Lung cancer! AstraZeneca Imfinzi (Infyfan) is approved by the U.S. FDA for first-line treatment of wide-stage small cell lung cancer (ES-SCLC)!

March 30 , 2020 /PRNewswire
BIOON/ -- AstraZeneca recently announced that the U.S Food and Drug Administration (
FDA ) has approved the anti-PD-L1 therapy Imfinzi (Infyin) Van, generic name: durvalumab, duvalliu monoantigen), Combined Standard Care (SoC) containing platinum chemotherapy (eposide etoside and cisplatin or caplon), first-line treatment of a wide range of small cell lung cancer (ES-SCLC) adult patients SCLC is an invasive, fast-growing cancer that, although initially responding to platinum-containing chemotherapy, can quickly recur and progress This approval will provide an important first-line treatment for ES-SCLC patients It is worth mentioning that Imfinzi is the only PD-1/PD-L1 immunotherapy that has been confirmed to provide significant survival benefits in combination with SoC-containing platinum chemotherapy (eposide etosides and cisplatin or caplatinum) this approval is based on positive data for the PHASE III CASPIAN test The results showed that the combination of fixed-dose Imfinzi and SoC-containing platinum chemotherapy showed statistically significant and clinical improvements in total survival (OS) compared to standard nursing (SoC) platinum-containing chemotherapy Based on the findings, Imfinzi's joint SoC first-line treatment of platinum chemotherapy ES-SCLC was first obtained in Singapore in February 2020 and is currently under regulatory review in the European Union and Japan "The u.S FDA approve of Imfinzi, bringing a new drug to the urgently selected COMMUNITY of ES-SCLC patients," said Dave Fredrickon, executive vice president of oncology at AstraZeneca Imfinzi is the only immunotherapy that is combined with chemotherapy to significantly improve patient survival and remission, representing a significant advance in the treatment of this devastating disease "
CASPIAN is a random, open label, multi-center, global Phase III study that compares the efficacy and safety of imfinzi-SoC-containing platinum chemotherapy (eposide-cisplatin or ca-platinum), Imfinzi-tremelimumab-SoC-with-platinum chemotherapy, soC-based chemotherapy first-line treatment sylhoines of ES-SCLC patients Among them, the Imfinzi-tremelimumab-SoC-containing platinum chemotherapy combination is a dual-immune checkpoint blocking combination chemotherapy program consisting of CTLA4 checkpoint inhibitor tremelimumab (an anti-CTLA4 monoantigen), PD-L1 checkpoint inhibitor Imfinzi (an anti-PD-L1 monoantigen) and SoC chemotherapy In the study, Imfinzi was given a fixed dose (1500 mg), administered every three weeks, treated for 4 cycles, and patients in the experimental group received up to 4 cycles of SoC chemotherapy, while the control group allowed up to 6 cycles of SoC chemotherapy and preventive brain radiation therapy (PCI) The study was conducted in more than 200 clinical centers in 22 countries, including the United States, Europe, South America, Asia and the Middle East The primary endpoint is total lifetime (OS) In June 2019, the CASPIAN trial reached a major end: a mid-term analysis of a program conducted by the Independent Data Monitoring Committee (IDMC) showed that the risk of
death in the Imfinzi-SoC chemotherapy group was reduced by 27% compared to the SoC chemotherapy group (HR-0.73,95% CI: 0.591-0.909), the , the total survival of the significantly extended (median OS: 13.0 months (11.5, 14.8) v 10.3 months (9.3, 11.2) , 18 months survival rate increased significantly (33.9% v 24.7%) In addition, in all end-of-the-terms, the Imfinzi-SoC chemotherapy group showed therapeutic benefits compared to the SoC chemotherapy group, including a significant increase in progression-free survival rate at 12 months of (PFS rate: 17.5% v 4.7%) Increased objective remission rate identified at 12 months (ORR: 67.9% v 57.6%) increased in the proportion of patients with and 12-month remission (DOR): 22.7% v 6.3%) In this study, the safety and tolerance of the Imfinzi-SoC chemotherapy regimen was consistent with previous studies In the Imfinzi-SoC treatment group, 61.5 percent of patients had a level 3 or 4 adverse event, 62.4 percent in the SoC chemotherapy group, and a similar proportion of patients in the 2 group who were discontinued for adverse events (9.4 percent v 9.4 percent) based on the results of the study, Imfinzi is the first tumor immunotherapy in PATIENTs with ES-SCLC that show survival benefits and improves long-lasting remission but it is worth noting that in the final analysis, the Imfinzi-tremelimumab-SoC solution did not reach the main endpoint of a statistically significant improvement in OS compared to SoC In the study, the safety and tolerance of Imfinzi and tremelimumab were consistent with the known safety of these drugs The figures will be presented at the upcoming medical conference 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 widespread disease, i.e the cancer has spread widely throughout the lungs or to other parts of the body SCLC is an aggressive, fast-growing cancer that relapses and progresses rapidly, despite initial reactions to platinum-containing chemotherapy The prognosis was particularly poor, with only 6% of SCLC patients surviving five years after diagnosis Imfinzi (Infyfan, Duvaliu monoantigen) is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 with PD-1 and CD80, thus blocking the immune escape of tumor
and releasing the suppressed immune response To date, Imfinzi has been approved in more than 60 countries (including the United States, Japan, China, and the European Union as a whole) for treatment of non-reprecyibility of non-rectructive, stage III non-small cell lung cancer (NSCLC) patients who have not developed disease progressonomes after platinum-based chemotherapy synchrotron radiotherapy In addition, Imfinzi has been approved in more than 10 countries, including the United States, for advanced bladder cancer patients who have received chemotherapy containing platinum Just recently, based on data from the Phase III CASPIAN trial, Imfinzi's Joint Standard Care (SoC) chemotherapy first-line treatment for wide-term non-small cell lung cancer (ES-SCLC) received the world's first regulatory approval in Singapore The application for the indications is also currently under review by EU and Japanese regulators As part of a broader development of lung cancer, Imfinzi is also being tested in another Phase III clinical study, ADRIATIC, where the ACLC patients received simultaneous chemotherapy (CCRT) for simultaneous chemotherapy (CCRT), which is expected to be available in 2021 tremelimumab is a 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 and Persimmon Squibb have been targeted by the same target CTLA-4 for the antibody drug Yervoy (Ipitano) , AstraZeneca is currently conducting a large clinical project to evaluate The treatment of Imfinzi as a combination of single-drug therapy and combined tremelimab and its drugs for NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer
, cervical cancer, bile duct cancer and other solid tumors (biovalleybioon.com) original source: Imfinzi approved in the US for extenive-tage cell lung cancer