- Citius Pharmaceuticals Inc (NASDAQ: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.
