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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We created a new form of PPE to restart surgery for deaf children during coronavirus

  <span class="attribution"><span class="source">Douglas Hartley</span>, <span class="license">Author provided</span></span>
Douglas Hartley, Author provided

When the coronavirus pandemic first hit the UK, thousands of surgical procedures were put on hold. For a surgeon like me who performs operations on deaf children to restore their hearing, this created a significant moral dilemma – I wanted to get back into surgery to provide this vital care, but I didn’t want to inadvertently catch or pass on COVID-19 in the process.

I regularly carry out cochlear implant surgery, a process in which a surgeon embeds an electronic device which stimulates the hearing nerve in the ear. The scientific evidence is clear that this surgery needs to be performed at the earliest opportunity so that these children can benefit from being able to hear at a vital stage in their development.

But performing the surgery as normal would have put both children and surgical teams in danger. We needed to come up with another way of doing things. Our team in Nottingham had to combine creativity and science to develop a novel and safe way to restart cochlear implant surgery in a matter of just a few weeks.

This article is part of Conversation Insights
The Insights team generates long-form journalism derived from interdisciplinary research. The team is working with academics from different backgrounds who have been engaged in projects aimed at tackling societal and scientific challenges.

A grave risk

Soon after the pandemic began, some of the earliest reports, notably those from China and Italy, suggested that healthcare workers were at significantly higher risk of contracting COVID-19 compared to the general public, and that treating ear, nose and throat (ENT) conditions was particularly risky.

I was deeply saddened when I was told that the one of the first healthcare workers in the UK to die of COVID-19 was Amged El-Hawrani, a 55-year-old ENT colleague from the university hospitals of Derby and Burton. El-Hawrani succumbed to this dreadful disease on March 28 in Leicester’s Glenfield hospital. Although I never had the pleasure of meeting him, his passing was a huge shock to us all. And his exposure to the virus during his care for his patients was a stark reminder of the brutality of this disease.

A picture of Amged El-Hawrani, smiling wearing medical scrubs.
Amged El-Hawrani was one of the first health workers in the UK to lose his life to coronavirus. University Hospitals of Derby and Burton/NHS

Like other ENT departments across the world, our service at Nottingham University Hospitals NHS Trust initially halted all elective procedures in March when the pandemic hit the UK, so we could concentrate our team’s efforts on the management of our sickest patients, including those conditions requiring emergency admission, and our cancer services.

Although this initial response proved effective, we were aware that we were not meeting the needs of other patients with time-critical, albeit not life-threatening, conditions. These patients included children who are born deaf and need cochlear implant surgery to restore their hearing as quickly as possible to maximise their chances of developing normal speech and language. Delaying cochlear implant surgery can

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