Citius Oncology’s Lymphir shows positive results in gynecologic cancers

Citius Oncology (CTOR)announced positive topline results from a completed investigator-initiated Phase1 clinical trial evaluating the direct T-regulatory, or 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 and a 48% clinical benefit rate among 21 evaluable patients. Full safety and clinical efficacy results are expected to be presented at an international cancer conference later this year.