The combination therapy was designated for priority review from the MHLW in
'I am very pleased that the combination therapy of Tecentriq and Avastin has been approved for the treatment of HCC in patients with poor prognosis and limited treatment options,' said Dr.
The approval is based on the results from the global phase III IMbrave150 study in patients with unresectable HCC without prior systemic therapy. The combination of Tecentriq and Avastin reduced the risk of death by 42% (OS hazard ratio: 0.58; 95%CI: 0.42-0.79; p = 0.0006 [stratified log-rank test]) and reduced the risk of disease worsening or death by 41% (PFS hazard ratio: 0.59; 95%CI: 0.47-0.76; p< 0.0001 [stratified log-rank test]) compared to sorafenib monotherapy. Adverse reactions were observed in 276 of 329 (83.9%) patients treated with Tecentriq and Avastin. The most frequent (10% or more) adverse reactions included; hypertension, proteinuria, fatigue, increased AST, pruritus, infusion-related reaction, diarrhea, increased ALT, and decreased appetite. The results of the study have been published in the
About IMbrave150 study
IMbrave150 is a global Phase III, multicenter, open-label study of 501 people with unresectable HCC who have not received prior systemic therapy. People were randomized 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. People received the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Co-primary endpoints were overall survival (OS) and progression free survival (PFS) by independent-review facility (IRF) per RECIST v1.1. Secondary efficacy endpoints included objective response rate (ORR), time to progression (TTP) and duration of response (DOR) as well as patient-reported outcomes (PROs), safety and pharmacokinetics.
About hepatocellular carcinoma (HCC)
HCC accounts for over 90% of liver cancer and is an aggressive type of cancer with limited treatment options hence it is a major cause of cancer deaths worldwide.1, 2) In
Contact:
Tel: +81-3-3273-0881
Email: pr@chugai-pharm.co.jp
(C) 2020 Electronic News Publishing, source