UNLOXCYT is an innovative immunotherapy offering hope for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for surgery or radiation. This breakthrough treatment is designed to empower the immune system to target cancer more effectively. UNLOXCYT was approved on December 13, 2024.
What is the name of the drug, and what does it do?
UNLOXCYT (pronounced un-LOX-sit) is a programmed death ligand-1 (PD-L1) blocking antibody. By targeting PD-L1, it enhances the body’s immune response, helping to slow down tumor growth and, in some cases, shrink tumors.
How does it work?
PD-L1 is a protein that allows cancer cells to evade immune system attacks. UNLOXCYT blocks PD-L1, enabling immune cells to recognize and destroy cancer cells. Additionally, it induces antibody-dependent cell-mediated cytotoxicity (ADCC), which further enhances its tumor-fighting effects.
What did the research discover?
In a clinical trial involving 109 patients with advanced or metastatic CSCC, UNLOXCYT demonstrated strong efficacy. Among patients with metastatic CSCC, 47% experienced significant tumor shrinkage, and 8% achieved complete remission. For those with locally advanced CSCC, 48% showed tumor shrinkage, with 10% achieving complete remission. The median duration of response for metastatic patients was not reached, with 84% maintaining their response for at least six months, and 54% for over 12 months. These findings underscore the potential of UNLOXCYT to provide durable responses for patients with few other treatment options.
What are some of the side effects?
The most common side effects of UNLOXCYT include:
- Fatigue
- Muscle or bone pain
- Rash
- Diarrhea
- Low thyroid hormone levels (hypothyroidism)
- Constipation
- Nausea
- Headache
- Itchy skin
- Swelling
- Infections, including urinary tract infections
Rare but serious side effects include immune-mediated reactions, such as pneumonitis, colitis, and hepatitis, as well as infusion-related reactions.
What are the dosage recommendations, and how is it prescribed?
UNLOXCYT is administered as a 1,200 mg intravenous infusion every three weeks. Each infusion lasts 60 minutes and is done in a medical setting where patients can be monitored for adverse reactions. Treatment continues until the disease progresses or side effects become unmanageable.
Source
Checkpoint Therapeutics. Prescribing information for UNLOXCYT (cosibelimab-ipdl). December 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf
