late-Stage Lymphoma Trial - Citius Pharma (NASDAQ:CTXR)

Citius Pharmaceuticals Inc CTXR reported topline results from the Phase 3 trial of I/ONTAK (E7777) for persistent or recurrent cutaneous T-cell lymphoma (CTCL).
I/ONTAK (E7777) is an engineered IL-2-diphtheria toxin fusion protein. No new safety signals were identified.
Citius anticipates filing a marketing application with the FDA in 2H of 2022.
The Independent Review Committee (IRC) determined that the study achieved an ORR of 36.2% (25 patients out of 69).
An Investigator Efficacy Analysis determined that the study achieved an ORR of 42.3% (30 patients out of 71).
The median duration of response was 6.5 months (IRC) and 5.7 months (investigator).
The clinical benefit ratio was observed at 49.3% (IRC) and 53.5% (investigator).
Read Next: FDA Signs Off Citius Pharma's Phase 2 Trial With Halo-Lido In Hemorrhoids.
The FDA recently provided additional written comments indicating that their efficacy evaluation will be based on study results showing the lower limit of a 95% confidence interval to exceed a clinically relevant response rate.
In the trial, ORR will need to be supported by an adequate magnitude of the duration of response and an acceptable risk/benefit ratio.
Price Action: CTXR shares are down 4.39% at $1.76 during the market session on the last check Wednesday.