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

October 23, 2019 / BIOON / -- cancer immunotherapy giant Merck& CO) recently announced that the European Drug Administration (EMA) Committee on human medicinal products (CHMP) has issued a positive review opinion, recommending and approving two schemes of keytruda (Coretta, common name: pembrolizumab, pabolizumab), the first-line treatment for 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 expression of PD-L1 (with positive score [CPS] ≥ 1) Currently, CHMP's recommendations will be reviewed by the European Commission (EC), and a final decision is expected in the fourth quarter of 2019 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 The positive opinion of CHMP is based on the data of keynote-048 (nct02358031), a key phase III clinical study 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 and combined chemotherapy, significantly prolonged OS in patients with CPS ≥ 1 compared with 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 The positive opinion of CHMP further confirms the potential of keytruda as a monotherapy and combination chemotherapy, which is expected to help patients and solve the high unmet medical needs in this invasive head and neck cancer " 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 MSD has the largest clinical development project of immunooncology in HNSCC field, and is continuing to promote a number of registered studies, using keytruda as a single therapy, and combining with other cancer treatment drugs, including keynote-412 and keynote-689 research Original source: Merck receives positive EU CHMP operation for two new regions of keytruda ® (pembrolizumab) as first line treatment for metastatic or unexpected recurrent head and neck squares cell carcinoma