"Optimized Edition" Herceptin! FC optimized immune-enhanced antibody margetuximab treatment of stomach cancer is strong, and then Ding medicine was introduced into China for development!

!--webeditor: "page title" - - July 11, 2020 /PRNewswire/ -- Reding Pharmaceutical Partners MacroGenics recently announced the evaluation of HER2 target antibody margetuximab in conjunction with Mercaiton anti-PD-1 therapy Keytruda (Coreda, generic name: pembrozumali b, Paboli zumas) as a chemotherapy-free treatment of HER2-positive patients with advanced gastroesophageal adenocarcinoma (GEA) in the efficacy and safety of a Phase II study (CP-MGAH22-0, NCT02689284) has been published in Lancet Oncologythis is a single-arm, open-label, Ib/II dose increment and cohort expansion study conducted in patients with local late-stage non-resectionability or metastatic HER2-positive gastric cancer who have previously been treated with at least quatrline torituzumab (trastuzumab) plus chemotherapypatients in the group were patients with gastric cancer (GC) or gastroesophageal junction (GEJ) cancer, whose tumors were IHC3-positive or IHC2-FISH positive at the time of diagnosis, regardless of PD-L1 expression, which was subsequently identified in available archived tumor tissuepublished data as of July 10, 201992 patients treated with margetuximab at the recommended stage II dose (every 3 weeks, 15 mg/kg) were able to perform a performance evaluationmedian follow-up for 19.9 months, the objective remission rate (ORR) was 18% (17/92) in the overall population, with partial remission plus total remission (PR-CR) and disease control (DCR) at 53% (49/92, CR-PR-stabilized disease (SD) )median progression-free survival (PFS) was 2.7 months (95% CI: 1.6-4.3) and median total lifetime (OS) was 12.5 months (95% CI:9.1-14.1)the study, the activity of margetuximab and Keytruda was more pronounced in the key biomarker-positive subgroupthe most significant benefits ofwere observed in patients with HIGH HER2 high expression (HER2 IHC3 positive) and PD-L1 positive at diagnosisin this dual-positive subgroup, the ORR was 44% (11/25), the DCR was 72% (18/25), the PFS median was 4.8 months (95% CI: 1.6-13.9), and the OS median was 20.5 months (95% CI:8.1-NR)patients with initial LY2-positive GEA may lose herta2 expression after treatment for quatelseuzumabin the second-line treatment study, 42% of patients with circulating tumor DNA (ctDNA) did not detect HER2amp, indicating the absence of HER2 prior to treatment with qural monitavirus, margetuximab and Keytrudain this study, the presence of HER2amp in ctDNA was associated with higher remission rates60% (9/15) or 80% (12/15) of her2amp-positive/HER2 IHC3-IHC3-L1-positive patientsconsistent with previous studies of margetuximab in other tumor types, which showed that the associated analysis of patient samples treated with GEA showed increased immunity against HER2-specific T-cells, indicating the potential for participation in congenital and adaptive immune responsesstudies, the tolerance of margetuximab and Keytruda was acceptable 20% of patients developed adverse events (TRAE) associated with grade 3 treatment, the most common of which were anemia (4%) and infusion-related reactions (3%) No treatment-related deaths have been reported the above results show that these data in the second-line patients with quordmal monotomare resistance provide a theoretical basis for the ongoing Phase II/III MAHOGANY clinical trial (NCT04082364) MAHOGANY study is evaluating margetuximab joint immunological checkpoint inhibitors, combination or non-co-chemotherapy, first-line treatment of HER2-positive gastric cancer (GC) or gastroesophageal junction cancer (GEJC) patients, the study is being conducted by MacroGenics and Reding Pharmaceuticals in a number of clinical centers around the world, re-Ding Pharmaceuticals will conduct clinical development of the product in China "Currently, the standard of treatment for patients with metastatic gastroesophageal adenocarcinoma (GEA) relies heavily on cytotoxic chemotherapy," said Stephen Eck, Senior Vice President and Chief Medical Officer, macroGenics Clinical Development, published data suggest that a chemotherapy-free regimen combined with margetuximab's immune enhancement properties and checkpoint-blocking may improve clinical outcomes in some patients with metastatic HER2-positive gastric esophageal adenocarcinoma and provide a strong theoretical basis for the ongoing PHASE II/III MAHOGANY study "gastric cancer (GC) or gastroesophageal junction cancer (GEJC) collectively known as gastroesophageal adenocarcinoma (GEA), is the fifth most common type of cancer in the world and the second most common type of cancer in China most GC and GEJC patients are late at the time of diagnosis, so the prognosis is poor, with a 5-year survival rate of 5-20% chemotherapy is the standard treatment for first-line treatment, and HER2-positive patients can use chemotherapy and queratonomedratox, which accounts for about 20% the end of November 2018, ZLAB and MacroGenics entered into a broad strategic cooperation agreement, obtaining exclusive licenses for the development and commercialization of three immunothatology products in Chinese mainland, Hong Kong, Macau and Taiwan margetuximab is a Fc-optimized monotorinis that targets human epidermal growth factor receptor 2 (HER2) HER2 is expressed in breast cancer, gastroesophageal cancer and other solid tumors margetuximab is designed to provide HER2 blocking effects and has a HER2 binding and anti-proliferation effect similar to quercetmal monotortonyl !--/ewebeditor:!--webeditor: !--webeditor: page title" - In addition, margetuximab has been engineered to increase the involvement of its immune system through MacroGenics Fc optimization technology, and to increase the lethality of cancer cells through antibody-dependent cell-mediated cytotoxicity (ADCC) in addition to gastroesophageal adenocarcinoma, margetuximab is also being developed and used in combination with chemotherapy to treat metastatic HER2-positive breast cancer patients who have previously received treatment with anti-HER2 targeted therapy December 2019, MacroGenics submitted to the FDA a Bioproduct License Application (BLA) for patients with metastatic HER2-positive breast cancer under the joint chemotherapy program, which is under FDA review and has a target date for the Prescription Drug User Charges Act (PDUFA) on December 18, 2020 June, the FDA also granted margetuximab the right to treat gastric and gastroesophageal cancers () Original source: MacroGenics Science Lancet Oncology Publication of Margetuximab Data in Gastric Cancer !--/ewebeditor: page.