The regulatory approval indicated Tecentriq plus chemotherapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in China
Roche’s monoclonal antibody for lung cancer, Tecentriq is approved in China. (Credit: F. Hoffmann-La Roche Ltd.)
Swiss healthcare company Roche has obtained the China National Medical Products Administration (NMPA) approval for Tecentriq (atezolizumab) in combination with chemotherapy to treat a type of lung cancer.
The regulatory approval indicated the drug, in combination with chemotherapy (carboplatin and etoposide) for the treatment of extensive-stage small-cell lung cancer (ES-SCLC) in China.
Roche chief medical officer and global product development head 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.”
Tecentriq is a monoclonal antibody that binds with PD-L1, a protein expressed on tumour cells and tumour-infiltrating immune cells, to block its interactions with both PD-1 and B7.1 receptors.
The drug is believed to activate T-cells by inhibiting PD-L1, and is used as cancer immunotherapy in combination with other immunotherapies, targeted medicines and chemotherapies to address a broad range of cancers.
Tecentriq in combination with chemotherapy was evaluated in the IMpower133 clinical trial
According to the company, lung cancer is the most common type of cancers, and SCLC accounts for approximately 15% of all diagnosed lung cancer cases.
In addition, the results from IMpower133, a Phase III, multicentre, double-blinded, randomised placebo-controlled study of Tecentriq, has supported the regulatory approval in China.
The IMpower133 trial has evaluated the efficacy and safety of Tecentriq in combination with chemotherapy, compared to chemotherapy that included carboplatin and etoposide alone, in chemotherapy-naïve adults with ES-SCLC.
The study results showed that Tecentriq plus chemotherapy offered significantly longer life in patients, and has also reduced the risk of disease progression or death, compared to chemotherapy alone. The drug and chemotherapy combination showed consistent safety with the known safety profile.
Furthermore, the company said that it intends to conduct multiple clinical trials across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers, including studies evaluating Tecentriq in combination with other medicines and alone.