FDA Approves Roche’s PD-L1 Biomarker Assay

Roche today (29 July) announced approval of the VENTANA PD-L1 (SP142) Assay¹ by the US Food and Drug Administration (FDA) as a complementary diagnostic to provide PD-L1 status on patients who are considering treatment with the FDA approved Roche immunotherapy TECENTRIQ (atezolizumab) for metastatic urothelial cancer (mUC). This test is the first to evaluate patient PD-L1 status using immune cell staining and scoring within the tumor microenvironment, providing clinicians with information that may guide immunotherapy decisions².
 
This personalized cancer immunotherapy and complementary diagnostic is the first major advancement in more than 30 years in the treatment of urothelial cancer (UC)³. UC is the fourth most common cancer in men in the United States and accounts for 5% of all new cancers reported. About 77,000 new cases of UC are diagnosed in the US annually, with approximately 16,000 deaths occurring each year. Men are three to four times more likely to suffer from this cancer⁴.
 
“We are very pleased with the FDA approval of our PD-L1 assay as a complementary diagnostic with TECENTRIQ,” said Ann Costello, Head of Roche Tissue Diagnostics. “Through collaboration with our Roche Pharmaceuticals colleagues, we are committed to transforming science through innovative diagnostics and breakthrough medicines, providing patients a deeper understanding of their disease and immunotherapy options.”
 
“Roche’s ability to deliver a predictive test for our pathology customers, who provide important clinical information to oncologists, ultimately benefits patients in search of answers and treatment options,” said Jack Phillips, Head of Roche Diagnostics North America. “This assay, which supports patients with urothelial cancer—a disease with limited treatment options—has the potential to improve the standard of care.”
 
Roche will continue to pursue regulatory approval for the PD-L1 (SP142) assay in combination with TECENTRIQ in other cancer indications and in other countries. PD-L1 testing is not required for the use of TECENTRIQ, but it may provide additional information for physicians and inform patient dialogue. The PD-L1 (SP142) assay is widely accessible for use with the company’s BenchMark ULTRA automated staining instrument.
 
References
¹This product is intended for in vitro diagnostic (IVD) use.
²The PD-L1 (SP142) assay is proven to select patients most likely to respond to treatment with TECENTRIQ, as demonstrated by higher overall response rates in the IMvigor 210 clinical trial. The novel approach uses immunohistochemistry (IHC) technology designed to visually enhance and score PD-L1 protein on tumor-infiltrating immune cells. In an analysis based on 14.4 months of median follow up, TECENTRIQ shrank tumors (ORR) in 15 percent (95% CI: 11, 19) of people evaluable for efficacy (n=310) whose disease progressed after platinum-based chemotherapy. TECENTRIQ shrank tumors in 26 percent (95% CI: 18, 36) of people whose disease had medium and high levels of PD-L1 expression (n=100).
³UC cancer is also known as urothelial cell carcinoma, transitional cell carcinoma or the urinary tract or urothelial bladder cancer. The majority of urothelial tumors arise in the bladder with the remainder originating in the renal pelvis, urethra or ureter.
⁴American Cancer Society 2016 bladder cancer statistics.