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Citius Oncology Announces Positive Topline Results from Investigator‑Initiated Phase 1 Study of LYMPHIR™ in Combination with Pembrolizumab in Relapsed or Refractory Gynecologic Cancers
Study data from patients with relapsed or refractory gynecologic cancers signals the potential of LYMPHIR to augment immune checkpoint inhibitor
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"Study data from patients with relapsed or refractory gynecologic cancers signals the potential of LYMPHIR to augment immune checkpoint inhibitor efficacyTopline data of University of Pittsburgh-led trial to be presented at an upcoming international cancer conference later this yearCRANFORD, N.J., March 10, 2026 /PRNewswire/ -- 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.\n \n \n \n \n \n \n \nPatients 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.\"We are encouraged by the favorable safety profile and sustained disease control observed in this heavily pretreated patient population. Evidence from the study suggests augmented anti-tumor activity when LYMPHIR is combined with KEYTRUDA and warrants further exploration in Phase 2 settings,\" stated Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma.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.\"The efficacy signal shown by this combination is incredibly exciting considering the minimal impact immuno-oncology has made in ovarian cancer thus far. ...