Media Release

Roche’s VENTANA PD-L1 (SP263) Assay gains CE label expansion to inform treatment decisions in lung cancer patients being considered for KEYTRUDA (pembrolizumab) immunotherapy

  • Lung cancer remains the leading cause of cancer deaths, with nearly 1.6 million deaths worldwide.
  • PD-L1 is a protein involved in the suppression of the immune system, which can impact the body’s ability to fight cancer.
  • The VENTANA PD-L1 (SP263) Assay1 is now available for countries accepting the CE mark to identify untreated and previously treated metastatic non-small cell lung cancer (mNSCLC) patients eligible for KEYTRUDA immunotherapy.

Tucson, AZ, May 5, 2017 – Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced the launch of the VENTANA PD-L1 (SP263) Assay as an in vitro diagnostic2 test for KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, to identify untreated and previously treated metastatic non-small cell lung cancer (mNSCLC) patients eligible for the immunotherapy. KEYTRUDA is marketed by Merck & Co., Inc., Kenilworth N.J., US, known as MSD outside the US and Canada. The assay is available in countries accepting the CE mark.3

Lung cancer remains the leading cause of cancer deaths, with an annual estimated 12.9 percent of all new cancer cases and nearly 1.6 million deaths worldwide. NSCLC accounts for approximately 85 percent of all lung cancer cases.4 During the past three decades, lung cancer has shown the least improvement in survival rates when compared with other cancers.5

The VENTANA PD-L1 (SP263) Assay is the only fully automated PD-L1 assay for KEYTRUDA to launch on Roche’s BenchMark series of instruments. The launch should significantly increase patient access to PD-L1 testing given Roche’s extensive global diagnostic instrument base.

“Roche first launched the VENTANA PD-L1 (SP263) Assay in September 2016 as a diagnostic test for previously treated metastatic NSCLC patients in countries accepting the CE mark. We are very pleased to expand its application to include patients being considered for KEYTRUDA immunotherapy as the first line of treatment,” said Ann Costello, Head of Roche Tissue Diagnostics. “The assay provides new insights into possible treatment options for this potentially deadly disease.”

Roche will continue to pursue regulatory approval for the VENTANA PD-L1 (SP263) Assay in other cancer indications and in other geographies. For more information, go to

1This product is intended for in vitro diagnostic (IVD) use.
2The VENTANA PD-L1 (SP263) Assay has demonstrated equivalence to the CE marked PD-L1 IHC 22C3 pharmDx assay, which has previously demonstrated clinical utility through data from KEYNOTE-024 and KEYNOTE-010. KEYNOTE-024 was a phase 3, randomized, open-label, active-controlled, multicenter trial of 305 patients with metastatic NSCLC who were treatment naïve and whose tumors had high PD-L1 expression based on a tumor PD-L1 expression ≥50% and without EGFR or ALK genomic tumor aberrations. Outcome data showed superior progression free survival and overall survival in first-line treatment of mNSCLC with PD-L1 expression ≥50%. KEYNOTE-010 was an open-label, randomized, active-controlled, multicenter, phase 2/3 trial of 1,033 patients with mNSCLC that had progressed following platinum-containing chemotherapy, and if appropriate, targeted therapy for EGFR or ALK genomic tumor aberrations. Superior overall survival vs docetaxel at PD-L1 expression ≥1% was observed. For a CE mark, Roche relied on a method comparison study carried out by AstraZeneca, which compares data from currently available PD-L1 assays, DAKO pharmDx 22C3 (used in the clinical studies of KEYTRUDA), DAKO pharmDx 28-8 (used in the clinical studies of OPDIVO), and SP263.
3Please consult your local representative for availability and restrictions.
4Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0. Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Published 2013-12-12. Updated 2014-01-09. Accessed 2016-02-08.
5Siegel R, Naishadham D, Jemal A. Cancer Statistics, 2013. CA Cancer J Clin. 2013;63(1):11-30.

About VENTANA PD-L1 (SP263) Assay

VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the Programmed Death Ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and other tumor tissues stained with OptiView DAB IHC Detection Kit on a BenchMark series automated staining instrument.

PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with KEYTRUDA® (pembrolizumab).

PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab).

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

VENTANA, BENCHMARK and OPTIVIEW are trademarks of Roche. Other product names and trademarks are the property of their respective owners.


VENTANA PD-L1 (SP263) Assay staining in non-small cell lung cancer (NSCLC) with membranous and cytoplasmic staining of the tumor cells

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