Citius Oncology, Inc. ("Citius Oncology") (NASDAQ:CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (NASDAQ:CTXR), today announced positive topline results from a completed investigator‑initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators. This study evaluated the direct T-regulatory (Treg) cell depletion activity of LYMPHIR™ (denileukin diftitox‑cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies.
Patients with relapsed or refractory gynecological cancer have poor prognoses and very limited treatment options. This dose-escalation Phase 1 non-chemotherapy based clinical study aimed to establish a recommended dose of LYMPHIR in combination with pembrolizumab for a Phase 2 study. In 25 evaluable patients, no unexpected safety signals or serious immune-related adverse events were observed at any dose level.
The trial explored efficacy and demonstrated a 24 % objective response rate (ORR) and a 48 % clinical benefit rate (CBR, defined as complete response, partial response and/or stable disease for six months or greater) among 21 evaluable patients. Full safety and clinical efficacy results are expected to be presented at an international cancer conference later this year.