The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a scientific opinion on the combination of atezolizumab with bevacizumab for the treatment of adults with unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy. The treatment will be available through the Early Access to Medicines Scheme (EAMS).
The data suggest the combination of atezolizumab and bevacizumab is associated with better progression-free survival (PFS) and overall survival (OS), compared with standard care and sorafenib.
A total of 501 patients with untreated unresectable HCC were entered into the study.
Six-month PFS was 54.5% in the group treated with atezolizumab and bevacizumab compared with 37.2% in those treated with sorafenib. The combination also prolonged OS; 6-month OS was 84.8% compared with 72.3% with sorafenib.
The most frequent AEs with the combination treatment were hypertension, proteinuria, fatigue, and decreased appetite. The most frequent serious side effects were pyrexia (3%) oesophageal varices haemorrhage (2%), and gastrointestinal haemorrhage (2%).
A separate study is ongoing to evaluate the combination of atezolizumab and bevacizumab compared with active surveillance after resection in patients with a high risk of recurrence.
This scientific opinion is not a licence for the drug, nor is it a recommendation for use of the treatment.