Roche's PD-L1 Inhibitor Tecentriq Approved in China for Small Cell Lung Cancer

On February 12, the National Medical Products Administration (NMPA) approved Roche’s marketing application for atezolizumab (Tecentriq) for the treatment of small cell lung cancer (SCLC), and the approval document has been issued. This marks the second PD-L1 monoclonal antibody approved for market entry in China, following AstraZeneca’s Imfinzi.

The results of the Phase III IMpower133 study in patients with small-cell lung cancer showed that, in the intent-to-treat (ITT) population, Tecentriq combined with chemotherapy significantly prolonged overall survival (OS) compared with chemotherapy alone (12.3 vs. 10.3 months). Additionally, the combination regimen significantly reduced the risk of disease progression or death compared with chemotherapy alone (progression-free survival [PFS]: 5.2 vs. 4.3 months; hazard ratio [HR] = 0.77, 95% confidence interval [CI]: 0.62–0.96; P = 0.017). The safety profile of Tecentriq in combination with chemotherapy was consistent with the known safety profile of Tecentriq.

Tecentriq in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) was approved by the FDA on March 19, 2019, and by the European Union on September 6, 2019. Currently, in addition to small cell lung cancer, Tecentriq has been approved for the indications of urothelial carcinoma, non-small cell lung cancer, and triple-negative breast cancer. In 2019, Tecentriq generated sales of CHF 1.875 billion.

Lung cancer is the most common type of cancer globally. In 2018, there were 2.1 million newly diagnosed cases of lung cancer worldwide, resulting in 1.8 million deaths. Lung cancer is primarily classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). SCLC accounts for approximately 15% of all lung cancer cases, and about 70% of SCLC patients are diagnosed at the "extensive stage," which typically indicates a poor prognosis. Compared to other lung cancer subtypes, SCLC is more aggressive, grows rapidly, and metastasizes earlier.

Currently, eight PD-1 (PD-L1) inhibitors have been approved for marketing in China. Among them, AstraZeneca’s Imfinzi was approved in China on December 9, 2019, for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) that has not progressed following concurrent chemoradiotherapy.

Note: The original text has been abridged.