Esophageal cancer immunotherapy! Opdivo (Odivo) was approved in Taiwan, China, and, regardless of PD-L1 status, significantly extends its lifetime!

esophageal cancer (photo: medindia.net)June 07, 2020 /Bio ValleyBIOON / - Japanese drugmaker Ono Pharma recently announced that its Taiwan subsidiary Ono Pharma Taiwan (OPTW) has received the Taiwan Food and Drug Administration (T
FDA) Additional indication approval for opdivo (Chinese-based immunotherapy foroncology: Odivo, generic name: Navuliu monotomatogen, nivolumab): Non-removable late or recurrent esophageal squamous cell carcinoma (ESCC) for the progression of the condition after fluorium and platinum-containing chemotherapyOno Pharmaceuticals, the original developer of Opdivo, a partnership with BMS in 2011 to grant the development and commercialization rights of Persimmon's Opdivo in addition to Japan, South Korea and TaiwanIn July 2014, the two sides further expanded their strategic cooperation to develop and commercialize a variety of immunotherapy (including monodrug and combination therapies) for cancer patients in Japan, Korea, and TaiwanFebruary, BMS announced that Opdivo had been approved in Japan for patients with end-of-recital or recurrent esophageal cancer who are progressing after chemotherapyThe approval is also the first in Opdivo's treatment of advanced esophageal cancerIn clinical studies, Opdivo significantly extended survival and improved overall quality of life compared to chemotherapy, regardless of PD-L1 expressionThe drug will provide an important second-line treatment for patients with advanced esophageal cancerthis approval is based on the results of Phase III attraction-3Clinical Trial sandals(ONO-4538-24/CA209-473; NCT02569242)This multicenter, random, open-label, global study was conducted in patients with non-recitable advanced or recurrent squamous cell carcinoma (ESCC) who are difficult to treat or intolerance to a combination of first-line fluorine and platinum drugs, evaluating the efficacy and safety of Opdivo relative to chemotherapy (doselitethine or yewol) The patient stake occurred mainly in Asia, where up to 96% of patients in the two treatment groups were from Asia In 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 Persimmon AndonPharmaceutical data show 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- 0.019), 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) Opdivo treatment group and chemotherapy group 12 monthsurvival rate (OS rate) was 47% (95% CI:40-54), 34% (95% CI:28-41), and 18-month survival rate (OS rate) was 31% (95% CI:24-37), 21% (95% CI:15-27), respectively Opdivo's survival benefits were observed regardless of the level of PD-L1 expression in tumor 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 orR, the Opdivo treatment group and the chemotherapy group were 19% (95% CI: 14-26) and 22% (95% CI:15-29), respectively However, studies have shown 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) the safety of Opdivo 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 The five-year relative survival rate of patients diagnosed metastatic disease in was 8% or less The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, accounting for 90% and 10% of all esophageal cancer cases, respectively Globally, it is estimated that 572,000 new cases are diagnosed each year and about 500,000 people die from esophageal cancer Most cases are diagnosed with advanced disease, which affects 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 In Taiwan, China, about 2,600 new cases of esophageal cancer are confirmed and 1,700 deaths are confirmed each year in the field of esophageal cancer immunotherapy, at the end of July 2019, Mercado's anti-PD-1 therapy Keytruda (Coreida, generic name: pemlizumab, Pabolizumab) was approved by the U.S FDA to treat Patients with PD-L1-positive esophageal squamous cell cancer (ESCC) as a FDA approved tests to determine patients with tumor expression PD-L1 (combined positive score (CPS) s.10), recurrence, local late or metastatic ESCC who have progression of the disease after receiving one or more system therapies 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) this 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 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 (BioValleyBioon.com) original origin: Opdivo (Nivolumab) Fusion Infusion app roved for The Siou Sious Cell Carinoma of The Squamous Cell Carinoma of The Cancer in Taiwan