Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

...Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

...Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained approval for an additional indication of Tecentriq® Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)], an anti-cancer agent/humanized anti-PD-L1 monoclonal antibody, and Avastin® Intravenous Infusion 100 mg/4 mL and 400 mg/16 mL [generic name: bevacizumab (genetical recombination)], an anti-cancer agent/humanized anti-VEGF monoclonal antibody, for the treatment of unresectable hepatocellular carcinoma (HCC) from the Ministry of Health, Labour and Welfare (MHLW).

TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Atezolizumab plus bevacizumab is recommended as an option for treating advanced or unresectable hepatocellular carcinoma (HCC) in adults who have not had previous systemic treatment, only if....they have Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Recommendations...First-Line Therapy...Atezolizumab-bevacizumab (atezo + bev) may be offered as first-line treatment for most patients with advanced HCC...

First-line lenvatinib or the combination of atezolizumab and bevacizumab are also included as category 1 options for these patients (C-P class A liver function only).

Genentech...announced that the Phase III IMbrave050 study met its primary endpoint of recurrence-free survival (RFS) at the prespecified interim analysis. The study is evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as adjuvant treatment following surgery for people with early-stage hepatocellular carcinoma (HCC) at high risk of disease recurrence.

A trend toward improved OS and PFS per IRF RECIST 1.1 was observed with atezolizumab + bevacizumab versus sorafenib (OS: hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.29, 1.34; PFS: HR: 0.64; 95% CI: 0.36, 1.12). ORRs per IRF RECIST 1.1 and HCC mRECIST were 43% and 50% with atezolizumab + bevacizumab and 26% and 30% with sorafenib, respectively.

This global, phase 3, open-label, randomized clinical trial (IMbrave150) recruited patients aged ≥18 years with locally advanced metastatic or unresectable HCC...Across all age groups, patients receiving atezolizumab plus bevacizumab had longer median OS (<65: 18.0 vs 12.2 months [HR, 0.57; 95% CI, 0.40-0.82]; ≥65 to <75: 19.4 vs 14.9 months [HR, 0.80; 95% CI, 0.52-1.23]; ≥75: 24.0 vs 18.0 months [HR, 0.72, 95% CI, 0.37-1.41]) and PFS than those receiving sorafenib.

The IMbrave150 trial found median overall survival was 19.2 months in patients treated with atezo+bev vs 13.4 months for those treated with sorafenib alone, the current standard treatment (HR, 0.66 [95% CI, 0.52-0.85]; P=0.0009)....All patients in the trial had nonresectable HCC – the most common form of liver cancer – and had not previously been treated with systemic therapy.

Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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....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.

Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab–bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib....In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progression-free survival outcomes than sorafenib.

Roche...announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer.