Drug updated on 3/28/2025
| Dosage Form | Injection (intravenous; 300 mg/5 mL [60 mg/mL]) |
| Drug Class | Programmed death ligand-1 |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation
Latest News
Summary
- This summary is based on the review of one randomized controlled trial. [1]
- In participants with metastatic cutaneous squamous cell carcinoma (CSCC), the objective response rate (ORR) was 47.4% (95% confidence interval [CI]: 36.0% to 59.1%).
- The median duration of response (DOR) was not reached; response duration ranged from 1.4+ to 34.1+ months, with responses ongoing in 73.0% of participants at data cutoff.
- In participants with metastatic CSCC, common treatment-emergent adverse events (TEAEs) included fatigue (26.9%), rash (16.7%), and anemia (15.4%).
- Immune-related adverse events (irAEs) occurred in 23.1% of participants, with 2.6% experiencing grade 3 events; no grade 4 or 5 irAEs and no treatment-related deaths were reported.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Unloxcyt (cosibelimab-ipdl) Prescribing Information. | 2024 | Checkpoint Therapeutics |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma | 78Subjects F: 24% M: 76% | 2023 | Journal for ImmunoTherapy of Cancer |
Document Title
Sex Distribution:
F:24%
M:76%
78Subjects
Year:
2023
Source:Journal for ImmunoTherapy of Cancer