Tecentriq is a monoclonal antibody designed to bind with PD-L1 protein that is expressed on tumour cells and tumour-infiltrating immune cells, restricting its interactions with both PD-1 and B7.1 receptors. Tecentriq may facilitate the activation of T-cells by inhibiting PD-L1.
The Chinese approval was based on data from the 403-patient Phase III IMpower133 study, which demonstrated that Tecentriq plus chemotherapy helped people significantly longer compared against chemotherapy alone.
The combined therapy also significantly minimised the risk of disease worsening or death compared against chemotherapy alone.
Roche’s IMpower133 is a phase III, multicentre, double-blinded and randomised placebo-controlled trial designed to assess the efficacy and safety of Tecentriq plus chemotherapy against chemotherapy alone in chemotherapy-naïve adults with ES-SCLC.
Last month, China NMPA also accepted the supplemental Biologics License Application (sBLA) for Tecentriq plus Avastin (bevacizumab) to treat people with unresectable hepatocellular carcinoma (HCC).
The sBLA was submitted based on data from the Phase III IMbrave150 study that achieved both of its co-primary endpoints, including OS and PFS.
Roche global product development head and chief medical officer Dr Levi Garraway said: “Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now.
“This approval makes Tecentriq the first cancer immunotherapy available in China for the initial treatment of extensive-stage small cell lung cancer less than a year after the US FDA and EMA approvals, marking a swift and important step forward for patients with this aggressive and difficult-to-treat disease.”
In January this year, Roche announced that Tecentriq failed to meet its primary endpoint in phase III muscle-invasive urothelial cancer (MIUC) trail.
Tecentriq is being assessed in an extensive development programme, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers.
The programme includes trials assessing Tecentriq in both alone, as well as in combination with other medicines.