Skin CancerASCO 2021

Libtayo Safe and Effective in Immunocompromised Patients with Advanced Skin Cancer

ASCO 2021 Highlights
Chase Doyle

Skin cancer includes several types of cancer. The most common type of non-melanoma skin cancer is basal-cell carcinoma. The second most common skin cancer type is called cutaneous squamous-cell carcinoma (or CSCC). In the United States, about 1.8 million patients are diagnosed with CSCC every year, making it one of the most common types of cancer.

Promising New Findings

According to new findings presented at the 2021 ASCO Annual Meeting, the use of immunotherapy is safe and effective in immunosuppressed or immunocompromised patients with advanced CSCC. These results come from a study called CemiplimAb-rwlc Survivorship and Epidemiology (or C.A.S.E.), which showed that overall 45.5% of immunocompromised patients responded to Libtayo (cemiplimab-rwlc) treatment.

Guilherme Rabinowits, MD

“The safety, tolerability, and effectiveness of cemiplimab in certain immunosuppressed or immunocompromised patients with advanced CSCC appear to be consistent with those observed in clinical trials that excluded these patients,” said Guilherme Rabinowits, MD, a Hematologist/Oncologist at Miami Cancer Institute/Baptist Health South Florida, Miami, at the ASCO meeting.

Because patients who have impaired immune systems are frequently excluded from clinical trials of immunotherapies, these results have the potential to change the standard of care for immunocompromised patients with CSCC, said Dr. Rabinowits.

Cemiplimab, a PD-1 inhibitor that blocks the activity of the PD-1 protein found on cancer cells that encourages the growth of cancer cells, was the first immunotherapy to be approved by the FDA for the treatment of locally advanced or metastatic CSCC. More recently, cemiplimab was also approved by the FDA as the first-line treatment of patients with advanced basal-cell carcinoma.

The C.A.S.E. Study

At the ASCO meeting, Dr. Rabinowits presented the results of the C.A.S.E. study, showing that cemiplimab is safe and effective for patients with advanced CSCC who are immunocompromised or immunosuppressed. In immunocompromised or immunosuppressed patients, the immune system is weakened because of certain medical conditions, or because those patients have an auto-immune condition and they are taking immunosuppressant medications to fight that auto-immune condition.

Patients who are immunocompromised or immunosuppressed are also at increased risk of solid tumors and for skin cancer. The risk of non-melanoma skin cancer in these patients is increased by as much as 10 times and up to 250 times compared with people who are not immunosuppressed or immunocompromised.

Immunocompromised patients are usually excluded from clinical trials of immunotherapies, yet clinical trials are the main way that researchers find information about the safety and effectiveness of new cancer therapies.

Although cemiplimab has already been approved by the FDA for patients with advanced CSCC, it was not known if it could also benefit patients who are immunocompromised or immunosupressed.

To answer this question, the C.A.S.E. study also included immunocompromised and immunosuppressed patients.

Study Results

Dr. Rabinowits discussed the results of the C.A.S.E. study that evaluated the effectiveness, safety, quality of life, and survivorship in patients with advanced CSCC who received cemiplimab. All patients with advanced CSCC, including immunocompromised or immunosuppressed patients, were qualified to be included.

By March 2021, 138 patients were enrolled in the study, and 30 of them were immunocompromised: 6 patients had received a transplant, 14 patients had a blood cancer, and 10 patients had an auto-immune disorder. The average length of cemiplimab treatment was 21 weeks, but 9 patients received the drug for at least 48 weeks.

At the ASCO meeting, Dr. Rabinowits focused his analysis on the patients with advanced-stage CSCC who were immunosuppressed or immunocompromised.

Overall, nearly half (45.5%) of the immunosuppressed or immunocompromised patients had a response to cemiplimab therapy. In addition, although 8 patients were excluded from the final analysis, 6 of these patients also had a response to cemiplimab therapy.

“Further follow-up and additional data would add to our general understanding of safety and effectiveness of anti-PD-1 therapy in these patient populations,” Dr. Rabinowits noted.

Side Effects

In all, 1 patient in the study discontinued cemiplimab because of a side effect, and 8 patients discontinued treatment for other reasons.

As with all immunotherapies, 6 patients who received cemiplimab had immune-related side effects, including fatigue, skin itching on the forehead and chest, elevated laboratory blood levels, reduced lymphocytes, and hypothyroidism.

In addition, 1 patient had acute kidney failure, so cemiplimab treatment was stopped, and the skin cancer returned. The patient is now on dialysis, but that patient is planning to resume cemiplimab for the treatment of the skin cancer.

Although 4 deaths were reported during the study, the deaths were not related to treatment with cemiplimab, Dr. Rabinowits emphasized.

Key Points

  • About 1.8 million Americans are diagnosed with cutaneous squamous-cell carcinoma (or CSCC) every year, the second most common skin cancer
  • Cemiplimab, a PD-1 inhibitor, was the first immunotherapy to be approved by the FDA for advanced or metastatic CSCC
  • Until recently, no information was available about the safety and effectiveness of immunotherapy in immunocompromised patients
  • The C.A.S.E. study evaluated cemiplimab in immunocompromised and immunosuppressed patients with advanced CSCC
  • The results showed that nearly half (45.5%) of those patients had a response to immunotherapy with cemiplimab

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Last modified: August 19, 2021

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