- The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study.
- This additional approval will allow more patients with locally advanced and metastatic non-small cell lung cancer broader access to the immunotherapy Libtayo.
- PD-L1 testing provides clinicians with essential information that helps guide clinical decision making and improve patient outcomes.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the VENTANA PD-L1 (SP263) Assay is available in countries accepting the CE mark as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients eligible for treatment with Libtayo® (cemiplimab), a PD-1 inhibitor therapy developed by Regeneron.
More than 60 percent of patients diagnosed with non-small cell lung cancer are diagnosed at locally advanced or metastatic stage (Stage III-IV).2 With the launch of the VENTANA PD-L1 (SP263) Assay, more patients may have access to an additional immunotherapy option with Libtayo, potentially improving their treatment pathway and outcomes.
“With our companion diagnostics, we can help ensure each patient gets the most appropriate targeted treatment. This approval gives eligible advanced lung cancer patients access to the immunotherapy Libtayo as a first-line treatment,”
said Jill German, Head of Pathology Lab at Roche Diagnostics.
“Our high medical value PD-L1 assay portfolio is continuing to help improve access to personalised medicine.”
The VENTANA PD-L1 (SP263) Assay is the only CE IVD product available with NSCLC indications for four different immunotherapy drugs, offering oncologists a broad range of treatment options for patients. Treating non-small cell lung cancer as early as possible may improve patient outcomes.
Lung cancer is the leading cause of cancer death worldwide. Every year, more than 2.2 million people are diagnosed with lung cancer globally and up to 85 percent of these cases are non-small cell lung cancer.3,4
More information about the VENTANA PD-L1 (SP263) Assay as a companion diagnostic will be presented at the European Society for Medical Oncology on 10 September 2022 in a session titled ”Clinical interchangeability of PD-L1 IHC assays for the treatment of first-line NSCLC with cemiplimab”.