Cosibelimab, sold under the brand name Unloxcyt, is a monoclonal antibody used for the treatment of

cutaneous squamous-cell carcinoma Cutaneous squamous-cell carcinoma (cSCC), also known as squamous-cell carcinoma of the skin or squamous-cell skin cancer, is one of the three principal types of skin cancer, alongside basal-cell carcinoma and melanoma. cSCC typically presents as ...

. It is a human immunoglobulin G1 (IgG1) programmed death ligand-1 (PD-L1) blocking antibody. The most common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection. Cosibelimab was approved for medical use in the United States in December 2024.

Medical uses

Cosibelimab is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the treatment of adults with metastatic

or locally advanced cutaneous squamous-cell carcinoma who are not candidates for curative surgery or curative radiation.

History

Efficacy was evaluated in study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label trial in 109 participants with metastatic cutaneous squamous-cell carcinoma or locally advanced cutaneous squamous-cell carcinoma who were not candidates for curative surgery or curative radiation. Participants were excluded if they had any of the following: active or suspected autoimmune disease, allogeneic transplant within six months prior to treatment, prior treatment with anti-PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy, uncontrolled or significant cardiovascular disease, ECOG PS • 2, or infection with HIV, hepatitis B, or hepatitis C.

Society and culture

Legal status

Cosibelimab was approved for medical use in the United States in December 2024.

Names

Cosibelimab is the international nonproprietary name. Cosibelimab is sold under the brand name Unloxcyt.

References

External links

* * * {{Authority control Monoclonal antibodies for tumors