Citius Oncology has reported encouraging topline results from a Phase 1 clinical trial testing its cancer therapy LYMPHIR alongside the widely used immunotherapy Keytruda in patients with recurrent or treatment-resistant gynecologic cancers.

 

The investigator-initiated study, conducted by researchers at the University of Pittsburgh, evaluated the ability of LYMPHIR (denileukin diftitox-cxdl) to directly deplete regulatory T-cells when used in combination with the PD-1 immune checkpoint inhibitor pembrolizumab. The trial focused on women with relapsed or refractory ovarian and endometrial cancers—patients who typically face poor outcomes and few treatment options.

 

The Phase 1 dose-escalation trial enrolled 25 evaluable patients and was designed to determine the recommended dose of LYMPHIR to move forward into a Phase 2 study. Investigators reported no unexpected safety signals or serious immune-related adverse events across all dose levels.

 

"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 Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma.

 

Researchers also saw early signs of clinical activity. Among 21 evaluable patients, the combination therapy delivered a 24% objective response rate (ORR) and a 48% clinical benefit rate (CBR)—defined as complete response, partial response, or stable disease lasting six months or longer.

 

Investigators say the results are particularly notable given the limited progress immunotherapy has made in certain gynecologic cancers.

 

"The efficacy signal shown by this combination is incredibly exciting considering the minimal impact immuno-oncology has made in ovarian cancer thus far. If these findings are confirmed in subsequent studies, we may have a transformational therapy on our hands," said Alexander Olawaiye, principal investigator of the study.