Welcome the 2nd PD-L1 in China! First line treatment of small cell lung cancer approved by Roche tecentriq

On February 13, 2020, the State Food and Drug Administration officially approved the Roche PD-L1 monoclonal antibody tecentriq (atezolizumab, atelizumab) The specific indications are: tecentriq combined with chemotherapy is used for the first-line treatment of extensive stage small cell lung cancer (SCLC) It is worth noting that the combination chemotherapy of atizumab is the first in the world, and the only tumor immunotherapy approved for the first-line treatment of extensive small cell lung cancer in China at present Atizumab is the second PD-L1 tumor immunotherapy approved by China after imfinzi (durvalumab) of AstraZeneca 2020 02, 13, the issue of drug approval notice: Source: China National Drug Administration SCLC new line of treatment standard new lung cancer is the highest incidence rate and mortality rate in China In recent years, lung cancer incidence in China has shown a rapid growth trend Lung cancer can be divided into NSCLC and SCLC according to the pathological type, and SCLC accounts for about 15% of lung cancer The prognosis of SCLC patients is very poor, 2 / 3 of patients have reached the extensive stage at the initial diagnosis, that is, the disease has been found at the time of far-end organ or lymph node metastasis, the 5-year average survival rate after diagnosis is only 2% At present, chemotherapy is a common clinical treatment for extensive SCLC, but only 20% of patients with extensive SCLC will have complete remission of symptoms after treatment, and often have drug resistance again soon, with a very low 5-year survival rate Therefore, there are a lot of unmet treatment needs in the field of SCLC, and patients with SCLC also need more effective innovative treatment programs Atizumab is the first innovative drug that has been proved to bring significant benefits to patients with SCLC for more than 30 years It is understood that this approval is based on the results of impower 133, a landmark study of immunotherapy for extensive SCLC Impower133 is a global multicenter three-phase clinical trial A total of 403 patients with extensive SCLC were randomly divided into two groups The efficacy and safety of combination chemotherapy with atelizumab and chemotherapy alone were compared According to this study, compared with chemotherapy, the combination of atizumab and chemotherapy can significantly prolong the total survival period of patients with SCLC, and reduce the risk of death of patients in this study by 30% Specifically, the combination chemotherapy of atizumab can significantly reduce the risk of disease deterioration and death (PFS = 5.2 vs 4.3 months; HR = 0.77, 95% CI: 0.62-0.96; P = 0.017) At the same time, the study suggests that the combination chemotherapy of atizumab can bring lasting benefits to patients with SCLC During the 13.9-month follow-up, the proportion of patients with sustained remission in the experimental group was three times higher than that in the chemotherapy group (15% vs.5%) The study of impower133 is the first significant breakthrough in the first-line treatment of extensive SCLC in 30 years The combination chemotherapy of atelizumab has replaced the traditional first-line chemotherapy and become the new first-line treatment standard of extensive SCLC The new driving force for Roche's global performance growth in May 2016, atizumab was first approved by the US FDA for the second-line treatment of bladder cancer; in October 2016, it was approved by the FDA for the treatment of metastatic NSCLC In December 2018, atizumab combined with bevacizumab, paclitaxel and carboplatin was approved by FDA for the treatment of metastatic non squamous NSCLC patients without EGFR or ALK gene mutation; in March 2019, it was approved for the first-line treatment of SCLC and Sanyin breast cancer, and tecentriq is the only tumor immunotherapy approved for TNBC at present With the development of more indications, the market performance of atelizumab is more and more outstanding Recently, Roche announced its financial report for 2019, achieving annual sales of CHF 61.46 billion (about USD 63.45 billion), a year-on-year growth of 9% at a fixed exchange rate The pharmaceutical business increased by 11% year on year to CHF 48.51 billion, while the diagnostic business also increased by 3%, with sales reaching CHF 12.95 billion In terms of drugs, avidin, Herceptin and rituximab are still the three carriages to drive performance However, as the competition for bio similar drugs intensifies, the growth of overall performance is more from other newly listed drugs Among them, atilizumab's performance was amazing, with sales of CHF 1875 million in 2019, a year-on-year increase of 143% At present, atizumab is carrying out a number of clinical applications in China, involving a variety of indications such as non-small cell lung cancer, triple negative breast cancer, melanoma, esophageal squamous cell carcinoma, and liver cell carcinoma It is believed that there is still a large room for the growth of atizumab in the future Photo source of some clinical trials of atizumab in China: drug clinical registration and information publicity platform