secwatch.observer — SEC 8-K summary
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Issuer:     Citius Pharmaceuticals, Inc. (CTXR)
CIK:        0001506251
Form:       8-K
Filed at:   2024-11-12T23:59:59+00:00
Accession:  0001213900-24-096268
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1506251/000121390024096268/0001213900-24-096268-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1506251/000121390024096268/ea0220670-8k_citius.htm
  HTML page:      https://secwatch.observer/filing/0001213900-24-096268

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer