FDA Approves PD-L1 IHC 22C3 PharmDx Assay as Companion Diagnostic for Cemiplimab in NSCLC


The FDA has approved the PD-L1 IHC 22C3 pharmDx assay, developed by Agilent Technologies Inc, for expanded use in patients with non–small cell lung cancer.

The FDA has approved the PD-L1 IHC 22C3 pharmDx assay, developed by Agilent Technologies Inc, for expanded use in patients with non—small cell lung cancer (NSCLC).1 The assay can now be utilized to help identify patients who may be candidates for treatment with cemiplimab-rwlc (Libtayo), which was granted FDA approval on February 22, 2021, for use as a single agent in the first-line treatment of patients with advanced NSCLC who have a PD-L1 tumor proportion score of 50% or higher.

The regulatory decision was based on findings from an analysis of 710 patients with a PD-L1 expression of 50% or higher who were randomized to receive cemiplimab in the phase 3 EMPOWER-Lung 1 trial (NCT033088540). Here, the agent resulted in a 32% reduction in the risk of death compared with chemotherapy. Specifically, the median overall survival (OS) in the investigative arm was 22 months versus 14 months with chemotherapy (HR, 0.68; 95% CI, 0.53-0.87; P = .0022).2

Moreover, the median progression-free survival (PFS) with cemiplimab was 6.2 months per blinded independent central review compared with 5.6 months with chemotherapy (HR, 0.59; 95% CI, 0.49-0.72; P <.0001). The survival benefit associated with cemiplimab was reported across all subgroups evaluated in the trial, with the exception of OS in female patients.

“Anti—PD-1 therapies, including [cemiplimab], continue to broaden the potential for the treatment of patients across different cancer types,” Sam Raha, president of Agilent’s Diagnostics and Genomics Group, stated in a press release. “With the FDA approval of PD-L1 IHC 22C3 pharmDx as a companion diagnostic for treatment with [cemiplimab] monotherapy in advanced NSCLC, Agilent further strengthens its ability to elevate pathologist confidence in reporting results to oncologists and bolsters our role as a global pioneer in developing companion diagnostics for targeted treatments.”

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