China's non resectable stage III non-small cell lung cancer ushers in a new era of immunotherapy! Imfinzi, the AstraZeneca PD-L1 inhibitor, was approved!

December 13, 2019 / BIOON / -- AstraZeneca AstraZeneca recently announced that China's National Drug Administration (nmpa) has officially approved durvalumab, the PD-L1 immunosuppressant, for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) patients who have not developed disease progression after receiving platinum based chemotherapy combined with radiotherapy The approval is based on the primary analysis of PFS by Pacific, a phase III clinical trial, and supported by OS data, which has been published in the New England Journal of Medicine (NEJM) The results of Pacific clinical trials showed that the use of duvalizumab injection immunotherapy after concurrent radiotherapy and chemotherapy reduced the risk of death in patients with stage III non-small cell lung cancer by nearly 32%, the median progression free survival (PFS) was 16.8 months, and the total 3-year survival rate (OS) was 57% Dulithumab injection is the first and only PD-L1 immunosuppressant approved for the treatment of stage III lung cancer in mainland China This approval marks a new era of immunotherapy for stage III non-small cell lung cancer in China Mr Wang Lei, global executive vice president of AstraZeneca and President of international business and China, said: "I would like to thank the State Drug Administration and relevant departments for their high attention to the unmet treatment needs of lung cancer patients and the access to innovative treatment methods The approval of duvalizumab injection for marketing is of great significance, which brings more hope to patients with stage III non-small cell lung cancer It also enables AstraZeneca to better fulfill its commitment of "rooting in China, serving China", benefit more Chinese lung cancer patients, and help to achieve the goal of "healthy China 2030" Clinical trials in Pacific Among the patients with stage III non resectable non-small cell lung cancer, no matter the expression state of PD-L1 after platinum based concurrent radiotherapy and chemotherapy, compared with the placebo group, the consolidation treatment with duvalizumab injection showed statistically and clinically significant changes in PFS and OS Goodness Duvalizumab reduced the risk of death by 32% (HR 0.68) and prolonged the median progression free survival by more than 11 months (median progression free survival: 16.8 months vs 5.6 months, HR 0.52) Professor Wu Yilong, life-long director of Guangdong Provincial People's Hospital, said: "the most critical indicator of tumor treatment measures is whether it can make patients survive for a long time, or even clinical cure Stage III lung cancer is a stage with hope of cure, and the emergence of immunotherapy gives more patients a chance of clinical cure The PACIFIC study enrolled patients with stage III non-small cell lung cancer who had not progressed and could not be resected after receiving concurrent radiotherapy and chemotherapy, and compared the efficacy of PD-L1 inhibitor duvaliumab injection with placebo for consolidation treatment The newly published 3-year survival rate has reached 57%, and the 5-year survival rate is expected to exceed 50% It can be said that duvalizumab injection has changed the treatment mode of stage III non-small cell lung cancer, which is a revolutionary breakthrough " Among the patients treated with duvalizumab injection, the most common adverse reactions (incidence equal to or higher than 20%) included cough, fatigue, pneumonia or radiation pneumonia, upper respiratory tract infection, dyspnea and rash 29% of the patients treated with duvalizumab had serious adverse reactions, and 15% of the patients stopped treatment because of adverse reactions In October 2019, the three-year survival rate data of Pacific clinical trial was published in Journal of theoretical oncology Duvalizumab injection showed long-term effectiveness as before Professor Wu Yilong said: "in NCCN guidelines, duvalizumab injection immunotherapy after concurrent radiotherapy and chemotherapy is listed as the standard treatment plan for stage III lung cancer Duvalizumab injection is the only immunotherapy drug approved for non resectable stage III non-small cell lung cancer patients and used after concurrent radiotherapy and chemotherapy It is hoped that duvalizumab injection will bring more patients with stage III lung cancer in China with the hope of coming to bed for cure after being launched in China " Based on the clinical trial data of Pacific, duvalizumab injection has been approved by 54 countries and regions in the world for the treatment of unresectable stage III non-small cell lung cancer patients with clinical cure hope, including the United States, Japan and Europe The Pacific model of dovalizumab injection after radiotherapy and chemotherapy is a globally recognized standard treatment for stage III non-small cell lung cancer Stage III NSCLC is usually divided into three types: IIIA, IIIB and IIIc according to the scope of local metastasis and the possibility of surgery Different from stage IV lung cancer, stage III lung cancer has the possibility of clinical cure Most patients with stage III NSCLC cannot be operated on when they are diagnosed In the past few decades, the treatment of stage III non-small cell lung cancer is very limited, which is generally based on synchronous radiotherapy and chemotherapy, followed by close monitoring of the disease process Imfinzi is a human monoclonal antibody against PD-L1, which can block the binding of PD-L1 with PD-1 and CD80, thus blocking tumor immune escape and releasing the inhibited immune response Enfant has been approved for the treatment of advanced bladder cancer in 11 countries and regions including the United States As a part of the new drug research and development project, yingfeifan is currently exploring the treatment prospects in the fields of non-small cell lung cancer, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, cervical cancer, bile duct cancer and other solid tumors in the form of single drug or combination of CTLA-4 antibody tremelimumab and other new drugs Original source: AstraZeneca