Esophageal cancer (ESCC) immunotherapy! Permian Opdivo (Odivo) was approved by the U.S. FDA: No matter how PD-L1 significantly extends the lifetime!
Last Update: 2020-06-16
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June 10, 2020 /PRNewswire/ -- BMS has announced that the U.SFood and Drug Administration (FDA) has approved the anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, navuliu monotomareactor) a new indication that is used to treat patients with non-resectionable, late, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone chemotherapy based on fluorium and platinumIn particular, Opdivo was approved as the first tumor immunotherapy for use in the above-mentioned ESCC patient population regardless of PD-L1 expression levelThe indications application was previously granted priority review by the FDAClinical data show that Opdivo extends total survival compared to chemotherapy, and the benefit does not depend on PD-L1 expressionThe prognosis of patients with late esophageal squamous cell carcinoma is poor and treatment options are very limitedThis approval will provide ESCC patients with an important second-line treatment option, extending survival while improving the quality of lifeThe approval is based on the results of Phase III ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242)The data showed that Opdivo showed better total survival (OS) results than the researchers' choice of doscel alcohol or yew alcohol (HR-0.77; 95% CI: 0.62-0.96; p-0.0189)The median OS in the methane chemotherapy group was 8.4 months (95% CI: 7.2-9.9), while the median OS in the Opdivo treatment group reached 10.9 months (95% CI: 9.2-13.3), regardless of PD-L1 expression level"Many cases of esophageal cancer are diagnosed at the advanced stage, when the disease can have a significant impact on the health of patients," said Adam Lenkowsky, general manager and director of oncology, immunology, cardiology and cardiovascular in The U.SOnce the condition worsens in patients with advanced esophageal squamous cell carcinoma, treatment options are very limitedThe Opdivo approval will provide a new treatment for patients with advanced esophageal squamous cell carcinoma, regardless of PD-L1 expression levelsThis reflects our commitment to providing new options to meet the unmet medical needs of our patients and giving us a better understanding of the full potential of immunotherapy for the treatment of gastrointestinal tumors"ATTRACTION-3 is a multicenter, random, open-label, global study conducted in patients with non-recitability late or recurrent ESCC who are difficult to treat or tolerate in combination with first-line fluorine and platinum drugs, evaluating the efficacy and safety of Opivoivo relative to chemotherapy (doxisisel or yewalcohol)The patient stake occurred mainly in Asia, where up to 96% of patients in the two treatment groups were from AsiaIn the study, the patient was treated until the disease worsened or was not acceptable lying toxic The primary endpoint of the study was Total Lifetime (OS), and the secondary endpoint included total remission rate (ORR), progression-free survival (PFS), disease control rate (DCR), mitigation duration (DOR), and safety The study was sponsored by Ono Pharma, an Opdivo partner of Baxter The results showed that the study reached the main endpoint of OS: compared to the chemotherapy group, the Opdivo treatment group OS showed a statistically significant improvement and a 23% reduction in the risk of death (HR-0.77, 95% CI:0.62-0.96, p-0 .0189), median OS extension of 2.5 months (10.9 months (95% CI: 9.2-13.3) vs 8.4 months (95% CI: 7.2-9.9) The 12-month and 18-month survival rates (OS rates) in the Opdivo treatment group were 47% (95% CI:40-54) and 31% (95% CI:24-37), and the chemotherapy group was 34% (95% CI:28-41) and 21% (95% CI:15-27), respectively Opdivo's survival benefits were observed regardless of tumor PD-L1 expression levels An exploratory analysis of patient reporting results showed a significant overall improvement in the quality of life of patients treated with Opdivo compared to chemotherapy In terms of ORR, the Opdivo treatment group and the chemotherapy group were 19% (95% CI:14-26) and 22% (95% CI:15-29), respectively However, the study showed that Opdivo significantly extended the duration of moderate remission compared to chemotherapy (DOR: 6.9 months (95% CI: 5.4-11.1) vs 3.9 months (95% CI: 2.8-4.2) At the end of the data, 7 patients in the Opdivo treatment group remained in remission and the chemotherapy group had 2 patients In terms of progression-free survival (PFS), there was no significant difference between the Opdivo treatment group and the chemotherapy group (HR.08 .95% CI: 0.87-1.34) In this study, opdivo's safety was consistent with previous studies in ESCC and other solid tumors Compared to chemotherapy, Opdivo treats fewer adverse events (TRAE) than chemotherapy, with a 60% incidence of TREA at any level in Opdivo patients and 95% of chemotherapy patients The Opdivo treatment group had a lower incidence of TREA at level 3 or 4 compared to chemotherapy groups (18% vs 63%), and the same proportion of patients in 2 groups who experienced TREA leading to discontinuation (9%) Esophageal cancer is the seventh most common cancer in the world and the sixth leading cause of death from cancer Patients diagnosed with metastatic disease had a five-year relative survival rate of 8% or less The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for about 90% and 10% of all esophageal cancers It is estimated that 572,000 new cases are diagnosed each year and about 500,000 die from esophageal cancer Most cases are diagnosed with advanced disease seiswho, which should affect the daily life of the patient, including dietary ability Asia has the highest prevalence of esophageal cancer, with 444,000 cases diagnosed each year, accounting for 80 per cent of cases of esophageal cancer worldwide It is worth mentioning that at the end of July 2019, The keytruda (Coreida, generic name: pembrolizumab, Pabolizumab) was approved by the U.S FDA to treat PD-L1-positive esophageal squamous Cell carcinoma (ESCC) patients, specifically: a FDA-approved test to determine tumor expression PD-L1 (combined positive score (CPS) s.10), recurrent, locally advanced or metastatic ESCC patients who have undergone one or more system therapy Keytruda is the first anti-PD-1 treatment approved for the treatment of patients with recurrent locally advanced or metastatic ESCC (Tumor Expression PD-L1, CPS-10) The approval is based on data from two clinical studies, KEYNOTE-181 (NCT02564263) and KEYNOTE-180 (NCT02559687) Data from the KEYNOTE-181 study showed that in patients with ESCC tumor expression PD-L1 (CPS-10), Keytruda treated patients with improved OS (median OS: 10.3 months 5% CI: 7.0-13.5" vs 6.7 months (95% CI: 4.8-8.6; HR 0.64 )95% CI: 0.46-0.90) Data from the KEYNOTE-180 study showed that in 35 patients with ESCC patients with tumor expression PD-L1 (CPS-10), the ORR was 20% (95% CI: 8.0, 37.0) In 7 patients with remission, dOR ranged from 4.2 months to 25.1 months, 71% of patients (5 cases) DOR was 6 months, and 57% of patients (3) DOR was 12 months (BioValley Bioon.com) Original source: U.S Food and Drug Administration approves s Opdivo ® (nivolumab) for treatment of the patient s with The Squamous Cell Carinoma (ESCC) After Supor Fluopyrimidine-and Platinum-George-Calum-George-Calum-George-Calum
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