Immunotherapy for lung cancer in China! Keysruda (coreda) was approved for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) combined with chemotherapy!

November 27, 2019 / BIOON / -- cancer immunotherapy giant Merck& CO) recently announced that keytruda (Chinese trade name: coreida, common name: pembrolizumab, pabolizumab) has been approved by the National Drug Administration of China (nmpa), and combined with carboplatin and paclitaxel for the first-line treatment of metastatic squamous cell non-small cell lung cancer (NSCLC) This new indication was fully approved based on the overall survival (OS) results of the key phase III keynote-407 trial, including extended interim data in Chinese patients It is worth mentioning that this approval is also keytruda's third first-line approval in NSCLC treatment in less than a year Now, the drug is the first anti PD-1 therapy approved by China for the first-line treatment of squamous and non squamous NSCLC combined with chemotherapy, and single drug treatment of NSCLC (tumor proportion score [TPS] ≥ 1%) Professor Cheng Ying, President of Jilin Cancer Hospital, said: "in the keynote-407 study, keytruda combined chemotherapy significantly improved the overall and progression free survival of patients with metastatic squamous non-small cell lung cancer Lung cancer is the leading cause of cancer deaths in China, so this approval is an important milestone for patients and families facing this difficult disease to treat " Keynote-407 is a randomized, double-blind, placebo-controlled study conducted in 560 patients with previously untreated (primary) metastatic squamous NSCLC Keytruda was evaluated in combination with chemotherapy (carboplatin + paclitaxel or albumin binding paclitaxel) and compared with chemotherapy (carboplatin + paclitaxel or albumin binding paclitaxel) alone Data from a pre-determined interim analysis showed that keytruda combined chemotherapy resulted in a statistically significant improvement in overall survival (OS) and progression free survival (PFS) compared to chemotherapy Specifically, keytruda combined chemotherapy significantly prolonged OS and reduced the risk of death by 36% compared with chemotherapy (median OS: 15.9 months vs 11.3 months, HR = 0.64 [95% CI: 0.49-0.85], P < 0.0017) In addition, keytruda combined chemotherapy significantly prolonged PFS and reduced the risk of disease progression or death by 44% (median PFS: 6.4 months vs 4.8 months, HR = 0.56 [95% CI: 0.45-0.70], P < 0.0001) Exploratory analysis showed that keytruda combined with chemotherapy showed OS and PFS benefits compared with chemotherapy, regardless of the expression level of PD-L1 Extended study data in Chinese patients showed that keytruda combined chemotherapy reduced the risk of death by 56% (HR = 0.44 [95% CI: 0.24-0.81]) compared with chemotherapy The expanded study in China also showed improvement in PFS Keytruda combined chemotherapy reduced the risk of disease progression or death by 68% (HR = 0.32 [95% CI: 0.21-0.49]) compared with chemotherapy Other findings from the keynote-407 China extension study were recently presented at the ESMO Asia 2019 conference Dr Jonathan Cheng, vice president of oncology clinical research, Merck Research Laboratory, said: "this approval has expanded our current lung cancer indications in China, including keytruda combined chemotherapy for patients with squamous cell carcinoma, which is a particularly difficult lung cancer to treat It is important that keytruda provides the basis for lung cancer treatment in China, and now more non-small cell lung cancer patients have the opportunity to benefit from keytruda combination therapy " "In less than a year, we have obtained three first-line approvals for keytruda combined chemotherapy or monotherapy for non-small cell lung cancer," said Joseph Romanelli, President of MSD China Keytruda combined chemotherapy or as a single drug treatment has been proved to have significant survival benefits compared with chemotherapy We will continue to work closely with external stakeholders to bring this important treatment option to patients " Lung cancer is the main cause of cancer death in China and even in the world It is formed in lung tissue, usually in cells in the airway Every year, there are more than 787000 newly diagnosed lung cancer cases and 631000 deaths in China The two main types of lung cancer are non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) NSCLC is the most common type of lung cancer, accounting for about 85% of all cases NSCLC has many subtypes, including adenocarcinoma (40% of lung cancer), squamous cell carcinoma (25% - 30%) and large cell carcinoma (10% - 15%) 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 Merck's keytruda ® (pembrolizumab) now approved in China for first line treatment of metastatic squares non small cell lung cancer (NSCLC) in combination with chemotherapy