Citius Oncology Presents Promising Phase 1 Data for LYMPHIR in Gynecologic Cancers
Citius Pharmaceuticals, Inc. announced that its subsidiary, Citius Oncology, Inc., presented Phase 1 clinical data at the American Society of Clinical Oncology (ASCO) Annual Meeting for LYMPHIR (denileukin diftitox-cxdl) in combination with pembrolizumab. The data evaluated patients with recurrent or refractory gynecologic malignancies, showing durable responses and manageable tolerability. Key findings included a 24% Overall Response Rate (ORR) and a median progression-free survival of 20.5 months among patients achieving clinical benefit. A Phase 2 expansion study is planned.
Key Highlights
- Citius Oncology presented Phase 1 data for LYMPHIR in combination with pembrolizumab in recurrent/refractory gynecologic malignancies at ASCO.
- The study showed a 24% Overall Response Rate (ORR) in 21 efficacy-evaluable patients, with 5 partial responses.
- Median duration of response was 21.1 months for partial responders, with 80% still experiencing clinical benefit.
- Endometrial cancer patients previously treated with checkpoint inhibitors showed a 33% ORR, with one ongoing response over three years.
- 48% of efficacy-evaluable patients achieved clinical benefit (CR, PR, or durable stable disease > 6 months).
- Median progression-free survival (mPFS) was 20.5 months for patients achieving clinical benefit.
- A Phase 2 expansion study is planned to further evaluate the combination in gynecologic cancers.
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