Citius reports 27% ORR in Phase I trial of pembrolizumab + LYMPHIR for recurrent solid tumors

Citius Pharmaceuticals, Inc.

27% objective response rate (4/15) and 33% clinical benefit rate; median PFS 57 weeks for patients with clinical benefit.
Trial enrolled 21 patients; three more to enroll before Phase I portion completes.
Combination well-tolerated; only one DLT (capillary leak syndrome) at 12 mcg/kg; no serious immune-related AEs.
Two of four partial responders had prior anti-PD-1 therapy, suggesting potential in checkpoint-resistant patients.
Phase II expansion planned across broader solid tumor types including gynecologic and other histologies.

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