Sanofi and Regeneron Announce FDA Approval of PD-1 Inhibitor Libtayo for First-Line Treatment of Advanced NSCLC with High PD-L1 Expression

Today, Sanofi and Regeneron jointly announced that the U.S. FDA has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (Tumor Proportion Score ≥50%). These patients have metastatic or locally advanced disease, and their tumors do not harbor EGFR, ALK, or ROS1 alterations. In China, cemiplimab has also been approved to conduct clinical trials, either in combination with platinum-based chemotherapy or as monotherapy, for the first-line treatment of patients with advanced or metastatic NSCLC.

Lung cancer is the leading cause of cancer-related deaths both globally and in China. In 2020, there were an estimated 2.2 million new cases worldwide. In China, more than 780,000 people are diagnosed with lung cancer each year, and over 620,000 die from the disease. Approximately 84% of all lung cancers are non-small cell lung cancer (NSCLC), with 75% of these cases diagnosed at an advanced stage. It is estimated that 25%-30% of patients have high PD-L1 expression.

Libtayo is a fully humanized monoclonal antibody that targets the PD-1 immune checkpoint receptor on the surface of T cells. By binding to PD-1, it blocks cancer cells from using the PD-1 pathway to suppress T-cell activation, thereby enhancing the anti-tumor immune response of T cells. This PD-1 inhibitor has previously received FDA approval for the treatment of advanced basal cell carcinoma and locally advanced or metastatic cutaneous squamous cell carcinoma.

Recent Phase 3 clinical trial data published in The Lancet showed that, among patients with tumor PD-L1 expression ≥50% confirmed by FDA-approved tests, Libtayo reduced the risk of death by 43% compared with chemotherapy. Notably, this trial allowed patients initially assigned to the chemotherapy arm to cross over to Libtayo upon disease progression; approximately 70% of patients who initially received chemotherapy crossed over to the Libtayo arm during the trial. Detailed efficacy data from the clinical trial are as follows.

“Libtayo has been approved for the treatment of first-line advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression, adding a potent new therapeutic option for physicians and patients,” said Naiyer Rizvi, MD, a member of the clinical trial steering committee and affiliated with Columbia University Irving Medical Center. “Notably, most chemotherapy patients in this trial crossed over to the Libtayo arm upon disease progression. Furthermore, the trial permitted the enrollment of patients with clinically stable brain metastases, as well as those with locally advanced disease who were not candidates for definitive chemoradiotherapy. These findings provide important new data for physicians considering Libtayo for diverse patient populations.”

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed hospital.

References:

[1] FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%. Retrieved February 22, 2021, from https://www.globenewswire.com/news-release/2021/02/22/2179862/0/en/FDA-approves-Libtayo-cemiplimab-rwlc-monotherapy-for-patients-with-first-line-advanced-non-small-cell-lung-cancer-with-PD-L1-expression-of-50.html

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