Roche's VENTANA PD-L1 (SP142) Assay approved as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq in combination with Abraxane

F. Hoffmann-La Roche Ltd / Roche's VENTANA PD-L1 (SP142) Assay approved as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq in combination with Abraxane . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• PD-L1 (SP142) was the enrollment assay used in the IMpassion130 trial, the first positive phase III immunotherapy regimen study in triple-negative breast cancer
• Each year about 300,000 women are diagnosed globally with triple-negative breast cancer, an aggressive disease with limited treatment options that represents 15 percent of all breast cancer cases¹
• This approval is an important step in Roche's personalized healthcare strategy to fit treatments to patients who can benefit most from a specific medicine
  
  

Basel, 11 March 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration approval of the VENTANA PD-L1 (SP142) Assay² as the first companion diagnostic to aid in identifying triple-negative breast cancer (TNBC) patients eligible for treatment with the Roche cancer immunotherapy Tecentriq(atezolizumab)³ plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]). Assessment of PD-L1 biomarker status on tumor-infiltrating immune cells with the assay is essential for identifying those patients most likely to benefit from the treatment.

A diagnosis of triple-negative breast cancer means that the three most common proteins associated with breast cancer growth - estrogen receptor, progesterone receptor and HER2/neu - are not expressed on the tumor.

"Triple-negative breast cancer is an aggressive disease that, until now, has had limited treatment options," said Michael Heuer, CEO of Roche Diagnostics. "This assay plays a pivotal role in helping physicians identify patients that can benefit from Tecentriq therapy, providing better patient care. At Roche, we build on our capacity to research both targeted medicines and companion diagnostics under one roof, so we can provide the right treatment to the right patient at the right time."