FDA's Libtayo Approval Offers Another Option for Skin Cancer Subtype With Previous 'Historically Limited' Treatments

In February, the Food and Drug Administration (FDA) approved Libtayo (cemiplimab-rwlc) to treat patients with locally advanced basal cell carcinoma, making it the first immunotherapy option for these patients. The FDA also granted Libtayo approval for the treatment of patients with advanced basal cell carcinoma previously treated with a Hedgehog pathway inhibitor or patients for whom Hedgehog pathway inhibitors were not appropriate.

According to the American Cancer Society, basal cell carcinoma is the most common type of skin cancer, making up approximately 80% of skin cancer diagnoses. There are an estimated 2 million new cases of basal cell carcinoma each year. Although most basal cell carcinomas are easily excised and 100% curable, there is a small proportion of tumors that are considered locally advanced or not easily amenable to resection or other therapy.

“Basal cell cancers are generally thought of as benign cancers, no big deal,” Dr. Karl Lewis, professor of medicine at University of Colorado School of Medicine in Aurora, said in an interview with CURE®. “That’s fortunately true for most basal cell cancers that develop, but it’s such a common cancer that even a small percentage of these become problematic, locally advanced or metastatic. Still, as a consequence, it affects a significant number of people.”

Before the FDA approval, patients with locally advanced basal cell carcinoma were treated with Hedgehog pathway inhibitors, which were originally “a really big breakthrough for this group of patients,” Lewis said. “(Hedgehog pathway inhibitors were) able to get the tumor to shrink down in a large percentage of these patients and really change the course of the disease.”

Hedgehog pathway inhibitors were the only option a few years ago for these patients. Unfortunately, not all patients with locally advanced basal cell carcinoma responded to the therapy. In addition, patients could not take these inhibitors long term despite responding to the treatment because of significant side effects such as fatigue, muscle spasms, hair loss and impaired sense of taste.

Libtayo gives patients with locally advanced basal cell carcinoma an option for medical treatment if they have not been successful with Hedgehog pathway inhibitors.

“They have an option that is trying to use their immune system to attack the cancer,” Lewis said. “A good percentage of these patients will have their cancers shrink and their cancers controlled. For those (patients) that (Libtayo) works in, (as) for other cancers, immune therapies tend to be durable, so they have the potential to get long-term benefit from their treatment.”

Although most patients tolerate Libtayo well, some patients may experience significant toxicities or other autoimmune side effects. There is a risk that a patient’s immune system may start attacking normal tissues in the body.

“It varies from patient to patient because all of our immune systems are different,” Lewis said. “In one person, their immune system might have a predisposition to attack their liver. In somebody else, it might be their colon. We just don’t know. Most of the side effects are relatively mild, but some can be severe, so we have to watch for that.”

Lewis added that the FDA approval of Libtayo gives patients another therapy option for a disease that can be difficult to treat.

“The options for treating this disease historically have been extremely limited,” Lewis said. “… Now we have two very good effective options, the Hedgehog inhibitors and the big approval of immune therapy in this disease. It’s very exciting.”

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