Citius Oncology Presents LYMPHIR Clinical Data

Citius Oncology (CTOR), a majority-owned subsidiary of Citius Pharmaceuticals (CTXR), highlighted Phase 1 clinical data presented May 30 at the American Society of Clinical Oncology Annual Meeting evaluating Lymphir in combination with pembrolizumab in patients with recurrent or refractory gynecologic malignancies. "LYMPHIR's ability to transiently deplete immunosuppressive regulatory T-cells may help address immune resistance in the tumor microenvironment and enhance the effect of checkpoint inhibitors. The encouraging clinical signals and tolerability profile observed in this study support continued clinical evaluation of this 'chemo-free' immunomodulatory approach, especially in tumors where resistance to checkpoint inhibitors remains a significant challenge," said Dr. Myron Czuczman, Chief Medical Officer of Citius Oncology. Key Efficacy and Safety findings presented at ASCO included: 24% Overall Response Rate among the 21 efficacy-evaluable patients (5 partial responses). Median duration of response had not yet been reached because only 1 of the 5 partial responders had progressed at the time of analysis (80% of PRs were continuing to experience clinical benefit). The current duration of response times (time since PR was achieved) were 4.2-35 months with a median of 21.1 months. 33% ORR in endometrial cancer patients previously treated with checkpoint inhibitors, including one patient with an ongoing response greater than three years. 48% of efficacy-evaluable patients (10 of 21) achieved clinical benefit, defined as complete response, partial response, or durable stable disease lasting at least six months: Median progression-free survival of 20.5 months (95% CI: 6.5 - NA) among the 10 patients who achieved clinical benefit; overall mPFS across all 21 efficacy-evaluable patients was 5.8 months (95% CI: 2.2 - NA); 5 patients had a PFS of greater than 20 months including 1 patient with greater than 30 months PFS;Of the 24/25 pts evaluable for dose limiting toxicities, only 1 case of reversible Gr 3 capillary leak syndrome was observed at the highest dose level. A maximum tolerated dose was not achieved. 16 serious adverse events were observed in seven patients treated at the highest dose level. No new safety signals or grade 3 or greater immune-related adverse events were observed.