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Roche Gets Expanded CE Mark for Ventana PD-L1 Assay to ID NSCLC Patients for Tecentriq

NEW YORK – Roche said on Wednesday that its Ventana PD-L1 test has received a CE label expansion for its Ventana PD-L1 SP263 test to determine non-small cell lung cancer patients' eligibility for Roche's immune checkpoint inhibitor Tecentriq (atezolizumab).

The label expansion is based on data from the Phase III IMpower010 study, in which stage II to IIIA NSCLC patients whose tumors express PD-L1 in at least half of their tumor cells, as determined by the Ventana PD-L1 SP263 assay, benefited from Tecentriq versus best-supportive care after prior treatment with adjuvant chemo.

The European Commission approved Tecentriq for this indication — post-chemo adjuvant treatment for stage II to IIIA PD-L1-high NSCLC patients — in June. The new CE label expansion means the Ventana PD-L1 SP263 assay will be used as a method to identify those high PD-L1-expressing patients who are eligible for the immunotherapy in Europe.

Last year, the US Food and Drug Administration also approved Tecentriq for NSCLC patients after chemotherapy with the Ventana PD-L1 assay as an approved companion diagnostic, but set the PD-L1 expression cutoff at tumors that express the protein in greater than or equal to 1 percent, as opposed to the higher 50 percent cutoff in Europe. 

Oncologists have been debating the optimal cutoffs and diagnostic assays for measuring the PD-L1 biomarker since the IMpower010 data first began to read out. The benefit of adjuvant Tecentriq for patients with low-to-mid-range PD-L1 expression in the IMpower010 trial was not as clear as it was for the group of patients who expressed PD-L1 in at least half of their tumor cells.