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

Roche 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.

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development Commented “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, 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.”

Dr Arndt Vogel, Professor of Medicine at Hannover Medical School Commented “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, 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 a class I, A recommendation by the European Society for Medical Oncology (ESMO) for the treatment of unresectable HCC, as well as by many clinical practice guidelines globally.

Roche is committed to tackling liver disease right across the disease journey, from the earliest stages through to advanced disease, with the ultimate goal of one day stopping chronic liver disease.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMbrave150 study

IMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable HCC who had not received prior systemic therapy. People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until disease progression or unacceptable toxicity. The two primary endpoints were OS and independent review facility (IRF)-assessed PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Additional study endpoints included IRF-assessed overall response rate (ORR) per RECIST v1.1 and HCC mRECIST.

About hepatocellular carcinoma

HCC is an aggressive cancer with limited treatment options and is a major cause of cancer deaths worldwide. Every year, more than 750,000 people worldwide are diagnosed with HCC, with the majority of cases in Asia and almost half of all cases in China. In the US, the number of liver cancer cases have more than tripled since 1980 and HCC represents the fastest-rising cause of cancer-related death, while in Europe, liver cancer is also on the rise, accounting for more than 80,000 diagnoses and approximately 77,000 deaths each year. HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption, and typically presents at an advanced stage. The prognosis for unresectable HCC remains poor, with few systemic therapeutic options and a 1-year survival rate of less than 50% following diagnosis.

About the Tecentriq and Avastin combination

There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.

About Tecentriq

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7. receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer, small cell lung cancer, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Avastin

Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

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