Lung cancer immunotherapy breakthrough! Roche tecentriq's first line treatment of extensive small cell lung cancer (es-sclc) is approved by the European Union soon

July 28, 2019 / BIOON / -- Roche, a Swiss pharmaceutical giant, recently announced that the European Drug Administration (EMA) human pharmaceutical products Committee (CHMP) has issued positive review opinions and recommended approval of PD-L1 tumors Immunotherapy tecentriq (atezolizumab) combined with chemotherapy (carboplatin + etoposide) was used for the first-line treatment of adult patients with extensive small cell lung cancer (es-sclc) Now, CHMP's review comments will be submitted to the European Commission (EC), which will refer to CHMP's comments and make a final review decision within the next 2-3 months In the United States, the FDA approved the indications in March this year This approval makes tecentriq combined chemotherapy (carboplatin + etoposide) the first and only cancer immunotherapy approved for early treatment of es-sclc, and also the first new first-line treatment scheme approved by FDA for es-sclc patients in the past 20 years The positive review opinion of CHMP is based on the results of phase III clinical study impower 133 This study showed that compared with chemotherapy, tecentriq + chemotherapy significantly prolonged the overall survival time (median OS: 12.3 months vs 10.3 months; HR = 0.70, 95% CI: 0.54-0.91, P = 0.0069), and significantly improved the one-year OS survival rate (51.7% vs 38.2%) 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), and doubled the annual PFS rate (12.6% vs 5.4%) It is worth mentioning that this study is the first phase III clinical study to confirm that the first-line treatment of es-slcl based on cancer immunotherapy can significantly improve OS and PFS In this study, the safety of tecentriq combined with chemotherapy was consistent with that of the known tecentriq Sandra horning, Roche's chief medical officer and head of global product development, said, "we are pleased to receive CHMP's positive review of our tecentriq based lung cancer combination treatment program Tecentriq combined chemotherapy may solve the high unmet medical needs in this kind of invasive lung cancer In this kind of lung cancer, it is difficult to improve OS " According to the World Health Organization (who), lung cancer is the leading cause of cancer death in the world It causes nearly 1.8 million deaths every year, which means more than 4800 people die every day There are two main types of lung cancer, non-small cell lung cancer (NSCLC) and SCLC Among them, SCLC accounts for about 15% of lung cancer cases, and most patients (70%) are diagnosed as "extensive stage", which usually means poor prognosis SCLC is an aggressive disease that is often not detected until the cancer progresses to the advanced stage Chemotherapy (combined with or without radiotherapy) has always been the standard first-line care plan However, most patients relapse within one year Different from other lung cancer subtypes, SCLC is characterized by invasive, rapid growth and early occurrence of metastatic diseases Tecentriq is a monoclonal antibody that targets a protein called PD-L1 expressed on tumor cells and tumor infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors Tecentriq can activate T cells by inhibiting PD-L1 Tecentriq has the potential to be a basic combination therapy for cancer immunotherapy, targeted drugs and various cancer chemotherapy programs In lung cancer, Roche is conducting a number of phase III studies to evaluate tecentriq as a single drug therapy or combination therapy with other drugs 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) Small cell lung cancer (SCLC) is an increasingly competitive treatment area In June this year, keytruda (Coretta, common name: pembrolizumab, pabolizumab) was approved by the US FDA as a single drug therapy for patients with advanced small cell lung cancer (SCLC) during or after chemotherapy with platinum and at least one other previous treatment This approval also marks keytruda's first indication in SCLC In addition, AstraZeneca announced at the end of June this year that Caspian, a phase III clinical study for the first-line treatment of extensive small cell lung cancer (es-sclc) with imfinzi (durvalumab), a PD-L1 tumor immunotherapy, reached the main end point of overall survival (OS) ahead of schedule Original source: CHMP recommendations EU approval of Roche's tecentriq in combination with chemotherapy as an initial treatment of results with extended stage small cell lung cancer