Citius Pharmaceuticals Inc. (NASDAQ: CTXR) has completed patient recruitment in the pivotal third phase study of I/ONTAK, which is an engineered IL-2-diphtheria toxin fusion protein for treating recurrent cutaneous T-cell lymphoma patients.
I/ONTAK study treatment phase results are expected in 1H 2022
The study’s treatment phase is finished, and topline results are expected in the first half of 2022. The company expects to file a biologics license application with the US Food and Drug Administration in the second half of 2022.
CEO Myron Holubiak said, “Completing enrollment in the Pivotal Phase 3 study of I/ONTAK moves us another step closer to expanding treatment options for patients suffering from advanced CTCL. We expect I/ONTAK’s unique mechanism-of-action to offer oncologists an important therapeutic alternative to current targeted therapies which have limited duration of response and are often discontinued due to toxicity. We look forward to reviewing the complete safety and efficacy data and anticipate providing topline results in the first half of next year, followed by a BLA submission in the second half of 2022.”
The study enrolled 70 recurrent or persistent CTCL patients
In the main part of the I/ONTAK Phase 3 study, an open-label, multicenter, single-arm Pivotal study of I/ONTAK in persons with recurrent or persistent CTCL, a total of 70 patients were included. The primary study with an appropriate dose level of 9 micrograms per kilogram of I/ONTAK was approved after positive efficacy findings from an early 21-subject lead-in study. Every 21 days, subjects received I/ONTAK through intravenous infusion over 60 minutes (+/-10 minutes) on 5 successive days.
The Objective Response Rate is the key outcome measure for the main study. The ORR is the percentage of patients who significantly reduce tumor size and can be characterized as having either a partial or complete response (CR). The research’s primary endpoint and quality of life evaluation will be based on a combined data set that includes patients from both the main study and the lead-in component who received 9 micrograms per kilogram.
