Checkpoint Therapeutics Receives Approval for PD-L1 Therapy

The approval of cosibelimab-ipdl provides an option for patients with cutaneous squamous cell carcinoma

December 13, 2024 (Sacramento, California) The FDA has approved a new immunotherapy for adult patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, called cosibelimab-ipdl (Unloxcyt).

Cutaneous squamous cell carcinoma is the second most common type of skin cancer. Although many cases are not life-threatening, advanced cutaneous squamous cell carcinoma can be a life-threatening condition. Unfortunately, patients with metastatic disease have 10-year survival rates between 10-20%.

The therapy is an antibody directed against the programmed death ligand-1 (PD-L1). Through the binding of the antibody to PD-L1, it will interfere with the immune checkpoint and therefore allow the immune system to recognize and attack cancer cells. The ligand, PD-L1, is often increased in abundance on the surface of cutaneous squamous cell carcinoma cells.

The new approval is another nod to the power of the body’s natural immune system in fighting cancer. Using immunotherapy, such as immune checkpoint inhibitors, bispecific antibodies, CAR T-cells, and TILs, has revolutionized the treatment options for patients with cancer. Some of these agents recently showed 10-year survival data for malignancies that were once considered incurable. Now, there is another option to include in the formulary.

Cosibelimab-ipdl was approved after efficacy evaluation in a multicenter Study CK-301-101 (NCT03212404) that measured objective response rate and the duration of response. Almost half of patients with metastatic cutaneous squamous cell carcinoma and locally advanced cutaneous squamous cell carcinoma showed a response to cosibelimab. The median length of the positive drug response was not reached and still ongoing in patients with metastatic cutaneous squamous cell carcinoma when the trial was finished. For patients with locally advanced cutaneous squamous cell carcinoma, the average patient had a response to the treatment that lasted 17.7 months.

The approval of cosibelimab-ipdl may also provide an agent with better tolerability and fewer side effects for patients. In a Phase 1 study, the safety profile in patients with metastatic cutaneous squamous cell carcinoma was manageable and lower compared to other PD-1/PD-L1 targeting agents. The most common adverse effects reported were fatigue, rash, and anemia, and these were mild to moderate in severity with no participants experiencing events that required the drug to be stopped due to the treatment effects.

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About AIM at Skin Cancer
AIM at Skin Cancer is a global foundation focused on nonmelanoma skin cancers such as basal cell carcinoma and cutaneous squamous cell carcinoma. Our mission: By educating patients, healthcare professionals, and the public, and by advocating for survivors and their families, AIM at Skin Cancer’s goal is to reduce the incidence of nonmelanoma skin cancer while improving the lives of those it affects.  Follow our groundbreaking initiatives on Facebook and YouTube.

MEDIA CONTACT: Samantha Guild, President, AIM at Skin Cancer
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About Skin Cancer
Skin cancer, such as cutaneous squamous cell carcinoma and basal cell carcinoma, is the most common form of cancer worldwide. Each year, more people are diagnosed with skin cancer in the U.S. than all other cancers combined. Recent data suggest over 2 million people were treated for nonmelanoma skin cancer in the U.S. in a single year. Skin cancers occur more frequently in males than females. Ultraviolet radiation exposure is estimated to cause 83.0% of squamous cell skin cancer and 80.5% of basal cell carcinoma among specific populations with high susceptibility to damage from ultraviolet radiation in a short amount of time.