Tecentriq plus Avastin is the first and only approved cancer regimen for unresectable hepatocellular carcinoma (HCC) in Europe
Roche Tower in Basel, Switzerland. (Credit: Taxiarchos228/Wikipedia.)
Roche has obtained the European Commission (EC) approval for Tecentriq (atezolizumab) plus Avastin (bevacizumab) to treat advanced hepatocellular carcinoma (HCC) in adults, who had not received prior systemic therapy.
Tecentriq is a monoclonal antibody that targets PD-L1, a protein expressed on tumour cells and tumour-infiltrating immune cells. The drug blocks the protein, inhibiting its interactions with PD-1 and B71 receptors, and help activate T-cells.
The drug has been approved in the US, the EU and other countries, either as monotherapy or in combination with targeted therapies, to treat certain types of non-small cell lung cancer, small cell lung cancer, urothelial cancer, and liver cancers.
Avastin is a biologic antibody designed to target VEGF, a protein that plays a key role across the lifecycle of a tumour. The drug binds to the VEGF protein to prevent its interactions with receptors on blood vessel cells and stops the blood supply to the tumour.
The Swiss healthcare company said that the Tecentriq plus Avastin combination was believed to strengthen the immune system to fight a wide spectrum of cancers.
Roche chief medical officer and global product development head Levi Garraway said: “Tecentriq in combination with Avastin is the first treatment to be approved in over a decade that has improved overall survival for people with previously untreated advanced or unresectable hepatocellular carcinoma.
“We’re delighted that people in Europe can now benefit from this combination and we look forward to working with individual countries within the EU to ensure people can access the combination as soon as possible.”
EC approval is based on Phase 3 IMbrave150 trial results
The European regulatory approval is based on results from the IMbrave150, a Phase 3 multicentre, open-label study in 501 people with unresectable HCC who had not received prior systemic therapy.
The study demonstrated that treatment using Tecentriq plus Avastin reduced the overall survival (OS) or death by 42% and the progression-free survival (PFS) or risk of disease worsening or death by 41%, compared with sorafenib.
Bleeding in the gastrointestinal tract and fever include the most frequent serious adverse reactions in the clinical trial.
The EC approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), granted in September 2020.
In May 2020, the US Food and Drug Administration has approved the drug regimen for the treatment of metastatic HCC in people who had not received systemic therapy before.
Also, the China National Medical Products Administration has approved the combination for the treatment of unresectable HCC who have not received prior systemic therapy, in October this year.
Overall, the combination has been approved in 59 countries for the treatment of people with unresectable HCC.
Hannover Medical School professor Arndt Vogel said: “The results of the IMbrave150 study mark a breakthrough in the treatment of advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting.
“After many failures in the last 12 years, the combination of Tecentriq and Avastin shows improvement in overall survival compared to sorafenib and offers patients the opportunity for improved disease control with a high overall response rate.”