Immunotherapy for stage III lung cancer! AstraZeneca PD-L1 tumor immunotherapy imfinzi US label update, 3-year survival rate 57%

July 23, 2019 / BIOON / - AstraZeneca, a British pharmaceutical giant, recently announced that the US Food and Drug Administration (FDA) has approved the treatment of PD-L1 tumor The U.S prescription information of patients with unresectable stage III non-small cell lung cancer (NSCLC) who did not progress after receiving concurrent radiotherapy and chemotherapy (CRT) with platinum containing regimen was updated by immunotherapy imfinzi (durvalumab), and included in the total survival time (OS) data of stage III clinical study Pacific The label update is based on a two-year OS analysis published in the New England Journal of medicine in September 2018, which showed that patients treated with imfinzi after CRT had significant and clinically proven OS benefits compared with those treated with placebo, regardless of the expression of PD-L1: imfinzi reduced the risk of death by 32% compared with placebo (HR = 0.68, 95% CI: 0.53-0.87; P= 0.0025）。 In a three-year follow-up post hoc OS analysis published at the ASCO annual meeting in 2019, the results of imfinzi were consistent with the data at the two-year time point, showing that imfinzi reduced the risk of death by 31% compared with placebo (HR = 0.69, 95% CI: 0.55-0.86) After three years of follow-up, 57% (95% CI: 52.3-61.4) of the patients in the imfinzi treatment group were still alive, and the median OS was not yet reached 44% (95% CI: 37.0-49.9) of the patients in the placebo group were still alive, and the median OS was 29.1 months According to the results of phase III clinical study Pacific, imfinzi has been approved by more than 45 countries, such as the United States, the European Union, Japan, etc., for the treatment of unresectable phase III NSCLC Since it was first approved in February 2018, more than 20000 patients have been treated with imfinzi Imfinzi is recommended as the only post CRT consolidation immunotherapy for unresectable stage III NSCLC patients in the NCCN guidelines Imfinzi may cause serious and potentially fatal adverse events (AE) In the previous two years of OS analysis, the most common adverse reactions (≥ 20%) in patients treated with imfinzi and placebo were cough (35.2% vs 25.2%), fatigue (24.0% vs 20.5%), dyspnea (22.3% vs 23.9%) and radiation pneumonia (20.2% vs 15.8%) 30.5% of the patients in the imfinzi treatment group had grade 3 or grade 4 adverse events, 15.4% stopped treatment due to adverse events, and 26.1% and 9.8% in the placebo group, respectively NSCLC in stage III (local advanced stage) is usually divided into three subclasses (IIIA, IIIB, IIIc), which are defined by the extent of tumor local spread and the possibility of surgery Stage III is different from stage IV, in which cancer has spread (metastasized) to distant organs, and the current stage III treatment is aimed at curing It is estimated that stage III NSCLC accounts for about one third of NSCLC Most of the patients with stage III NSCLC were diagnosed as non resectable tumor The former standard treatment was chemotherapy and radiotherapy (CRT), and then actively monitored the progress of the disease But the prognosis of this disease is not ideal, and the long-term survival rate is very low It is worth mentioning that imfinzi is the only tumor immunotherapy approved for the treatment of stage III NSCLC patients after radiotherapy and chemotherapy (CRT) Imfinzi is a kind of PD-L1 immunotherapy, targeting to combine with programmed cell death factor ligand 1 (PD-L1), blocking the interaction of PD-L1 with PD-1 and CD80, antagonizing the immune escape strategy of tumor and releasing the inhibition of immune response At present, AstraZeneca is carrying out a large-scale clinical project, in which part of the research is evaluating the single drug therapy of imfinzi and the combination therapy of tremelimumab for the first-line treatment of solid tumors such as NSCLC, small cell lung cancer, locally advanced or metastatic urothelial cancer, head and neck cancer Original source: imfinzi ® (durvalumab) us label updated with overall survival data in unexpected, stage III non small cell lung cancer