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The approval of the first-line treatment was granted to Regeneron Pharmaceuticals.
The FDA has approved cemiplimab-rwlc (Libtayo; Regeneron) for the first-line treatment of advanced non-small cell lung cancer (NSCLC) for tumors with high PD-L1 expression (tumor proportion score 50%) and without certain aberrations in patients with either metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation.
The approval of cemiplimab-rwlc followed priority review by the agency, as well as a separate approval as a first immunotherapy indicated for certain patients with advanced basal cell carminoma (BCC). Investigators highlighted that the clinical trial on which the NSCLC approval was based included a patient population often underrepresented in key NSCLC clinical trials.
Cemiplimab-rwlc is a fully-human monoclonal antibody that targets the immune checkpoint receptor PD-1 on T-cells. In effect, the drug is able to block cancer cells from occupying the PD-1 pathway.
Lung cancer is the leading cause of cancer death worldwide, with approximately 2.2 million new cases diagnosed in 2020 alone. Cancer researchers have estimated that 84% of lung cancers are NSCLC, 75% of which are diagnosed in its advanced stages.
Approval for the first-line NSCLC indication was based on the open-label, randomized, multi-center phase 3 EMPOWER-Lung 1 clinical trial, which focused on investigating first-line treatment with cemiplimab-rwlc in patients with advanced NSCLC and who tested positive for PD-L1 in 50% of tumor cells and without EGFR, ALK, or ROS1 aberrations. Investigators confirmed PD-L1 expression through the Agilent Dako PD-L1 IHC 22C3 pharmDx kit.
The clinical trial measured overall survival (OS) and progression free survival (PFS) in 710 patients with either previously untreated metastatic, stage IV NSCLC, or locally advanced, stage IIIB/C NSCLC who were not candidates for surgical resection or definitive chemoradiation, or who had progressed following treatment with definitive chemoradiation. Patients were randomized to either receive cemiplimab-rwlc (n=283) or chemotherapy (n=280).
Data showed that cemiplimab-rwlc reduced the risk of death by 32% compared with chemotherapy. Patients treated with cemiplimab-rwlc showed a median PFS of 8 months, with a range between 6 and 9 months, whereas patients receiving chemotherapy exhibited 6-month median PFS rate, with a range from 5 to 6 months.
Researchers assessed safety in 355 patients in the treatment group; rash (15%) and cough (11%) were the most frequent adverse reactions. As for serious reactions, investigators reported pneumonitis (2%) most often. Six percent of patients discontinued treatment with cemiplimab-rwlc due to adverse reactions.
"We developed Libtayo to deliver clinically meaningful benefits to patients suffering from a diverse range of cancers and to establish a foundation for potential future immunotherapy combinations. Today's approval continues to support this vision," said Israel Lowy, MD, PhD, senior vice president of translational and clinical sciences, oncology at Regeneron.
"Libtayo has already changed the treatment paradigm for certain patients with advanced cutaneous squamous cell carcinoma and is poised to do the same for advanced basal cell carcinoma. Now, Libtayo has the opportunity to make a meaningful difference for the many US patients battling advanced non-small cell lung cancer. Libtayo is being investigated in a variety of settings, and we hope to share updates later this year on our pivotal trials in cervical cancer and in combination with chemotherapy in advanced non-small cell lung cancer," Lowy said.