Citius Oncology reports Phase 1 combo data: 24% ORR, 33% in endometrial cancer; Phase 2 planned

Citius Pharmaceuticals, Inc.

Phase 1 trial of LYMPHIR + pembrolizumab in 25 heavily pre-treated gynecologic cancer patients showed 24% ORR (5 partial responses); median duration of response not reached.
In endometrial cancer patients previously treated with checkpoint inhibitors, ORR was 33%; one response ongoing >3 years.
48% of 21 evaluable patients achieved clinical benefit; median PFS among that group was 20.5 months.
Safety manageable: only one Gr 3 CLS at highest dose; no new safety signals or Gr 3+ immune-related AEs.
A Phase 2 expansion study is being planned to further evaluate the combo in gynecologic cancers.

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