Citius Pharmaceuticals Inc. (NASDAQ: CTXR) has announced that it has finalized patient enrolment in the Pivotal Phase 3 study of its engineered IL-2-diphtheria toxin fusion protein, I/ONTAK, in the treatment of patients with recurrent or persistent cutaneous T-cell Lymphoma.
Citius to release topline findings in 1H 2022
The study’s treatment phase is finished, and topline results will be available in 1H 2022. The company will file a biologics license application (BLA) with the US Food and Drug Administration (FDA) in the 2H 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.”
In the main part of the I/ONTAK Phase 3 study, a multicenter, open-label, single-arm Pivotal study of I/ONTAK in persons with persistent or recurrent CTCL, a total of 70 patients were included (NCT01871727). The primary study with an appropriate dose level of 9 micrograms per kilogram (mcg/kg) of I/ONTAK was approved after positive efficacy findings from an early 21-subject lead-in study. Every 21 days, subjects were given I/ONTAK by intravenous infusion over 60 minutes (+/-10 minutes) on five consecutive days.
The primary study endpoint was Objective Response Rate
The study’s primary endpoint was Objective Response Rate, defined as the number of subjects that had considerable tumor size reduction counted as achieving complete response or partial response. In addition, the company will conduct the quality of life and primary endpoint analyses of the study combined with data set from participants in the main study, including participants in the lead part of the study that received 9 micrograms per kg through the cutoff date. Secondary endpoints include evaluation of response time, response duration, and safety.
