First line immunotherapy for head and neck cancer! Two schemes of kestruda were approved by the European Union to treat PD-L1 positive patients

November 21, 2019 / BIOON / -- cancer immunotherapy giant Merck& CO) recently announced that the European Commission (EC) has approved two schemes of keytruda (Coretta, common name: pembrolizumab, pabolizumab) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC), specifically as a single drug therapy or combined with a common chemotherapy (Platinum + 5-fluorouracil [5-FU]) for tumor table Patients with PD-L1 (with positive score [CPS] ≥ 1) It is worth mentioning that keytruda is the first anti-PD-1 therapy approved by the European Union, which can be used as single drug therapy or combination therapy for the first-line treatment of head and neck cancer with tumor expression of PD-L1 (CPS ≥ 1) In the United States, keytruda was approved by the FDA in June this year for two new indications, first-line treatment for patients with metastatic or unresectable recurrent HNSCC, specifically: (1) as a single drug therapy, for patients with tumor expression of PD-L1 (with positive score [CPS] ≥ 1); (2) combined with a common chemotherapy program (Platinum + 5-fluorouracil [5-FU]), regardless of patients' tumor What is the status of PD-L1 expression This approval makes keytruda the first approved anti-PD-1 therapy for patients with metastatic or unresectable recurrent HNSCC, and the first anti-PD-1 therapy to significantly improve overall survival (OS) in such patients This approval is based on data from key phase III clinical study keynote-048 (nct02358031) This is a randomized, open label study designed to evaluate the efficacy and safety of keytruda as a single drug therapy or combined with platinum (cisplatin or carboplatin) and 5-fluorouracil chemotherapy compared with the current HNSCC first-line treatment standard care regimen, extreme (Erbitux [cetuximab, cetuximab] + platinum [cisplatin or carboplatin] + 5-fluorouracil combination therapy) The results showed that keytruda, as a single drug therapy (HR = 0.74 [95% CI: 0.61-0.90], P = 0.00133) and combined chemotherapy (HR = 0.65 [95% CI: 0.53-0.80], P = 0.00002), significantly prolonged the total survival time (OS) compared with the first-line standard treatment (extreme) "Head and neck cancer is still a devastating disease with poor long-term prognosis, and it's difficult to improve the survival rate in more than 10 years," said Dr Jonathan Cheng, vice president of clinical research, moshadong research laboratory Keytruda is now the first anti-PD-1 treatment for metastatic or recurrent head and neck cancer, which will help patients and solve the high unmet medical needs in this invasive cancer This EU approval underscores our commitment to change the way cancer is treated around the world " Keytruda belongs to PD - (L) 1 tumor immunotherapy, which helps detect and fight against tumor cells by improving the ability of human immune system Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thus activating T lymphocytes that may affect tumor cells and healthy cells So far, a number of PD - (L) 1 tumor immunotherapies have been approved worldwide, among which keytruda is the leader in this field and has approved more than 20 treatment indications MSD has the largest clinical development project in immunooncology in the industry At present, more than 1000 clinical trials are investigating the role of keytruda in various types of tumors and treatment backgrounds The keytruda clinical project aims to understand the role of the drug in cancer and factors that may predict patients' benefits from keytruda treatment, including exploring several different biomarkers Original source: European Commission Approves Two New Regimens of Merck 's KEYTRUDA? (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and nek square hills cell carillona (hNSC)