Liver

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European Commission approves Roche’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer

  • Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved in Europe for the treatment of unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer

  • Tecentriq combination improved overall survival and progression-free survival compared with the previous standard of care

Basel, 2 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

“Tecentriq in combination with Avastin is the first treatment to be approved in over a decade that has improved overall survival for people with previously untreated advanced or unresectable hepatocellular carcinoma,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We’re delighted that people in Europe can now benefit from this combination and we look forward to working with individual countries within the EU to ensure people can access the combination as soon as possible.”

“The results of the IMbrave150 study mark a breakthrough in the treatment of advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting,” said Dr Arndt Vogel, Professor of Medicine at Hannover Medical School. “After many failures in the last 12 years, the combination of Tecentriq and Avastin shows improvement in overall survival compared to sorafenib and offers patients the opportunity for improved disease control with a high overall response rate.”

The approval is based on results from the Phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin reduced the risk of death (overall survival [OS]) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42–0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival [PFS]) by 41% (HR=0.59; 95% CI: 0.47–0.76; p<0.0001), compared with sorafenib. IMbrave150 is the first Phase III cancer immunotherapy study to show an improvement in both OS and PFS in people with unresectable HCC compared with sorafenib. Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. The most frequent serious adverse reactions for the combination (≥2%) were bleeding in the gastrointestinal tract and fever. These results were published in the New England Journal of Medicine on 14 May 2020.

Today’s approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September 2020. In May 2020, the US Food and Drug Administration approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy. In addition, in October 2020 the China National Medical Products Administration approved the combination for the treatment of people with unresectable HCC who have not received prior systemic therapy. In total, the combination is now approved in 59 countries for people with unresectable HCC. Tecentriq in combination with Avastin was also recently included as

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Cites Link to Nonalcoholic Fatty Liver Disease and Importance of Early Detection

Echosens, a high-technology company offering the FibroScan family of products, urges increased awareness of the rise of liver cancer rates, which have more than tripled since 1980, while death rates have more than doubled during this time. About 21,000 Americans are diagnosed with primary liver cancer each year—twice as common in men than in women. Risk factors include other liver diseases, including cirrhosis, chronic hepatitis B, chronic hepatitis C and non-alcoholic fatty liver disease (NAFLD). NAFLD may be a key driver of increased cancer associated with obesity, while non-alcoholic steatohepatitis (NASH) is the fastest growing cause of liver cancer among transplant candidates.

“People with NAFLD have higher rates of several types of cancer, with the greatest increase seen for liver cancer and other gastrointestinal cancers,” says Jon Gingrich, CEO, Echosens North America. “Point-of-care examinations, monitoring and ongoing assessment of liver fat and stiffness as provided by FibroScan, a rapid, non-invasive point of care examination, can identify individuals who are asymptomatic and undiagnosed for liver damage.”

Researchers have found that liver cancer, NAFLD, hepatitis C and liver transplants are prevalent in 40-80% of people who have Type 2 diabetes and in 30-90% of people who are obese. Being overweight or obese is responsible for about 85% of fatty liver disease.

“Approximately 30,000 people die from liver cancer each year and these numbers have continued to rise in recent years,” says Lynn Gardner Seim, Executive Vice President and Chief Operating Officer, American Liver Foundation. “It is essential that patients at risk for liver cancer, including those who have previously been diagnosed with hepatitis C, NAFLD, NASH and other liver diseases, talk with their doctors and have a plan in place for getting screened.”

Traditional approaches to assessing liver health, such as liver biopsy and advanced radiological imaging, may not be cost effective nor accessible to the broader at-risk population. FibroScan directly measures physical properties of stiffness and fat liver to provide reproducible results and allow for both diagnosis and monitoring of liver stiffness and liver fat. It is also recognized worldwide as the reference for non-invasive liver diagnosis supported with more than 2,000 medical publications and 40 guideline recommendations.

About Echosens

Echosens, the developer of FibroScan®, is an innovative high-technology company offering a full range of products and services supporting physicians in their assessment and management of patients with chronic liver diseases. FibroScan is supported by over 2,500 peer-reviewed publications and examinations are covered by Medicare, Medicaid and many insurance plans. For more information, please visit http://www.echosens.us and follow us on Twitter (@echosensNA).

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Contacts

Media:
Brittany Tedesco
CPR Communications
[email protected]
201.641.1911 x 14

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