Lung cancer pound! AstraZeneca IMFINZI EU is about to be approved: first-line treatment of extensive small cell lung cancer (ES-SCLC)!

!--webeditor: "page title" - 28 July 2020 // AstraZeneca recently announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued an active review recommending approval for anti-PD-L 1 Therapy Imfinzi (Infifan, generic name: durvalumab, dofvaliu monotorthes), combined standard care (SoC) contains platinum chemotherapy (eposide-calpinor or oplyn-ciscosis-cisplatin), first-line treatment of patients with extensive small cell lung cancer (ES-SCLC).SCLC is an aggressive, fast-growing cancer that, although initially responded to with platinum-containing chemotherapy, usually recurs and progresses quickly.now, CHMP's positive comments will be reviewed by the European Commission (EC), which is expected to make a final review decision within the next two months., if approved, will provide an important first-line treatment for the ES-SCLC patient population.in the United States, Imfinzi received FDA approval at the end of March 2020 to treat adult ES-SCLC patients with platinum-containing chemotherapy (eposide-caropin or optoside-cisplatin) first-line treatment.note, Imfinzi is the only PD-1/PD-L1 immunotherapy that has been shown to provide significant survival benefits in combination with SoC platinum-containing chemotherapy (despotinite plus cisplatin or cappel.chMP's positive opinion, based on the results of the CASPIAN trial phase III.data has been published in The Lancet, a leading international medical journal.data show that fixed-dose Imfinzi and SoC platinum-containing chemotherapy were shown to show statistically significant and clinical improvements in total survival (OS) compared to standard care (SoC) chemotherapy.based on this finding, Imfinzi's joint SoC-platinum-containing chemotherapy first-line treatment ES-SCLC was the world's first batch in Singapore in February 2020 and approved in the United States and other countries.is currently under regulatory scrutiny in Japan and other countries., CASPIAN is a random, open-label, multi-center, global Phase III study that compares the efficacy and safety of IMFinzi-SoC-platinum-containing chemotherapy (deprecator-cisplatin or cap- or platinum), Imfinzi-tremelibammum-SoC-platinum-containing chemotherapy, and SoC-platinum-containing chemotherapy., the Imfinzi-tremelimumab-SoC-platinum-containing chemotherapy combination is a combination of dual immunological checkpoint blocking combined chemotherapy regimens consisting of CTLA4 checkpoint inhibitor tremelymumab (an anti-CTLA4 monotophoid), PD-L1 checkpoint inhibitor Imfinzi (an anti-PD-L1 monotag) and SoC chemotherapy.study, Imfinzi administered at a fixed dose (1500 mg), administered every three weeks, and treated 4 cycles, and patients in the experimental group received up to four cycles of SoC chemotherapy, while the control group was allowed up to six cycles of SoC chemotherapy and preventive brain radiation therapy (PCI).the study was conducted at more than 200 clinical centers in 22 countries, including the United States, Europe, South America, Asia and the Middle East. the primary endpoint of theis Total Lifetime (OS).June 2019, the CASPIAN trial reached a major endpoint: an interim analysis of a program conducted by the Independent Data Monitoring Board (IDMC) showed that the risk of death in the Imfinzi-SoC chemotherapy group was reduced by 27% compared to the SoC chemotherapy group (HR.73, 95% CI: 0.591-0.9.9 09, p-0.0047), significantly longer total lifetime (median OS: 13.0 months (11.5, 14.8) vs 10.3 months (9.3, 11.2), 18-month survival significantly increased (33.9% vs 24.7%). in addition, in terms of all efficacy endpoints, the Imfinzi-SoC chemotherapy group showed therapeutic benefits compared to the SoC chemotherapy group, including a significant increase in the survival rate of no progression at 12 months (PFS rate: 17.5% vs 4.7%), an increase in objective remission rate at 12 months (ORR: 67.9% vs 57.6%), and an increase in the proportion of patients with sustained remission (DOR 2.7%) at 12 months (DOR 2.7%). the latest analysis released at the end of May 2020, more than 2 years after the median follow-up, imfinzi-SoC chemotherapy showed ongoing efficacy, reducing the risk of sustaining death by 25% compared to SoC chemotherapy (HR-0.75; 95% CI:0.62-0.91; nominal p-0.0032). updated median OS was 12.9 months and the SoC chemotherapy group was 10.5 months. in an after-the-fact analysis, the estimated 24-month survival rate was 22.2% in the Imfinzi-SoC chemotherapy group and 14.4% in the SoC chemotherapy group. post-mortem analysis showed that the survival rate was 24 months with no progression, with 11% in the Imfinzi-SoC chemotherapy group and 2.9% in the SoC chemotherapy group. in addition, the Imfinzi-SoC chemotherapy group maintained a high objective remission rate (ORR: 68% vs 58%), and in the after-the-fact analysis, the proportion of patients with a duration of 24 months of remission was 13.5% in the Imfinzi-SoC chemotherapy group and 3.9% in the SoC chemotherapy group. at 24 months, 12% of patients in the Imfinzi-SoC chemotherapy group continued to receive Imfinzi treatment. based on this finding, Imfinzi is the first oncology immunotherapy to show survival benefits and improve lasting relief in patients with ES-SCLC. but it is worth noting that in the final analysis, the Imfinzi-tremelimumab-SoC scheme did not achieve a statistically significant improvement in OS in comparison to SoC. the study, the safety and tolerance of Imfinzi and Tremelimumab were consistent with the known safety of these drugs. lung cancer is the leading cause of cancer death in both men and women, accounting for about one-fifth of all cancer deaths. lung cancer is roughly divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which SCLC accounts for about 15%. about two-thirds of SCLC patients are diagnosed with a widespread disease, i.e. the cancer has spread widely across the lungs or to other parts of the body. SCLC is an aggressive, fast-growing cancer that, although initially responded to with platinum-containing chemotherapy, recurs and progresses quickly. prognosis was particularly poor, with only 6% of SCLC patients still surviving five years after diagnosis. !--/ewebeditor-!--." - Imfinzi (Infifan, Dofalyumono) is a human-derived PD-L1 monoclonal antibody that blocks the combination of PD-L1 with PD-1 and CD80, thereby blocking tumor immune escape and releases suppressed immune responses. So far, Imfinzi has been approved in more than 60 countries (including the United States, Japan, China, and the Entire European Union) for the non-resectionability of non-resectionability, stage III non-small cell lung cancer (NSCLC) patients who have not progressed after receiving platinum-based chemotherapy syncyleated radiation. , Imfinzi has been approved in more than 10 countries, including the United States, for advanced bladder cancer patients who have previously received platinum-containing chemotherapy. as part of a broad development of lung cancer, Imfinzi is also being tested in another Phase III clinical study, ADRIATIC, in which the Evaluation Board receives Imfinzi treatment after simultaneous chemotherapy (CCRT) in patients with SCLC, which is expected to be available by 2021. tremelimumab is a human monoclonal antibody that targets cytotoxic T lymphocyte antigen 4 (CTLA-4), blocks the activity of CTLA-4, promotes T-cell activation, initiates tumor immune response, and promotes cancer cell death. tremelimumab with the antibody drug Yervoy (Ipitu monoanti) targeted with the same target CTLA-4. currently, AstraZeneca is currently conducting a major clinical project to evaluate Imfinzi as a monodrug therapy and a combination of tremelimab and its drug for the treatment of NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary cancer and other solid tumors. () Original origin: Imfinzi ardford in the EU by CHMP for the range-stage small cell cell cancer !--/ewebeditor: page.