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Regeneron’s Libtayo combination granted FDA approval for non-small-cell lung cancer

The decision was based on superior survival outcomes of Libtayo plus chemotherapy


Regeneron’s PD-1 inhibitor Libtayo (cemiplimab-rwlc) has been approved by the US Food and Drug Administration (FDA) in combination with platinum-based chemotherapy as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC).

Specifically, the treatment is indicated for patients with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS1 aberrations, and those eligible for treatment must either have metastatic or locally advanced tumours that are not candidates for surgical resection or definitive chemoradiation, the company specified in a statement.

The approval is based on positive results from the global phase 3 trial, EMPOWER-Lung 3, that investigated Libtayo in combination with a physician's choice of platinum-doublet chemotherapy, compared to platinum-doublet chemotherapy alone.

Efficacy in EMPOWER-Lung 3 was assessed in 466 patients who were randomised to receive either Libtayo 350mg or placebo intravenously every three weeks, plus histology-specific platinum-doublet chemotherapy.

The study showed patients receiving the combination therapy achieved a 22-month overall survival, versus 13 months in those receiving chemotherapy alone. This significant improvement in overall survival, which was the primary endpoint of the trial, was the basis for the Independent Data Monitoring Committee’s recommendation that the trial be stopped early.

Lung cancer is the leading cause of cancer-related deaths worldwide. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages.

There are treatment options available for those diagnosed with stage 3 NSCLC, however if a patient progresses to stage 4 – otherwise known as metastatic cancer – the options available are often limited to the prolonging of life and palliative care provisions.

Libtayo is also approved in the US for the treatment of patients with advanced squamous cell carcinoma that has spread or cannot be cured by surgery or radiation, as well as for the treatment of locally advanced or metastatic basal cell carcinoma.

David Gandara, professor emeritus and senior advisor of the thoracic oncology programme at the University of California Davis Comprehensive Cancer Center, said: "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.

“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. Clearly, this is an advance which is clinically meaningful for our patients with advanced stage non-small cell lung cancer."

Article by
Emily Kimber

9th November 2022

From: Regulatory



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