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FDA Approves Libtayo, Chemotherapy as First-Line Treatment for Advanced Non-Small Cell Lung Cancer

FDA Approves Libtayo, Chemotherapy as First-Line Treatment for Advanced Non-Small Cell Lung Cancer

Officials with the FDA approved cemiplimab-rwlc (Libtayo; Regeneron) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.Efficacy results comparing the cemiplimab-rwlc combination to chemotherapy alone showed a 22-month median overall survival versus 13 months. 

Patients must have either metastatic or locally advanced tumors that are not eligible for surgical resection or definitive chemoradiation. They may be treated with the combination regardless of programmed death-ligand 1 (PD-L1) expression or histology. This marks the second advanced NSCLC indication and expands the patient population eligible to receive a cemiplimab-rwlc-based regimen to include patients irrespective of PD-L1 expression levels.

“This second FDA approval for cemiplimab-rwlc in advanced non-small cell lung cancer greatly broadens the scope in which a cemiplimab-rwlc-based regimen can be prescribed to encompass a wide range of patients, either as single agent in those with PD-L1 ≥50% or now in combination with chemotherapy irrespective of PD-L1 expression or tumor histology,” said David R. Gandara, MD, senior advisor of the Thoracic Oncology Program at the University of California Davis Comprehensive Cancer Center, in a press release.

Cemiplimab-rwlc is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. It has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

The approval is based on findings from the global phase 3 EMPOWER-Lung 3 trial, which investigated cemiplimab-rwlc in combination with a physician’s choice of platinum-doublet therapy, compared to platinum-doublet chemotherapy alone. The trial enrolled 466 participants with locally advanced or metastatic NSCLC, irrespective of PD-L1 expression or tumor histology, and with no ALK, EGFR, or ROS1 aberrations. Of those patients, 43% had tumors with squamous histology, 67% had tumors with less than 50% PD-L1 expression, 15% had inoperable locally advanced disease not eligible for definitive chemoradiation, and 7% had pretreated and clinically stable brain metastases.

“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,” Gandara said in the press release. “Clearly, this is an advance which is clinically meaningful for our patients with advanced stage non-small cell lung cancer.”

The patients were randomized 2:1 to receive either cemiplimab-rwlc 350 mg (n=312) or placebo (n=154) intravenously every 3 weeks, plus histology-specific platinum-doublet chemotherapy. The trial was halted early based on a recommendation by the Independent Data Monitoring Committee after the cemiplimab-rwlc combination demonstrated a significant improvement in overall survival (OS), which was the primary endpoint.

According to the study, efficacy results comparing the cemiplimab-rwlc combination to chemotherapy alone showed a 22-month median OS versus 13 months, representing a 29% relative reduction in the risk of death. The 12-month probability of survival was 66% for the cemiplimab-rwlc combination versus 56% for chemotherapy, based on Kaplan-Meier estimates.

Additionally, the cemiplimab-rwlc arm demonstrated an 8-month median progression-free survival (PFS) versus 5 months in the placebo arm, representing a 44% reduction in the risk of disease progression. The 12-month probability of PFS for the cemiplimab-rwlc combination was 38% versus 16% for chemotherapy.

Finally, the cemiplimab-rwlc combination arm had a 43% overall response rate versus 23% in the placebo arm. The duration of response was 16 months with the cemiplimab-rwlc combination versus 7 months with placebo.

“Libtayo is now approved for extending the survival of patients with advanced non-small cell lung cancer as both a monotherapy in high PD-L1 expressors and in combination with chemotherapy irrespective of PD-L1 expression levels, achieving a high bar that has only been met by 1 other PD-1 targeting agent,” said Israel Lowy, MD, PhD, senior vice president of translational and clinical sciences, oncology at Regeneron, in the press release. “With this FDA approval, Libtayo can expand its role as a key treatment option for advanced non-small lung cancer, in addition to serving as a standard-of-care for 2 advanced non-melanoma skin cancers.”

Safety was assessed in 312 patients in the cemiplimab-rwlc combination group and 153 patients in the chemotherapy group. The most common adverse events (AEs) occurring in more than 15% of patients were alopecia (37% cemiplimab-rwlc combination, 43% placebo), musculoskeletal pain (30% cemiplimab-rwlc combination, 36% placebo), nausea (25% cemiplimab-rwlc combination, 16% placebo), fatigue (23% cemiplimab-rwlc combination, 18% placebo), peripheral neuropathy (23% cemiplimab-rwlc combination, 19% placebo), and decreased appetite (17% cemiplimab-rwlc combination, 12% placebo). Serious AEs occurred in 25% of patients, with treatment discontinuations due to AEs in 5% of patients and fatal AEs in 6%. No new safety signals were observed for cemiplimab-rwlc.

“We welcome this latest approval for Libtayo as a first-line combination treatment for appropriate patients with advanced lung cancer,” said Andrea Ferris, president and CEO at the LUNGevity Foundation, in the press release. “Lung cancer remains one of the most common cancers worldwide, and every new treatment option is an important step forward against this deadly cancer.”


Libtayo (Cemiplimab-rwlc) in Combination With Chemotherapy Approved by the FDA as First-Line Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC). News release. Regeneron; November 8, 2022. Accessed November 9, 2022. https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-rwlc-combination-chemotherapy-approved-fda

November 9, 2022


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