First line immunotherapy for renal cell carcinoma and head and neck cancer! Kestruda has been approved three first-line treatment indications in Japan!

December 23, 2019 / BIOON / -- cancer immunotherapy giant Merck & Co recently announced that Japan's drugs and medical devices The PMDA has approved three new first-line treatment indications of keytruda (Chinese trade name: coreida, common name: pembrolizumab, mAb) for anti PD-1 therapy: (1) first-line treatment of unresectable or metastatic renal cell carcinoma (RCC) patients combined with inlyta (axitinib); and (2) first-line treatment of recurrent or distant metastasis of head and neck cancer patients combined with chemotherapy; (3) As the first line of single drug therapy for recurrent or distant metastasis of head and neck cancer patients Up to now, keytruda has been approved for six cancer types and high microsatellite instability (MSI-H) tumors in Japan "In Japan, advanced renal cell carcinoma and head and neck cancer have always been associated with poor prognosis, and new treatment options are needed," said Dr Jonathan Cheng, vice president of oncology clinical research, mosadong research laboratory Today's approval of three new frontline keytruda programs is an important milestone for patients diagnosed with these malignancies, which will provide Japanese patients with an important alternative to standard therapy " Based on the results of the keynote-426 trial, the data showed that keytruda plus inlyta combined therapy significantly prolonged the overall survival (OS: HR = 0.53 [95% CI: 0.38-0.74], P = 0.00005) and progression free survival (PFS: HR = 0.69 [95% CI: 0.56-0.84], P = 0.00012) compared with sunitinib alone Keytruda first-line approval for recurrent or metastatic head and neck cancer is based on the results of the phase III keynote-048 trial The trial evaluated keytruda combined chemotherapy (Platinum + 5-fluorouracil [5-FU]), keytruda monotherapy, and standard therapy (cetuximab + platinum + 5-FU) for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma The results showed that keytruda combined chemotherapy significantly prolonged the overall survival compared with standard therapy (OS: HR = 0.77 [95% CI: 0.63-0.93]; P = 0.00335) As a single drug therapy, keytruda showed non inferiority compared with standard therapy (HR = 0.85 [95% CI: 0.71-1.03]; P = 0.00014) In addition, keytruda monotherapy showed a statistically significant improvement in OS in patients with tumor expression of PD-L1 (CPS ≥ 1) compared to standard therapy 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 activates T lymphocytes that may affect tumor cells and healthy cells by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 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 It is worth mentioning that at the end of November this year, keytruda was approved by China National Drug Administration (nmpa) to combine carboplatin and paclitaxel for the first-line treatment of metastatic squamous cell non-small cell lung cancer (NSCLC) 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%) Keytruda has previously been approved by nmpa for the treatment of unresectable or metastatic melanoma that failed first-line treatment Source: Merck's keytruda ® (pembrolizumab) approved in Japan for three new first line indications across advanced internal cell carcinoma (RCC) and recurrence or distance metastatic head and neck cancer