CHMP recommends approval of Tecentriq plus Avastin for unresectable hepatocellular carcinoma.- Roche

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.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% (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 (at least 2%) were bleeding in the gastrointestinal tract and fever. these results were published in the new england journal of medicine on 14 may 2020.>