China's second PD-L1 therapy! Tecentriq of Roche was approved to treat extensive small cell lung cancer (es-sclc) with first-line chemotherapy

February 15, 2020 / bioun / -- Roche recently announced that China's National Drug Administration (nmpa) has approved the combination of chemotherapy (carboplatin + etoposide) and chemotherapy (atezolizumab, atzumab) for the treatment of patients with extensive small cell lung cancer (es-sclc) It is worth mentioning that tecentriq is the second PD-L1 drug approved in China after the approval of AstraZeneca anti PD-L1 therapy imfinzi (yingfeifan, general name: durvalumab, duvalizumab) by the State Food and Drug Administration on December 10, 2019 In addition to 6 PD-1 drugs, 8 PD-1 / L1 drugs are currently on the market in China In the United States and the European Union, tecentriq was approved for the above indications in March 2019 and September 2019, respectively Tecentriq combined chemotherapy (carboplatin + etoposide) is the first and only cancer immunocombination therapy approved for early treatment of es-sclc, which has significantly improved the overall survival (OS) and progression free survival (PFS) for the first time in more than 20 years Dr Levi Garraway, Roche's chief medical officer and head of global product development, said: "small cell lung cancer is an important area of unmet demand in China, with limited progress so far Within less than a year after the approval of FDA and EMA, tecentriq has become the first cancer immunotherapy in China that can be used for the initial treatment of extensive small cell lung cancer, marking a rapid and important step forward for patients with this aggressive and refractory disease " Lung cancer is the most common cancer in China and the main cause of cancer death In general, small cell lung cancer (SCLC) accounts for about 15% of all lung cancer cases Two thirds of them are diagnosed in the "extensive" stage, and the prognosis of this disease is poor The mean five-year survival rate of patients with es-sclc was only 2% This approval is based on the results of the phase III impower 133 study This study showed that in the intention to treat (ITT) population, tecentriq + chemotherapy significantly prolonged the overall survival compared with chemotherapy alone (median OS: 12.3 months vs 10.3 months; HR = 0.70, 95% CI: 0.54-0.91, P = 0.0069) In addition, compared with chemotherapy, tecentriq + chemotherapy significantly reduced the risk of disease progression or death by 23% (median PFS: 5.2 months vs 4.3 months, HR = 0.77, 95% CI: 0.62-0.96, P = 0.017) Follow up analysis showed that at the 18th month, the OS rate of patients receiving tecentriq + chemotherapy was 34%, while that of the chemotherapy group was 21% In this study, the safety of tecentriq combined with chemotherapy was consistent with that of the known tecentriq It is worth mentioning that this is the first clinically significant progress in the first-line treatment of es-sclc in more than 20 years In China, nmpa also accepted tecentreq's SBLA in January 2020: tecentreq combined with Avastin (Avastin, general name: Bevacizumab) for the treatment of unresectable liver cancer (HCC) patients who have not received systematic therapy before, which is the most common type of liver cancer The application is based on the results of the phase III imbrave150 study The data shows that compared with the current standard nursing drug sorafenib (sorafenib), tecentriq + Avastin regimen has a statistically significant and clinically significant improvement in total survival (OS) and progression free survival (PFS) Worldwide, more than 750000 people are diagnosed with HCC every year, which is the most common type of liver cancer Most cases occur in Asia, and almost half cases occur in China In addition, the incidence rate of liver cancer is increasing in Europe and the United States The number of liver cancer cases in the United States has increased more than two times since 1980 Tecentriq belongs to PD - (L) 1 tumor immunotherapy It aims to bind to a protein named PD-L1 expressed on tumor cells and tumor infiltrating immune cells, and block its interaction with PD-1 and B7.1 receptors By inhibiting PD-1, tecentriq can activate T cells, which has the potential to be used as a basic combination therapy for cancer immunotherapy, targeted drugs and various cancer chemotherapy Up to now, tecentriq has been approved in the United States, the European Union and other countries in the world as a single drug therapy, as well as combined targeted therapy and / or chemotherapy, to treat various types of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), some types of metastatic urothelial cancer (MUC), PD-L1 positive triple negative breast cancer (TNBC) Roche has developed a wide range of development plans for tecentriq, including a number of ongoing and planned phase III studies involving various types of lung cancer, urogenital cancer, skin cancer, breast cancer, gastrointestinal cancer, gynecological cancer and head and neck cancer This includes studies of tecentriq alone or in combination with other drugs Source: China National Medical Products Administration grants approval of Roche 's Tecentriq in combination with chemotherapy as first-line treatment of people with extension stage small cell including cancer