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Roche's PD-L1 Assay Receives Expanded CE Mark as Companion Diagnostic for Libtayo in Combination with Chemotherapy

NextEdge Admin

15 Jun 2024

2 min 15 sec

Roche recently announced a significant development regarding its Ventana PD-L1 (SP263) assay, which has received a CE-IVDR label expansion. This expansion allows the assay to be used as a companion diagnostic alongside Regeneron's Libtayo (cemiplimab) in conjunction with platinum-based doublet chemotherapy for patients with lung cancer. Initially receiving CE marking in 2022 for identifying non-small cell lung cancer patients eligible for Libtayo treatment, the assay also gained FDA approval in the previous year for use with Libtayo.

During Regeneron's EMPOWER-Lung 3 study, the Ventana PD-L1 (SP263) assay played a crucial role in identifying patients whose tumors expressed programmed death ligand-1 protein. Results from the trial demonstrated a substantial survival benefit: patients treated with Libtayo plus platinum-based doublet chemotherapy showed a median survival of nearly 22 months, compared to 12.6 months for those receiving chemotherapy alone.

This immunohistochemical test is now approved to determine eligibility for five different immunotherapy drugs, including Genentech's Tecentriq (atezolizumab). It operates on Roche's BenchMark Ultra instrument and utilizes the OptiView DAB IHC Detection Kit for visualization.

Roche's expansion of the Ventana PD-L1 (SP263) assay's label underlines its growing significance in personalized medicine, particularly in optimizing treatment decisions for lung cancer patients by identifying those most likely to benefit from combined immunotherapy and chemotherapy regimens. This advancement marks a pivotal step towards improving outcomes and tailoring therapies based on individual patient characteristics