The data from the late-stage study showed a statistically significant improvement in RFS in people with HCC at high risk of disease recurrence post liver resection or ablation with curative intent
A product image of Tecentriq. (Credit: F. Hoffmann-La Roche Ltd)
Roche has announced that Tecentriq (atezolizumab) plus Avastin (bevacizumab) combination therapy has shown a reduction of cancer reoccurrence in people with certain types of adjuvant liver cancer in the phase 3 IMbrave050 study.
The data from the study showed a statistically significant improvement in recurrence-free survival (RFS) in patients with hepatocellular carcinoma (HCC) at high risk of disease recurrence post liver resection or ablation with curative intent.
Tecentriq is a cancer immunotherapy authorised for some aggressive and hard-to-treat types of cancer. The monoclonal antibody binds with a protein called programmed death ligand-1 (PD-L1) to activate T-cells.
The Tecentriq, Avastin investigational combination lowered the risk of cancer reoccurrence by 28% in HCC patients when compared with active surveillance, at a median follow-up of 17.4 months.
The overall survival (OS) was found immature (7%) at the time of data analysis. The independent review facility (IRF)-RFS data was also found to be consistent in general across clinical subgroups of the trial.
Additionally, the safety data for the combination therapy was found to be consistent with the well-established safety profile of Tecentriq and Avastin along with the underlying disease.
Roche chief medical officer and global product development head Levi Garraway said: “Four out of five people with HCC who receive surgery with curative intent may still see their cancer return. Thus, an urgent need exists for adjuvant treatments to prevent early recurrence and improve survival rates.
“With Tecentriq plus Avastin already a standard of care in unresectable HCC, we are pleased with the potential of these results and look forward to seeing more mature data.”
IMbrave050 is a global, multicentre, open-label, randomised study with the goal to assess the safety and efficacy of adjuvant Tecentriq plus Avastin in comparison to active surveillance.
The trial randomised 668 people with a ratio of 1:1 to receive either Tecentriq plus Avastin for a period of 12 months or 17 cycles, or no intervention with active surveillance.
Roche said that the primary endpoint was independent review facility-assessed RFS. The key secondary endpoints included OS, RFS as set by the investigator and RFS in patients having PD-L1-positive disease.
In December last year, the US Food and Drug Administration (FDA) approved Tecentriq for adult and paediatric patients, aged two years and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).