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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EU must step up response to COVID-19, Commission warns as infections spike

By Francesco Guarascio



a flag flying in front of a building: FILE PHOTO: European Union flags flutter outside the European Commission headquarters in Brussels, Belgium


© Reuters/YVES HERMAN
FILE PHOTO: European Union flags flutter outside the European Commission headquarters in Brussels, Belgium

BRUSSELS (Reuters) – The European Commission proposed on Wednesday a series of new measures to fight the COVID-19 pandemic in the European Union, saying the new spike in infections on the continent was “alarming”.

As Europe again becomes the world’s epicentre of the pandemic, the EU executive urged the 27 EU governments to do more and in a more coordinated fashion against the virus.

“The relaxation of applied measures during the summer months was not always accompanied by steps to build up sufficient response capacity,” the Commission warned in a statement as part of its formal proposal to EU governments for action.

To better trace the spread of infections, Brussels said EU governments should coordinate their testing strategies and make a larger use of rapid antigen tests, despite the global supply for these kits is now tightening.

It warned the “current shortfalls in testing capacity” required swift action.

Last week, European Commission President Ursula von der Leyen said the EU executive would direct 100 million euros ($118 million) to buy up to 22 million antigen tests to meet EU countries’ “immediate needs”. It is now urging states to buy more through a joint procurement scheme.

It also said states should have common testing requirements for incoming travellers, including tests at arrival if tests were not available in the country of departure. It called for coordinated rules on quarantines.

AVOIDING SHORTAGES

To avoid risks of new shortages of medical equipment, which dogged the bloc at the beginning of the pandemic in spring, the Commission said it had launched a joint procurement for gear needed to inoculate people, such as syringes and disinfectants.

It also extended to April a temporary suspension of customs duties and sales tax on import of medical equipment.

EU countries could also exempt COVID-19 testing kits and vaccines from sales tax, the Commission said.

The Commission also repeated its call on EU governments to quickly devise vaccination strategies so that the most vulnerable people could quickly access COVID-19 vaccines if and when effective shots will be available.

(Reporting by Francesco Guarascio @fraguarascio, editing by Robin Emmott)

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