The European Commission has approved the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) as a first-line treatment for adults with advanced or inoperable hepatocellular carcinoma (HCC), the most common form of liver cancer.
This decision follows the recommendation of the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA).
The Tecentriq-Avastin combination is now the first and only immunotherapy regimen approved in Europe for this patient group.
“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,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a press release.
“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,” Garraway said.
Tecentriq and Avastin are anti-cancer therapies developed and marketed by Genentech, a Roche subsidiary. While Tecentriq is an immune checkpoint inhibitor that works by blocking a mechanism used by cancer cells to avoid being targeted and destroyed by immune cells, Avastin is an anti-angiogenic therapy that limits tumor growth by restricting its blood supply.
This combination was also approved for people newly diagnosed with advanced HCC in the U.S. earlier this year. Likewise, it was approved by the Chinese National Medical Products Administration (NMPA) as a first-line treatment for patients in that country with inoperable HCC.
All approvals were based on data from the IMbrave150 Phase 3 trial (NCT03434379), investigating if first-line treatment with the Tecentriq-Avastin combination therapy is superior to standard care — Nexavar (sorafenib) — at improving survival outcomes.
Data from the trial, which enrolled 501 people with locally advanced or metastatic HCC, showed the Tecentriq-Avastin combo reduced the risk of death by 42%, and the risk of disease worsening or death by 41%, compared with Nexavar.
A larger percentage of patients given the combination therapy responded to treatment than did those given Nexavar (27.3% vs. 11.9%).
“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,” said Arndt Vogel, MD, a professor of medicine at Hannover Medical School.
“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,” Vogel added.
The incidence of severe (grade 3) and life-threatening (grade 4) adverse events was similar in patients receiving the combination therapy (57%) or Nexavar (55%). The most common serious adverse reactions associated with the combo therapy included gastrointestinal tract bleeds and fever.
IMbrave150 was the first trial to show evidence of superiority of a cancer immunotherapy regimen over standard of care treatment in patients with this particular type of cancer.
These findings were also supported by data from a systematic review and meta-analysis presented at the 2020 ASCO Virtual Scientific Program.
This analysis, which was based on data from nine clinical trials, including IMbrave150, REFLECT (NCT01761266), and CheckMate-459 (NCT02576509), suggested the Tecentriq-Avastin combo’s efficacy was superior to that of several approved therapies for inoperable HCC, including Lenvima (lenvatinib) and Opdivo (nivolumab).
Tecentriq and Avastin in combination is now approved to treat patients with inoperable HCC in 59 countries, Roche reported in its release.
Genentech is also exploring the potential of Tecentriq, both alone and in combination with other medications, to treat other types of cancers, including lung, genitourinary (urinary and male reproductive system), skin, breast, gastrointestinal, gynecological, and head and neck cancers.
