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Roche PD-L1 Assay Nabs Expanded CE Mark as CDx for Libtayo, Chemotherapy Combo

NEW YORK – Roche announced this week that its Ventana PD-L1 (SP263) assay received a CE-IVDR label expansion for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in combination with platinum-based doublet chemotherapy in lung cancer patients. 

The assay previously received CE marking in 2022 for identifying patients with non-small cell lung cancer who may be eligible for treatment with Libtayo. The test received US Food and Drug Administration approval for use with Libtayo last year. 

The assay was used as part of Regeneron's EMPOWER-Lung 3 study to identify patients whose tumors expressed programmed death ligand-1 protein. The trial reported increased survival to nearly 22 months for patients who were treated with Libtayo in combination with platinum-based doublet chemotherapy compared to 12.6 months for chemotherapy patients, a Roche spokesperson said via email. 

The immunohistochemical test is approved to determine eligibility for five different immunotherapy drugs, including Genentech's Tecentriq (atezolizumab). It runs on Roche's BenchMark Ultra instrument and is visualized using the OptiView DAB IHC Detection Kit.