- Lung cancer remains the leading cause of cancer-related deaths worldwide, with more than 2.2 million people diagnosed globally last year.1
- The VENTANA PD-L1 (SP263) Assay helps determine which non-small cell lung cancer patients may benefit from treatment with atezolizumab immunotherapy based on the results of the Phase III IMpower010 study.
- This new test expands Roche’s industry leading portfolio of companion diagnostics and builds on our commitment to improve personalized healthcare for better patient outcomes.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA PD-L1 (SP263) Assay in non- small cell lung cancer (NSCLC) as a companion diagnostic test for atezolizumab, advancing the company's commitment to guide clinical decision making through innovative, high quality assays that improve patient access to personalized healthcare.
The current standard of care for patients with early stage lung cancer is surgery to remove the tumor, which may be followed by chemotherapy. Unfortunately, about half of these patients will have their cancer return following surgery.2 Atezolizumab received FDA approval on 15 October 2021 as adjuvant treatment following surgery and platinum-based chemotherapy for adults whose Stage II-IIIA NSCLC tumors have PD-L1 expression on ≥1% of tumor cells. The VENTANA PD-L1 (SP263) Assay identifies NSCLC patients who may be eligible for (atezolizumab) monotherapy in this indication.
"Early detection of lung cancer can change the treatment pathway for patients and give them more treatment options,” said Thomas Schinecker, CEO Roche Diagnostics. “We are proud to offer a companion diagnostic PD-L1 test that identifies lung cancer patients who may qualify for atezolizumab therapy. With the FDA approval of this companion diagnostic test, clinicians now have an effective tool for offering better patient care through targeted immunotherapy treatment."
The VENTANA PD-L1 (SP263) Assay was used as part of the IMpower010 study sponsored by Genentech, a member of the Roche Group, to identify patients whose tumors expressed the PD-L1 protein. The IMpower010 clinical study began in 2015 with the goal of understanding how patients would respond to treatment with atezolizumab following traditional surgery and chemotherapy. In 2021, Genentech reported a 34% reduction in the risk of disease recurrence or death amongst atezolizumab patients whose tumors were shown to express PD-L1 protein. For details of the study go to www.roche.com.
About the VENTANA PD-L1 (SP263) Assay
VENTANA PD-L1 (SP263) Assay is used to detect programmed death ligand-1 (PD-L1) protein in non-small cell lung carcinoma (NSCLC) patients. PD-L1 expression on tumor cells and immune cells has been shown in clinical studies to help predict the likelihood a patient may benefit from PD-L1/PD-1 immunotherapy drugs.3-6
VENTANA PD-L1 (SP263) Assay testing is performed on a BenchMark ULTRA instrument and is visualized using the OptiView DAB IHC Detection Kit.
Roche has developed a leading, comprehensive and differentiated lung cancer immunohistochemical portfolio, with biomarkers that support multiple guidelines for the diagnosis and stratification of lung cancers.7-9