Clinical TrialJun 1, 2026, 04:30 PM
Citius Oncology: LYMPHIR Combo Shows Promising Phase 1 Data in Gynecologic Cancers
AI Summary
Citius Oncology, Inc. announced the presentation of Phase 1 clinical data for LYMPHIR (denileukin diftitox-cxdl) in combination with pembrolizumab in recurrent or refractory gynecologic malignancies at the ASCO Annual Meeting. The investigator-initiated study demonstrated durable responses and manageable tolerability, with a 24% Overall Response Rate (ORR) and a median Progression-Free Survival (mPFS) of 20.5 months for patients achieving clinical benefit. Encouraging signals were observed in heavily pre-treated patients, including those previously treated with immune checkpoint inhibitors. A Phase 2 expansion study is planned.
Key Highlights
- Phase 1 study of LYMPHIR + pembrolizumab showed 24% Overall Response Rate (ORR) in 21 efficacy-evaluable patients.
- Median Progression-Free Survival (mPFS) was 20.5 months for patients achieving clinical benefit (48% of evaluable patients).
- 33% ORR observed in endometrial cancer patients previously treated with checkpoint inhibitors.
- One case of reversible Grade 3 capillary leak syndrome (CLS) observed at the highest dose level; maximum tolerated dose not achieved.
- Ongoing translational studies aim to identify biomarkers for optimized future development strategies.
- A Phase 2 expansion study is planned to further evaluate the combination in gynecologic cancers.
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