Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 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. Based on this recommendation, a final decision regarding approval of Tecentriq in combination with Avastin in this disease setting, along with the full details of the approved indication, is expected from the European Commission in the near future.
“Today’s recommendation by the CHMP is a major step towards bringing Tecentriq in combination with Avastin to people in Europe who suffer from advanced or unresectable hepatocellular carcinoma,” said Levi Garraway, Chief Medical Officer and Head of Global Product Development.
The recommendation from the CHMP 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 per cent (hazard ratio [HR]=0.58; 95 per cent CI: 0.42–0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival [PFS]) by 41 per cent (HR=0.59; 95 per cent 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 per cent of people receiving Tecentriq and Avastin and 55 per cent of people receiving sorafenib. The most frequent serious adverse reactions (≥2%) were bleeding in the gastrointestinal tract and fever. These results were published in the New England Journal of Medicine on 14 May 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 and in September 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. 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’s development programme for Tecentriq includes 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.