Avastin and Tecentriq combination wins approval in China and Europe

GlobalData Healthcare 10 November 2020 (Last Updated November 10th, 2020 10:07)

Avastin and Tecentriq combination wins approval in China and Europe

On 29 October, Roche’s combination of Avastin (bevacizumab), a vascular endothelial growth factor (VEGF) inhibitor, and Tecentriq (atezolizumab), a programmed death-ligand 1 (PD-L1), received approval from the China National Medical Products Administration (NMPA) as a first-line treatment for advanced hepatocellular carcinoma (HCC). Soon after, on 2 November, the combination was approved by the European Commission for the same use. It followed quickly after a 17 September recommendation by the Committee for Medicinal Products for Human Use (CHMP). Recent approvals for Avastin plus Tecentriq mark the availability of the combination across US, Europe, Japan, and China.

Earlier this year, on 29 May, Roche announced the first approval of Avastin and Tecentriq for first-line advanced HCC by the Food and Drug Administration (FDA), and a few months later, Chugai Pharmaceutical, a subsidiary controlled by Roche, announced the approval of Avastin and Tecentriq by the Ministry of Health, Labour and Welfare (MHLW) in Japan on 25 September. GlobalData interviewed KOLs from five major European pharmaceutical markets (5EU: France, Germany, Italy, Spain, and the UK) and China who believed that the majority of patients would receive Avastin plus Tecentriq in the first-line setting, except for patients with a contraindication to either drug such as a high risk of bleeding or an autoimmune condition. The superiority of the combination over Nexavar (sorafenib), the current standard of care (SoC), was based on the results of the Phase III IMbrave150 study of patients with unresectable or metastatic HCC. In this study, the 12-month overall survival rate was 67.2% in the Avastin plus Tecentriq group compared with 54.6% in the Nexavar group. While median overall survival was not reached in this study, median progression-free survival increased from 4.3 months in the Nexavar group to 6.8 months in patients treated with Avastin plus Tecentriq.

Prior to approval of Roche’s combination of VEGF and PD-L1 inhibitors, the key strategy for first-line treatment of advanced HCC was multikinase inhibitors (TKIs), including Bayer’s Nexavar, which was approved in 2007 in Europe and 2008 in China, and Eisai’s Lenvima (lenvatinib), which was approved in 2018 in Europe and China. The approval of Avastin plus Tecentriq not only changed the SoC for HCC but also shifted the focus of R&D toward combination therapies. As a result, GlobalData expects the combination to change the HCC market landscape by capturing a dominant share of the market.