FDA Approves Libtayo for Second Indication in Advanced Lung Cancer


The new indication expands the patient population eligible for a Libtayo-based regimen to include combination treatment with chemotherapy irrespective of PD-L1 expression levels.

The FDA has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. Patients may be treated with this combination irrespective of PD-L1 expression.

Developed by Regeneron, Libtayo is fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. It is also approved to treat patients with advanced cutaneous squamous cell carcinoma, basal cell carcinoma, advanced non-small cell lung cancer without chemotherapy.

Lung cancer is the leading cause of cancer death worldwide. In recent years, more than 236,000 annual new cases have been diagnosed in the United States. About 84% of all lung cancers are non-small cell lung cancer, with 75% of these cases diagnosed in advanced stages.

David R. Gandara, M.D.

David R. Gandara, M.D.

“The approval is based on a Phase 3 trial designed to closely resemble a patient population with varied disease presentations that physicians manage in everyday clinical practice,” David R. Gandara, M.D., professor emeritus and senior advisor of the Thoracic Oncology Program at the University of California Davis Comprehensive Cancer Center. “Even with these diverse disease presentations, cemiplimab-rwlc combined with chemotherapy demonstrated a marked increase in overall survival, at a median of 22 months versus 13 months with chemotherapy alone.”

The recent FDA approval is based on data from the global phase 3 trial, EMPOWER-Lung 3, that investigated Libtayo in combination with a physician’s choice of a platinum-doublet chemotherapy, compared with platinum-doublet chemotherapy alone. The trial enrolled 466 patients with locally advanced or metastatic NSCLC, irrespective of PD-L1 expression or tumor histology, and with no ALK, EGFR or ROS1 aberrations.

The study found that Libtayo resulted in a median overall survival of 22 month versus 13 months chemotherapy, representing a 29% relative reduction in the risk of death. Median grogression-free survival for Libtayo was eight months versus five months for chemotherapy, representing a 44% reduction in the risk of disease progression.

Safety was assessed in 312 patients in the Libtayo combination group and 153 patients in the chemotherapy group. The most common adverse reactions in the Libtayo combination group were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite. Serious adverse reactions occurred in 25% of patients, with treatment discontinuations due to adverse reactions in 5% and fatal adverse reactions in 6%. No new Libtayo safety signals were observed.

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