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 (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.”

Click to continue reading on OncLive.