Good news! Keysruda is the third indication approved by China for the treatment of PD-L1 positive lung cancer!

October 8, 2019 / BIOON / -- cancer immunotherapy giant Merck& CO) recently announced that China National Drug Administration (nmpa) has approved keytruda (pembrolizumab, general name: pembrolizumab) as a single drug therapy for first-line treatment of non-small cell lung cancer (NSCLC) Specifically, a nmpa approved test method has been adopted to confirm the expression of PD-L1 (tumor proportion score [TPS] ≥ 1%) Local advanced or metastatic NSCLC without EGFR or ALK genomic aberrations This new indication was fully approved based on the overall survival (OS) results of the phase III keynote-042 study, including the region wide extended data from patients in China It is worth mentioning that Keytruda is now the first anti PD-1 therapy approved in China, which can be used as single drug therapy and combined chemotherapy in the first line treatment of NSCLC patients This approval is also the third indication approved by keytruda in China The two previously approved indications are: (1) for the treatment of unresectable or metastatic melanoma that fails in the first-line treatment; (2) for the first-line treatment of metastatic non squamous non-small cell lung cancer that is EGFR gene mutation negative and alk negative, combined with pemetrexed and platinum chemotherapy Keynote-042 is an international, randomized, multicenter, open label, positive drug control test for NSCLC patients with stage III, metastatic NSCLC, tumor expression PD-L1 (TPS ≥ 1%) who are not suitable for surgical resection or radical radiotherapy and chemotherapy and who have not received systematic treatment before In the expansion of the global study on Chinese patients, the results showed that keytruda single drug therapy significantly improved OS compared with chemotherapy: TPS ≥ 50% (HR = 0.62 [95% CI: 038-1.00]), TPS ≥ 20% (HR = 0.62 [95% CI: 0.41-0.95]), and TPS ≥ 1% (HR = 0.65 [95% CI: 0.45-0.94]), respectively The results from the keynote-042 Chinese extended study were recently first published at the IASLC 2019 world lung cancer conference sponsored by the International Lung Cancer Research Association, and showed consistent results among Chinese patients Dr Jonathan Cheng, deputy director of cancer research center of moshadong research laboratory, said: "keytruda is the first anti-PD-1 therapy approved in China that can be used as a single drug therapy or combined with chemotherapy as a first-line treatment for advanced non-small cell lung cancer patients Keytruda monotherapy is an important new treatment for patients who do not want to be treated in combination It shows a significant improvement in survival outcomes " "In China, we launched keytruda a year ago and have had an impact on patient care in the approved indications," said Joseph Romanelli, President of MSD (China) Co., Ltd Now keytruda has approved a third indication in China, and we look forward to providing an additional effective treatment option for non-small cell lung cancer patients with PD-L1 level ≥ 1% in China " Current situation of lung cancer in China: lung cancer is the main cause of cancer death in China and even in the world 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%) Merck's keytruda? (pembrolizumab) now approved as monthly in China for first line treatment of certain patients with advanced non small cell lung cancer (NSCLC) who tumors express PD-L1